Generic Name

Miconazole Nitrate 2% Topical

Precaution

For external use only. Avoid introduction into the eyes. Lactation: not known whether distributed into milk; use caution

Indication

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 externa, mycoses secondarily infected with bacteria.

Contra Indication

History of sensitivity reactions to Miconazole or any of the components of the preparation.

Dose

N/A

Side Effect

Irritation,BurningmMaceration,Allergic contact dermatitis Irritation, burning, maceration, allergic contact dermatitis (all rare)

Pregnancy Category

Mode of Action

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

Interaction

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.

Pregnancy Category Note

Pregnancy Category: C Lactation: not known whether distributed into milk; use caution

Adult Dose

Topical/Cutaneous Adult: Tinea cruris, corporis & cutaneous canidiasis: Apply to affected area BID for 2 weeks Tinea versicolor: Apply once daily to affected area for 2 weeks Tinea pedis: Apply BID to affected area for 4 weeks

Child Dose

Tinea <2 years: Safety and efficacy not established >2 years: Apply BID for up to 1 month

Renal Dose

N/A

Administration

N/A