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

mylan pharmaceuticals inc. - bepotastine besilate (unii: 6w18mo1qr3) (bepotastine - unii:hyd2u48ias) - bepotastine besilate ophthalmic solution, 1.5% is a histamine h1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see adverse reactions (6.2)] . there are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, rhod, on a mg/m2 basis) [see data] . the background risk of major birth defects and miscarriage for the indicated pop

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

bausch & lomb incorporated - bepotastine besilate (unii: 6w18mo1qr3) (bepotastine - unii:hyd2u48ias) - bepotastine besilate ophthalmic solution, 1.5% is a histamine h1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see adverse reactions (6.2)] . risk summary there are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, rhod, on a mg/m2 basis) [see data] . the background risk of major birth defects and miscarriage for the

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

apotex corp. - bepotastine besylate (unii: 6w18mo1qr3) (bepotastine - unii:hyd2u48ias) - bepotastine besilate ophthalmic solution, 1.5% is a histamine h1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see adverse reactions ( 6.2 )]. risk summary there are no available human data for the use of bepotastine besilate during pregnancy to inform any drug-associated risks. oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, rhod, on a mg/m2 basis) [see data] .   the background risk of major birth defects and miscarriage for the indicated populat

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

bausch & lomb americas inc. - bepotastine besylate (unii: 6w18mo1qr3) (bepotastine - unii:hyd2u48ias) - bepotastine besilate ophthalmic solution, 1.5% is a histamine h1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see adverse reactions (6.2)] . risk summary there are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, rhod, on a mg/m2 basis) [see data] . the background risk of major birth defects and miscarriage for the

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

alembic pharmaceuticals inc. - bepotastine besilate (unii: 6w18mo1qr3) (bepotastine - unii:hyd2u48ias) - bepotastine besilate ophthalmic solution 1.5% is a histamine h1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see adverse reactions (6.2) ]. risk summary there are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, rhod, on a mg/m2 basis) [see data ]. the background risk of major birth defects and miscarriage for th

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

bausch & lomb incorporated - bepotastine besylate (unii: 6w18mo1qr3) (bepotastine - unii:hyd2u48ias) - bepotastine besilate 15 mg in 1 ml - bepreve® (bepotastine besilate ophthalmic solution) 1.5% is a histamine h1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. bepreve is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see adverse reactions (6.2)] . risk summary there are no available human data for the use of bepreve during pregnancy to inform any drug-associated risks. oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, rhod, on a mg/m2 basis) [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the

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

alembic pharmaceuticals limited - bepotastine besilate (unii: 6w18mo1qr3) (bepotastine - unii:hyd2u48ias) - bepotastine besilate ophthalmic solution 1.5% is a histamine h1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see adverse reactions (6.2) ]. risk summary there are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, rhod, on a mg/m2 basis) [see data ]. the background risk of major birth defects and miscarriage for th

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

nihon generic co.,ltd - bepotastine besilate - white tablet, diameter: 7.1mm, thickness: 3.0mm

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

nihon generic co.,ltd - bepotastine besilate - white tablet, diameter:6.1mm, thickness:2.7mm

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

towa pharmaceutical co., ltd. - bepotastine besilate - white tablet with split line, diameter: 9.0mm, thickness: 4.2mm