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Brimonidine (Topical)

Medically reviewed by Drugs.com. Last updated on Aug 29, 2020.

Pronunciation

(bri MOE ni deen)

Index Terms

  • Brimonidine Tartrate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Mirvaso: 0.33% (30 g) [contains methylparaben, propylene glycol]

Brand Names: U.S.

  • Mirvaso

Pharmacologic Category

  • Alpha2-Adrenergic Agonist

Pharmacology

Relatively selective alpha2-receptor agonist that when applied topically may decrease erythema through direct vasoconstriction.

Metabolism

Hepatic

Excretion

Urine

Time to Peak

Maximum plasma concentrations observed after 15 days

Use: Labeled Indications

Rosacea: Topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years and older.

Contraindications

Hypersensitivity to brimonidine or any component of the formulation.

Canadian labeling: Additional contraindications (not in the US labeling): Neonates and infants (<2 years)

Dosing: Adult

Rosacea: Topical: Apply a pea-size amount once daily as a thin layer across the entire face covering the central forehead, each cheek, nose, and chin.

Dosing: Geriatric

Refer to adult dosing.

Administration

Topical: Apply smoothly and evenly as a thin layer across the entire face (central forehead, each cheek, nose, and chin) avoiding the eyes and lips. Wash hands immediately after applying. Do not apply to open wounds or irritated skin.

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).

Drug Interactions

Blood Pressure Lowering Agents: Brimonidine (Topical) may enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

CNS Depressants: Brimonidine (Topical) may enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Digoxin: Brimonidine (Topical) may enhance the bradycardic effect of Digoxin. Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Brimonidine (Topical). Monoamine Oxidase Inhibitors may increase the serum concentration of Brimonidine (Topical). Monitor therapy

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Flushing (3%)

Central nervous system: Burning sensation of skin (2%), localized warm feeling (1%), paresthesia (1%)

Dermatologic: Erythema (4%), acne vulgaris (1%), allergic contact dermatitis (1%; due to active ingredient [1 case] or preservative [1 case]), contact dermatitis (1%), dermatitis (1%), skin pain (1%)

Ophthalmic: Blurred vision (1%)

Respiratory: Nasal congestion (1%)

<1%, postmarketing, and/or case reports: Angioedema, bradycardia, dizziness, facial erythema, hypersensitivity reaction, hypotension (including orthostatic), pallor, pharyngeal edema, swelling of lips, swollen tongue, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Erythema: Effects of brimonidine gel may begin to diminish within hours of application; recurrent and sometimes worsening erythema (compared to baseline) has been observed at or outside of the treatment areas. Symptoms appear to resolve following discontinuation of therapy.

• Flushing: Intermittent flushing (increased frequency or new onset) occurring ~30 minutes to several hours after application has been observed; symptoms appear to resolve following discontinuation of therapy.

• Hypersensitivity: Allergic contact dermatitis has been reported; angioedema, throat tightening, tongue swelling, and urticaria may also occur. Discontinue use if significant hypersensitivity reactions occur.

• Pallor: Pallor or excessive whitening has been observed at or outside of the treatment areas.

• Systemic effects: Bradycardia, hypotension (including orthostatic hypotension), and dizziness have been reported; may require hospitalization. Systemic effects may be due to use in unapproved dosing and indications (eg, use after laser procedures).

Disease-related concerns:

• Cardiovascular disease: May lower blood pressure; use with caution in patients with orthostatic hypotension or with severe, unstable, or uncontrolled cardiovascular disease. May potentiate vascular insufficiency; use with caution in patients with cerebral or coronary insufficiency, scleroderma, thromboangiitis obliterans, and Raynaud phenomenon.

• Depression: Use with caution in patients with depression.

• Sjögren syndrome: Use with caution in patients with Sjögren syndrome.

Other warnings/precautions:

• Accidental ingestion: Serious adverse events (eg, respiratory distress with apneic episodes requiring intubation, sinus bradycardia, diaphoresis, lethargy, confusion and psychomotor hyperactivity) were reported in 2 children following accidental ingestion of brimonidine gel. Advise patients to store gel out of the reach of children.

• Appropriate use: For external use only; not for oral, ophthalmic, or intravaginal use; avoid contact with eyes and lips. Do not apply to open wounds or irritated skin.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Patient Education

What is this drug used for?

• It is used to treat rosacea.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing

• Redness

• Pale skin

• Burning

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe skin irritation

• Dizziness

• Passing out

• Slow heartbeat

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.