Generic Name and Formulations:
Miconazole 50mg; buccal tablet.

Company:
Praelia Pharmaceuticals
Indications for ORAVIG:
Local treatment of oropharyngeal candidiasis.

Adult:
Do not crush, chew, or swallow. Alternate application site. Apply to upper gum region, hold in place for 30 seconds to ensure adhesion. ≥16yrs: 50mg once daily in the AM for 14 consecutive days.

Children:
<16yrs: not recommended.

Pharmacological Class:
Azole.

Contraindications:
Allergy to milk protein concentrate.

Warnings/Precautions:
History of hypersensitivity to azoles; monitor and discontinue if allergic reactions develop. Hepatic Impairment. Pregnancy (Cat.C). Nursing mothers.

Interactions:
May potentiate anticoagulant effects with warfarin (monitor PT, INR, evidence of bleeding). Caution with drugs metabolized by CYP2C9 and CYP3A4 (eg, oral hypoglycemics, phenytoin, ergot alkaloids).

Adverse Reactions:
Diarrhea, headache, nausea, dysgeusia, upper abdominal pain, vomiting, possible allergic reactions.

How Supplied:
Buccal tabs—14