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

akorn - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - dorzolamide 20 mg in 1 ml - dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to betablockers (failed to achieve target iop determined after multiple measurements over time). the iop-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see clinical studies (14) ] . dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see warnings and precautions (5.1) ] . dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia, second or third degree atrioventric

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

physicians total care, inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol - unii:817w3c6175) - dorzolamide 20 mg in 1 ml - dorzolamide hydrochloride-timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target iop determined after multiple measurements over time). the iop-lowering of dorzolamide hydrochloride-timolol maleate ophthalmic solution b.i.d. was slightly less than seen with the concomitant administration of 0.5% timolol b.i.d. and 2.0% dorzolamide t.i.d. (see clinical pharmacology, clinical studies ). dorzolamide hydrochloride-timolol maleate ophthalmic solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see warnings); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see warnings); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

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

teva pharmaceuticals usa, inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 20 mg in 1 ml - dorzolamide hydrochloride ophthalmic solution, 2% is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution, 2% is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)]. teratogenic effects pregnancy category c developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day. these doses represent estimated plasma cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively. there are no adequate and well-controlled studies in pregnant women. dorzolamide hydrochloride op

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

a-s medication solutions - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 20 mg in 1 ml - dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1) ]. teratogenic effects. pregnancy category c. developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day. these doses represent estimated plasma cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively. there are no adequate and well-controlled studies in pregnant women. dorzolamide hydrochloride should be used during pre

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - dorzolamide as hydrochloride - eye drops, solution - dorzolamide as hydrochloride 20 mg/ml - dorzolamide - dorzolamide s.k. is indicated for the treatment of eleveated intraocular pressure in patients with ocular hypertension, openangle glaucoma and in some patients secondary glaucoma.

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - dorzolamide hydrochloride - eye drops solution - 20 mg/ml - dorzolamide

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dorzolamide hydrochloride,timolol maleate -

Canada - English - Health Canada

jamp pharma corporation - dorzolamide (dorzolamide hydrochloride) - solution - 2% - dorzolamide (dorzolamide hydrochloride) 2% - carbonic anhydrase inhibitors

Canada - English - Health Canada

generic medical partners inc - dorzolamide (dorzolamide hydrochloride) - solution - 2% - dorzolamide (dorzolamide hydrochloride) 2% - carbonic anhydrase inhibitors

Canada - English - Health Canada

micro labs limited - dorzolamide (dorzolamide hydrochloride) - solution - 2% - dorzolamide (dorzolamide hydrochloride) 2%