Brimonidine topical

Rosacea

Topical Rosacea Indicated for persistent facial erythema of rosacea Adult: Apply once daily until erythema subsides, apply thinly, divide the dose over the forehead, chin, nose, and cheeks, max. 1 g of gel per day

<18 years: Safety and efficacy not established

Hypersensitivity

Caution with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or SjÖgren’s syndrome Alpha-2 adrenergic agents can lower blood pressure; caution with severe or unstable/uncontrolled cardiovascular disease Serious adverse reactions may occur following accidental ingestion of alpha-2 agonists by children; keep out of reach of children Not for oral, ophthalmic, or intravaginal use Erythema involving areas of face previously not affected by erythema and areas (e.g., neck and chest) outside of treatment sites reported Treatment effect of topical gel may begin to diminish hours after application Increased frequency of flushing and/or erythema with flushing following gel application reported Pallor or excessive whitening at or outside application site, following treatment with topical gel.reported Allergic contact dermatitis reported Hypersensitivity reactions following gel application include angioedema, throat tightening, tongue swelling, and urticaria; Institute appropriate therapy and discontinue therapy, if clinically significant hypersensitivity reaction occurs

Not Classi Pregnancy There are no adequate and well-controlled studies in pregnant women Animal data In animal studies, brimonidine crossed the placenta and entered into fetal circulation to a limited extent; this drug should be used during pregnancy only if potential benefit justifies potential risk to fetus This drug was not teratogenic when given at oral doses up to 2.5 mg/kg/day in pregnant rats during gestation days 6 through 15 and 5 mg/kg/day in pregnant rabbits during gestation days 6 through 18 Lactation Not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk Because of potential for serious adverse reactions from topical gel in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

1-10% Flushing (10%) Erythema (8%) Nasopharyngitis (5%) Skin-burning sensation (4%) Increased intraocular pressure (4%) Headache (4%)

Alpha-2 adrenergic agonist