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

bausch & lomb incorporated - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. risk summary there are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women to inform drug-associated risks. in animal reproduction studies, intravenous (iv) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data embryofetal studies were conducted in pregnant rabbits administered latanoprost daily by iv injection on gestation days 6 through 18, to target the period of organogenesis. a no observed adverse effect level (noael) was not established for rabbit developmental toxicity. post-implantation loss due to late resorption was shown at doses ≥0.2 mcg/kg/day (equivalent to 1.3 times the maximum recommended human ophthalmic dose [rhod], on a mg/m² basis, assuming 100% absorption). spina bifida and abortion occurred at 5 mcg/kg/day (equivalent to 32 times the maximum rhod). total litter loss due to early resorption was observed at doses ≥50 mcg/kg/day (324 times the maximum rhod). transient signs of maternal toxicity were observed after iv dosing (increased breathing, muscle tremors, slight motor incoordination) at 300 mcg/kg/day (1946 times the maximum rhod). no maternal toxicity was observed at doses up to 50 mcg/kg/day. embryofetal studies were conducted in pregnant rats administered latanoprost daily by iv injection on gestation days 6 through 15, to target the period of organogenesis. a noael for rat developmental toxicity was not established. cleft palate was observed at 1 mcg/kg (equivalent to 3.2 times the maximum rhod, on a mg/m² basis, assuming 100% absorption). brain porencephalic cyst(s) were observed ≥50 mcg/kg (162 times the maximum rhod). skeletal anomalies were observed at 250 mcg/kg (811 times the maximum rhod). no maternal toxicity was detectable at 250 mcg/kg/day. prenatal and postnatal development was assessed in rats. pregnant rats were administered latanoprost daily by iv injection from gestation day 15, through delivery, until weaning (lactation day 21). no adverse effects on rat offspring were observed at doses up to 10 mcg/kg/day (32 times the maximum rhod, on a mg/m2 basis, assuming 100% absorption). at 100 mcg/kg/day (324 times the maximum rhod), maternal deaths and pup mortality occurred. risk summary it is not known whether this drug or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when latanoprost ophthalmic solution is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for latanoprost ophthalmic solution and any potential adverse effects on the breastfed child from latanoprost ophthalmic solution. safety and effectiveness in pediatric patients have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

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

akorn - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. risk summary there are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women.to inform drug-associated risks. in animal reproduction studies, intravenous (iv) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data embryofetal studies were conducted in pregnant rabb

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

rising pharma holdings, inc. - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. risk summary there are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women to inform drug-associated risks. in animal reproduction studies, intravenous (iv) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data embryofetal studies were conducted in pregnant rabb

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

physicians total care, inc. - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.

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

rebel distributors corp - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.

Malta - English - Medicines Authority

cipla (eu) limited hillbrow house, hillbrow road, esher, surrey, kt10 9nw, united kingdom - latanoprost - eye drops, solution - latanoprost 50 µg/ml - ophthalmologicals

Canada - English - Health Canada

mylan pharmaceuticals ulc - latanoprost - solution - 50mcg - latanoprost 50mcg - prostaglandin analogs

Canada - English - Health Canada

mantra pharma inc - latanoprost - solution - 50mcg - latanoprost 50mcg - prostaglandin analogs

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - latanoprost - eye drops, solution - 50 microgram(s)/millilitre - prostaglandin analogues1); latanoprost

Canada - English - Health Canada

apotex inc - latanoprost; timolol (timolol maleate) - solution - 50mcg; 5mg - latanoprost 50mcg; timolol (timolol maleate) 5mg - beta-adrenergic agents