Fungusol Cream

Therapeutic Class

Antifungals, Topical

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Cream (NRN: 04-2045): Miconazole nitrate BP 2% w/w.

Pack: 20 g (in tube).

Lotion (NRN: 04-1486): Miconazole nitrate BP 2% w/v.

Pack: 50 mL.

Powder (NRN: 04-1324): Miconazole nitrate BP 2% w/w

Pack: 20 g.

Pharmacology

Miconazole nitrate is a synthetic antifungal agent. It is an imidazolinyl methyl derivative of bis – (2, 4 – dichlorobenzyl) ether. It interferes with the permeability of the fungal cell membrane and has a broad antifungal spectrum of activity, possessing also some anti-bacteria activity.

Miconazole inhibits the growth of the common dermatophytes namely Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum; the yeast-like fungus, Candida albicans and the organism responsible for tinea versicolor (Malessezia furfur). It also has in-vitro activity against Cladosporium madurilia, Phialophora species, Pseudollescheria boydii and gram positive bacteria including Staphylococci and Streptococci.

Indications

Treatment of fungal infection of the skin and nails. These include tinea pedis (athlete’s foot), tinea corporis caused byTrichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum; cutaneous candidiasis (moniliasis), tinea versicolor, ringworm, onychomycosis and vaginal candidiasis.

Contra-indications

Hypersensitivity to Miconazole or any of the ingredients.

Precautions/Warnings

If reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. There have been isolated reports of local irritation and allergic contact dermatitis with the use of Miconazole nitrate.

Interactions

The major interactions are with Astemizole, Warfarin and Terfenadine.

Adverse Effects

Unlike nystatin, some miconazole is absorbed by the intestinal tract when used orally (and possibly if used vaginally); this may lead to drug interactions.

Interactions are possible with anticoagulants, phenytoin, terbinafine, some newer atypical antipsychotics, cyclosporin and some statins used to treat hypercholesterolemia.

Dosage & Administration

Apply twice daily (morning and evening) to the affected area in patients with tinea pedis, tinea corporis, and cutaneous candidiasis. It should be used once a day in patients with tinea versicolor.

Candida infections, tinea cruris and corporis should be treated for two weeks after relief of symptoms and tinea pedis for one month in order to reduce the possibility of re-occurrence.

Storage/Handling Recommendations

Keep all medicine in a cool dry place.

Keep out of the reach of children.