Version July 2025
Candidiasis, oropharyngeal, mild disease (alternative agent): Buccal: 50 mg (1 tablet) applied to the upper gum region (canine fossa) once daily for 7 to 14 days (Ref).
No dosage adjustment necessary.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
Refer to adult dosing.
(For additional information see "Miconazole (oral): Pediatric drug information")
Candidiasis, oropharyngeal, mild disease (alternative agent): Adolescents: Limited data available in ages <16 years: Buccal tablet: 50 mg (1 tablet) applied to the upper gum region (canine fossa) once daily for 7 to 14 days (Ref).
Altered kidney function:
Adolescents ≥16 years: Buccal: No dosage adjustment necessary.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; systemic exposure following buccal miconazole administration is minimal, but miconazole is metabolized by the liver.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Gastrointestinal: Gastrointestinal signs and symptoms (21% to 26%; including diarrhea [6% to 9%], nausea [5% to 7%], upper abdominal pain [2% to 3%], vomiting [3% to 4%], xerostomia [3%])
Infection: Infection (12% to 16%; including gastroenteritis [1%], upper respiratory tract infection [2%])
Local: Application-site reaction (12%; including burning sensation of mouth, gingival pain, gingival swelling, glossalgia, mouth pain, oral discomfort, oral itching [gingival], oral mucosa ulcer, tongue ulcer, toothache)
Nervous system: Neurological signs and symptoms (11% to 13%; including ageusia [2%], dysgeusia [3%], fatigue [3%], headache [5% to 8%])
1% to 10%:
Hematologic & oncologic: Hematologic abnormality (7%; including anemia [3%], lymphocytopenia [2%], neutropenia [<1%])
Hepatic: Increased gamma-glutamyl transferase (1%)
Nervous system: Pain (1%)
Respiratory: Pulmonary signs and symptoms (5%; including cough [3%], pharyngitis [<1%])
Postmarketing: Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)
Hypersensitivity to miconazole, milk protein concentrate, or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylactic reactions, have been reported. There is no information regarding cross-reactivity between miconazole and other azole antifungals.
Disease-related concerns:
• Hepatic impairment: Although systemic absorption is typically minimal, use with caution in patients with hepatic impairment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Buccal:
Oravig: 50 mg [contains corn starch, milk protein concentrate]
No
Tablets (Oravig Buccal)
50 mg (per each): $102.69
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Apply in the morning after brushing teeth. With dry hands, place either side of the tablet against the upper gum above the incisor tooth; hold tablet in place with slight pressure over the upper lip for 30 seconds. Placing the rounded side of the tablet against the gum may be more comfortable. Alternate sides of the mouth with each application; do not crush, chew, or swallow. Avoid chewing gum or other actions that could interfere with the tablet (eg, rinsing mouth too vigorously) while in place.
If the tablet does not adhere to the gum or falls off within 6 hours of application, the same tablet should be repositioned immediately. If the tablet does not adhere after repositioning, use a new tablet. If the tablet is swallowed within 6 hours of application, the patient should drink a glass of water and apply a new tablet (only once). If the tablet falls off or is swallowed >6 hours after application, a new tablet should not be applied until the next regularly scheduled dose.
Buccal: Tablets: Apply in the morning after brushing teeth. With dry hands, place either side of the tablet against the upper gum above the incisor tooth; hold tablet in place with slight pressure over the upper lip for 30 seconds. Placing the rounded side of the tablet against the gum may be more comfortable. Alternate sides of the mouth with each application; do not crush, chew, or swallow. Avoid chewing gum or other actions that could interfere with the tablet (eg, rinsing mouth too vigorously) while in place.
If the tablet does not adhere to the gum or falls off within 6 hours of application, the same tablet should be repositioned immediately. If the tablet does not adhere after repositioning, use a new tablet. If the tablet is swallowed within 6 hours of application, the patient should drink a glass of water and apply a new tablet (only once). If the tablet falls off or is swallowed >6 hours after application, a new tablet should not be applied until the next regularly scheduled dose.
Candidiasis, oropharyngeal, mild: Treatment of oropharyngeal candidiasis.
Miconazole may be confused with metroNIDAZOLE, Micronase, Micronor
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Fosphenytoin-Phenytoin: Miconazole (Oral) may increase serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor
Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may decrease therapeutic effects of Saccharomyces boulardii. Risk X: Avoid
Sulfonylureas: Miconazole (Oral) may increase hypoglycemic effects of Sulfonylureas. Miconazole (Oral) may increase serum concentration of Sulfonylureas. Risk C: Monitor
Warfarin: Miconazole (Oral) may increase serum concentration of Warfarin. Risk C: Monitor
There is minimal systemic absorption following buccal application.
Miconazole buccal tablets are an alternative treatment for oropharyngeal candidiasis in nonpregnant patients; however, local topical treatment of oropharyngeal candidiasis is preferred during pregnancy (HHS [OI adult] 2024).
It is not known if miconazole is present in breast milk.
There is minimal systemic absorption following buccal application. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Food and drink can be taken normally; chewing gum should be avoided.
Monitor patients with a history of hypersensitivity to azoles for signs and symptoms of hypersensitivity reaction.
Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability causing leaking of nutrients
Duration: Buccal adhesion: 15 hours
Absorption: Minimal
