Miconazole (buccal)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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
- The following serious adverse drug reactions are discussed in detail in other sections of labeling:
Clinical Trial Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
- The overall safety of ORAVIG was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects.
HIV Infected Patients
- Two trials were conducted in immunocompromised HIV infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 ORAVIG, 287 control) and one non-comparative trial (N = 25).
- In the randomized, double blind trial (Study 1), 290 HIV infected subjects used ORAVIG once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are presented in Table 1.
- Overall local adverse reactions, including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritis, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and altered taste, were reported by 35 (12.1%) patients who received miconazole buccal tablet compared to 27 (9.4%) patients who received clotrimazole troches.
Head and Neck Cancer Patients
- In the randomized, open-label comparative trial of oropharyngeal candidiasis in patients with head and neck cancer who had received radiation therapy (Study 2), 147 patients used ORAVIG once daily for 14 days and 147 patients used 125 mg of miconazole oral gel four times daily for 14 days. Adverse reactions occurring in ≥2% of patients in either arm are listed in Table 2.
Overall local adverse reactions, including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, and application site discomfort or pain, were experienced by 14 (9.5%) patients who used ORAVIG compared to 16 (10.9%) patients who used miconazole gel.
Overall ORAVIG Safety Experience In Patients and Healthy Subjects
- Adverse reactions reported in the overall safety database of 480 subjects who received miconazole buccal tablet is listed in Table 3.
- Discontinuation of ORAVIG due to adverse drug reactions occurred in 0.6% overall.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Miconazole (buccal) 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) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Miconazole (buccal) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Miconazole (buccal) with respect to geriatric patients.
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
- Oral
Monitoring
There is limited information regarding Monitoring of Miconazole (buccal) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Miconazole (buccal) in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Miconazole (buccal) in the drug label.
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 Pharmacodynamics of Miconazole (buccal) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Miconazole (buccal) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Miconazole (buccal) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Miconazole (buccal) in the drug label.
How Supplied
Storage
There is limited information regarding Miconazole (buccal) Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Miconazole (buccal) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Miconazole (buccal) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Miconazole (buccal) in the drug label.
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
- ORAVIG®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "miconazole tablet".
- ↑ "http://www.ismp.org". External link in
|title=
(help)
{{#subobject:
|Page Name=Miconazole (buccal) |Pill Name=No image.jpg |Drug Name= |Pill Ingred=|+sep=; |Pill Imprint= |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}} |Pill Color=|+sep=; |Pill Shape= |Pill Size (mm)= |Pill Scoring= |Pill Image= |Drug Author= |NDC=
}}
{{#subobject:
|Label Page=Miconazole (buccal) |Label Name=Miconazole (buccal)11.png
}}
{{#subobject:
|Label Page=Miconazole (buccal) |Label Name=Miconazole (buccal)11.png
}}