Each gram of cream contains 2.0% w/w miconazole nitrate with 0.16% w/w of chlorocresol as preservative.
Pharmacology: Pharmacodynamics: Miconazole is an imidazole antifungal agent which interferes with ergosterol synthesis and therefore alters the permeability of the cell membrane of sensitive fungi.
Pharmacokinetics: Miconazole has shown fungistatic activity, in vitro, against a number of fungi causing systemic mycoses such as Coccidioides immitis, Histoplasma capsulatum, Blastomyces dermatitides and Cryptococcus neoformans. Miconazole appears to act on the fungal cell wall and membranes inducing permeability changes which alter the ionic macromo lecular composition of the effected cells. At high concentrations, Miconazole has shown fungicidal activity against various organisms. Miconazole readily penetrates the stratum corneum into the blood. Absorption is no more than 1.3% from the vagina.
For treatment of Tinea pedis (athlete's foot), tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum, in the treatment of cutaneous candidiasis (moniliasis) and in the treatment of tinea versicolor.
Skin infection: Apply once or twice daily for 2-5 weeks.
Nail infection: Apply once daily. Treatment should be continued at least one week after disappearance of all signs and symptoms.
Overdosage with Miconazole nitrate in humans has not been reported to date.
It is contraindicated in individuals who are hypersensitive to any of the components.
If irritation or sensitivity occurs, treatment should be discontinued.
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
Avoid contact with eyes and mucous membranes (for external use only). Advise to consult doctor if there is no improvement in 4 weeks (for athlete's foot) or 2 weeks (for jock itch). Prolonged use of Miconazole, like any topical antimicrobial agent, may give rise to overgrowth of non susceptible organisms.
Use during pregnancy: Safety for use in pregnancy has not been established. Since Miconazole nitrate is absorbed in small amounts following topical administration, the drug should be used in the first trimester of pregnancy only if in the judgement of the treating clinician such treatment is considered essential to the welfare of the patient and the expected benefits outweigh any potential risks.
Use during lactation: It is not known whether or not Miconazole nitrate is excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing mother.
Adverse effects from topical application to the vagina include burning, itching or irritation in about 7% of recipients and infrequently pelvic cramps (0.2%), headache, hives or skin rash. Irritation, burning and maceration are rare after cutaneous application.
Miconazole is considered safe for use during pregnancy, although vaginal use should be avoided during the first trimester.
Keep container well closed. Protect from strong light. Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
D01AC02 - miconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Decozol cream 2%
15 g x 1's
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