Each vaginal insert contains Clotrimazole, USP 100 mg.
Clotrimazole offers efficient treatment for all vaginal infections caused by Candida species, Torulopsis species, Trichomonas vaginalis and certain gram positive and gram negative microorganisms.
Pharmacology: Pharmacokinetics: Clotrimazole penetrates well into the various skin layers. Six hours after administration its concentrations do not merely attain, but many times exceed the MIC values. No measurable quantities of the active substance could be detected in the serum in absorption studies. A systemic effect need not, therefore, be taken into account.
Vaginal candidiasis, vaginal trichomoniasis, mixed vaginal infections, bacterial vaginitis and infective leucorrhoea.
One Clotrimazole Vaginal Insert to be inserted as deeply as possible in the vagina each evening for 6 consecutive nights. This is best achieved with the applicator when lying on the back with legs pulled in a little towards the body (see Cautions for Usage).
The treatment should not be carried out during menstruation but should be completed before this begins.
Clotrimazole Vaginal Inserts are colourless and do not stain the underwear.
Hypersensitivity to Clotrimazole.
Experimental and clinical investigations do not yield any evidence that effects harmful to the mother or child can be anticipated from the use of Clotrimazole during pregnancy. Particular attention should be paid to hygienization of the birth canal during the last 4-6 weeks of pregnancy.
Skin reactions (irritation, redness, burning and allergic reactions) may occur in very rare cases.
Special Directions For Using the Applicator: 1. Pull out plunger until it stops. Place one Vaginal Insert into the applicator.
2. Insert applicator containing the Insert carefully as deep as possible into the vagina (this is done best by lying on the back).
3. Push plunger until it stops, thereby depositing the Insert into the vagina.
4. After use, remove plunger completely by pulling it out of the applicator.
Thereafter wash both in warm (not boiling) soapy water and dry completely.
Store at temperature not exceeding 30°C.
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.