Daktarin Oral Gel

Daktarin Oral Gel

miconazole

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Miconazole
Indications/Uses
Therapeutic & prophylactic treatment of candidiasis of the oropharyngeal cavity & GIT.
Dosage/Direction for Use
Oropharyngeal candidiasis Adult & childn ≥2 yr 2.5 mL qds, divide into smaller portions & apply to the affected area. Continue for at least 1 wk after symptoms disappear. For oral candidiasis, remove dental prostheses at night & brushed w/ the gel. Infant 6-24 mth 1.25 mL qds, divide into smaller portions & apply to the affected area. Continue for at least 1 wk after symptoms disappear. GIT candidiasis Adult w/ difficulty swallowing tab, childn & infant ≥6 mth 20 mg/kg/day in 4 divided doses. Max: 250 mg (10 mL oral gel) qds. Continue for at least 1 wk after symptoms disappear.
Contraindications
Hypersensitivity. Co-administration w/ drugs metabolized by CYP3A4. Liver dysfunction. Infant <6 mth or in those w/ undeveloped swallowing reflex.
Special Precautions
Observe careful monitoring & titration in concomitant use w/ anticoagulants eg, warfarin. Monitor miconazole & phenytoin levels w/ concomitant use. Concomitant use w/ oral hypoglycemics eg, sulfonlyureas.
Adverse Reactions
Dysgeusia; dry mouth, nausea, oral discomfort, vomiting; abnormal product taste. Regurgitation.
Drug Interactions
May increase &/or prolong effects, including adverse effects of drugs metabolised by the CYP3A4 & CYP2C9 enzyme; may inhibit metabolism of CYP3A metabolized drugs eg, substrates known to prolong QT-interval eg, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole & terfenadine; ergot alkaloids; HMG-CoA reductase inhibitors eg, simvastatin & lovastatin; triazolam & oral midazolam. Possible increase or prolongation of the therapeutic outcome &/or adverse effects eg, drugs metabolized by CYP2C9 eg, oral anticoagulants eg, warfarin; oral hypoglycemics eg, sulfonylureas; phenytoin); other drugs metabolized by CYP3A4 eg, HIV protease inhibitors eg, saquinavir; certain antineoplastic agents eg, vinca alkaloids, busulfan & docetaxel; certain Ca-channel blockers eg, dihydropyridines & verapamil; certain immunosuppressive agents eg, cyclosporine, tacrolimus, sirolimus (rapamycin). Alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostasol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil & trimetrexate.
MIMS Class
Oropharyngeal anti-infectives
ATC Classification
A01AB09 - miconazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
Presentation/Packing
Form
Daktarin Oral Gel 2%
Packing/Price
10 g x 1's
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