الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

american regent, 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. teratogenic effects reproduction studies have been performed in rats and rabbits. in rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. latanoprost ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. safety and effectiv

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

sandoz 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 rabbit

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

greenstone llc - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml - latanoprost 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 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

الولايات المتحدة - الإنجليزية - 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.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

par pharmaceutical, inc. - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost 0.04 mg in 1 ml - travoprost ophthalmic solution usp, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. none pregnancy category c teratogenic effects: travoprost was teratogenic in rats, at an intravenous (iv) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (mrhod), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. travoprost was not teratogenic in rats at iv doses up to 3 mcg/kg/day (75 times the mrhod), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times the mrhod). travoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at iv doses >3 mcg/kg/day (75 times the mrhod) and in mice at subcutaneous doses >0.3 mcg/kg/day (7.5 times the mrhod). in the offspring of female rats that received travoprost subcutaneously from day 7 of pregnancy to lacta

الولايات المتحدة - الإنجليزية - 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

الولايات المتحدة - الإنجليزية - 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

الولايات المتحدة - الإنجليزية - 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.

الولايات المتحدة - الإنجليزية - 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.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

lupin limited - bimatoprost (unii: qxs94885mz) (bimatoprost - unii:qxs94885mz) - bimatoprost 0.3 mg in 1 ml - bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. none teratogenic effects:   in embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost which achieved at least 33 or 97 times, respectively, the maximum intended human exposure based on blood auc levels. at doses at least 41 times the maximum intended human exposure based on blood auc levels, the gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup body weights were reduced. there are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. because animal reproductive studies are not always predictive of human response. bimatoprost ophthalmic solution, 0.03% should be administered during pregnancy only if the potential benefit justifies the