Brimonidine (topical)

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Brimonidine (topical)
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

Brimonidine (topical) is an alpha adrenergic agonist that is FDA approved for the treatment of facial erythema of rosacea. Common adverse reactions include erythema, flushing, skin burning sensation, and contact dermatitis..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.

Dosage

  • Apply a pea-size amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. MIRVASO topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips.

DOSAGE FORMS AND STRENGTHS

  • MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque aqueous gel. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • None

Warnings

Potentiation of Vascular Insufficiency

Severe Cardiovascular Disease

  • Alpha-2 adrenergic agonists can lower blood pressure. MIRVASO topical gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease.

Serious Adverse Reactions Following Ingestion of MIRVASO topical gel

  • Two young children of a subject in a clinical trial experienced serious adverse reactions following accidental ingestion of MIRVASO topical gel. Adverse reactions experienced by one or both children included lethargy, respiratory distress with apneic episodes (requiring intubation), sinus bradycardia, confusion, psychomotor hyperactivity, and diaphoresis. Both children were hospitalized overnight and discharged the following day without sequelae.
  • Keep MIRVASO topical gel out of reach of children.

Erythema and Flushing

  • Some subjects in the clinical trials discontinued use of MIRVASO topical gel because of erythema or flushing.
  • The effect of MIRVASO topical gel may begin to diminish hours after application. For some subjects in the clinical trials, erythema was reported to return worse compared to the severity at baseline [see Adverse Reactions (6)].
  • Intermittent flushing occurred in some subjects treated with MIRVASO topical gel. The onset of flushing relative to application of MIRVASO topical gel varied, ranging from approximately 30 minutes to several hours.
  • Erythema and flushing appeared to resolve after discontinuation of MIRVASO topical gel.

Adverse Reactions

Clinical Trials 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 practice.
  • During clinical trials, 1210 subjects were exposed to MIRVASO topical gel. A total of 833 subjects were treated for persistent (nontransient) erythema associated with rosacea, and 330 of those were treated once daily for 29 days in vehicle-controlled trials.
  • Adverse reactions that occurred in at least 1% of subjects treated with MIRVASO topical gel once daily for 29 days and for which the rate for MIRVASO topical gel exceeded the rate for vehicle are presented in Table 1.
This image is provided by the National Library of Medicine.

Open-label, Long-term Study

  • An open-label study of MIRVASO topical gel when applied once daily for up to one year was conducted in subjects with persistent (nontransient) facial erythema of rosacea. Subjects were allowed to use other rosacea therapies. A total of 276 subjects applied MIRVASO topical gel for at least one year. The most common adverse events (> 4% of subjects) for the entire study were flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).

Allergic contact dermatitis

  • Allergic contact dermatitis to MIRVASO topical gel was reported in approximately 1% of subjects across the clinical development program. Two subjects underwent patch testing with individual product ingredients. One subject was found to be sensitive to brimonidine tartrate, and one subject was sensitive to phenoxyethanol (a preservative).

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Brimonidine (topical) in the drug label.

Drug Interactions

Anti-hypertensives/Cardiac Glycosides

  • Alpha-2 agonists, as a class, may reduce blood pressure. Caution in using drugs such as beta-blockers, anti-hypertensives and/or cardiac glycosides is advised.

CNS Depressants

  • Although specific drug-drug interactions studies have not been conducted with MIRVASO topical gel, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.

Monoamine Oxidase Inhibitors

  • Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Brimonidine (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Brimonidine (topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Brimonidine (topical) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Brimonidine (topical) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Brimonidine (topical) with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Brimonidine (topical) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Brimonidine (topical) in the drug label.

Overdosage

  • No information is available on overdose in adults with MIRVASO topical gel.
  • Oral overdoses of other alpha-2 adrenergic agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
  • Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained

Pharmacology

There is limited information regarding Brimonidine (topical) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Brimonidine (topical)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Brimonidine (topical) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Brimonidine (topical) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Brimonidine (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Brimonidine (topical) in the drug label.

How Supplied

  • MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque gel, supplied in a laminated tube with a child resistant cap in the following sizes:
  • 30 gram NDC 0299-5980-30
  • 45 gram NDC 0299-5980-45

Storage

  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).

Images

Drug Images

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Package and Label Display Panel

  • Patients using MIRVASO topical gel should receive the following information and instructions:
  • This medication is to be used as directed by the physician.
  • It is for external use only.
  • MIRVASO topical gel should not be applied to irritated skin or open wounds.
  • Avoid contact with the eyes and lips.
  • Patients should wash their hands immediately after applying the medication.
  • Some patients using MIRVASO topical gel may experience erythema or flushing.
  • Patients should report any adverse reactions to their physician.
  • Keep out of reach of children.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Brimonidine (topical) in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ "brimonidine tartrate gel".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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