United States - English - 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

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

alembic pharmaceuticals inc. - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - 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 pregnanc

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

sandoz inc - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution 0.004% is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost ophthalmic solution should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 defec

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

bryant ranch prepack - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution 0.004% is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost ophthalmic solution should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 an embryo-fetal study was conducted in pregnant rats administered travoprost once daily by sc injection from gestation day (gd) 6 to 18, to target the period of organogenesis. at 10 mcg/kg (60 times the maximum recommended human ocular dose [mrhod], based on estimated plasma cmax ), travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. travoprost caused post-implantation loss at 10 mcg/kg. the no observed adverse effect level (noael) for post-implantation loss was 3 mcg/kg (18 times the mrhod, based on estimated plasma cmax ). the maternal noael was 10 mcg/kg. an embryo-fetal study was conducted in pregnant mice administered travoprost once daily by sc injection from gd 6 to 11, to target the period of organogenesis. at 1 mcg/kg (6 times the mrhod, based on estimated plasma cmax ), travoprost caused postimplantation loss and decreased fetal weight. the no observed adverse effect level (noael) for malformations was 0.3 mcg/kg (2 times the mrhod, based on estimated plasma cmax ). the maternal noael was 1 mcg/kg. pre/postnatal studies were conducted in rats administered travoprost once daily by subcutaneous injection from gd 7 (early embryonic period) to postnatal day 21 (end of lactation period). at doses of greater than or equal to 0.12 mcg/kg/day (0.7 times the mrhod, based on estimated plasma cmax ), adverse pregnancy outcomes (embryo-fetal lethality, abortion, and early delivery), low-birth weight and developmental delays were observed. the noael for adverse pregnancy outcomes, low-birth weight and developmental delay was 0.1 mcg/kg (0.6 times the mhrod, based on estimated plasma cmax ). the noael for maternal toxicity was 0.72 mcg/kg (4 times the mhrod, based on estimated plasma cmax ). risk summary there are no data on the effects of travoprost on the breastfed child or milk production. it is not known if travoprost is present in human milk following ophthalmic administration. a study in lactating rats demonstrated that radio-labeled travoprost and/or its metabolites were excreted in milk following subcutaneous administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for travoprost ophthalmic solution and any potential adverse effects on the breastfed child from travoprost ophthalmic solution. use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. no clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

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

bryant ranch prepack - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution 0.004% is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost ophthalmic solution should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 an embryo-fetal study was conducted in pregnant rats administered travoprost once daily by sc injection from gestation day (gd) 6 to 18, to target the period of organogenesis. at 10 mcg/kg (60 times the maximum recommended human ocular dose [mrhod], based on estimated plasma cmax ), travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. travoprost caused post-implantation loss at 10 mcg/kg. the no observed adverse effect level (noael) for post-implantation loss was 3 mcg/kg (18 times the mrhod, based on estimated plasma cmax ). the maternal noael was 10 mcg/kg. an embryo-fetal study was conducted in pregnant mice administered travoprost once daily by sc injection from gd 6 to 11, to target the period of organogenesis. at 1 mcg/kg (6 times the mrhod, based on estimated plasma cmax ), travoprost caused postimplantation loss and decreased fetal weight. the no observed adverse effect level (noael) for malformations was 0.3 mcg/kg (2 times the mrhod, based on estimated plasma cmax ). the maternal noael was 1 mcg/kg. pre/postnatal studies were conducted in rats administered travoprost once daily by subcutaneous injection from gd 7 (early embryonic period) to postnatal day 21 (end of lactation period). at doses of greater than or equal to 0.12 mcg/kg/day (0.7 times the mrhod, based on estimated plasma cmax ), adverse pregnancy outcomes (embryo-fetal lethality, abortion, and early delivery), low-birth weight and developmental delays were observed. the noael for adverse pregnancy outcomes, low-birth weight and developmental delay was 0.1 mcg/kg (0.6 times the mhrod, based on estimated plasma cmax ). the noael for maternal toxicity was 0.72 mcg/kg (4 times the mhrod, based on estimated plasma cmax ). risk summary there are no data on the effects of travoprost on the breastfed child or milk production. it is not known if travoprost is present in human milk following ophthalmic administration. a study in lactating rats demonstrated that radio-labeled travoprost and/or its metabolites were excreted in milk following subcutaneous administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for travoprost ophthalmic solution and any potential adverse effects on the breastfed child from travoprost ophthalmic solution. use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. no clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

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

micro labs limited - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution 0.004% (ionic buffered solution) is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost ophthalmic solution 0.004% (ionic buffered solution) should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general pop

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

apotex corp. - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (iop) in patients with open angle glaucoma or ocular hypertension. none risk summary   there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk.   in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.   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   an embryo-fetal study was conducted in pregnant rats administered travoprost once daily by sc injection from gestation day (gd) 6 to 18, to target the period of organogenesis. at 10 mcg/kg (60 times the maximum recommended human ocular dose [mrhod], based on estimated plasma cmax ), travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. travoprost caused post-implantation loss at 10 mcg/kg. the no observed adverse effect level (noael) for post-implantation loss was 3 mcg/kg (18 times the mrhod, based on estimated plasma cmax ). the maternal noael was 10 mcg/kg. an embryo-fetal study was conducted in pregnant mice administered travoprost once daily by sc injection from gd 6 to 11, to target the period of organogenesis. at 1 mcg/kg (6 times the mrhod, based on estimated plasma cmax ), travoprost caused post-implantation loss and decreased fetal weight. the no observed adverse effect level (noael) for malformations was 0.3 mcg/kg (2 times the mrhod, based on estimated plasma cmax ). the maternal noael was 1 mcg/kg.   pre/postnatal studies were conducted in rats administered travoprost once daily by subcutaneous injection from gd 7 (early embryonic period) to postnatal day 21 (end of lactation period). at doses of greater than or equal to 0.12 mcg/kg/day (0.7 times the mrhod, based on estimated plasma cmax) , adverse pregnancy outcomes (embryo-fetal lethality, abortion, and early delivery), low-birth weight and developmental delays were observed. the noael for adverse pregnancy outcomes, low-birth weight and developmental delay was 0.1 mcg/kg (0.6 times the mhrod, based on estimated plasma cmax ). the noael for maternal toxicity was 0.72 mcg/kg (4 times the mhrod, based on estimated plasma cmax ). risk summary there are no data on the effects of travoprost on the breastfed child or milk production. it is not known if travoprost is present in human milk following ophthalmic administration. a study in lactating rats demonstrated that radio-labeled travoprost and/or its metabolites were excreted in milk following subcutaneous administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for travoprost ophthalmic solution 0.004% and any potential adverse effects on the breast-fed child from travoprost ophthalmic solution 0.004%. use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. no clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

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

golden state medical supply, inc. - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (iop) in patients with open angle glaucoma or ocular hypertension. none risk summary   there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk.   in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.   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   an embryo-fetal study was conducted in pregnant rats administered travoprost once daily by sc injection from gestation day (gd) 6 to 18, to target the period of organogenesis. at 10 mcg/kg (60 times the maximum recommended human ocular dose [mrhod], based on estimated plasma c max ), travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. travoprost caused post-implantation loss at 10 mcg/kg. the no observed adverse effect level (noael) for post-implantation loss was 3 mcg/kg (18 times the mrhod, based on estimated plasma c max ). the maternal noael was 10 mcg/kg. an embryo-fetal study was conducted in pregnant mice administered travoprost once daily by sc injection from gd 6 to 11, to target the period of organogenesis. at 1 mcg/kg (6 times the mrhod, based on estimated plasma c max ), travoprost caused post-implantation loss and decreased fetal weight. the no observed adverse effect level (noael) for malformations was 0.3 mcg/kg (2 times the mrhod, based on estimated plasma c max ). the maternal noael was 1 mcg/kg.   pre/postnatal studies were conducted in rats administered travoprost once daily by subcutaneous injection from gd 7 (early embryonic period) to postnatal day 21 (end of lactation period). at doses of greater than or equal to 0.12 mcg/kg/day (0.7 times the mrhod, based on estimated plasma c max) , adverse pregnancy outcomes (embryo-fetal lethality, abortion, and early delivery), low-birth weight and developmental delays were observed. the noael for adverse pregnancy outcomes, low-birth weight and developmental delay was 0.1 mcg/kg (0.6 times the mhrod, based on estimated plasma c max ). the noael for maternal toxicity was 0.72 mcg/kg (4 times the mhrod, based on estimated plasma c max ). risk summary there are no data on the effects of travoprost on the breastfed child or milk production. it is not known if travoprost is present in human milk following ophthalmic administration. a study in lactating rats demonstrated that radio-labeled travoprost and/or its metabolites were excreted in milk following subcutaneous administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for travoprost ophthalmic solution 0.004% and any potential adverse effects on the breast-fed child from travoprost ophthalmic solution 0.004%. use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. no clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

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

mylan pharmaceuticals inc. - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. none. risk summary there are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. in animal reproduction studies, subcutaneous (sc) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. because animal reproductive studies are not always predictive of human response, travoprost should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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

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

physicians total care, inc. - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - travoprost 0.04 mg in 1 ml - travatan z® (travoprost ophthalmic solution) 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 preg