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

padagis us llc - brinzolamide (unii: 9451z89515) (brinzolamide - unii:9451z89515) - brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma. brinzolamide ophthalmic suspension is contraindicated in patients who are hypersensitive to any component of this product. risk summary there are no adequate and well-controlled studies in pregnant women to inform drug-associated risk. in reproductive toxicity studies, brinzolamide administered orally to rats induced fetal toxicity at 375 times the recommended human ophthalmic dose (rhod) based on mg/kg. in rabbits, no fetal toxicity was observed following oral administration (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4%, and of miscarriage is 15% to 20%, of clinically recognized pregnancies. data animal data embryo-fetal studies were conducted in

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

s.a. alcon-couvreur n.v. - timolol (timolol maleate), brinzolamide - drops eye (suspension) - 5mg/ml+ 10mg/ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

liqvor cjsc - timolol (timolol maleate), brinzolamide - drops eye (suspension) - 5mg/ml+ 10mg/ml

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

novartis pharmaceuticals australia pty ltd - brinzolamide, quantity: 10 mg/ml - eye drops - excipient ingredients: benzalkonium chloride; disodium edetate; sodium chloride; tyloxapol; mannitol; carbomer 974p; hydrochloric acid; sodium hydroxide; purified water - brinzoquin eye drops 1.0% are indicated to decrease intraocular pressue in: ocular hypertension & open-angle glaucoma.

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

novartis pharmaceuticals australia pty ltd - brinzolamide, quantity: 10 mg/ml - eye drops - excipient ingredients: benzalkonium chloride; disodium edetate; sodium chloride; tyloxapol; mannitol; carbomer 974p; hydrochloric acid; sodium hydroxide; purified water - azopt 1.0% eye drops are indicated to decrease intraocular pressure in : ocular hypertension; open-angle glaucoma.

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

alcon laboratories, inc. - brinzolamide (unii: 9451z89515) (brinzolamide - unii:9451z89515), brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brinzolamide 10 mg in 1 ml - simbrinza (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. simbrinza is contraindicated in patients who are hypersensitive to any component of this product. simbrinza is contraindicated in neonates and infants (under the age of two years) [see use in specific populations (8.4)]. developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (20, 60, and 120 times the recommended human ophthalmic dose) produced maternal toxicity at 6 mg/kg/day and a significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly higher than the historic value at 1 and 6 mg/kg. in rats, statistically decreased body weights of fetuses from dams receiving oral doses of 18 mg/kg/day (180 times the recommended

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

novartis pharmaceuticals australia pty ltd - brinzolamide -

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

alcon laboratories, inc. - brinzolamide (unii: 9451z89515) (brinzolamide - unii:9451z89515) - brinzolamide 10 mg in 1 ml - azopt® is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma. azopt is contraindicated in patients who are hypersensitive to any component of this product. risk summary there are no adequate and well-controlled studies in pregnant women to inform drug-associated risk. in reproductive toxicity studies, brinzolamide administered orally to rats induced fetal toxicity at 375-times the recommended human ophthalmic dose (rhod) based on mg/kg. in rabbits, no fetal toxicity was observed following oral administration (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4%, and of miscarriage is 15% to 20%, of clinically recognized pregnancies. data animal data embryo-fetal studies were conducted in pregnant rats administered 0, 2, 6, or 18 mg/kg/day bri

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - brinzolamide - glaucoma, open-angle; ocular hypertension - ophthalmologicals - azopt is indicated to decrease elevated intraocular pressure in:ocular hypertension;open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.

Israel - English - Ministry of Health

novartis israel ltd - brimonidine tartrate; brinzolamide - eye drops, suspension - brimonidine tartrate 2 mg/ml; brinzolamide 10 mg/ml - brinzolamide, combinations - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction.