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

upsher-smith laboratories, llc - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (iop) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled iop; the iop-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see warnings and precautions (5.1, 5.3)] . brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardi

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

apotex corp - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - brimonidine tartrate and timolol maleate ophthalmic solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (iop) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled iop; the iop-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [ see warnings and precautions   ( 5.1 , 5.3 ) ] . brimonidine tartrate and timolol maleate ophthalmic solution is contraindicated in patie

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

bryant ranch prepack - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. brimonidine tartrate ophthalmic solution, 0.15% is contraindicated in patients with hypersensitivity to any component of this product. pregnancy category: b reproductive studies performed in rats and rabbits with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to brimonidine tartrate ophthalmic solution, 0.15%. dosing at this level produced an exposure in rats and rabbits that is 80 and 40 times higher than the exposure seen in humans, respectively. there are no adequate and well-controlled studies in pregnant women. in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. brimonidine tartrate ophthalmic solution, 0.15% 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 this drug is excreted in human milk. in animal studies, brimonidine tartrate was excreted in breast milk. 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. in a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years), the most commonly observed adverse events with brimonidine tartrate ophthalmic solution 0.2% dosed three-times-daily were somnolence (50%-83% in patients ages 2 to 6 years) and decreased alertness. in pediatric patients 7 years of age or older (>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. the safety and effectiveness of brimonidine tartrate ophthalmic solution have not been studied in pediatric patients below the age of 2 years. brimonidine tartrate ophthalmic solution is not recommended for use in pediatric patients under the age of 2 years. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

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

sandoz inc - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (iop) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled iop; the iop-lowering of brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see warnings and precautions (5.1, 5.3)]. brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% i

Malta - English - Medicines Authority

allergan pharmaceuticals ireland castlebar road, westport, county mayo, ireland - brimonidine tartrate, timolol - eye drops, solution - brimonidine tartrate 2 mg/ml timolol 5 mg/ml - ophthalmologicals

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

pacific pharma, inc. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution 0.1% or 0.15% 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 0.1% and 0.15% is contraindicated in neonates and infants (under the age of 2 years). brimonidine tartrate ophthalmic solution 0.1% and 0.15% 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 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 0.1% and 0.15% 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 0.1% and 0.15% 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 0.1% and 0.15% 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 (50-83% 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 0.1% and 0.15% has not been studied in patients with hepatic impairment. brimonidine tartrate ophthalmic solution 0.1% and 0.15% 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)

apotex corp. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.15% 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, 0.15%, 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 (50-83% 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)

alembic pharmaceuticals inc. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.15% 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 0.15%,1 drop in both eyes three

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

alembic pharmaceuticals limited - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.15% 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 0.15%,1 drop in both eyes three

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

abbvie pty ltd - brimonidine tartrate, quantity: 1.5 mg/ml - eye drops, solution - excipient ingredients: sodium chloride; potassium chloride; borax; sodium hydroxide; sodium chlorite; purified water; calcium chloride dihydrate; boric acid; carmellose sodium; hydrochloric acid; magnesium chloride hexahydrate - enidin p 1.5 eye drops are effective in lowering elevated intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension. enidin p 1.5 eye drops can be used in the treatment of glaucoma as either monotherapy or in combination with topical beta blockers.