Dosing and uses of Oravig (miconazole oral)
Adult dosage forms and strengths
buccal tablet
- 50mg
Oropharyngeal Candidiasis
Indicated for local treatment of oropharyngeal candidiasis
Apply 50 mg buccal tab to gum region qDay for 14 consecutive days
Buccal tablet designed to adhere to the gum; do not to crush, chew, or swallow the tablet
Pediatric dosage forms and strengths
buccal tablet
- 50mg
Oropharyngeal Candidiasis
Indicated for local treatment of oropharyngeal candidiasis
<16 years: Safety and efficacy not established
16 years or older: As adults; Apply 50 mg buccal tab to gum region qDay for 14 consecutive days
Buccal tablet designed to adhere to the gum; do not to crush, chew, or swallow the tablet
Oravig (miconazole oral) adverse (side) effects
1-10%
Diarrhea (6%)
Nausea (4.6%)
Headache (5%)
Dysgeusia (2.9%)
Upper abdominal pain (2.5%)
Vomiting (2.5%)
Warnings
Contraindications
Hypersensitivity to miconazole or other components
Milk protein allergy
Cautions
Monitor closely in patients with history or allergic reaction to other azole antifungals; discontinue immediately at first sign of hypersensitivity
No formal drug interaction studies have been performed with miconazole buccal administration
Coadministration of miconazole (topical, intravaginal, oral administration) with warfarin has resulted in enhancement of anticoagulant effect; closely monitor for evidence of bleeding, prothrombin time, and INr
Known CYP2C9 and CYP3A4 inhibitor; although the systemic absorption is minimal and plasma concentrations are substantially lower than when given IV, the potential for interaction with drugs metabolized via CYP2C9 and CYP3A4 (eg, oral hypoglycemics, phenytoin, ergot alkaloids) cannot be ruled out
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk, caution advised
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Oravig (miconazole oral)
Mean maximum salivary concentration: (7 hr after application) 15 mcg/mL
Average saliva exposure: AUC 55.23 mcg-hr/mL
Plasma concentration: below lower limit of quantification (even after 7 days)
Metabolism: Absorbed miconazole metabolized by liver (<1%); no active metabolites
Half-life: (following systemic administration) 24 hr
Mechanism of action
Azole antifungal agent; inhibits enzyme cytochrome P450 14-alpha-demethylase resulting in ergosterol synthesis inhibition
