Miconazole
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From MedlinePlus, U.S. National Library of Medicine
Azole Antifungal
Dosing in kidney impairment
Renal Impairment Less than 1% of miconazole is excreted as unchanged drug in the urine; therefore, no adjustment to therapy is necessary in patients with renal impairment.
Dosing in liver impairment
Hepatic Impairment Miconazole is metabolized by the liver. While miconazole systemic exposure is minimal following the application of ORAVIG, ORAVIG should be administered with caution in patients with hepatic impairment.
Preparation and administration
Administration Instructions ORAVIG should be applied in the morning, after brushing the teeth. The tablet should be applied with dry hands. The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion.
The tablet is round on one side for comfort, but either side of the tablet can be applied to the gum. Once applied, ORAVIG stays in position and gradually dissolves. [ See Clinical Pharmacology ] Subsequent applications of ORAVIG should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away any remaining tablet material.
In addition, ORAVIG should not be crushed, chewed or swallowed. Food and drink can be taken normally when ORAVIG is in place but chewing gum should be avoided. If ORAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet still does not adhere, a new tablet should be placed.
If ORAVIG is swallowed within the first 6 hours , the patient should drink a glass of water and a new tablet should be applied only once. If ORAVIG falls off or is swallowed after it was in place for 6 hours or more, a new tablet should not be applied until the next regularly scheduled dose. [ see Patient Counseling Information ].
Drug interactions
Check miconazole against a medication listLabel text (3 paragraphs)
Warfarin: Miconazole may enhance anticoagulant effect. Monitor prothrombin time, INR, and watch for bleeding (7.1).
7.1 Warfarin Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Cases of bleeding and bruising following the concomitant use of warfarin and topical, intravaginal, or oral miconazole were reported. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if ORAVIG is administered concomitantly with warfarin. Also monitor for evidence of bleeding.
7.2 Drugs Metabolized Through CYP 2C9 and 3A4 No formal drug interaction studies have been performed with ORAVIG. Miconazole is a known inhibitor of CYP2C9 and CYP3A4. Although the systemic absorption of miconazole following ORAVIG administration is minimal and plasma concentrations of miconazole are substantially lower than when given intravenously, the potential for interaction with drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics, phenytoin, or ergot alkaloids cannot be ruled out.
Contraindications
4 CONTRAINDICATIONS ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product. Known hypersensitivity to miconazole, milk protein concentrate, or any other component of the product.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal data, ORAVIG may cause fetal harm when administered to pregnant women. There are no available data on ORAVIG use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, prolonged gestation, dystocia and/or increased number of resorptions were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. (See Data). Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Miconazole nitrate administered orally at doses of 80 mg/kg/day or higher to pregnant rats or rabbits crossed the placenta and resulted in embryo- and fetotoxicity, including increased fetal resorptions. These doses also resulted in prolonged gestation and dystocia in rats, but not in rabbits.
Embryofetotoxicity was not observed in intravenous studies with miconazole at lower doses of 40 mg/kg/day in rats and 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIG buccal tablet, based on body surface area comparisons. Teratogenicity was not reported in any animal study with miconazole.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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