Clotrimazole

Cisapride is metabolised by the enzyme CYP3A4 in the liver. Because azoles inhibit this enzyme, concomitant administration of cisapride with these substances such as clotrimazole may increase the risk of heart rhythm disturbances (prolongation of QT interval, ventricular arrhythmias, TORSADE DES POINTES). Therefore, cisapride should not be co-administered with clotrimazole.

Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses.

At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted.

At the low systemic exposures of clotrimazole following vaginal treatment, harmful effects with respect to reproductive toxicity are not predicted. During pregnancy the treatment should be carried out with clotrimazole pessary, since these can be inserted without using an applicator.

Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

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.

Clotrimazole has no or negligible influence on the ability to drive or use machines.

The following adverse drug reactions are based on spontaneous reports, thus the frequency of individual events is not known (cannot be estimated from data).

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

Very rarely, systemic hypersensitivity reactions may occur.

Reproductive system and breast disorders: genital peeling, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage.

Gastrointestinal disorders: abdominal pain.

General disorders and administration site conditions: Administration site pain, oedema peripheral (at administration site).

Skin and subcutaneous tissue disorders: Dermatitis contact, dermatitis allergic, erythema, pruritus, rash, urticaria, blister, skin exfoliation, eczema, dry skin, skin irritation, skin maceration, skin burning sensation.

These side effects are reversible after discontinuation of the treatment.