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

sandoz inc - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate 1.5 mg in 1 ml - 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. 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 h

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

physicians total care, inc. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate 1.5 mg in 1 ml - 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 brimonidine tartrate or any component of this medication. it is also contraindicated in patients receiving monoamine oxidase (mao) inhibitor therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

abbvie limited - brimonidine tartrate 1.5 mg/ml;   - eye drops, solution - 1.5 mg/ml - active: brimonidine tartrate 1.5 mg/ml   excipient: boric acid calcium chloride dihydrate carmellose sodium hydrochloric acid magnesium chloride hexahydrate potassium chloride purified water sodium borate pentahydrate sodium chloride sodium chlorite as purite sodium hydroxide - alphagan® p 1.5 eye drops are effective for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

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

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

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

pacific pharma, 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 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)

physicians total care, inc. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate 2 mg in 1 ml - brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. the lop lowering efficacy of brimonidine tartrate ophthalmic solution 0.2% 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 0.2% is contraindicated in patients with hypersensitivity to brimonidine tartrate or any component of this medication. it is also contraindicated in patients receiving monoamine oxidase (mao) inhibitor therapy.

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

regimed medical - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine 2.0 mg in 1 ml - brimonidine tartrate ophthalmic solution is indicated for lowering intraocular pressure 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 patients with hypersensitivity to brimonidine tartrate or any component of this medication. it is also contraindicated in patients receiving monoamine oxidase (mao) inhibitor therapy.

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

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/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 bradycardia; second or third degree atrioventricular block; overt cardiac failure [see warnings and precautions (5.2)] ; cardiogenic shock. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). local hypersensitivity reactions have occurred following the use of different components of brimonidine tartrate/timolol maleate ophthalmic solution. brimonidine tartrate/timolol maleate 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 mg/kg/day) achieved auc exposure values 580 and 37-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate/timolol maleate ophthalmic solution, 1 drop in both eyes twice daily. teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum recommended human ocular dose of 0.012 mg/kg/day on a mg/kg basis (mrhod)] demonstrated no evidence of fetal malformations. although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. doses of 1,000 mg/kg/day (83,000 times the mrhod) were maternotoxic in mice and resulted in an increased number of fetal resorptions. increased fetal resorptions were also seen in rabbits at doses 8,300 times the mrhod without apparent maternotoxicity. 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/timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. timolol has been detected in human milk following oral and ophthalmic drug administration. 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/timolol maleate 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/timolol maleate ophthalmic solution is contraindicated in children under the age of 2 years [see contraindications (4.3)] . during post-marketing 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 and timolol maleate have not been studied in children below the age of 2 years. the safety and effectiveness of brimonidine tartrate/timolol maleate ophthalmic solution have been established in the age groups 2 – 16 years of age. use of brimonidine tartrate/timolol maleate ophthalmic solution in these age groups is supported by evidence from adequate and well-controlled studies of brimonidine tartrate/timolol maleate ophthalmic solution in adults with additional data from a study of the concomitant use of brimonidine tartrate ophthalmic solution 0.2% and timolol maleate ophthalmic solution in pediatric glaucoma patients (ages 2 to 7 years). in this study, brimonidine tartrate ophthalmic solution 0.2% was dosed three times a day as adjunctive therapy to beta-blockers. the most commonly observed adverse reactions were somnolence (50%-83% in patients 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. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

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

actavis pharma, inc. - 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