Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

alcon couvreur - brinzolamide, timolol maleate - eye drops, suspension - 10, 5 mg/ml

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

novartis pharma k.k. - brinzolamide; timolol maleate - white to faintly yellowish white ophthalmic suspension; (plastic bottle) 5ml; (cap) purple

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

bryant ranch prepack - brinzolamide (unii: 9451z89515) (brinzolamide - unii:9451z89515) - brinzolamide ophthalmic suspension 1% is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. brinzolamide ophthalmic suspension 1% is contraindicated in patients who are hypersensitive to any component of this product. pregnancy category c developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (20, 62, and 125 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 (375 times the recommended human ophthalmic dose) during gestation were proportional to the reduced maternal weight gain, with no statistically significant effects on organ or tissue development. increases in unossified sternebrae, reduced ossification of the skull, and unossified hyoid that occurred at 6 and 18 mg/kg were not statistically significant. no treatment-related malformations were seen. following oral administration of 14 c-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood. there are no adequate and well-controlled studies in pregnant women. brinzolamide ophthalmic suspension 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in a study of brinzolamide in lactating rats, decreases in body weight gain in offspring at an oral dose of 15 mg/kg/day (312 times the recommended human ophthalmic dose) were seen during lactation. no other effects were observed. however, following oral administration of 14 c-brinzolamide to lactating rats, radioactivity was found in milk at concentrations below those in the blood and plasma. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from brinzolamide ophthalmic suspension 1%, 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. a three-month controlled clinical study was conducted in which brinzolamide ophthalmic suspension 1% was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. patients were not required to discontinue their iop-lowering medication(s) until initiation of monotherapy with brinzolamide ophthalmic suspension 1%. iop-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated iop was between 0 and 2 mmhg. five out of 32 patients demonstrated an increase in corneal diameter of one millimeter. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

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

bausch & lomb incorporated - 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 pregnant rats administered 0, 2, 6, or 18 mg/kg/day brinzolamide by oral gavage on gestation days 6 to 17, to target the period of organogenesis. decreased fetal body weight with reduced skeletal ossification were observed at 18 mg/kg/day (375 times the rhod based on mg/kg). the no-observed-adverse-effect-level (noael) for fetal toxicity was 6 mg/kg/day (125 times the rhod). decreased maternal weight gain was observed at 18 mg/kg/day. the noael for maternal toxicity was 6 mg/kg/day (125 times the rhod). embryo-fetal studies were conducted in pregnant rabbits administered 0, 1, 3, or 6 mg/kg/day of brinzolamide by oral gavage on gestation days 6 to 18, to target the period of organogenesis. no treatment-related fetal effects were observed at any dose. the noael for fetal toxicity was 6 mg/kg/day (125 times the rhod based on mg/kg). maternal weight loss during pregnancy was observed at 3 mg/kg/day (63 times the rhod) and above. the noael for maternal toxicity was 1 mg/kg/day (21 times the rhod). a peri-/postnatal study was conducted in rats administered brinzolamide by oral gavage from gestation day 16 through lactation day 20. decreased pup body weight was observed at 15 mg/kg/day (313 times the rhod based on mg/kg). the noael for developmental toxicity was 5 mg/kg/day (104 times the rhod). following oral administration of 14 c-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood. risk summary there are no data on the presence of brinzolamide in human milk, the effects on the breastfed infant, or the effects on milk production. brinzolamide has been detected in the milk of lactating rats. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for brinzolamide ophthalmic suspension and any potential adverse effects on the breastfed child from brinzolamide ophthalmic suspension. a 3-month controlled clinical study was conducted in which brinzolamide ophthalmic suspension was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. patients were not required to discontinue their iop-lowering medication(s) until initiation of monotherapy with brinzolamide ophthalmic suspension. iop-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated iop was between 0 mmhg and 2 mmhg. five out of 32 patients demonstrated an increase in corneal diameter of one millimeter. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

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

bryant ranch prepack - 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 pregnant rats administered 0, 2, 6, or 18 mg/kg/day brinzolamide by oral gavage on gestation days 6 to 17, to target the period of organogenesis. decreased fetal body weight with reduced skeletal ossification were observed at 18 mg/kg/day (375 times the rhod based on mg/kg). the no-observed-adverse-effect-level (noael) for fetal toxicity was 6 mg/kg/day (125 times the rhod). decreased maternal weight gain was observed at 18 mg/kg/day. the noael for maternal toxicity was 6 mg/kg/day (125 times the rhod). embryo-fetal studies were conducted in pregnant rabbits administered 0, 1, 3, or 6 mg/kg/day of brinzolamide by oral gavage on gestation days 6 to 18, to target the period of organogenesis. no treatment-related fetal effects were observed at any dose. the noael for fetal toxicity was 6 mg/kg/day (125 times the rhod based on mg/kg). maternal weight loss during pregnancy was observed at 3 mg/kg/day (63 times the rhod) and above. the noael for maternal toxicity was 1 mg/kg/day (21 times the rhod). a peri-/postnatal study was conducted in rats administered brinzolamide by oral gavage from gestation day 16 through lactation day 20. decreased pup body weight was observed at 15 mg/kg/day (313 times the rhod based on mg/kg). the noael for developmental toxicity was 5 mg/kg/day (104 times the rhod). following oral administration of 14 c-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood. risk summary there are no data on the presence of brinzolamide in human milk, the effects on the breastfed infant, or the effects on milk production. brinzolamide has been detected in the milk of lactating rats. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for brinzolamide ophthalmic suspension and any potential adverse effects on the breastfed child from brinzolamide ophthalmic suspension. a 3-month controlled clinical study was conducted in which brinzolamide ophthalmic suspension was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. patients were not required to discontinue their iop-lowering medication(s) until initiation of monotherapy with brinzolamide ophthalmic suspension. iop-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated iop was between 0 mmhg and 2 mmhg. five out of 32 patients demonstrated an increase in corneal diameter of one millimeter. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

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

waymade healthcare plc - timolol maleate; brinzolamide - eye drops - 5mg/1ml ; 10mg/1ml

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

mawdsley-brooks & company ltd - timolol maleate; brinzolamide - eye drops - 5mg/1ml ; 10mg/1ml