United States - English - 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 - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dorzolamide hydrochloride,timolol maleate -

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

Canada - English - Health Canada

jamp pharma corporation - dorzolamide (dorzolamide hydrochloride) - solution - 20mg - dorzolamide (dorzolamide hydrochloride) 20mg - carbonic anhydrase inhibitors

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

golden state medical supply, inc. - 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 risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data developmental toxicity studies were conducted in pregnant rabbits administered dorzolamide hydrochloride orally during the period of organogenesis from gestation days 6 through 18 at doses of 0.2, 1, 2.5, 5, and 10 mg/kg/day. the developmental lowest observed adverse effect level (loael) was 2.5 mg/kg/day, based on vertebral malformations and decreased fetal body weight. the maternal loael was 2.5 mg/kg/day, based on metabolic acidosis and reduced weight gain. the maternal and developmental no adverse effect levels (noaels) were 1 mg/kg/day. the rabbit doses of 1 and 2.5 mg/kg/day represent estimated plasma c max levels in rabbits 15 and 37 times higher than the lower limit of detection in human plasma following ocular administration, respectively. dorzolamide hydrochloride was administered orally to rats during late gestation and lactation (gestation day 17 through postpartum day 20) at doses of 0.1, 1, or 7.5 mg/kg/day. the developmental loael was 7.5 mg/kg/day, based on reduced birth weight, reduced weight gain, and a slight delay in postnatal development (incisor eruption, vaginal canalization and eye openings) secondary to lower offspring body weight. this 7.5 mg/kg/day dose represents an estimated plasma c max level in rats 52 times higher than the lower limit of detection in human plasma following ocular administration. the developmental noael was 1 mg/kg/day. the maternal loael was 1 mg/kg/day, based on reduced body weight gain. the maternal noael was 0.1 mg/kg/day. the rat doses of 1 and 0.1 mg/kg/day represent estimated plasma c max levels in rats approximately 8.0 times and approximately equal (1x), respectively to the lower limit of detection in human plasma following ocular administration. risk summary there are no data on the presence of dorzolamide hydrochloride ophthalmic solution in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dorzolamide hydrochloride ophthalmic solution and any potential adverse effects on the breast-fed child from dorzolamide hydrochloride ophthalmic solution. dorzolamide is present in the milk of lactating rats (see data) . data animal data lactating rats were dosed orally with 7.5 mg/kg/day of dorzolamide hydrochloride; dorzolamide and the n-desethyl metabolite were detected in the milk. safety and effectiveness of dorzolamide hydrochloride ophthalmic solution have been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-treatment-controlled trial. no overall differences in safety or effectiveness have been observed between elderly and younger patients. dorzolamide has not been studied in patients with severe renal impairment (crcl < 30 ml/min). because dorzolamide and its metabolite are excreted predominantly by the kidney, dorzolamide hydrochloride ophthalmic solution is not recommended in such patients. dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.

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

arrow pharma pty ltd - dorzolamide hydrochloride,timolol maleate -

Israel - English - Ministry of Health

rafa laboratories ltd - dorzolamide as hydrochloride - ophthalmic solution - dorzolamide as hydrochloride 20 mg/ml - dorzolamide - dorzolamide - for the treatment of eleveated intraocular pressure in patients with ocular hypertension, open-angle glaucoma and in some patients secondary glaucoma.

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%