Contraindications
Hypersensitivity. Oral gel: Infants <4 months or with underdeveloped swallowing reflex. Concomitant use with drugs that prolong QT-interval (e.g. astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole, terfenadine); ergot alkaloid, HMG-CoA reductase inhibitors, triazolam, and oral midazolam.
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Special Precautions
Hepatic impairment. Neonates (when used for skin fungal infections) and children. Pregnancy and lactation. Patient Counselling Avoid contact of topical preparations with the mucosa of the eyes. Avoid inhalation of spray powder. Vaginal preparations may decrease the effectiveness of latex contraceptive agents (e.g. condoms and diaphragms).
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Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylactic reactions, angioedema), serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis), skin irritation.
Gastrointestinal disorders: Nausea, dry mouth, vomiting, oral discomfort, regurgitation, diarrhoea, upper abdominal pain.
General disorders and administration site conditions: Application site reactions (e.g. irritation, burning, warmth, pruritus).
Nervous system disorders: Headache, dysgeusia.
Reproductive system and breast disorders: Dysmenorrhoea, vaginal burning sensation, genital pruritus, vulvovaginal discomfort.
Skin and subcutaneous tissue disorders: Rash, pruritus, skin burning sensation, inflammation, hypopigmentation.
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Drug Interactions
May increase or prolong the therapeutic and adverse effects of warfarin, phenytoin, fosphenytoin, sulfonylureas, saquinavir, vinca alkaloids, busulfan, docetaxel, Ca channel blockers (e.g. dihydropyridines, verapamil), immunosuppressants (e.g. ciclosporin, tacrolimus, sirolimus), carbamazepine, cilostazol, buspirone, disopyramide, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine, reboxetine.
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ATC Classification
D01AC02 - miconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
A01AB09 - miconazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth. A07AC01 - miconazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of intestinal infections. S02AA13 - miconazole ; Belongs to the class of antiinfectives used in the treatment of ear infections. G01AF04 - miconazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections. J02AB01 - miconazole ; Belongs to the class of imidazole derivatives. Used in the systemic treatment of mycotic infections. |