Miconazole (buccal)

Miconazole (buccal)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Miconazole (buccal) is an antifungal that is FDA approved for the treatment of oropharyngeal candidiasis in adults. Common adverse reactions include diarrhea, headache, nausea, dysgeusia, upper abdominal pain, and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.

Dosing

• The recommended dosing schedule for ORAVIG is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days.

DOSAGE FORMS AND STRENGTHS

• ORAVIG is a buccal tablet containing 50 mg of miconazole. ORAVIG tablets are round, off-white tablets, with a rounded side and a flat side. The tablets are marked with an “L” on the flat side.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Miconazole (buccal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Miconazole (buccal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Miconazole (buccal) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Miconazole (buccal) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Miconazole (buccal) in pediatric patients.

Contraindications

• ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product.

Warnings

Hypersensitivity

• Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole products, including ORAVIG. Discontinue ORAVIG immediately at the first sign of hypersensitivity.

• There is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Miconazole (buccal) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Miconazole (buccal) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Miconazole (buccal) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Miconazole (buccal) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Miconazole (buccal) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Miconazole (buccal) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Miconazole (buccal) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Miconazole (buccal) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Miconazole (buccal) in geriatric settings.

Gender

There is no FDA guidance on the use of Miconazole (buccal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Miconazole (buccal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Miconazole (buccal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Miconazole (buccal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Miconazole (buccal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Miconazole (buccal) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Miconazole (buccal) Administration in the drug label.

Monitoring

There is limited information regarding Miconazole (buccal) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Miconazole (buccal) and IV administrations.

Overdosage

There is limited information regarding Miconazole (buccal) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Miconazole (buccal) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Miconazole (buccal) Mechanism of Action in the drug label.

Structure

There is limited information regarding Miconazole (buccal) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Miconazole (buccal) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Miconazole (buccal) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Miconazole (buccal) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Miconazole (buccal) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Miconazole (buccal) How Supplied in the drug label.

Storage

There is limited information regarding Miconazole (buccal) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

This image is provided by the National Library of Medicine.

Precautions with Alcohol

Alcohol-Miconazole (buccal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Miconazole (buccal) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Miconazole (buccal) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.