Composition
Each gram Cream Contains Miconazole Nitrate BP 10 mg.
Pharmacology
Miconazole is a broad-spectrum antimycotic which offers a high antifungal activity against dermatophytes, Yeasts and other phyco-Asco and adelomycetes, with a potent antibacterial activity against Gram-positive bacilli and cocci. Fungidal proved to be markedly effective in secondary infected mycoses, which under other treatments were resistant or reappeared.
Indications
Skin and nail infections due to dermatophytes, yeasts, and other fungi such as; Tinea capitis, corporis, manuum, pedis, barbae, cruris, unguium or onychomycosis. Pityriasis versicolor, candidiasis of skin and nails, stomatitis angularis, otitis eterna. Since Mitigal has an antibacterial effect on Gram-positive bacteria, it may be used in mycoses secondarily infected with such bacteria.
Dosage & Administration
The dosage is the same for all ages.
For skin infections: Apply some cream to the lesions twice daily and rub it well with finger until it has fully penetrated the skin. All lesions usually disappear after 2 to 5 weeks. Prolong treatment for some 10 days to prevent relapse.
For nail infections: Clip infected nail as shortly as possible. Apply some cream once daily to the infected nail and rub with your finger, and cover nail with a non-perforated occlusive plastic bandage. Also after loosening of the infected nail (from 2-3 weeks onwards) uninterrupted treatment should be continued until the growth of a new nail has set in and a definite cure can be observed (usually after seven months or more).
Cornaindication
No contraindication is known.
Warnings & Precautions
If the concomitant use of Miconazole and anticoagulant is considered, the anti-coagulant effect should be monitored and titrated. Miconazole and phenytoin plasma levels should also be monitored when used concomitantly. In infants and young children, caution must be taken to ensure that the gel does not obstruct the throat.
Side Effect
Occasionally nausea and vomiting, diarrhea with long-term use, and rarely allergic reactions.
Pregnancy & Lactation
There is no information regarding the safety of Miconazole oral gel during pregnancy. So Miconazole oral gel should be avoided in pregnant women if possible or the potential hazards should be balanced against the possible benefits. As many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing woman.
Drug Interaction
- Concomitant treatment with Terfenadine, Astemizole and Cisapride should be avoided because in vitro studies suggest that Miconazole may inhibit their metabolism, so these products miqht precipitated.
- Miconazole may delay Phenytoin and Cyclosporine metabolism and this might precipitate Phenytoin and Cyclosporine toxicity, respectively.
Overdose
Accidental overdosage may cause vomiting and diarrhea. Treatment is symptomatic and supportive. A specific antidote is not available.
Storage
Store in a cool & dry place below 30°C. Keep away from light and moisture. Keep all medicines out of the reach of children.
Packing
Mitigal Cream: Each pack has an aluminum tube containing 10-gram of cream
