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

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)

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

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - brinzolamide, brimonidine tartrate - ocular hypertension; glaucoma, open-angle - ophthalmologicals - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction.

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)

galderma laboratories, l.p. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate 5 mg in 1 g - mirvaso (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. mirvaso topical gel is contratindicated in patients who have experienced a hypersensitivity reaction to any component. reactions have included angioedema, urticaria, 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 mirvaso topical gel in pregnant women. in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. mirvaso 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 not

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

akorn - 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) ]. 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 rab

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - brimonidine tartrate - eye drops - 2mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - brimonidine tartrate - eye drops - 2mg/1ml