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

sandoz pty ltd - dorzolamide hydrochloride,timolol maleate -

USA - engelsk - 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-timolol maleate is indicated for the reduction of elevated intraocular pressure (iop) 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 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-timolol maleate 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-timolol maleate is contraindicated in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock [see warnings and precautions (5.2)] . do

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 22.3 mg in 1 ml - dorzolamide hcl ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hcl ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product. dorzolamide hcl ophthalmic solution 2% instructions for use please follow these instructions carefully when using dorzolamide hcl ophthalmic solution 2%. use dorzolamide hcl ophthalmic solution 2% as prescribed by your doctor. 1. if you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after dorzolamide hcl ophthalmic solution 2%. 2. wash hands before each use. 3. to open the bottle, remove the shrink neck band and unscrew the cap by turning counter clockwise. 4. tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye. 5. instill drops as directed by your doctor. ophthalmic medications, if handled improperly, can beco

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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: benzalkonium chloride; water for injections; sodium hydroxide; sodium citrate dihydrate; hyetellose; mannitol - the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: sodium hydroxide; benzalkonium chloride; hyetellose; water for injections; mannitol; sodium citrate dihydrate - the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: sodium citrate dihydrate; benzalkonium chloride; mannitol; hyetellose; sodium hydroxide; water for injections - the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: hyetellose; sodium citrate dihydrate; mannitol; sodium hydroxide; benzalkonium chloride; water for injections - the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

USA - engelsk - NLM (National Library of Medicine)

bausch & lomb incorporated - 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 beta-blockers (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 atrioventricula

USA - engelsk - NLM (National Library of Medicine)

golden state medical supply, inc. - 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 atrioventricular block, overt cardiac failure, and cardiogenic shock [see warnings and precautions (5.2) ] . dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.3) ] . teratogenic effects. pregnancy category c. developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥2.5 mg/kg/day (37 times the recommended human ophthalmic dose) 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 (15 times the recommended human ophthalmic dose). teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity. there are no adequate and well-controlled studies in pregnant women. dorzolamide hydrochloride and timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether dorzolamide is excreted in human milk. timolol maleate has been detected in human milk following oral and ophthalmic drug administration. because of the potential for serious adverse reactions from dorzolamide hydrochloride and timolol maleate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of dorzolamide hydrochloride ophthalmic solution and timolol maleate ophthalmic solution have been established when administered individually in pediatric patients aged 2 years and older. use of these drug products in these children is supported by evidence from adequate and well-controlled studies in children and adults. safety and efficacy in pediatric patients below the age of 2 years have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

USA - engelsk - NLM (National Library of Medicine)

bausch & lomb incorporated - 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 ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)] . risk summary there are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the clinical exposure). the background r