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Miconazole (Oral)

Medically reviewed by Drugs.com. Last updated on Sep 14, 2020.

Pronunciation

(mi KON a zole)

Index Terms

  • Miconazole Nitrate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Buccal:

Oravig: 50 mg [contains corn starch, milk protein concentrate]

Brand Names: U.S.

  • Oravig

Pharmacologic Category

  • Antifungal Agent, Imidazole Derivative
  • Antifungal Agent, Oral Nonabsorbed

Pharmacology

Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability causing leaking of nutrients

Absorption

Minimal

Duration of Action

Buccal adhesion: 15 hours

Use: Labeled Indications

Treatment of oropharyngeal candidiasis

Contraindications

Hypersensitivity to miconazole, milk protein concentrate, or any component of the formulation

Dosing: Adult

Oropharyngeal candidiasis (mild disease): Buccal tablet: 50 mg (1 tablet) applied to the upper gum region (canine fossa) once daily for 7 to 14 days (HHS [OI adult 2020]; IDSA [Pappas 2016])

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Oropharyngeal candidiasis (mild): Adolescents ≥16 years: Refer to adult dosing.

Administration

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.

Dietary Considerations

Should be taken whole; do not crush, chew, or swallow. Food and drink can be taken normally; chewing gum should be avoided.

Storage

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.

Drug Interactions

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

Adverse Reactions

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%)

Warnings/Precautions

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.

Disease-related concerns:

• Hepatic impairment: Although systemic absorption is typically minimal, use with caution in patients with hepatic impairment.

Pregnancy Considerations

There is minimal systemic absorption following buccal application. Topical treatment of oropharyngeal candidiasis in pregnancy is preferable to the use of systemic medications when possible (HHS [OI adult 2017]).

Patient Education

What is this drug used for?

• It is used to treat fungal infections in the mouth.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Change in taste

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Application site pain or swelling

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.