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

sandoz 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 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)

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)

micro labs limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - 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 clinic

Canada - English - Health Canada

mylan pharmaceuticals ulc - dorzolamide (dorzolamide hydrochloride); timolol (timolol maleate) - solution - 20mg; 5mg - dorzolamide (dorzolamide hydrochloride) 20mg; timolol (timolol maleate) 5mg - beta-adrenergic agents

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

leading pharma, 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 atrioventricul

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

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

apotex pty ltd - dorzolamide hydrochloride,timolol maleate -

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

apotex pty ltd - dorzolamide hydrochloride -

Canada - English - Health Canada

alcon canada inc - dorzolamide (dorzolamide hydrochloride) - solution - 2.0% - dorzolamide (dorzolamide hydrochloride) 2.0% - carbonic anhydrase inhibitors

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

a-s medication solutions - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - 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 cmax 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 cmax 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 cmax 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 . dorzolamide hydrochloride (dor zoe’ la mide hye” droe klor’ ide) ophthalmic solution usp, 2% 1. before using the medication for the first time, be sure the tamper evident ring between the bottle and the cap is unbroken (see figure a).   step 1. wash your hands. step 2 . before opening the bottle for the first time, tear off the tamper evident ring to break the seal (see figure b).   step 3. to open the bottle, remove the cap by turning it in the counterclockwise direction (see figure c). giving your dorzolamide hydrochloride ophthalmic solution step 4 . tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye. (see figure d).   step 5. turn your dorzolamide hydrochloride ophthalmic solution dispenser upside down and hold and press gently middle of the bottle with your thumb until a single drop is placed in your eye. do not touch your eye or eyelid with the dropper tip. (see figure e).   step 6. if your doctor has told you to use dorzolamide hydrochloride ophthalmic solution in both eyes, repeat steps 4 and 5 to give your dorzolamide hydrochloride ophthalmic solution. after using your dorzolamide hydrochloride solution step 7. replace the cap by turning it clockwise until tight. (see figure f).   after you have used all of your dorzolamide hydrochloride ophthalmic solution doses, there will be some dorzolamide hydrochloride ophthalmic solution medicine left in the dispenser. do not try to remove the extra medicine from the dorzolamide hydrochloride ophthalmic solution dispenser. throw away your dorzolamide hydrochloride ophthalmic solution dispenser in your household trash. how should i store dorzolamide hydrochloride ophthalmic solution? - store dorzolamide hydrochloride ophthalmic solution between 59˚f to 86˚f (15˚c to 30˚c) - protect from light - safely throw away medicine that is out of date or no longer needed. keep dorzolamide hydrochloride ophthalmic solution and all medicines out of the reach of children. important information about using dorzolamide hydrochloride ophthalmic solution - if you have any eye or skin reactions, especially conjunctivitis or eyelid reactions to dorzolamide hydrochloride ophthalmic solution, stop using it and call your doctor right away. - if you have eye surgery or have a problem such as trauma or infection of your eye while using dorzolamide hydrochloride ophthalmic solution, call your doctor right away. - if you do not handle eye medicines the right way the medicine can become contaminated. if the tip of the dispenser touches your eye or areas around your eye, the tip can become contaminated with bacteria which can cause an eye infection and other serious problems including loss of eyesight. - if you use other eye medicines dropped onto the eye like dorzolamide hydrochloride ophthalmic solution, use the medicines at least 5 minutes before or after you use dorzolamide hydrochloride ophthalmic solution. - dorzolamide hydrochloride ophthalmic solution contains benzalkonium chloride which may be absorbed by soft contact lenses. if you wear contact lenses, remove them before you use your dorzolamide hydrochloride ophthalmic solution. you can place your contact lenses back into your eyes 15 minutes after using your dorzolamide hydrochloride ophthalmic solution. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: micro labs limited bangalore – 560 099, india. manufactured for: micro labs usa inc. somerset, nj 08873 rev.10/2021