Generic Name and Formulations:
Miconazole 50mg; buccal tablet.
Midatech Pharma US Inc.
Indications for ORAVIG:
Local treatment of oropharyngeal candidiasis.
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.
<16yrs: not recommended.
Allergy to milk protein concentrate.
History of hypersensitivity to azoles; monitor and discontinue if allergic reactions develop. Hepatic Impairment. Pregnancy (Cat.C). Nursing mothers.
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).
Diarrhea, headache, nausea, dysgeusia, upper abdominal pain, vomiting, possible allergic reactions.
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