Oropharyngeal & Esophageal Candidiasis. Hypersensitivity; hepatic impairment. Porphyria.

Aural Anti-fungal preparations

Miconazole is a synthetic broad spectrum anti-fungal agent and acts against pathogenic fungi including yeast and dermatophytes and gram-positive bacteria (Staphylococcus and Streptococcus spp). It acts by inhibiting membrane sterol synthesis and interfering with the permeability of the fungal cell membranes.

Administration: Buccal tablet designed to adhere to the gum; do not to crush, chew, or swallow the tablet. Adult Dose: Oropharyngeal & Esophageal Candidiasis. 1 buccal tablet once daily (apply in the morning) for 7-14 days. Child Dose: <16 years: Safety and efficacy not established 16 years or older: 1 buccal tablet once daily (apply in the morning) for 7-14 days.

May increase anticoagulant effect of warfarin. May increase or prolong the effect of the following drugs: Oral hypoglycaemics (e.g. sulfonylureas), phenytoin, HIV protease inhibitors (e.g. saquinavir), antineoplastic agents (e.g. vinca alkaloids, busulfan, docetaxel), Ca channel blockers (e.g. dihydropyridines, verapamil), immunosuppressive agents (e.g. ciclosporin, tacrolimus, sirolimus), carbamazepine, cilostazol, buspirone, disopyramide, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine. Potentially Fatal: Increased risk of cardiac arrhythmia w/ astemizole, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole, terfenadine. May increase exposure to ergot alkaloids leading to ergotism. May increase the risk of rhabdomyolysis w/ HMG-CoA reductase inhibitors (e.g. simvastatin and lovastatin). May increase the effect of triazolam and oral midazolam.

Hypersensitivity; hepatic impairment. Porphyria.

1-10% Diarrhea (6%),Nausea (4.6%),Headache (5%),Dysgeusia (2.9%),Upper abdominal pain (2.5%),Vomiting (2.5%)

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.

Precaution: Discontinue if sensitization or irritation occurs. Pregnancy and lactation. Lactation: Unknown whether distributed in breast milk, caution advised

keep in a dry place away from light and heat. Keep out of the reach of children.

Miconazole inhibits ergosterol synthesis thus damaging fungal cell wall membrane and increases its permeability, allowing leakage of nutrients.