Miconazole (buccal): Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag={{KS}} | |authorTag={{KS}} | ||
|aOrAn= | |genericName=miconazole | ||
|aOrAn=an | |||
|drugClass=antifungal | |||
|indicationType=treatment | |indicationType=treatment | ||
| | |indication=[[candidiasis|oropharyngeal candidiasis]] in adults | ||
|adverseReactions= | |adverseReactions=[[diarrhea]], [[headache]], [[nausea]], [[dysgeusia]], [[abdominal pain|upper abdominal pain]], and [[vomiting]] | ||
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | ||
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<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult=== | |fdaLIADAdult===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. | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--FDA-Labeled Indications and Dosage (Pediatric)--> | <!--FDA-Labeled Indications and Dosage (Pediatric)--> | ||
|fdaLIADPed= | |fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | ||
<!--Guideline-Supported Use (Pediatric)--> | <!--Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedGuideSupport= | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | |clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | ||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | ||
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | ||
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers. | |useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers. | ||
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|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | ||
|administration=* Oral | |administration=* Oral | ||
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | ||
<!--IV Compatibility--> | <!--IV Compatibility--> | ||
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | |IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | ||
= | |overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label. | ||
<!--Drug box 2--> | <!--Drug box 2--> | ||
| | |structure= | ||
< | |PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label. | ||
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label. | |||
| | |||
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label. | |nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label. | ||
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label. | |clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label. | ||
|howSupplied=* | |howSupplied=* | ||
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | ||
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
|brandNames=* ORAVIG®<ref>{{Cite web | title =miconazole tablet| url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ef3b205e-8526-48a0-afce-ddcef865d907 }}</ref> | |brandNames=* ORAVIG®<ref>{{Cite web | title =miconazole tablet| url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ef3b205e-8526-48a0-afce-ddcef865d907 }}</ref> | ||
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref> | |||
|drugShortage= | |drugShortage= | ||
}} | }} |
Revision as of 17:49, 22 May 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
Disclaimer
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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
There is limited information regarding Miconazole (buccal) Contraindications in the drug label.
Warnings
There is limited information regarding Miconazole (buccal) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Miconazole (buccal) in the drug label.
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
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