New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - dorzolamide hydrochloride 22.26 mg/ml equivalent to dorzolamide 20 mg/ml; timolol maleate 6.83 mg/ml equivalent to timolol 5 mg/ml - eye drops, solution - 20mg/ml, 5mg/ml - active: dorzolamide hydrochloride 22.26 mg/ml equivalent to dorzolamide 20 mg/ml timolol maleate 6.83 mg/ml equivalent to timolol 5 mg/ml excipient: benzalkonium chloride hyetellose mannitol sodium citrate sodium hydroxide water for injection - arrow - dortim is indicated for the treatment of elevated intraocular pressure (iop) in patients with: · ocular hypertension · open-angle glaucoma · pseudoexfoliative glaucoma · or other secondary open-angle glaucoma's and who are: · insufficiently responsive to topical beta blocker monotherapy · currently receiving concomitant antiglaucoma therapies such as dorzolamide hcl and timolol maleate.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - dorzolamide hydrochloride 22.26 mg/ml equivalent to dorzolamide 20 mg/ml; timolol maleate 6.83 mg/ml equivalent to timolol 5 mg/ml - eye drops, solution - 20 mg/ml + 5 mg/ml - active: dorzolamide hydrochloride 22.26 mg/ml equivalent to dorzolamide 20 mg/ml timolol maleate 6.83 mg/ml equivalent to timolol 5 mg/ml excipient: benzalkonium chloride hyetellose mannitol sodium citrate sodium hydroxide water for injection - indicated for the treatment of elevated intraocular pressure (iop) in patients with: · ocular hypertension · open-angle glaucoma · pseudoexfoliative glaucoma · other secondary open-angle glaucoma and who are: · insufficiently responsive to topical beta blocker monotherapy · currently receiving concomitant antiglaucoma therapies such as dorzolamide hcl and timolol maleate

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

a-s medication solutions - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - 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 is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)]. 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 maj

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

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

florida pharmaceutical products, llc - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - dorzolamide hydrochloride and timolol maleate ophthalmic solution, usp 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, usp 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 atri

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - dorzolamide hydrochloride timolol maleate - eye drops solution - 20+5 mg/ml

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

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

Australia - English - 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 - English - 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.