(mi KON a zole)
- Miconazole Nitrate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Oravig: 50 mg [DSC] [contains milk protein concentrate]
Brand Names: U.S.
- Oravig [DSC]
- Antifungal Agent, Imidazole Derivative
- Antifungal Agent, Oral Nonabsorbed
Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability causing leaking of nutrients
Duration of Action
Buccal adhesion: 15 hours
Use: Labeled Indications
Treatment of oropharyngeal candidiasis
Hypersensitivity to miconazole, milk protein concentrate, or any component of the formulation
Oropharyngeal candidiasis: Buccal tablet: 50 mg (1 tablet) applied to the upper gum region once daily for 14 days
Refer to adult dosing.
Dosing: Renal Impairment
No dosage adjustment necessary.
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling; use with caution.
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.
Should be taken whole; do not crush, chew, or swallow. Food and drink can be taken normally; chewing gum should be avoided.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to15°C to 30°C (59°F to 86°F). Protect from moisture.
Fosphenytoin: Miconazole (Oral) may increase the serum concentration of Fosphenytoin. Monitor therapy
Phenytoin: Miconazole (Oral) may increase the serum concentration of Phenytoin. Monitor therapy
Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Avoid combination
Sulfonylureas: Miconazole (Oral) may enhance the hypoglycemic effect of Sulfonylureas. Miconazole (Oral) may increase the serum concentration of Sulfonylureas. Monitor therapy
Warfarin: Miconazole (Oral) may increase the serum concentration of Warfarin. Monitor therapy
>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%)
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. Monitor patients with a history of azole hypersensitivity.
• Hepatic impairment: Although systemic absorption is typically minimal, use with caution in patients with hepatic impairment.
Pregnancy Risk Factor
Adverse events were observed in some animal reproduction studies. There is minimal systemic absorption following buccal application.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, nausea, vomiting, diarrhea, abdominal pain, or change in taste. Have patient report immediately to prescriber inability to eat, stomatitis, severe mouth pain or irritation, application site pain, loss of strength and energy, or dysphagia (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.