Each gram of Candazole Cream contains 10 mg of clotrimazole in a white cream base.
Excipients/Inactive Ingredients: Benzyl alcohol, cetyl palmitate, cetostearyl alcohol, sorbitan monostearate, polysorbate 60, isopropyl myristate and purified water as excipients.
Pharmacology: Pharmacodynamics: Clotrimazole is a broad-spectrum imidazole anti-fungal against dermatophytes, including Epidermophytes, Microsporum, Trichophyton spp and Malassezia furfur and Candida species.
It permeates the chitin of the fungal cell wall and increases the membrane permeabililty to various intracellular substances. Most strains of dermatophytes and Candida species are inhibited by concentrations of less than 2 mcg/ml.
Pharmacokinetics: Clotrimazole is effective against a variety of fungi including Epidermophytes, yeast, Microsporum, Trichophyton spp., and Malassezia furfur. When applied topically, clotrimazole penetrates the epidermis. Actinomycetes, gram-positive bacteria, certain anaerobes (such as Bacteroides fragilis) and Trichomonas vaginalis are also inhibited. Absorption of clotrimazole is less than 0.5% after application to the intact skin. The small amount absorbed is metabolized in the liver to inactive compounds and excreted in the bile and urine.
Topical treatment of tinea pedis, tinea cruris, tinea corporis due to Trichophytes rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; tinea versicolor due to Malassezia furfur; erythrasma; candidiasis due to Candida albicans including cutaneous candidiasis, paronychia, external genital candidiasis and candidal balanitis.
Wash and dry affected areas. Apply sparingly on the affected parts and surrounding skin areas twice daily, morning and evening. Regular applications are essential for successful treatment. Treatment should be continued for two weeks after all clinical signs have disappeared. Attention to hygiene is important in the management of fungal diseases, particularly of the folds and the feet. If no improvement is seen after 4 weeks, diagnosis should be reviewed.
After topical application to the skin clotrimazole penetrates the epidermis and deeper layers of the skin but less than 0.5% of the dose is absorbed systemically. No information is available concerning overdosage in human beings following topical application.
Hypersensitivity to clotrimazole, or any component in the preparation.
If irritation or sensitivity occurs, treatment should be discontinued. Avoid contact with eyes and mucous membranes (for external use only). Consult doctor if no improvement is seen in 4 weeks (for athlete's foot) or 2 weeks (for jock itch).
Use in children: Do not use on children under 2 years of age except under the advice and supervision of a doctor.
In the first trimester of pregnancy, clotrimazole should only be used when considered essential to the welfare of the patient. It is not known whether clotrimazole is excreted in breast milk or whether it has a harmful effect on the newborn.
In a small fraction of recipients, clotrimazole when applied topically may cause stinging, erythema, oedema, vesiculation, desquamation, pruritus and urticaria.
Keep containers well closed. Protect from strong light. Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
D01AC01 - clotrimazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Candazole cream 1%
15 g x 1's
Candazole lotion 1%
10 mL x 1's
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