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* Discontinuation of ORAVIG due to adverse drug reactions occurred in 0.6% overall.
* Discontinuation of ORAVIG due to adverse drug reactions occurred in 0.6% overall.
|drugInteractions='''Warfarin'''


* Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Cases of bleeding and bruising following the concomitant use of warfarin and topical, intravaginal, or oral miconazole were reported. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if ORAVIG is administered concomitantly with warfarin. Also monitor for evidence of bleeding.
'''Drugs Metabolized Through CYP2C9 and 3A4'''
* No formal drug interaction studies have been performed with ORAVIG. Miconazole is a known inhibitor of CYP2C9 and CYP3A4. Although the systemic absorption of miconazole following ORAVIG administration is minimal and plasma concentrations of miconazole are substantially lower than when given intravenously, the potential for interaction with drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics, phenytoin, or ergot alkaloids cannot be ruled out.
|useInPregnancyFDA='''Pregnancy Category C'''
* There are no adequate and well-controlled clinical trials of ORAVIG in pregnant women. ORAVIG should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus.
* Miconazole nitrate administered orally at doses of 80 mg/kg/day or higher to pregnant rats or rabbits crossed the placenta and resulted in embryo- and fetotoxicity, including increased fetal resorptions. These doses also resulted in prolonged gestation and dystocia in rats, but not in rabbits. Embryofetotoxicity was not observed in intravenous studies with miconazole at lower doses of 40 mg/kg/day in rats and 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIG buccal tablet, based on body surface area comparisons. Teratogenicity was not reported in any animal study with miconazole.
|useInNursing=* It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ORAVIG is administered to a nursing woman.
|useInPed=* Safety and effectiveness of ORAVIG in pediatric patients below the age of 16 years have not been established. The ability of pediatric patients to comply with the application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking.
|useInGeri=* Clinical studies of ORAVIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
|useInRenalImpair=* Less than 1% of miconazole is excreted as unchanged drug in the urine; therefore, no adjustment to therapy is necessary in patients with renal impairment
|useInHepaticImpair=* Miconazole is metabolized by the liver. While miconazole systemic exposure is minimal following the application of ORAVIG, ORAVIG should be administered with caution in patients with hepatic impairment.
|overdose=* Overdose with miconazole in humans has not been reported in the literature.
* Miconazole absorption and systemic exposure following application of ORAVIG are minimal.
* Symptomatic and supportive care is the basis for management.
|packLabel=[[File:Miconazole buccal pt package insert.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|packLabel=[[File:Miconazole buccal pt package insert.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


Revision as of 20:34, 25 May 2015

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

  • 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:
  • Hypersensitivity reactions

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.
This image is provided by the National Library of Medicine.

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.
This image is provided by the National Library of Medicine.
  • 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.
This image is provided by the National Library of Medicine.
  • Discontinuation of ORAVIG due to adverse drug reactions occurred in 0.6% overall.

Postmarketing Experience

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

Drug Interactions

Warfarin

  • Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Cases of bleeding and bruising following the concomitant use of warfarin and topical, intravaginal, or oral miconazole were reported. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if ORAVIG is administered concomitantly with warfarin. Also monitor for evidence of bleeding.

Drugs Metabolized Through CYP2C9 and 3A4

  • No formal drug interaction studies have been performed with ORAVIG. Miconazole is a known inhibitor of CYP2C9 and CYP3A4. Although the systemic absorption of miconazole following ORAVIG administration is minimal and plasma concentrations of miconazole are substantially lower than when given intravenously, the potential for interaction with drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics, phenytoin, or ergot alkaloids cannot be ruled out.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Pregnancy Category C

  • There are no adequate and well-controlled clinical trials of ORAVIG in pregnant women. ORAVIG should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus.
  • Miconazole nitrate administered orally at doses of 80 mg/kg/day or higher to pregnant rats or rabbits crossed the placenta and resulted in embryo- and fetotoxicity, including increased fetal resorptions. These doses also resulted in prolonged gestation and dystocia in rats, but not in rabbits. Embryofetotoxicity was not observed in intravenous studies with miconazole at lower doses of 40 mg/kg/day in rats and 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIG buccal tablet, based on body surface area comparisons. Teratogenicity was not reported in any animal study with miconazole.


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

  • It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ORAVIG is administered to a nursing woman.

Pediatric Use

  • Safety and effectiveness of ORAVIG in pediatric patients below the age of 16 years have not been established. The ability of pediatric patients to comply with the application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking.

Geriatic Use

  • Clinical studies of ORAVIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

  • Less than 1% of miconazole is excreted as unchanged drug in the urine; therefore, no adjustment to therapy is necessary in patients with renal impairment

Hepatic Impairment

  • Miconazole is metabolized by the liver. While miconazole systemic exposure is minimal following the application of ORAVIG, ORAVIG should be administered with caution 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

  • Overdose with miconazole in humans has not been reported in the literature.
  • Miconazole absorption and systemic exposure following application of ORAVIG are minimal.
  • Symptomatic and supportive care is the basis for management.

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

{{#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

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.

{{#ask: Label Page::Miconazole (buccal) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

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.

  1. ↑ [dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ef3b205e-8526-48a0-afce-ddcef865d907 "miconazole tablet"] Check |url= value (help).
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