CLOTRIMADERM Vaginal cream Ref.[27831] Active ingredients: Clotrimazole

General

Clotrimaderm Vaginal cream and Clotrimaderm External Cream are not for ophthalmic use. Patients should seek medical advice if they have frequent vaginal infections or if their yeast infection returns in less than 2 months.

Patients should seek medical advice if they suffer from diabetes mellitus, or have underlying immunodeficiency disease (such as HIV-AIDS).

As with all topical agents, skin sensitization may result. Use of Clotrimaderm External Cream topical preparations should be discontinued should such reactions occur, and appropriate therapy instituted.

Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation.

While sexual relation may be had during treatment with clotrimazole topical preparations, most couples wait until treatment has finished as the partner could become infected.

Effects on Fertility

No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility.

Special Populations

Pregnant Women

There are limited amounts of data from the use of clotrimazole in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see REPRODUCTION AND TERATOLOGY). Although intravaginal application of clotrimazole hasshown negligible absorption from both normal and inflamed human vaginal mucosa, Clotrimaderm Vaginal cream should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient. The use of applicators may be undesirable in some pregnant patients.

Nursing Women

Available pharmacodynamics/toxicologicalstudies in animals have shown excretion of clotrimazole/metabolitesin milk. Breastfeeding should be discontinued during treatment with clotrimazole.

Adverse Drug Reaction Overview

Experimental, therapeutic, and large scale clinical studies have shown clotrimazole to be well tolerated after topical application.

For Clotrimazole External Cream

Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticarial)

Skin and subcutaneous skin disorders: blisters, discomfort/pain, edema, erythema, irritation, peeling/exfoliation, pruritis, rash, stinging/burning.

For Clotrimazole Vaginal Cream

Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticaria).

Reproductive system disorders and breast disorders: genital peeling, pruritis, edema, erythema, stinging, blistering, discomfort, general irritation of the skin and pelvic pain, vaginal hemorrhage.

Gastrointestinal disorder: abdominal pain.

Two of 419 (0.5%) patients treated with the 1% vaginal cream experienced adverse reactions judged to be possibly drug related. These were intercurrent cystitis and vaginal burning. Neither necessitated discontinuation of treatment. None were of serious consequence and no complications occurred.

In clinical trials, 2/217 patients (0.9%) who received 2% clotrimazole vaginal cream experienced an adverse reaction. Most adverse reactions involved local itching and burning. Only rarely was it necessary to discontinue treatment.

Overview

Concomitant medication with vaginal Clotrimazole and oral tacrolimus/sirolimus (immunosuppressants) might lead to increased tacrolimus/sirolimus plasma levels. Patients should thus be thoroughly monitored for symptoms of tacrolimus/sirolimus overdosage.