Safety & Tolerability

Contraindications

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

Warnings, Precautions and Adverse Reactions

Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole products, including Oravig. Discontinue Oravig immediately at the first sign of hypersensitivity.

There is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.

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 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.

Adverse Reactions

Adverse Reactions Reported in ≥ 2% of Patients and Healthy Subjects who Received Oravig in Clinical Trials.

(MedDRA v 9.1 System Organ Class and Preferred Term) N = 480 (%)
Patients with at least one AE 209 (43.5)
Gastrointestinal disorders 20.6
   Diarrhea 6.0
   Nausea 4.6
   Abdominal pain upper 2.5
   Vomiting 2.5
Infections and infestations 11.9
Nervous system disorders 10.6
   Headache 5.0
   Dysgeusia 2.9

Discontinuation of Oravig due to adverse drug reactions occurred in 0.6% overall.