Clotrimazole is a synthetic imidazole derivative with a broad-spectrum antimycotic action. Clotrimazole inhibits the biosynthesis of ergosterol, a major component of the cell membrane of yeast and fungal cells. It replaces the precursor lanosterol as a substrate for the fungal cytochrome P450 enzyme lanosterol-14- demethylase which catalyzes the conversion of lanosterol to ergosterol. This action alters the permeability of fungal cell walls. At fungistatic levels the main effect is inhibition of ergosterol synthesis but at higher concentrations there is an additional mechanism of membrane damage unrelated to sterol synthesis. Clotrimazole cream has a reliable action on dermatophytes, yeast and other fungi.

Indications

The confirmed indications for Clotrimazole cream include:
1. All dermatomycoses due to dermatophytes (e.g. Trichophyton species).
2. All dermatomycoses due to yeasts (Candida Species).
3. Dermatomycoses due to moulds and other fungi.
4. Skin diseases showing superinfections with these fungi.
The above mentioned dermatomycoses include interdigital mycoses (e.g. athlete's foot), paronychias (associated with nail mycoses), mycoses in skin folds, candida vulvitis, candida balanitis, pityriasis versicolor, and erythrasma.

Dosage and Administration

Wash skin with soap and water and dry thoroughly. Apply a thin layer of the cream 2-3 times daily and gently massage over affected area as directed by the doctor. For athlete's foot, pay special attention to the spaces between the toes. Best results in athlete's foot and ringworm are usually obtained with 4 weeks use of this product and in jock itch with 2 weeks use. The cream should be applied two or three times daily for one month for at least two weeks after the disappearance of all signs of infection. If satisfactory results have not occurred within these times, consult a doctor. For best results, follow directions and continue treatment for length of time indicated. The duration of treatment varies; it depends among other factors on the extent and localization of the disease. Recommended Duration of Treatment: 3-4 weeks for dermatomycoses, 1-2 weeks for candida vulvitis and candida balanitis, and approximately 3 weeks for erythrasma and pityriasis versicolor. In fungal infection of the feet, to prevent relapses, treatment should be continued for about 2 weeks beyond the disappearance of all sings of disease.


Side Effects

When applied topically Clotrimazole cream is well tolerated. Some patients using topical Clotrimazole cream reported local pruritus or burning. Allergic contact dermatitis has been reported as a result of topical Clotrimazole.

Contraindications
Known sensitivity or allergy to any ingredient of the product.

Drug interactions
Antagonism between imidazoles (including Clotrimazole) and polyene antibiotics in vitro has been reported. Induction of hepatic microsomal enzymes by Clotrimazole is not a problem with topical therapy.

Precautions

No information is available on the use of Clotrimazole in neonates and elderly. There is no information about the safety of this medicine during pregnancy. The extent to which Clotrimazole is excreted in breast milk is not known, but problems in humans have not been encountered. The cream is used to treat fungal infections of the penis or vagina may damage latex condoms and diaphragms. The effectiveness of these contraceptives may consequently be reduced, so alternative contraceptive precautions should be taken for at least five days after using this product. This preparation is for external use only.

Overdosage
Acute overdosage with topical application of Clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.

Pharmaceutical Precautions
Store in a cool dry place protected from light. Keep out of reach of children.

Commercial Packs
Tinazol® cream: Each gram cream contains 10 mg Clotrimazole BP and each tube contains 10 g cream.