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

bausch & lomb incorporated - 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 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 (50-83% 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.

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

indoco remedies limited - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. the iop 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. brimonidine tartrate ophthalmic solution, 0.2% is contraindicated in neonates and infants (under the age of 2 years) [see use in specific populations (8.4)]. brimonidine tartrate ophthalmic solution, 0.2% 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:

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

somerset therapeutics, llc - 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/

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

florida pharmaceutical products, llc - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. the iop 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. brimonidine tartrate ophthalmic solution, 0.2% is contraindicated in neonates and infants (under the age of 2 years) [see use in specific populations (8.4)]. brimonidine tartrate ophthalmic solution, 0.2% 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:

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

arms pharma sdn. bhd. - brimonidine tartrate -

Ireland - English - HPRA (Health Products Regulatory Authority)

abbvie limited - brimonidine tartrate; timolol maleate - eye drops, solution - beta blocking agents1); timolol, combinations

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.

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

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

abbvie pty ltd - brimonidine tartrate, quantity: 2 mg/ml - eye drops, solution - excipient ingredients: polyvinyl alcohol; benzalkonium chloride; citric acid; hydrochloric acid; sodium citrate dihydrate; sodium chloride; sodium hydroxide; purified water - indications:enidin eye drops are effective as monotherapy for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension in whom (beta symbol)-blockers are not tolerated or are contraindicated. indications as at 7 december 1999: enidin eye drops are effective in lowering elevated intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension.enidin eye drops can be used in the treatment of glaucoma either as monotherapy or in combination with topical beta-blockers.

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