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Oravig (Miconazole) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

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.

Drugs Metabolized Through CYP2C9 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.

OVERDOSAGE

Overdose with miconazole in humans has not been reported in the literature.

Miconazole absorption and systemic exposure following application of ORAVIG are minimal [ see Clinical Pharmacology (12.3)].

Symptomatic and supportive care is the basis for management.

CONTRAINDICATIONS

ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product.

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