Full Prescribing Info
COTREN VAGINAL TABLETS 100 mg: Each tablet contains: Clotrimazole 100 mg.
COTREN VAGINAL TABLETS 500 mg: Each tablet contains: Clotrimazole 500 mg.
Pharmacology: The drug acts by binding with phospholipids in cell membrane of susceptible fungi with a resultant change in membrane permeability.
Pharmacokinetics: Small amounts of clotrimazole are absorbed systemically when the drug is administered intravaginally. About 3-10% of an intravaginal dose of the drug reaches systemic circulation, principally as metabolites. The finding of low clotrimazole concentrations in serum and high concentration in vaginal secretions suggest that it remains in the vagina for 48 hours, and in some cases 72 hours, in fungicidal concentration.
Microbiology: Cotren inhibits or kills many fungi, including yeasts and dermatophytes; it is also effective against trichomonas vaginalis.
Vaginal infections caused by fungi-mainly candida and/or trichomonas.
Dosage/Direction for Use
First infections: In general, 2 Cotren vaginal tablets (100 mg) are inserted as deeply as possible into the vagina on three consecutive nights or 1 tablet of Cotren vaginal tablets (500 mg) as a single dose inserted deep in vaginal.
Reinfections: In general, 1 Cotren vaginal tablet (100 mg) is inserted as deeply as possible into the vagina on six consecutive nights. If necessary, 2 Cotren vaginal tablets daily, first in the morning and the second in the evening for 6-12 days.
This dose is only acceptable for non-pregnant patients.
Treatment should be timed so as to avoid the menstrual period and be finished before the onset of menstruation.
No symptom of overdosage has been reported. Should they occur, symptomatic treatment should be provided.
Hypersensitivity to Clotrimazole or any components of the preparation.
Special Precautions
Cotren may reduce the effectiveness of latex products such as condom; however it temporarily occurs only during treatment.
Use in Pregnancy: Cotren vaginal tablets should not be used with the applicator during pregnancy.
Use In Pregnancy & Lactation
Cotren vaginal tablets should not be used with the applicator during pregnancy.
Side Effects
Skin reactions (irritation, redness, burning and allergic reactions) may occur in very rare cases.
Store at a temperature not exceeding 30°C.
Shelf-Life: 5 years.
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Vag tab 100 mg (arrowhead shaped, biconvex, white, impressed "COTREN" on one side) x 20 x 6's. 500 mg (bullet shaped, biconvex, white, impressed "BIOLAB" on one side and "500" on the other) x 1 x 1's.
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