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

alembic pharmaceuticals limited - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.1% 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. pregnancy category b: 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, or 260- and 15-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution 0.1% or  0.15%, 1 drop in both ey

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

apotex corp. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.1% 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. pregnancy category b: 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, or 260- and 15-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution, 0.1%, 1 drop in both eyes three

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

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)

micro labs limited - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. the iop lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients. this loss of effect appears with a variable time of onset in each patient and should be closely monitored. brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years) [ see use in specific populations ( 8.4) ]. brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past [ see adverse reactions ( 6.1) and ( 6.2) ]. 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 mg/kg/day) achieved auc exposure values 375-fold higher or 19-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution 0.2%, one drop in one eye, twice 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 (greater than 20 kg), somnolence appears to occur less frequently (25%). approximately 16% of patients on brimonidine tartrate ophthalmic solution 0.2% 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.

Canada - English - Health Canada

pharmascience inc - brimonidine tartrate - solution - 0.2% - brimonidine tartrate 0.2% - alpha-adrenergic agonists

Canada - English - Health Canada

dominion pharmacal - brimonidine tartrate - solution - 0.2% - brimonidine tartrate 0.2% - alpha-adrenergic agonists

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - brimonidine tartrate 2 mg/ml - eq. brimonidine 1,3 mg/ml; timolol maleate 6,8 mg/ml - eq. timolol 5 mg/ml - eye drops, solution - 2 mg/ml - 5 mg/ml - brimonidine tartrate 2 mg/ml; timolol maleate 6.8 mg/ml - timolol

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - brimonidine tartrate 0.2%{relative};   - eye drops, solution - 0.2% w/v - active: brimonidine tartrate 0.2%{relative}   excipient: benzalkonium chloride citric acid polyvinyl alcohol sodium chloride sodium citrate sodium hydroxide water for injection - effective for lowering intraocular pressure in patients with ocular hypertension.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - brimonidine tartrate - ophthalmic solution - brimonidine tartrate 0.15 %w/v - brimonidine - brimonidine - alphagan is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - brimonidine tartrate, quantity: 2 mg/ml; brinzolamide, quantity: 10 mg/ml - eye drops, suspension - excipient ingredients: propylene glycol; boric acid; mannitol; tyloxapol; sodium chloride; sodium hydroxide; purified water; carbomer 974p; hydrochloric acid; benzalkonium chloride - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction