Dakrin 15gm

Oral treatment and prevention of fungal infections of the oropharynx and gastrointestinal tract, and of super infections due to Gram-positive bacteria.

The active ingredient, Miconazole, is a synthetic imidazole anti-fungal agent with a broad spectrum of activity against pathogenic fungi (including yeast and dermatophytes) and gram-positive bacteria (Staphylococcus and Streptococcus spp). It may act by interfering with the permeability of the fungal cell membranes. When administered orally, Miconazole is incompletely absorbed from the gastrointestinal tract, peak plasma levels of about 1 µg per ml have been achieved after a dose of 1 gm per day. Miconazole is inactivated in the body and 10-20% of an oral dose is excreted in the urine, mainly as metabolites, within 6 days. About 50% of an oral dose may be excreted unchanged in the faeces.

For oral administration: Dosage is based on 15 mg/kg/day.

• Adults: 1-2 tea-spoonfuls of gel four times daily
• Children aged 6 years and over: One tea-spoonful of gel four times daily
• Children aged 2-6 years: One tea-spoonful of gel twice daily
• Infants under 2 years: Half tea-spoonful of gel twice daily.

For localised lesions of the mouth: A small amount of gel may be applied directly to the affected area with a clean finger. For topical treatment of the oropharynx, the gel should be kept in the mouth for as long as possible. Treatment should be continued for up to 2 days after the symptoms have cleared.

For oral candidasis, dental prostheses: Should be removed at night and brushed with the gel.

Miconazole can inhibit the metabolism of drugs metabolised by the Cytochrome P450-3A and -2C9 families. This can result in an increase or prolongation of their effects, including side effects. Miconazole Oral Gel should not be used during treatment with the following drugs: terfenadine, astemizole,mizolastine, cisapride, triazolam, oral midazolam, dofetilide, quinidine, pimozide, CYP3A4 metabolised HMG-CoA reductase inhibitors such as simvastatin and lovastatin.

Miconazole is contraindicated in patients with known hypersensitivity to the active drug.

Occasionally, nausea and vomiting have been reported, and with long term treatment, diarrhoea. In rare instances, allergic reactions have been reported. There are isolated reports of hepatitis, for which the causal relationship with Miconazole has not been established.

In animals, Miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown. However, as with other imidazoles, Miconazole Oral Gel should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits. It is not known whether Miconazole is excreted in human milk. Caution should be exercised when prescribing Miconazole Oral Gel to nursing mothers.