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Triple Vita Drops with Fluoride PDF Print E-mail
Written by Ruai Pharmaceuticals   
Monday, 28 November 2011 08:49

Triple Vita Drops with Fluoride


Triple Vita Drops with Fluoride Drug Description


Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride)

DRUG DESCRIPTION

Each 1.0 mL supplies: Percentage of U. S. Recommended Daily Allowance
Infants Children Under Age 4 Years
Vitamin A, 1500 IU 100 60
Vitamin D, 400 IU 100 100
Vitamin C, 35 mg 100 88
Fluoride, 0.25 mg * *

* U. S. Recommended Daily Allowance has not been established.

Active ingredient for caries prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride.

Inactive Ingredients: Caramel Color, NF; Edetate Disodium, USP; Fruit (Natural & Artificial) Flavor; Glycerin, USP; Methylparaben, NF; Polysorbate 80, NF; Propylene Glycol, USP; Propylparaben, NF; Purified Water, USP; Sodium Benzoate, NF and Sodium Hydroxide, NE. May also contain Hydrochloric Acid, NF.

 

Triple Vita Drops with Fluoride


Triple Vita Drops with Fluoride Indications & Dosage


INDICATIONS

Triple Vita Drops with Fluoride 0.25 mg may be useful for infants whose diets are lacking in vitamins A, D and C.

Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) also provide fluoride for caries prophylaxis. Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) (vitamins A, D, C and fluoride supplement) were developed to provide fluoride in drop form for infants and young children from birth to 2 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride; and for children ages 2-3 years in areas where the drinking water contains 0.3 through 0.7 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus three basic vitamins.

DOSAGE AND ADMINISTRATION

1.0 mL daily, or as prescribed by the physician. May be dropped directly into mouth with the enclosed dropper, or mixed with cereal, fruit juice or other food.

USE FULL DOSAGE.

HOW SUPPLIED

Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) (vitamins A, D, C and fluoride) are available in bottles of 1 2/3 fl oz (50 mL).

RECOMMENDED STORAGE: Store at controlled room temperature, 15° -30° C (59° -86 °F). After opening, store away from direct light. REFRIGERATION IS NOT REQUIRED.

CAUTION: Federal law prohibits dispensing without prescription.

 

Triple Vita Drops with Fluoride


Triple Vita Drops with Fluoride Side Effects & Drug Interactions


SIDE EFFECTS

Allergic rash and other idiosyncrasies have been rarely reported.

DRUG INTERACTIONS

No information provided.

 

 

Triple Vita Drops with Fluoride


 

Triple Vita Drops with Fluoride Warnings & Precautions


WARNINGS

As in the case of all medications, keep out of the reach of children.

PRECAUTIONS

The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) , the physician should:

1. Determine the fluoride content of the drinking water.

2. Make sure the child is not receiving significant amounts of fluoride from other medications

3. Periodically check to make sure that the child does not develop significant dental fluorosis.

Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) should be dispensed in the original container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50- mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)

 

Triple Vita Drops with Fluoride


Triple Vita Drops with Fluoride Overdosage & Contraindications


OVERDOSE

No information provided.

CONTRAINDICATIONS

See WARNINGS and PRECAUTIONS.

 

Triple Vita Drops with Fluoride


 

Triple Vita Drops with Fluoride Clinical Pharmacology


CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries- resistant crystal, fluorapatite.

Three stages of fluoride deposition in tooth enamel can be distinguished:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.

3. After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and smaller amounts from saliva.

Triple Vita Drops with Fluoride


Triple Vita Drops with Fluoride Medication Guide


PATIENT INFORMATION

See WARNINGS and PRECAUTIONS.

Last Updated on Tuesday, 27 December 2011 15:45
 
Trimethoprim PDF Print E-mail
Written by Ruai Pharmaceuticals   
Monday, 28 November 2011 08:46

Trimethoprim


Trimethoprim Drug Description


TRIMETHOPRIM
(trimethoprim (trimethoprim (trimethoprim tablet) tablet) ) Tablet

DRUG DESCRIPTION

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) is a synthetic antibacterial available as 100 mg tablets for oral administration.

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) is 2,4-Diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It is a white to cream colored, odorless, bitter compound. The structural formula is represented below:

 

Trimethoprim Structural Formula Illustration

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) Tablets USP, 100 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate and stearic acid.

 

What are the precautions when taking trimethoprim tablet (Trimethoprim)?

Before taking trimethoprim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of anemia (due to folate deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, vitamin deficiency (folate or folic acid), diabetes, blood disorders (e.g., bone marrow suppression, G6PD deficiency).

This medication may make you more sensitive to the sun....

 

Trimethoprim


Trimethoprim Indications & Dosage


INDICATIONS

For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichiacoli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species and coagulase-negative Staphylococcus species, including S. saprophyticus.

Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to trimethoprim (trimethoprim (trimethoprim tablet) tablet) . Therapy may be initiated prior to obtaining the results of these tests.

DOSAGE AND ADMINISTRATION

The usual oral adult dosage is 100 mg of trimethoprim every 12 hours or 200 mg trimethoprim (trimethoprim (trimethoprim tablet) tablet) (two 100 mg tablets) every 24 hours, each for 10 days. The use of trimethoprim (trimethoprim (trimethoprim tablet) tablet) in patients with a creatinine clearance of less than 15 mL/min is not recommended.

For patients with a creatinine clearance of 15 to 30 mL/min, the dose should be 50 mg every 12 hours.

HOW SUPPLIED

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) Tablets USP, 100 mg are scored, oval-shaped, white tablets imprinted DAN DAN and 5571 supplied in bottles of 100.

Dispense in a tight, light-resistant container with child-resistant closure.

Store at 20°-25°C (68°-77°F) in a dry place. [See USP controlled room temperature.]

Watson Laboratories, Inc., Corona, CA 92880, USA. Revised: June 2006. FDA rev date: 5/1/2002

 

Trimethoprim


Trimethoprim Side Effects & Drug Interactions


SIDE EFFECTS

The adverse effects encountered most often with trimethoprim (trimethoprim (trimethoprim tablet) tablet) were rash and pruritus.

Dermatologic

Rash, pruritus, and phototoxic skin eruptions. At the recommended dosage regimens of 100 mg b.i.d. or 200 mg q.d. each for 10 days, the incidence of rash is 2.9% to 6.7%. In clinical studies which employed high doses of trimethoprim (trimethoprim (trimethoprim tablet) tablet) , an elevated incidence of rash was noted. These rashes were maculopapular, morbilliform, pruritic, and generally mild to moderate, appearing 7 to 14 days after the initiation of therapy.

Hypersensitivity

Rare reports of exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell Syndrome), and anaphylaxis have been received.

Gastrointestinal

Epigastric distress, nausea, vomiting, and glossitis. Elevation of serum transaminase and bilirubin has been noted, but the significance of this finding is unknown. Cholestatic jaundice has been rarely reported.

Hematologic

Thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia, and methemoglobinemia.

Metabolic

Hyperkalemia, hyponatremia.

Neurologic

Aseptic meningitis has been rarely reported.

Miscellaneous

Fever, and increases in BUN and serum creatinine levels.

DRUG INTERACTIONS

Trimethoprim may inhibit the hepatic metabolism of phenytoin. Trimethoprim (trimethoprim (trimethoprim tablet) tablet) , given at a common clinical dosage, increased the phenytoin half-life by 51% and decreased the phenytoin metabolic clearance rate by 30%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect.

Drug/Laboratory Test Interactions

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) can interfere with a serum methotrexate assay as determined by the Competitive Binding Protein Technique (CBPA) when a bacterial dihydrofolate reductase is used as the binding protein. No interference occurs, however, if methotrexate is measured by a radioimmunoassay (RIA). The presence of trimethoprim (trimethoprim (trimethoprim tablet) tablet) may also interfere with the Jaffé alkaline picrate reaction assay for creatinine resulting in over estimations of about 10% in the range of normal values.

 

Trimethoprim


 

Trimethoprim Warnings & Precautions


WARNINGS

Serious hypersensitivity reactions have been reported rarely in patients on trimethoprim (trimethoprim (trimethoprim tablet) tablet) therapy. Trimethoprim (trimethoprim (trimethoprim tablet) tablet) has been reported rarely to interfere with hematopoiesis, especially when administered in large doses and/or for prolonged periods.

The presence of clinical signs such as sore throat, fever, pallor or purpura may be early indications of serious blood disorders (see OVERDOSAGE: Chronic). Complete blood counts should be obtained if any of these signs are noted in a patient receiving trimethoprim (trimethoprim (trimethoprim tablet) tablet) and the drug discontinued if a significant reduction in the count of any formed blood element is found.

PRECAUTIONS

General

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) should be given with caution to patients with possible folate deficiency. Folates may be administered concomitantly without interfering with the antibacterial action of trimethoprim.

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) should also be given with caution to patients with impaired renal or hepatic function (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals to evaluate carcinogenic potential have not been conducted with trimethoprim.

Mutagenesis

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) was demonstrated to be nonmutagenic in the Ames assay. In studies at two laboratories, no chromosomal damage was detected in cultured Chinese hamster ovary cells at concentrations approximately 500 times human plasma levels; at concentrations approximately 1000 times human plasma levels in these same cells, a low level of chromosomal damage was induced at one of the laboratories. No chromosomal abnormalities were observed in cultured human leukocytes at concentrations of trimethoprim (trimethoprim (trimethoprim tablet) tablet) up to 20 times human steady-state plasma levels. No chromosomal effects were detected in peripheral lymphocytes of human subjects receiving 320 mg of trimethoprim (trimethoprim (trimethoprim tablet) tablet) in combination with up to 1600 mg of sulfamethoxazole per day for as long as 112 weeks.

Impairment of Fertility

No adverse effects on fertility or general reproductive performance were observed in rats given trimethoprim (trimethoprim (trimethoprim tablet) tablet) in oral dosages as high as 70 mg/kg/day for males and 14 mg/kg/day for females.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Trimethoprim (trimethoprim (trimethoprim tablet) tablet) has been shown to be teratogenic in the rat when given in doses 40 times the human dose. In some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with doses six times the human therapeutic dose.

While there are no large, well-controlled studies on the use of trimethoprim (trimethoprim (trimethoprim tablet) tablet) in pregnant women, Brumfitt and Pursell,3 in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or trimethoprim (trimethoprim (trimethoprim tablet) tablet) in combination with sulfamethoxazole. The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving trimethoprim (trimethoprim (trimethoprim tablet) tablet) and sulfamethoxazole. There were no abnormalities in the 10 children whose mothers received the drug during the first trimester. In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received trimethoprim (trimethoprim (trimethoprim tablet) tablet) and sulfamethoxazole at the time of conception or shortly thereafter.

Because trimethoprim may interfere with folic acid metabolism, trimethoprim (trimethoprim (trimethoprim tablet) tablet) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

The oral administration of trimethoprim (trimethoprim (trimethoprim tablet) tablet) to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival.

Nursing Mothers

Trimethoprim is excreted in human milk. Because trimethoprim (trimethoprim (trimethoprim tablet) tablet) may interfere with folic acid metabolism, caution should be exercised when trimethoprim (trimethoprim (trimethoprim tablet) tablet) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 months have not been established. The effectiveness of trimethoprim (trimethoprim (trimethoprim tablet) tablet) as a single agent has not been established in pediatric patients under 12 years of age.

Geriatric Use

Clinical studies of trimethoprim (trimethoprim (trimethoprim tablet) tablet) tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience4,5 has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Case reports of hyperkalemia in elderly patients receiving trimethoprim-sulfamethoxazole have been published.6 Trimethoprim (trimethoprim (trimethoprim tablet) tablet) is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor potassium concentrations and to monitor renal function by calculating creatinine clearance.

REFERENCES

3. Brumfitt W, Pursell R. Trimethoprim (trimethoprim (trimethoprim tablet) tablet) -sulfamethoxazole in the treatment of bacteriuria in women. J Infect Dis. 1973; 128 (suppl):S657-S663.

4. Lacey RW, Simpson MHC, Fawcett C, et al. Comparison of single-dose trimethoprim (trimethoprim (trimethoprim tablet) tablet) with a five-day course for the treatment of urinary tract infections in the elderly. Age and Ageing 10: 179-185, 1981.

5. Ewer TC, Bailey RR, Gilchrist NL, et al. Comparative study of norfloxacin and trimethoprim (trimethoprim (trimethoprim tablet) tablet) for the treatment of elderly patients with urinary tract infection. NZ Med J 101: 537-539, 1988.

6. Marinella MA. Trimethoprim (trimethoprim (trimethoprim tablet) tablet) -induced hyperkalemia: An analysis of reported cases. Gerontology 45: 209-212, 1999.

 

Trimethoprim


Trimethoprim Overdosage & Contraindications


OVERDOSE

Acute

Signs of acute overdosage with trimethoprim (trimethoprim (trimethoprim tablet) tablet) may appear following ingestion of 1 gram or more of the drug and include nausea, vomiting, dizziness, headaches, mental depression, confusion and bone marrow depression (see Chronic subsection).

Treatment consists of gastric lavage and general supportive measures. Acidification of the urine will increase renal elimination of trimethoprim (trimethoprim (trimethoprim tablet) tablet) . Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating the drug.

Chronic

Use of trimethoprim (trimethoprim (trimethoprim tablet) tablet) at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. If signs of bone marrow depression occur, trimethoprim (trimethoprim (trimethoprim tablet) tablet) should be discontinued and the patient should be given leucovorin; 5 to 15 mg leucovorin daily has been recommended by some investigators.

CONTRAINDICATIONS

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) tablets are contraindicated in individuals hypersensitive to trimethoprim (trimethoprim (trimethoprim tablet) tablet) and in those with documented megaloblastic anemia due to folate deficiency.

 

Trimethoprim


 

Trimethoprim Clinical Pharmacology


CLINICAL PHARMACOLOGY

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) is rapidly absorbed following oral administration. It exists in the blood as unbound, protein-bound and metabolized forms. Ten to twenty percent of trimethoprim (trimethoprim (trimethoprim tablet) tablet) is metabolized, primarily in the liver; the remainder is excreted unchanged in the urine. The principal metabolites of trimethoprim (trimethoprim (trimethoprim tablet) tablet) are the 1- and 3-oxides and the 3'- and 4'-hydroxy derivatives. The free form is considered to be the therapeutically active form. Approximately 44% of trimethoprim (trimethoprim (trimethoprim tablet) tablet) is bound to plasma proteins.

Mean peak plasma concentrations of approximately 1 mcg/mL occur 1 to 4 hours after oral administration of a single 100 mg dose. A single 200 mg dose will result in serum levels approximately twice as high. The half-life of trimethoprim (trimethoprim (trimethoprim tablet) tablet) ranges from 8 to 10 hours. However, patients with severely impaired renal function exhibit an increase in the half-life of trimethoprim (trimethoprim (trimethoprim tablet) tablet) , which requires either dosage regimen adjustment or not using the drug in such patients (see DOSAGE AND ADMINISTRATION). During a 13-week study of trimethoprim (trimethoprim (trimethoprim tablet) tablet) administered at a daily dosage of 200 mg (50 mg q.i.d.), the mean minimum steady-state concentration of the drug was 1.1 mcg/mL. Steady-state concentrations were achieved within 2 to 3 days of chronic administration, and were maintained throughout the experimental period.

Excretion of trimethoprim (trimethoprim (trimethoprim tablet) tablet) is primarily by the kidneys through glomerular filtration and tubular secretion. Urine concentrations of trimethoprim (trimethoprim (trimethoprim tablet) tablet) are considerably higher than are the concentrations in the blood.

After a single oral dose of 100 mg, urine concentrations of trimethoprim (trimethoprim (trimethoprim tablet) tablet) ranged from 30 to 160 mcg/mL during the 0- to 4-hour period and declined to approximately 18 to 91 mcg/mL during the 8- to 24-hour period. A 200 mg single oral dose will result in trimethoprim (trimethoprim (trimethoprim tablet) tablet) urine levels approximately twice as high. After oral administration, 50% to 60% of trimethoprim (trimethoprim (trimethoprim tablet) tablet) is excreted in the urine within 24 hours, approximately 80% of this being unmetabolized trimethoprim (trimethoprim (trimethoprim tablet) tablet) .

Since normal vaginal and fecal flora are the source of most pathogens causing urinary tract infections, it is relevant to consider the distribution of trimethoprim into these sites. Concentrations of trimethoprim (trimethoprim (trimethoprim tablet) tablet) in vaginal secretions are consistently greater than those found simultaneously in the serum, being typically 1.6 times the concentrations of simultaneously obtained serum samples. Sufficient trimethoprim (trimethoprim (trimethoprim tablet) tablet) is excreted in the feces to markedly reduce or eliminate trimethoprim-susceptible organisms from the fecal flora.

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) also passes the placental barrier and is excreted in human milk.

Microbiology

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the required enzyme, dihydrofolate reductase. This binding is much stronger for the bacterial enzyme than for the corresponding mammalian enzyme. Thus, trimethoprim (trimethoprim (trimethoprim tablet) tablet) selectively interferes with bacterial biosynthesis of nucleic acids and proteins.

In vitroserial dilution tests have shown that the spectrum of antibacterial activity of trimethoprim (trimethoprim (trimethoprim tablet) tablet) includes the common urinary tract pathogens with the exception of Pseudomonas aeruginosa.

The dominant non-Entero-bacteriaceae fecal organisms, Bacteroides spp. and Lactobacillusspp., are not susceptible to trimethoprim (trimethoprim (trimethoprim tablet) tablet) concentrations obtained with the recommended dosage.

Trimethoprim (trimethoprim (trimethoprim tablet) tablet) has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobic gram-positive microorganisms

Staphylococcusspecies (coagulase-negative strains, including S. saprophyticus)

Aerobic gram-negative microorganisms

Enterobacter species
Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

Susceptibility Testing Methods

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of trimethoprim (trimethoprim (trimethoprim tablet) tablet) powder. The MIC values should be interpreted according to the following criteria:

For testing Enterobacteri-aceae and Staphylococcus spp.:

 

MIC (mcg/mL) Interpretation
≤ 8 Susceptible (S)
≥ 16 Resistant (R)

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected. Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard trimethoprim (trimethoprim (trimethoprim tablet) tablet) a powder should provide the following MIC values:

 

Microorganism MIC (mcg/mL)
E. coli ATCC 25922 0.5 - 2.0
S. aureus ATCC 29213 1.0 - 4.0
aVery medium-dependent.
Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 5 mcg trimethoprim to test the susceptibility of microorganisms to trimethoprim (trimethoprim (trimethoprim tablet) tablet) .

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5 mcg trimethoprim (trimethoprim (trimethoprim tablet) tablet) disk should be interpreted according to the following criteria:

For testing Enterobacteri-aceae and Staphylococcus spp.:

 

Zone Diameter (mm) Interpretation
≥ 16 Susceptible (S)
11-15 Intermediate (I)
≤ 10 Resistant (R)

Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for trimethoprim (trimethoprim (trimethoprim tablet) tablet) .

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 5 mcg trimethoprim (trimethoprim (trimethoprim tablet) tablet) diskb should provide the following zone diameters in these laboratory test quality control strains.

 

Microorganism MIC (mcg/mL)
E. coli ATCC 25922 0.5 - 2.0
Microorganism Zone Diameter (mm)
E. coli ATCC 25922 21 - 28
S. aureus ATCC 25923 19 - 26

bMueller-Hinton agar should be checked for excessive levels of thymidine. To determine whether Mueller-Hinton medium has sufficiently low levels of thymidine and thymine, an Enterococcus faecalis (ATCC 29212 or ATCC 33186) may be tested with trimethoprim (trimethoprim (trimethoprim tablet) tablet) /sulfamethoxazole disks. A zone of inhibition ≥ 20 mm that is essentially free of fine colonies indicates a sufficiently low level of thymidine and thymine.

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically. 3rd ed.; Approved Standard. NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, Wayne, PA, January, 1997.

2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests. Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January, 1997.

 

Trimethoprim


Trimethoprim Medication Guide


PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

 

Trimethoprim


Trimethoprim Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

TRIMETHOPRIM - ORAL

 

(try-METH-oh-prim)

 

COMMON BRAND NAME(S): Proloprim, Trimpex

 

USES: Trimethoprim is an antibiotic used to treat bacterial infections. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat some lung infections (pneumocystis carinii pneumonia) and to prevent kidney infections in certain patients.

 

HOW TO USE: Take this medication by mouth on an empty stomach at least 1 hour before or 2 hours after a meal as directed by your doctor. It may be taken with food if stomach upset occurs. Dosage is based on your medical condition and response to therapy.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Inform your doctor if your condition persists or worsens after several days.

 

Trimethoprim


Trimethoprim Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, vomiting, stomach upset, loss of appetite, changes in taste, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: swollen tongue, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual paleness, mental/mood changes, tiredness with fast/pounding/irregular heartbeat, dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, stiff neck, persistent headache, muscle weakness.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before taking trimethoprim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of anemia (due to folate deficiency).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, vitamin deficiency (folate or folic acid), diabetes, blood disorders (e.g., bone marrow suppression, G6PD deficiency).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for mineral imbalance (high potassium blood level) and allergic reactions while using this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Trimethoprim passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

 

Trimethoprim


Trimethoprim Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: dofetilide.

If you are currently using this medication listed above, tell your doctor or pharmacist before starting trimethoprim.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: digoxin, methotrexate, phenytoin, procainamide.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This medication may interfere with certain laboratory tests (including kidney function and methotrexate blood levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include nausea, vomiting, headache, dizziness, mental/mood changes, confusion.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (e.g., complete blood counts, kidney function, cultures) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from moisture and light. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Trimethoprim


Trimethoprim Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because a very serious interaction may occur: dofetilide.

If you are currently using this medication listed above, tell your doctor or pharmacist before starting trimethoprim.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: digoxin, methotrexate, phenytoin, procainamide.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This medication may interfere with certain laboratory tests (including kidney function and methotrexate blood levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include nausea, vomiting, headache, dizziness, mental/mood changes, confusion.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (e.g., complete blood counts, kidney function, cultures) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from moisture and light. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Last Updated on Tuesday, 27 December 2011 15:49
 
Viroptic PDF Print E-mail
Written by Ruai Pharmaceuticals   
Monday, 28 November 2011 08:40

Viroptic


Viroptic Drug Description


VIROPTIC
(trifluridine) Solution

DRUG DESCRIPTION

VIROPTIC is the brand name for trifluridine (also known as trifluorothymidine, F3TdR,F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. The chemical name of trifluridine is αα α -trifluorothymidine; it has the following structural formula:

VIROPTIC (trifluridine) structural formula illustration

VIROPTIC sterile ophthalmic solution contains 1% trifluridine in an aqueous solution with acetic acid and sodium acetate (buffers), sodium chloride, and thimerosal 0.001% (added as a preservative). The pH range is 5.5 to 6.0 and osmolality is approximately 283 mOsm.

 

What are the possible side effects of trifluridine ophthalmic (Trifluridine, Viroptic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using trifluridine ophthalmic and call your doctor at once if you have any of these serious side effects:

  • severe swelling around your eyes;
  • tunnel vision; or
  • severe pain, burning, or other irritation of your eyes.

Keep using the medication and talk to your doctor if you have any of these less...

Read All Potential Side Effects and See Pictures of Viroptic »

 

What are the precautions when taking trifluridine (Viroptic)?

Before using trifluridine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes...

 

Viroptic


Viroptic Indications & Dosage


INDICATIONS

VIROPTIC (trifluridine) Ophthalmic Solution, 1% (trifluridine ophthalmic solution) is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.

DOSAGE AND ADMINISTRATION

Instill one drop of VIROPTIC (trifluridine) Ophthalmic Solution, 1% onto the cornea of the affected eye every 2 hours while awake for a maximum daily dosage of nine drops until the corneal ulcer has completely re-epithelialized. Following re-epithelialization, treatment for an additional 7 days of one drop every 4 hours while awake for a minimum daily dosage of five drops is recommended. If there are no signs of improvement after 7 days of therapy or complete re-epithelialization has not occurred after 14 days of therapy, other forms of therapy should be considered. Continuous administration of VIROPTIC (trifluridine) for periods exceeding 21 days should be avoided because of potential ocular toxicity.

HOW SUPPLIED

VIROPTIC (trifluridine) Ophthalmic Solution, 1% is supplied as a sterile ophthalmic solution in a plastic Drop Dose® dispenser bottle of 7.5 mL (NDC 61570-037-75).

Store under refrigeration 2° to 8°C (36° to 46°F).

Prescribing Information as of April 2007. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834

 

Viroptic


Viroptic Side Effects & Drug Interactions


SIDE EFFECTS

The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation (4.6%) and palpebral edema (2.8%). Other adverse reactions in decreasing order of reported frequency were superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.

 

 

Viroptic


Viroptic Warnings & Precautions


WARNINGS

The recommended dosage and frequency of administration should not be exceeded (See DOSAGE AND ADMINISTRATION).

PRECAUTIONS

General

VIROPTIC (trifluridine) Ophthalmic Solution, 1% should be prescribed only for patients who have a clinical diagnosis of herpetic keratitis. VIROPTIC (trifluridine) may cause mild local irritation of the conjunctiva and cornea when instilled, but these effects are usually transient. Although documented in vitro viral resistance to trifluridine has not been reported following multiple exposures to VIROPTIC (trifluridine) , the possibility of the development of viral resistance exists.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenic Potential

Trifluridine has been shown to exert mutagenic, DNA-damaging and cell-transforming activities in various standard in vitro test systems, and clastogenicactivity in Vicia faba cells. It did not induce chromosome aberrations in bone marrow cells of male or female rats following a single subcutaneous dose of 100 mg/kg, but was weakly positive in female, but not in male, rats following daily subcutaneous administration at 700 mg/kg/day for 5 days.

Although the significance of these test results is not clear or fully understood, there exists the possibility that mutagenic agents may cause genetic damage in humans.

Oncogenic Potential

Lifetime carcinogenicity bioassays in rats and mice given daily subcutaneous doses of trifluridine have been performed. Rats tested at 1.5, 7.5, and 15 mg/kg/day had increased incidences of adenocarcinomas of the intestinal tract and mammary glands, hemangiosarcomas of the spleen and liver, carcinosarcomas of the prostate gland, and granulosa-thecal cell tumors of the ovary. Mice were tested at 1, 5, and 10 mg/kg/day; those given 10 mg/kg/day trifluridine had significantly increased incidences of adenocarcinomas of the intestinal tract and uterus. Those given 10 mg/kg/day also had a significantly increased incidence of testicular atrophy as compared to vehicle control mice.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Trifluridine was not teratogenic at doses up to 5 mg/kg/day (23 times the estimated human exposure) when given subcutaneously to rats and rabbits. However, fetal toxicity consisting of delayed ossification of portions of the skeleton occurred at dose levels of 2.5 and 5 mg/kg/day in rats and at 2.5 mg/kg/day in rabbits. In addition, both 2.5 and 5 mg/kg/day produced fetal death and resorption in rabbits. In both rats and rabbits, 1 mg/kg/day (5 times the estimated human exposure) was a no-effect level. There were no teratogenic or fetotoxic effects after topical application of VIROPTIC (trifluridine) Ophthalmic Solution, 1% (approximately 5 times the estimated human exposure) to the eyes of rabbits on the 6th through the 18th days of pregnancy. In a non-standard test, trifluridine solution has been shown to be teratogenic when injected directly into the yolk sac of chicken eggs. There are no adequate and well-controlled studies in pregnant women. VIROPTIC (trifluridine) Ophthalmic Solution, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is unlikely that trifluridine is excreted in human milk after ophthalmic instillation of VIROPTIC (trifluridine) because of the relatively small dosage ( < 5 mg/day), its dilution in body fluids and its extremely short half-life (approximately 12 minutes). The drug should not be prescribed for nursing mothers unless the potential benefits outweigh the potential risks.

Pediatric Use

Safety and effectiveness in pediatric patients below six years of age have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

 

Viroptic


Viroptic Overdosage & Contraindications


OVERDOSE

Overdosage by ocular instillation is unlikely because any excess solution should be quickly expelled from the conjunctival sac. Acute overdosage by accidental oral ingestion of VIROPTIC (trifluridine) has not occurred. However, should such ingestion occur, the 75 mg dosage of trifluridine in a 7.5 mL bottle of VIROPTIC (trifluridine) is not likely to produce adverse effects. Single intravenous doses of 1.5 to 30 mg/kg/day in children and adults with neoplastic disease produce reversible bone marrow depression as the only potentially serious toxic effect and only after three to five courses of therapy. The acute oral LD50 in the mouse and rat was 4379 mg/kg or higher.

CONTRAINDICATIONS

VIROPTIC (trifluridine) Ophthalmic Solution, 1% is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.

 

Viroptic


Viroptic Clinical Pharmacology


CLINICAL PHARMACOLOGY

Trifluridine is a fluorinated pyrimidine nucleoside with in vitro and in vivo activity against herpes simplex virus, types 1 and 2 and vacciniavirus. Some strains of adenovirus are also inhibited in vitro.

VIROPTIC (trifluridine) is also effective in the treatment of epithelial keratitis that has not responded clinically to the topical adminstration of idoxuridine or when ocular toxicity or hypersensitivity to idoxuridine has occurred. In a smaller number of patients found to be resistant to topical vidarabine, VIROPTIC was also effective.

Trifluridine interferes with DNA synthesis in cultured mammalian cells. However, its antiviral mechanism of action is not completely known.

In vitro perfusion studies on excised rabbit corneas have shown that trifluridine penetrates the intact cornea as evidenced by recovery of parental drug and its major metabolite, 5-carboxy-2'-deoxyuridine, on the endothelial side of the cornea. Absence of the corneal epithelium enhances the penetration of trifluridine approximately two-fold.

Intraocular penetration of trifluridine occurs after topical instillation of VIROPTIC (trifluridine) into human eyes. Decreased corneal integrity or stromal or uveal inflammation may enhance the penetration of trifluridine into the aqueous humor. Unlike the results of ocular penetration of trifluridine in vitro, 5-carboxy-2'-deoxyuridine was not found in detectable concentrations within the aqueous humor of the human eye.

Systemic absorption of trifluridine following therapeutic dosing with VIROPTIC (trifluridine) appears to be negligible. No detectable concentrations of trifluridine or 5-carboxy-2'-deoxyuridine were found in the sera of adult healthy normal subjects who had VIROPTIC (trifluridine) instilled into their eyes seven times daily for 14 consecutive days.

Clinical Studies

During a controlled multicenter clinical trial, 92 of 97 (95%) patients (78 of 81 with dendritic and 14 of 16 with geographic ulcers) responded to therapy with VIROPTIC (trifluridine) as evidenced by complete corneal re-epithelialization within the 14-day therapy period. Fifty-six of 75 (75%) patients (49 of 58 with dendritic and 7 of 17 with geographic ulcers) responded to idoxuridine therapy. The mean time to corneal re-epithelialization for dendritic ulcers (6 days) and geographic ulcers (7 days) was similar for both therapies. In other clinical studies, VIROPTIC (trifluridine) was evaluated in the treatment of herpes simplex virus keratitis in patients who were unresponsive or intolerant to the topical administration of idoxuridine or vidarabine. VIROPTIC (trifluridine) was effective in 138 of 150 (92%) patients (109 of 114 with dendritic and 29 of 36 with geographic ulcers) as evidenced by corneal re-epithelialization. The mean time to corneal re-epithelialization was 6 days for patients with dendritic ulcers and 12 days for patients with geographic ulcers. The clinical efficacy of VIROPTIC (trifluridine) in the treatment of stromal keratitis and uveitis due to herpes simplex virus or ophthalmic infections caused by vacciniavirus and adenovirus has not been established by well-controlled clinical trials. VIROPTIC (trifluridine) has not been shown to be effective in the prophylaxis of herpes simplex virus keratoconjunctivitis and epithelial keratitis by well-controlled clinical trials. VIROPTIC (trifluridine) is not effective against bacterial, fungal, or chlamydial infections of the cornea or nonviral trophic lesions.

Animal Pharmacology And Animal Toxicology

Corneal wound healing studies in rabbits showed that VIROPTIC (trifluridine) did not significantly retard closure of epithelial wounds. However, mild toxic changes such as intracellular edema of the basal cell layer, mild thinning of the overlying epithelium and reduced strength of stromal wounds were observed.

Whereas instillation of VIROPTIC (trifluridine) into rabbit eyes during a subchronic toxicity study produced some degree of corneal epithelial thinning, a 12-month chronic toxicity study in rabbits in which VIROPTIC (trifluridine) was instilled into eyes in intermittent, multiple, full-therapy courses showed no drug-related changes in the cornea.

 

Viroptic


Viroptic Medication Guide


PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

 

Viroptic


Viroptic Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

TRIFLURIDINE DROPS - OPHTHALMIC

 

(try-FLEWR-ih-deen)

 

COMMON BRAND NAME(S): Viroptic

 

USES: This medication is used to treat herpes infection of the eye. Herpes is a virus that lives in the body quietly until an outbreak is triggered. Trifluridine is not a cure for the infection, but treatment of an outbreak can speed up the healing of the sores/swelling in the eye and lower the risk of complications (e.g., vision loss).

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat other eye infections caused by viruses (e.g., vaccinia virus infections).

 

HOW TO USE: To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

Tilt your head back, look up, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch as directed by your doctor. Look down and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and press gently. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

Use this medication usually every 2 hours while awake until the eye has healed. Do not use more than 9 drops into the eye in a 24-hour period. After healing, use this medication for another 7 days, usually every 4 hours while awake (at least 5 drops per day) or as directed by your doctor.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed. Stopping the medication too early may result in a return of the infection.

Do not use this medication more often or use longer than prescribed because doing so may increase the risk of side effects. This medication should not be used for more than 21 days at a time.

Tell your doctor if your condition worsens, does not improve after 7 days, or does not completely heal after 14 days.

 

Viroptic


Viroptic Consumer (continued)

SIDE EFFECTS: Temporary mild burning, stinging, and irritation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling eyelids, eye pain/redness, feeling as if something is in the eye, persistent blurred vision.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before using trifluridine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

 

Viroptic


Viroptic Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (e.g., eye exam) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Viroptic


Viroptic Patient Information Including Side Effects

Brand Names: Trifluridine, Viroptic

Generic Name: trifluridine ophthalmic (Pronunciation: trye FLURE i deen off THAL mik)

 

  • What is trifluridine ophthalmic (Viroptic)?
  • What are the possible side effects of trifluridine ophthalmic (Viroptic)?
  • What is the most important information I should know about trifluridine ophthalmic (Viroptic)?
  • What should I discuss with my healthcare provider before using trifluridine ophthalmic (Viroptic)?
  • How should I use trifluridine ophthalmic (Viroptic)?
  • What happens if I miss a dose (Viroptic)?
  • What happens if I overdose (Viroptic)?
  • What should I avoid while taking trifluridine ophthalmic (Viroptic)?
  • What other drugs will affect trifluridine ophthalmic (Viroptic)?
  • Where can I get more information?

 

What is trifluridine ophthalmic (Viroptic)?

Trifluridine ophthalmic is an antiviral medication. It fights eye infections that are caused by certain viruses.

Trifluridine ophthalmic is used to treat eye infections caused by the herpes simplex virus, which can lead to swelling or ulcers in the eyelids or cornea (surface of the eyeball).

Trifluridine ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of trifluridine ophthalmic (Viroptic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using trifluridine ophthalmic and call your doctor at once if you have any of these serious side effects:

  • severe swelling around your eyes;
  • tunnel vision; or
  • severe pain, burning, or other irritation of your eyes.

Keep using the medication and talk to your doctor if you have any of these less serious side effects:

  • mild eye pain, burning, stinging, itching, or redness;
  • blurred vision; or
  • feeling of pressure inside the eye.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about trifluridine ophthalmic (Viroptic)?

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus.

The usual dose of trifluridine ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Once your condition improves, you may need to keep using the medication 4 times daily (up to 5 drops per day) for another 7 days. Your doctor should check your eyes to determine how long you need to use the medicine.

If you wear contact lenses, remove them before applying trifluridine ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

Avoid using other eye medications while using trifluridine ophthalmic, unless your doctor has told you to.

Trifluridine ophthalmic may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

Related Drug Centers
  • Viroptic

 

Viroptic


Viroptic Patient Information including How Should I Take

In this Article

  • What is trifluridine ophthalmic (Viroptic)?
  • What are the possible side effects of trifluridine ophthalmic (Viroptic)?
  • What is the most important information I should know about trifluridine ophthalmic (Viroptic)?
  • What should I discuss with my healthcare provider before using trifluridine ophthalmic (Viroptic)?
  • How should I use trifluridine ophthalmic (Viroptic)?
  • What happens if I miss a dose (Viroptic)?
  • What happens if I overdose (Viroptic)?
  • What should I avoid while taking trifluridine ophthalmic (Viroptic)?
  • What other drugs will affect trifluridine ophthalmic (Viroptic)?
  • Where can I get more information?

What should I discuss with my healthcare provider before using trifluridine ophthalmic (Viroptic)?

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether trifluridine ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication in a child younger than 6 years old.

How should I use trifluridine ophthalmic (Viroptic)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

The usual dose of trifluridine ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Once your condition improves, you may need to keep using the medication 4 times daily (up to 5 drops per day) for another 7 days. Your doctor should check your eyes to determine how long you need to use the medicine.

Wash your hands before using the eye drops.

If you wear contact lenses, remove them before applying trifluridine ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye. Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it.

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

Store the eye drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

Related Drug Centers
  • Viroptic

 

Viroptic


Viroptic Patient Information including If I Miss a Dose

In this Article

  • What is trifluridine ophthalmic (Viroptic)?
  • What are the possible side effects of trifluridine ophthalmic (Viroptic)?
  • What is the most important information I should know about trifluridine ophthalmic (Viroptic)?
  • What should I discuss with my healthcare provider before using trifluridine ophthalmic (Viroptic)?
  • How should I use trifluridine ophthalmic (Viroptic)?
  • What happens if I miss a dose (Viroptic)?
  • What happens if I overdose (Viroptic)?
  • What should I avoid while taking trifluridine ophthalmic (Viroptic)?
  • What other drugs will affect trifluridine ophthalmic (Viroptic)?
  • Where can I get more information?

What happens if I miss a dose (Viroptic)?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Viroptic)?

Rinse the eye with water and seek emergency medical attention if you think you have used too much of this medicine.

An overdose of trifluridine ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while taking trifluridine ophthalmic (Viroptic)?

This medication may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Avoid using other eye medications while using trifluridine ophthalmic, unless your doctor has told you to.

What other drugs will affect trifluridine ophthalmic (Viroptic)?

There may be other drugs that can affect trifluridine ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about trifluridine ophthalmic written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed


 

Related Drug Centers
  • Viroptic
Last Updated on Wednesday, 27 June 2012 10:19
 
Tridione PDF Print E-mail
Written by Ruai Pharmaceuticals   
Monday, 28 November 2011 08:37

Tridione


Tridione Drug Description


Tridione
(trimethadione) Tablet, Chewable

BECAUSE OF ITS POTENTIAL TO PRODUCE FETAL MALFORMATIONS AND SERIOUS SIDE EFFECTS, TRIDIONE (trimethadione) SHOULD ONLY BE UTILIZED WHEN OTHER LESS TOXIC DRUGS HAVE BEEN FOUND INEFFECTIVE IN CONTROLLING PETIT MAL SEIZURES.

DRUG DESCRIPTION

TRIDIONE (trimethadione) is an antiepileptic agent. An oxazolidinedione compound, it is chemically identified as 3,5,5-trimethyloxozolidine-2,4-dione, and has the following structural formula:

 

Tridione (trimethadione) Structural Formula Illustration

TRIDIONE (trimethadione tablet) is a synthetic, water-soluble, white, crystalline powder. It is supplied in tablets for oral use only.

Inactive Ingredients

150 mg Dulcet Tablet: Corn starch, lactose, magnesium stearate, magnesium trisilicate, sucrose and natural/synthetic flavor.

 

What are the possible side effects of trimethadione (Tridione)?

If you experience any of the following serious side effects, stop taking trimethadione and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • a rash;
  • worsening of seizures;
  • sore throat or fever;
  • changes in vision;
  • easy or unusual bleeding or bruising;
  • bleeding nose; or
  • extreme drowsiness or...

Read All Potential Side Effects and See Pictures of Tridione »

Tridione


Tridione Indications & Dosage


INDICATIONS

TRIDIONE (trimethadione) is indicated for the control of petit mal seizures that are refractory to treatment with other drugs.

DOSAGE AND ADMINISTRATION

TRIDIONE (trimethadione tablet) is administered orally.

Usual Adult Dosage

0.9-2.4 grams daily in 3 or 4 equally divided doses (i.e., 300-600 mg 3 or 4 times daily).

Initially, give 0.9 gram daily; increase this dose by 300 mg at weekly intervals until therapeutic results are seen or until toxic symptoms appear.

Maintenance dosage should be the least amount of drug required to maintain control.

Children's Dosage

Usually 0.3-0.9 gram daily in 3 or 4 equally divided doses.

HOW SUPPLIED

TRIDIONE Dulcet® Tablets (trimethadione tablets) are supplied as white, chewable tablets bearing the Abbott Logo and a two-letter Abbo-Code designation LE for the 150 mg tablet, in bottles of 100 (NDC 0074-3753-01).

Recommended Storage

Store Dulcet tablets in refrigerator (2° - 8°C) to minimize crystallization. However some crystallization not harmful to product may occur. Keep tightly closed.

 

Tridione


Tridione Side Effects & Drug Interactions


SIDE EFFECTS

The following side effects, some of them serious, have been associated with the use of TRIDIONE (trimethadione).

Gastrointestinal

Nausea, vomiting, abdominal pain, gastric distress.

CNS/Neurologic

Drowsiness, fatigue, malaise, insomnia, vertigo, headache, paresthesias, precipitation of grand mal seizures, increased irritability, personality changes.

Drowsiness usually subsides with continued therapy. If it persists, a reduction in dosage is indicated.

Hematologic

Bleeding gums, epistaxis, retinal and petechial hemorrhages, vaginal bleeding, neutropenia, leukopenia, eosinophilia, thrombocytopenia, pancytopenia, agranulocytosis, hypoplastic anemia, and fatal aplastic anemia.

Dermatologic

Acneiform or morbilliform skin rash that may progress to exfoliative dermatitis or to severe forms of erythema multiforme.

Other

Hiccups, anorexia, weight loss, hair loss, changes in blood pressure, albuminuria, hemeralopia, photophobia, diplopia.

Fatal nephrosis has occurred.

Hepatitis has been reported rarely.

Lupus erythematosus, and lymphadenopathies simulating malignant lymphoma, have been reported.

Pruritus associated with lymphadenopathy and hepatosplenomegaly has occurred in hypersensitive individuals.

A myasthenia gravis-like syndrome has been reported.

 

Tridione


 

Tridione Warnings & Precautions


WARNINGS

TRIDIONE (trimethadione tablet) may cause serious side effects. Strict medical supervision of the patient is mandatory, especially during the initial year of therapy.

Rash

TRIDIONE (trimethadione) should be withdrawn promptly if skin rash appears, because of the grave possibility of the occurrence of exfoliative dermatitis or severe forms of erythema multiforme. Even a minor acneiform or morbilliform rash should be allowed to clear completely before treatment with TRIDIONE (trimethadione tablet) is resumed; reinstitute therapy cautiously.

Blood Dyscrasias

A complete blood count should be done prior to initiating therapy with TRIDIONE (trimethadione tablet) , and at monthly intervals thereafter. A marked depression of the blood count is an indication for withdrawal of the drug. If no abnormality appears within 12 months, the interval between blood counts may be extended. A moderate degree of neutropenia with or without a corresponding drop in the leukocyte count is not uncommon. Therapy need not be withdrawn unless the neutrophil count is 2500 or less; more frequent blood examinations should be done when the count is less than 3,000. Other blood dyscrasias, including leukopenia, eosinophilia, thrombocytopenia, pancytopenia, agranulocytosis, hypoplastic anemia, and fatal aplastic anemia, have occurred. Patients should be advised to report immediately such signs and symptoms as sore throat, fever, malaise, easy bruising, petechiae, or epistaxis, or others that may be indicative of an infection or bleeding tendency. TRIDIONE (trimethadione tablet) should ordinarily not be used in patients with severe blood dyscrasias.

Liver Dysfunction

Liver function tests should be done prior to initiating therapy with TRIDIONE (trimethadione tablet) , and at monthly intervals thereafter. Hepatitis has been reported rarely. Jaundice or other signs of liver dysfunction are an indication for withdrawal of the drug. TRIDIONE (trimethadione tablet) should ordinarily not be used in patients with severe hepatic impairment.

Renal Dysfunction

A urinalysis should be done prior to initiating therapy with TRIDIONE (trimethadione tablet) and at monthly intervals thereafter. Fatal nephrosis has been reported. Persistent or increasing albuminuria, or the development of any other significant renal abnormality, is an indication for withdrawal of the drug. TRIDIONE (trimethadione tablet) should ordinarily not be used in patients with severe renal dysfunction.

Ocular Dysfunction

Hemeralopia has occurred; this appears to be an effect of TRIDIONE (trimethadione tablet) on the neural layers of the retina, and usually can be reversed by a reduction in dosage. Scotomata are an indication for withdrawal of the drug. Caution should be observed when treating patients who have diseases of the retina or optic nerve.

Lupus- and Myasthenia-like Syndromes

Manifestations of systemic lupus erythematosus have been associated with the use of TRIDIONE (trimethadione tablet) , as they have with the use of certain other anticonvulsants. Lymphadenopathies simulating malignant lymphoma have occurred. Lupus-like manifestations or lymph node enlargement are indications for withdrawal of the drug. Signs and symptoms may disappear after discontinuation of therapy, and specific treatment may be unnecessary.

A myasthenia gravis-like syndrome has been associated with the chronic use of trimethadione. Symptoms suggestive of this condition are indications for withdrawal of the drug.

Drugs known to cause toxic effects similar to those of TRIDIONE (trimethadione tablet) should be avoided or used only with extreme caution during therapy with TRIDIONE (trimethadione tablet) .

Usage During Pregnancy and Lactation

THERE ARE MULTIPLE REPORTS IN THE CLINICAL LITERATURE WHICH INDICATE THAT THE USE OF ANTICONVULSANT DRUGS DURING PREGNANCY RESULTS IN AN INCREASED INCIDENCE OF BIRTH DEFECTS IN THE OFFSPRING. DATA ARE MORE EXTENSIVE WITH RESPECT TO TRIMETHADIONE, PARAMETHADIONE, PHENYTOIN AND PHENOBARBITAL THAN WITH OTHER ANTICONVULSANT DRUGS.

THEREFORE, ANTICONVULSANT DRUGS SUCH AS TRIDIONE (TRIMETHADIONE) SHOULD BE ADMINISTERED TO WOMEN OF CHILDBEARING POTENTIAL ONLY IF THEY ARE CLEARLY SHOWN TO BE ESSENTIAL IN THE MANAGEMENT OF THEIR SEIZURES. EFFECTIVE MEANS OF CONTRACEPTION SHOULD ACCOMPANY THE USE OF TRIDIONE (trimethadione tablet) IN SUCH PATIENTS. IF A PATIENT BECOMES PREGNANT WHILE TAKING TRIDIONE (trimethadione tablet) , TERMINATION OF THE PREGNANCY SHOULD BE CONSIDERED. A PATIENT WHO REQUIRES THERAPY WITH TRIDIONE (trimethadione tablet) AND WHO WISHES TO BECOME PREGNANT SHOULD BE ADVISED OF THE RISKS.

REPORTS HAVE SUGGESTED THAT THE MATERNAL INGESTION OF ANTICONVULSANT DRUGS, PARTICULARLY BARBITURATES, IS ASSOCIATED WITH A NEONATAL COAGULATION DEFECT THAT MAY CAUSE BLEEDING DURING THE EARLY (USUALLY WITHIN 24 HOURS OF BIRTH) NEONATAL PERIOD. THE POSSIBILITY OF THE OCCURRENCE OF THIS DEFECT WITH THE USE OF TRIDIONE (trimethadione tablet) SHOULD BE KEPT IN MIND. THE DEFECT IS CHARACTERIZED BY DECREASED LEVELS OF VITAMIN K-DEPENDENT CLOTTING FACTORS, AND PROLONGATION OF EITHER THE PROTHROMBIN TIME OR THE PARTIAL THROMBOPLASTIN TIME, OR BOTH. IT HAS BEEN SUGGESTED THAT PROPHYLACTIC VITAMIN K BE GIVEN TO THE MOTHER ONE MONTH PRIOR TO, AND DURING DELIVERY, AND TO THE INFANT, INTRAVENOUSLY, IMMEDIATELY AFTER BIRTH.

THE SAFETY OF TRIDIONE (trimethadione tablet) FOR USE DURING LACTATION HAS NOT BEEN ESTABLISHED.

To provide information regarding the effects of in utero exposure to Tridione (trimethadione tablet) , physicians are advised to recommend that pregnant patients taking Tridione (trimethadione tablet) enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including Tridione (trimethadione tablet) , increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Table 1. Risk by indication for antiepileptic drugs in the pooled analysis

Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients
Epilepsy 1.0 3.4 3.5 2.4
Psychiatric 5.7 8.5 1.5 2.9
Other 1.0 1.8 1.9 0.9
Total 2.4 4.3 1.8 1.9

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Tridione (trimethadione tablet) or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

PRECAUTIONS

Abrupt discontinuation of TRIDIONE (trimethadione tablet) may precipitate petit mal status. TRIDIONE (trimethadione tablet) should always be withdrawn gradually unless serious adverse effects dictate otherwise. In the latter case, another anticonvulsant may be substituted to protect the patient.

 

Tridione


Tridione Overdosage & Contraindications


OVERDOSE

Symptoms of acute TRIDIONE (trimethadione tablet) overdosage include drowsiness, nausea, dizziness, ataxia, visual disturbances. Coma may follow massive overdosage.

Gastric evacuation, either by induced emesis, or by lavage, or both, should be done immediately. General supportive care, including frequent monitoring of the vital signs and close observations of the patient, are required.

Alkalinization of the urine has been reported to enhance the renal excretion of dimethadione, the active metabolite of TRIDIONE (trimethadione tablet) .

A blood count and a careful evaluation of hepatic and renal function should be done following recovery.

CONTRAINDICATIONS

TRIDIONE (trimethadione tablet) is contraindicated in patients with a known hypersensitivity to the drug.

 

Tridione


 

Tridione Clinical Pharmacology


CLINICAL PHARMACOLOGY

TRIDIONE (trimethadione tablet) has been shown to prevent pentylenetetrazol-induced and thujone-induced seizures in experimental animals; the drug has a less marked effect on seizures induced by picrotoxin, procaine, cocaine, or strychnine. Unlike the hydantoins and antiepileptic barbiturates, TRIDIONE (trimethadione tablet) does not modify the maximal seizure pattern in patients undergoing electroconvulsive therapy.

TRIDIONE (trimethadione tablet) has a sedative effect that may increase to the point of ataxia when excessive doses are used. A toxic dose of the drug in animals (approximately 2 g/kg) produced sleep, unconsciousness, and respiratory depression.

Trimethadione is rapidly absorbed from the gastrointestinal tract. It is demethylated by liver microsomes to the active metabolite, dimethadione.

Approximately 3% of a daily dose of TRIDIONE (trimethadione tablet) is recovered in the urine as unchanged drug. The majority of trimethadione is excreted slowly by the kidney in the form of dimethadione.

Tridione


Tridione Medication Guide


PATIENT INFORMATION

Suicidal Thinking and Behavior

Patients, their caregivers, and families should be counseled that AEDs, including Tridione (trimethadione tablet) , may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to the healthcare providers.

Pregnancy Registry

Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see WARNINGS).

 

Tridione


Tridione Patient Information Including Side Effects

Brand Names: Tridione

Generic Name: trimethadione (Pronunciation: try meth ah DYE own)

 

  • What is trimethadione (Tridione)?
  • What are the possible side effects of trimethadione (Tridione)?
  • What is the most important information I should know about trimethadione (Tridione)?
  • What should I discuss with my healthcare provider before taking trimethadione (Tridione)?
  • How should I take trimethadione (Tridione)?
  • What happens if I miss a dose (Tridione)?
  • What happens if I overdose (Tridione)?
  • What should I avoid while taking trimethadione (Tridione)?
  • What other drugs will affect trimethadione (Tridione)?
  • Where can I get more information?

 

What is trimethadione (Tridione)?

Trimethadione is a seizure medication. The exact way that it works is unknown.

Trimethadione is used to control absence ("petit mal") seizures.

Trimethadione may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of trimethadione (Tridione)?

If you experience any of the following serious side effects, stop taking trimethadione and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • a rash;
  • worsening of seizures;
  • sore throat or fever;
  • changes in vision;
  • easy or unusual bleeding or bruising;
  • bleeding nose; or
  • extreme drowsiness or dizziness.

Other, less serious side effects may be more likely to occur. Continue to take trimethadione and talk to your doctor if you experience

  • mild dizziness, poor coordination, or drowsiness;
  • blurred or double vision, or irregular back-and-forth movements of the eyes;
  • decreased appetite, nausea, or vomiting; or
  • increased sensitivity of the skin to sunlight.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about trimethadione (Tridione)?

Do not stop taking this medication even if you feel better. It is important to continue taking trimethadione to prevent the seizures from recurring.

Carry or wear a medical identification tag to let others know that you are taking this medicine in the case of an emergency.

Use caution when driving, operating machinery, or performing other hazardous activities. Trimethadione may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Related Drug Centers
  • Tridione

 

Tridione


Tridione Patient Information including How Should I Take

In this Article

  • What is trimethadione (Tridione)?
  • What are the possible side effects of trimethadione (Tridione)?
  • What is the most important information I should know about trimethadione (Tridione)?
  • What should I discuss with my healthcare provider before taking trimethadione (Tridione)?
  • How should I take trimethadione (Tridione)?
  • What happens if I miss a dose (Tridione)?
  • What happens if I overdose (Tridione)?
  • What should I avoid while taking trimethadione (Tridione)?
  • What other drugs will affect trimethadione (Tridione)?
  • Where can I get more information?

What should I discuss with my healthcare provider before taking trimethadione (Tridione)?

Before taking trimethadione, tell your doctor if you have

  • liver disease;
  • kidney disease;
  • retinal or optic nerve (eye) disease;
  • a disease of the blood or bone marrow; or
  • acute intermittent porphyria.

You may not be able to take trimethadione, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Trimethadione is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Malformations of the face and head, heart, and nervous system have been reported. Do not take trimethadione without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether trimethadione passes into breast milk and how it might affect a nursing infant. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take trimethadione (Tridione)?

Take trimethadione exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose of trimethadione with a full glass of water.

Trimethadione can be taken on an empty stomach or with food to decrease stomach upset.

Chew the chewable tablets before swallowing them.

To ensure that you get a correct dose, measure the liquid form of trimethadione with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Carry or wear a medical identification tag to let others know that you are taking this medicine in the case of an emergency.

Do not stop taking this medication even if you feel better. It is important to continue taking trimethadione to prevent the seizures from recurring.

Store trimethadione at room temperature away from moisture and heat.

Related Drug Centers
  • Tridione

 

Tridione


Tridione Patient Information including If I Miss a Dose

In this Article

  • What is trimethadione (Tridione)?
  • What are the possible side effects of trimethadione (Tridione)?
  • What is the most important information I should know about trimethadione (Tridione)?
  • What should I discuss with my healthcare provider before taking trimethadione (Tridione)?
  • How should I take trimethadione (Tridione)?
  • What happens if I miss a dose (Tridione)?
  • What happens if I overdose (Tridione)?
  • What should I avoid while taking trimethadione (Tridione)?
  • What other drugs will affect trimethadione (Tridione)?
  • Where can I get more information?

What happens if I miss a dose (Tridione)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Tridione)?

Seek emergency medical treatment.

Symptoms of a trimethadione overdose include dizziness, drowsiness, poor coordination, nausea, vomiting, and changes in vision.

What should I avoid while taking trimethadione (Tridione)?

Do not drink alcohol while taking this medication. Alcohol can cause deep sedation or sleepiness. It may also increase the risk of having seizures.

Use caution when driving, operating machinery, or performing other hazardous activities. Trimethadione may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Avoid prolonged exposure to sunlight. Trimethadione may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when sun exposure is unavoidable.

What other drugs will affect trimethadione (Tridione)?

Trimethadione may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, pain relievers, anxiety medicines, other seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if trimethadione is taken with any of these medications. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

Drugs other than those listed here may also interact with trimethadione. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist has additional information about trimethadione written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Related Drug Centers
  • Tridione
Last Updated on Wednesday, 27 June 2012 10:18
 
Triamcinolone Ointment PDF Print E-mail
Written by Ruai Pharmaceuticals   
Monday, 28 November 2011 08:32

Triamcinolone Ointment


Triamcinolone Ointment Drug Description


Triamcinolone Acetonide (triamcinolone acetonide ointment)
Ointment USP, 0.025%, 0.1%

DRUG DESCRIPTION

Triamcinolone Acetonide (triamcinolone acetonide ointment) Ointment USP contains Triamcinolone Acetonide (triamcinolone acetonide ointment) [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5.

 

Fouqera® (Triamcinolone Acetonide) Structural Formula Illustration

Triamcinolone Acetonide (triamcinolone acetonide ointment) Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil.

Triamcinolone Acetonide (triamcinolone acetonide ointment) Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil.

 

What are the possible side effects of triamcinolone topical (Cinolar, Kenalog, Triderm)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing triamcinolone topical through your skin or gums:

  • blurred vision, or seeing halos around lights;
  • uneven heartbeats;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in...

Read All Potential Side Effects and See Pictures of Triamcinolone Ointment »

 

What are the precautions when taking triamcinolone acetonide ointment (Triamcinolone Ointment)?

Before using triamcinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, immune system problems.

Do not use if there is an infection or sore present in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if...

 

Triamcinolone Ointment


Triamcinolone Ointment Indications & Dosage


INDICATIONS

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION

Apply to the affected area as a thin film as follows: Triamcinolone Acetonide (triamcinolone acetonide ointment) Ointment USP, 0.025% two to four times daily; Triamcinolone Acetonide (triamcinolone acetonide ointment) Ointment USP, 0.1% two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Triamcinolone Acetonide (triamcinolone acetonide ointment) Ointment USP, 0.025%

80 gram tubes.........NDC 0168-0005-80

Triamcinolone Acetonide (triamcinolone acetonide ointment) Ointment USP, 0.1%

15 gram tubes.........NDC 0168-0006-15
80 gram tubes.........NDC 0168-0006-80
1 Lb jars.................NDC 0168-0006-16

Store at controlled room temperature 15°-30°C (59°-86°F).

E. Fougera & CO. a division of Altana Inc., Melville, New York 11747.

 

Triamcinolone Ointment


Triamcinolone Ointment Side Effects & Drug Interactions


SIDE EFFECTS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

 

Triamcinolone Ointment


 

Triamcinolone Ointment Warnings & Precautions


WARNINGS

No information provided.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steriod applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate anti-fungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Laboratory Tests

The following tests may be helpful in evaluating the H PA axis suppression: Urinary free cortisol test; ACTH stimulation test.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced H PA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamicpituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to chil-dren should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

 

Triamcinolone Ointment


Triamcinolone Ointment Overdosage & Contraindications


OVERDOSE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

 

Triamcinolone Ointment


Triamcinolone Ointment Clinical Pharmacology


CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

 

Triamcinolone Ointment


Triamcinolone Ointment Medication Guide


PATIENT INFORMATION

Patients using topical corticosteroids should receive the following information and instructions.

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
  5. Parents of pediatric patients should be advised not to use tight fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

 

Triamcinolone Ointment

 


Triamcinolone Ointment Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

TRIAMCINOLONE - TOPICAL

 

(trye-am-SIN-oh-lone)

 

COMMON BRAND NAME(S): Aristocort, Aristocort HP, Kenalog, Triderm

 

USES: This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Triamcinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium- to strong-potency corticosteroid. The potency depends on the strength and the form that you use. For details on the potency of your product, ask your pharmacist.

 

HOW TO USE: Use this medication only on the skin. Do not use it on the face, groin, or underarms unless directed to do so by your doctor.

Wash and dry your hands. Before applying the medication, clean and dry the affected area. Apply a thin film of the medication to the affected area and gently rub in, usually 2 to 4 times daily or as directed by your doctor. Do not cover, bandage or wrap the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes as this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water.

Use this medication only for the condition prescribed. Do not use it for longer than prescribed.

Inform your doctor if your condition persists or worsens.

 

Triamcinolone Ointment


Triamcinolone Ointment Consumer (continued)

SIDE EFFECTS: Burning, itching, irritation, or dryness may occur when this medication is first applied to the skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor promptly if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, greatly increased hair growth, "hair bumps" (folliculitis).

Skin infections can become worse when this medication is used. Notify your doctor if redness, swelling, or irritation do not improve.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before using triamcinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, immune system problems.

Do not use if there is an infection or sore present in the area to be treated.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Other medications in this class pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

 

Triamcinolone Ointment


Triamcinolone Ointment Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: corticosteroids taken by mouth (e.g., prednisone), drugs that suppress the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

Inform all your doctors that you use (or have used) this medication.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

 

Triamcinolone Ointment


Triamcinolone Ointment Patient Information Including Side Effects

Brand Names: Cinolar, Kenalog, Triderm

Generic Name: triamcinolone topical (Pronunciation: trye am SIN oh lone)

 

  • What is triamcinolone topical (Triamcinolone Ointment)?
  • What are the possible side effects of triamcinolone topical (Triamcinolone Ointment)?
  • What is the most important information I should know about triamcinolone topical (Triamcinolone Ointment)?
  • What should I discuss with my healthcare provider before using triamcinolone topical (Triamcinolone Ointment)?
  • How should I use triamcinolone topical (Triamcinolone Ointment)?
  • What happens if I miss a dose (Triamcinolone Ointment)?
  • What happens if I overdose (Triamcinolone Ointment)?
  • What should I avoid while using triamcinolone topical (Triamcinolone Ointment)?
  • What other drugs will affect triamcinolone topical (Triamcinolone Ointment)?
  • Where can I get more information?

 

What is triamcinolone topical (Triamcinolone Ointment)?

Triamcinolone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Triamcinolone topical is used to treat the inflammation caused by a number of conditions such as allergic reactions, eczema, and psoriasis. The dental paste form of triamcinolone is used to treat mouth ulcers.

Triamcinolone topical may also be used for other purposes not listed in this medication guide.

Triamcinolone Acetonide Topical 0.025% Cr-PER

What are the possible side effects of triamcinolone topical (Triamcinolone Ointment)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing triamcinolone topical through your skin or gums:

  • blurred vision, or seeing halos around lights;
  • uneven heartbeats;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • feeling tired.

Less serious side effects may include:

  • skin redness, burning, itching, or peeling;
  • thinning of your skin; or
  • blistering skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about triamcinolone topical (Triamcinolone Ointment)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with triamcinolone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of triamcinolone topical.

Triamcinolone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

Related Drug Centers
  • Triamcinolone Cream
  • Triamcinolone Lotion
  • Triamcinolone Ointment

 

Triamcinolone Ointment


Triamcinolone Ointment Patient Information including How Should I Take

In this Article

  • What is triamcinolone topical (Triamcinolone Ointment)?
  • What are the possible side effects of triamcinolone topical (Triamcinolone Ointment)?
  • What is the most important information I should know about triamcinolone topical (Triamcinolone Ointment)?
  • What should I discuss with my healthcare provider before using triamcinolone topical (Triamcinolone Ointment)?
  • How should I use triamcinolone topical (Triamcinolone Ointment)?
  • What happens if I miss a dose (Triamcinolone Ointment)?
  • What happens if I overdose (Triamcinolone Ointment)?
  • What should I avoid while using triamcinolone topical (Triamcinolone Ointment)?
  • What other drugs will affect triamcinolone topical (Triamcinolone Ointment)?
  • Where can I get more information?

What should I discuss with my healthcare provider before using triamcinolone topical (Triamcinolone Ointment)?

Do not use this medication if you are allergic to triamcinolone.

Before using triamcinolone topical, tell your doctor if you are allergic to any drugs, or if you have:

  • any skin infection, especially tuberculosis infection of the skin;
  • chicken pox or herpes infection (including cold sores);
  • diabetes; or
  • a stomach ulcer.

If you have any of these conditions, you may not be able to use triamcinolone topical, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether triamcinolone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of triamcinolone topical.

How should I use triamcinolone topical (Triamcinolone Ointment)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Triamcinolone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using triamcinolone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

If you are using the dental paste, apply the medication in a thin layer, just enough to cover the mouth ulcer. The paste may stick better if you dry the mouth ulcer before applying the medication.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with triamcinolone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use triamcinolone topical regularly to get the most benefit.

Store triamcinolone topical at room temperature away from moisture and heat.

Related Drug Centers
  • Triamcinolone Cream
  • Triamcinolone Lotion
  • Triamcinolone Ointment

 

 

Triamcinolone Ointment


Triamcinolone Ointment Patient Information including If I Miss a Dose

In this Article

  • What is triamcinolone topical (Triamcinolone Ointment)?
  • What are the possible side effects of triamcinolone topical (Triamcinolone Ointment)?
  • What is the most important information I should know about triamcinolone topical (Triamcinolone Ointment)?
  • What should I discuss with my healthcare provider before using triamcinolone topical (Triamcinolone Ointment)?
  • How should I use triamcinolone topical (Triamcinolone Ointment)?
  • What happens if I miss a dose (Triamcinolone Ointment)?
  • What happens if I overdose (Triamcinolone Ointment)?
  • What should I avoid while using triamcinolone topical (Triamcinolone Ointment)?
  • What other drugs will affect triamcinolone topical (Triamcinolone Ointment)?
  • Where can I get more information?

What happens if I miss a dose (Triamcinolone Ointment)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Triamcinolone Ointment)?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of triamcinolone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using triamcinolone topical (Triamcinolone Ointment)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use triamcinolone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

What other drugs will affect triamcinolone topical (Triamcinolone Ointment)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied triamcinolone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about triamcinolone topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Related Drug Centers
  • Triamcinolone Cream
  • Triamcinolone Lotion
  • Triamcinolone Ointment
Last Updated on Wednesday, 27 June 2012 10:17
 
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