(bri MOE ni deen)
Rosacea: Topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years and older.
Hypersensitivity to brimonidine or any component of the formulation.
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.
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling.
There are no dosage adjustments provided in the manufacturers labeling.
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.
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).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Mirvaso: 0.33% (30 g) [contains methylparaben, propylene glycol]
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
MAO Inhibitors: May enhance the adverse/toxic effect of Brimonidine (Topical). MAO Inhibitors may increase the serum concentration of Brimonidine (Topical). Monitor therapy
1% to 10%:
Cardiovascular: Flushing (3% to 10%)
Central nervous system: Burning sensation of skin (2% to 4%), headache (4%), localized warm feeling (1%), paresthesia (1%)
Dermatologic: Erythema (4% to 8%), acne rosacea (5%), 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: Increased intraocular pressure (4%), blurred vision (1%)
Respiratory: Nasopharyngitis (5%), nasal congestion (1%)
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.
- Sj ƒ ¶gren syndrome: Use with caution in patients with Sj ƒ ¶gren 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.
B
Adverse events were not observed in animal reproduction studies.
Relatively selective alpha2-receptor agonist that when applied topically may decrease erythema through direct vasoconstriction.
Hepatic
Urine
Maximum plasma concentrations observed after 15 days
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience flushing, redness, or burning. Have patient report immediately to prescriber severe skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.