brimonidine tartrate - search results

sandoz inc - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. teratogenicity studies have been performed in animals. brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. the highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5.0 mg/kg/day) achieved auc exposure values 360- and 20-fold higher than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution 0.1% 1 drop in both eyes three times daily. there are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. because animal reproduction studies are not always predictive of human response, brimonidine tartrate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. it is 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 the potential for serious adverse reactions from brimonidine tartrate ophthalmic solution 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. brimonidine tartrate ophthalmic solution is contraindicated in children under the age of 2 years [see contraindications (4.1)] . during postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. the safety and effectiveness of brimonidine tartrate have not been studied in children below the age of 2 years. in a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50 to 83% in patients ages 2 to 6 years) and decreased alertness. in pediatric patients 7 years of age (>20 kg), somnolence appears to occur less frequently (25%). approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence. no overall differences in safety or effectiveness have been observed between elderly and other adult patients. brimonidine tartrate ophthalmic solution has not been studied in patients with hepatic impairment. brimonidine tartrate ophthalmic solution has not been studied in patients with renal impairment. the effect of dialysis on brimonidine pharmacokinetics in patients with renal failure is not known.

United States - English - NLM (National Library of Medicine)

brimonidine gel

padagis israel pharmaceuticals ltd - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - 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. brimonidine topical gel is contraindicated in patients who have experienced a hypersensitivity reaction to any component. reactions have included angioedema, urticarial, and contact dermatitis [see warnings and precautions (5.6) and adverse reactions (6.1, 6.2) ]. pregnancy category b. there are no adequate and well-controlled studies of brimonidine topical gel in pregnant women. in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. brimonidine topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. brimonidine tartrate 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. it is n

United States - English - NLM (National Library of Medicine)

brimonidine gel

bryant ranch prepack - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - 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. brimonidine topical gel is contraindicated in patients who have experienced a hypersensitivity reaction to any component. reactions have included angioedema, urticarial, and contact dermatitis [see warnings and precautions (5.6) and adverse reactions (6.1, 6.2) ]. pregnancy category b. there are no adequate and well-controlled studies of brimonidine topical gel in pregnant women. in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. brimonidine topical gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. brimonidine tartrate 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. it is n

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

combigan eye drops (brimonidine tartrate 2mg/ml and timolol 5mg/ml opthalmic solution)

allergan malaysia sdn bhd - brimonidine tartrate; timolol maleate -