Cotren Vaginal Tablet

Clotrimazole.

Cotren 100 mg vaginal tablets contain Clotrimazole 100 mg.
Cotren 500 mg vaginal tablets contain Clotrimazole 500 mg.

PHARMACOLOGY: Pharmacodynamics: Clotrimazole exerts its antifungal activity by altering cell membrane permeability, apparently by binding with phospholipids in the fungal cell membrane. As a result of alteration of permeability, the cell membrane is unable to function as a selective barrier, and potassium and other cellular constituents are lost.
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.

Candidal vulvovaginitis caused by fungi usually Candida and Trichomonas.

The recommended dose of Clotrimazole 500 mg vaginal tablets for candidal vulvovaginitis is a vaginal suppository intravaginally for one day at bedtime. Alternatively, therapy with Clotrimazole 100 mg vaginal tablet, 2 vaginal tablets may be inserted into the vagina at bedtime for 3 consecutive nights. The Clotrimazole vaginal tablets should be inserted as deeply.
The recommended dose of Clotrimazole vaginal tablets for recurrent candidal vulvovaginitis is a 100 mg vaginal suppository intravaginally once daily at bedtime for 6 consecutive nights. The Clotrimazole vaginal tablets should be inserted as deeply.
Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation. Experimental and clinical investigations give no indication that Clotrimazole has any harmful effects on the mother and child when administered during pregnancy. Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy.

Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation. There is no specific antidote.

Clotrimazole is contraindicated in patients who are hypersensitive to the drug or any ingredient in the formulation.

If candidal vulvovaginitis does not improve within 3 days or if the condition persists beyond 7 days during self-medication with Clotrimazole vaginal tablets, the patient should consult a physician.
If symptoms of candidal vulvovaginitis recur within 2 months of using Clotrimazole vaginal tablets for self-medication, the patient should consult a physician.
Patients who are considering use of Clotrimazole vaginal tablets for self-medication should be advised not to use the drug if they have abdominal pain, fever or malodorous vaginal discharge.
Patients who are considering use of Clotrimazole vaginal tablets for self-medication should also be advised not to use the drug if vaginal pruritus or discomfort is occurring for the first time.
Intravaginal preparations of Clotrimazole may damage latex contraceptives and additional contraceptive measures are therefore necessary during local application.

Pregnancy: Category B.
In clinical trials, use of vaginally applied Clotrimazole in pregnant women in their second and third trimester has not been associated with ill effects. However, one study did find a significant increase in the risk spontaneous abortions (SABs) with first trimester vaginitis treatment. A later study speculated that this effect might have been due to inhibition of the critical enzyme aromatase. Until there are more data regarding this possible association, the best course is to avoid to use of Clotrimazole for vaginitis treatment in the first trimester.
Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clotrimazole is used by a nursing women.

Mild burning has occasionally occurred in patients receiving Clotrimazole vaginal tablets; rarely, itching, vulvar irritation or lower abdominal cramps, have been reported.

Progesterone: Antifungal Agent (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination.

Store at temperature not exceeding 30°C.

Preparations for Vaginal Conditions

G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.

E