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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Mirvaso: 0.33% (30 g) [contains methylparaben, propylene glycol]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Onreltea: 0.33% (2 g, 10 g, 30 g) [contains methylparaben, propylene glycol]
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. For external use only; not intended for intravaginal, ophthalmic, or oral use.
Rosacea: Topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years and older.
Brimonidine may be confused with bromocriptine
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
1% to 10%:
Cardiovascular: Flushing (3%)
Dermatologic: Acne vulgaris (1%), allergic contact dermatitis (1%), burning sensation of skin (2%), contact dermatitis (1%), dermatitis (1%), erythema of skin (4%; including rebound erythema), skin pain (1%)
Local: Localized warm feeling (1%)
Nervous system: Paresthesia (1%)
Ophthalmic: Blurred vision (1%)
Respiratory: Nasal congestion (1%)
Postmarketing:
Cardiovascular: Bradycardia, hypotension (including orthostatic hypotension)
Dermatologic: Pallor, urticaria
Hypersensitivity: Angioedema, hypersensitivity reaction, swelling of lips, swollen tongue
Nervous system: Dizziness
Respiratory: Pharyngeal edema
Hypersensitivity to brimonidine or any component of the formulation.
Canadian labeling: Additional contraindications (not in the US labeling): Neonates and infants (<2 years)
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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Blood Pressure Lowering Agents: Brimonidine (Topical) may enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
CNS Depressants: Brimonidine (Topical) may enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Digoxin: Brimonidine (Topical) may enhance the bradycardic effect of Digoxin. Risk C: 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). Risk C: Monitor therapy
Adverse events were not observed in animal reproduction studies.
It is not known if brimonidine is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
Relatively selective alpha2-receptor agonist that when applied topically may decrease erythema through direct vasoconstriction.
Metabolism: Hepatic
Time to peak: Maximum plasma concentrations observed after 15 days
Excretion: Urine
Gel (Mirvaso External)
0.33% (per gram): $23.13
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
