Version May 2024
Candidiasis, oropharyngeal, mild disease (alternative agent): Buccal tablet: 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.
Oropharyngeal candidiasis (mild): Adolescents ≥16 years: Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Local: Application site reaction (10% to 12%; including glossalgia, local discomfort, local pain, local pruritus, localized burning, localized edema, oral mucosa ulcer, toothache)
1% to 10%:
Central nervous system: Headache (5% to 8%), fatigue (3%), pain (1%)
Dermatologic: Pruritus (2%)
Endocrine & metabolic: Increased gamma-glutamyl transferase (1%)
Gastrointestinal: Diarrhea (6% to 9%), nausea (1% to 7%), dysgeusia (3% to 4%), vomiting (1% to 4%), oral discomfort (3%), xerostomia (3%), abdominal pain (1% to 3%), ageusia (2%), gastroenteritis (1%), sore throat (1%)
Hematologic & oncologic: Anemia (3%), lymphocytopenia (2%), neutropenia (1%)
Respiratory: Cough (3%), upper respiratory tract infection (2%)
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 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 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, 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.
Oral: Buccal tablet: 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 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 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, 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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Fosphenytoin: Miconazole (Oral) may increase the serum concentration of Fosphenytoin. Risk C: Monitor therapy
Phenytoin: Miconazole (Oral) may increase the serum concentration of Phenytoin. Risk C: Monitor therapy
Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination
Sulfonylureas: Miconazole (Oral) may enhance the hypoglycemic effect of Sulfonylureas. Miconazole (Oral) may increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy
Warfarin: Miconazole (Oral) may increase the serum concentration of Warfarin. Risk C: Monitor therapy
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] 2023).
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
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