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

somerset therapeutics, llc - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hydrochloride 0.5 mg in 1 ml - epinastine hcl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis. none in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd.  in both studies, no drug-induced teratogenic effects were noted. epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hcl ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

breckenridge pharmaceutical, inc. - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hydrochloride 0.5 mg in 1 ml - epinastine hcl ophthalmic solution 0.05% is indicated for the prevention of itching associated with allergic conjunctivitis. none teratogenic effects pregnancy category c in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd. in both studies, no drug-induced teratogenic effects were noted. epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hcl ophthalmic solution 0.05% should be used during pregnancy only if the potent

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

akorn - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis. none teratogenic effects pregnancy category c in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd. in both studies, no drug-induced teratogenic effects were noted. epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hydrochloride ophthalmic solution should be used during pregnancy only if the

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

apotex corp. - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis. none teratogenic effects pregnancy category c in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd. in both studies, no drug-induced teratogenic effects were noted.  epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd.  there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hydrochloride ophthalmic solution should be used during pregnancy only if t

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

sun pharmaceutical industries, inc. - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis. none teratogenic effects pregnancy category c in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd. in both studies, no drug-induced teratogenic effects were noted. epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hydrochloride ophthalmic solution should be used during preg

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - epinastine hydrochloride - ophthalmic solution - epinastine hydrochloride 0.05 %w/v - epinastine - epinastine - treatment of the symptoms of seasonal allergic conjunctivitis.

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

a-s medication solutions - epinastine hydrochloride (unii: gfm415s5xl) (epinastine - unii:q13wx941ef) - epinastine hcl ophthalmic solution 0.05% is indicated for the prevention of itching associated with allergic conjunctivitis. none teratogenic effects pregnancy category c in an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (mrohd) of 0.0014 mg/kg/day on a mg/kg basis. total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the mrohd. in both studies, no drug-induced teratogenic effects were noted. epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the mrohd. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, epinastine hcl ophthalmic solution 0.05% should be used during pregnancy only if the potent

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

nippon-chemiphar co.,ltd - epinastine hydrochloride - white to faint yellow tablet, diameter : approx. 6.6 mm, thickness : approx. 3.2 mm

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

nippon-chemiphar co.,ltd - epinastine hydrochloride - white to faint yellow tablet, diameter : approx. 8.1 mm, thickness : approx. 3.4 mm

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

sawai pharmaceutical co.,ltd. - epinastine hydrochloride - white to yellowish white dry syrup