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 hydrochloride-timolol maleate ophthalmic solution (preservative-free) 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 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 (14.1)] . dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) 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 ophthalmic solution (preservative-free) is contraindicated in patients with sinus bra

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - dorzolamide; timolol - eye drops, solution - 20 mg/ml+5 milligram(s)/millilitre - beta blocking agents1); timolol, combinations

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)

aurobindo pharma limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free 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 (14.1)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free 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 preservative free is contraindicated in patients with s

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

somerset therapeutics, llc - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - 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 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 e ffects . 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 e ffects on postnatal development of o ffspring. 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 e ffectiveness 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 adequateand 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 di fferences in safety or eff ectiveness have been observed between elderly and younger patients.

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

micro labs limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) -   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 contraindi

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

alembic pharmaceuticals inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - 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 atrioventricul

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

aurobindo pharma limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - 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

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

micro labs limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free 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 (14.1)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free 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 preservative free 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 preservative free 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 (31 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 (13 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 1000 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 preservative free 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 preservative free 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. read these instructions before using your dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your doctor about your medical condition or your treatment. important: - dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is for the eye only. do not swallow dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free. - dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free single-use containers are packaged in a foil pouch. - write down the date you open the foil pouch in the space provided on the pouch. every time you use dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free: step 1. wash your hands. step 2. take the strip of single-use containers from the pouch. step 3. pull off 1 single-use container from the strip. step 4. put the remaining strip of single-use containers back in the pouch and fold the edge to close the pouch. step 5. hold the single-use container upright. make sure that the solution is in the bottom part of the single-use container (see figure a).   step 6. open the single-use container by twisting off the tab (see figure b). step 7. tilt your head backwards. if you are unable to tilt your head, lie down. step 8. place the tip of the single-use container close to your eye. be careful not to touch your eye with the tip of the single-use container (see figure c). step 9. pull the lower eyelid downwards and look up. step 10. gently squeeze the container and let 1 drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free fall into the space between your lower eyelid and your eye. if a drop misses your eye, try again (see figure d). step 11 . blot any excess solution from the skin around the eye with a tissue. - if your doctor has told you to use drops in both eyes, repeat steps 7 to 11 for your other eye. - there is enough dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free in 1 single-use container for 1 or both of your eyes. - throw away the opened single-use container with any remaining dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free right away.   this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured by: micro labs limited bangalore- 560099, india. manufactured for: micro labs usa, inc. somerset, nj 08873 rev. 11/2021

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

gland pharma limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - 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 atrioventricul