United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

zentiva pharma uk ltd - dorzolamide hydrochloride; timolol maleate - eye drops - 20mg/1ml ; 5mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - dorzolamide hydrochloride - eye drops - 20mg/1ml

Canada - English - Health Canada

micro labs limited - dorzolamide (dorzolamide hydrochloride) - solution - 2% - dorzolamide (dorzolamide hydrochloride) 2%

Canada - English - Health Canada

micro labs limited - dorzolamide (dorzolamide hydrochloride) - solution - 2% - dorzolamide (dorzolamide hydrochloride) 2%

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

mundipharma pty ltd - dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: mannitol; sodium citrate dihydrate; benzalkonium chloride; hyetellose; water for injections; sodium hydroxide - trusopt eye drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open- angle glaucoma.

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

thea pharma inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - cosopt ® 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 cosopt 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)] . cosopt is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see warnings and precautions (5.1)] . cosopt 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)] . cosopt is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.3)] . teratogenic effects. 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. cosopt 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 cosopt 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 be established. no overall differences in safety or effectiveness have been observed between elderly and younger patients. what is cosopt? cosopt is a prescription eye drop solution that contains two medicines, dorzolamide hydrochloride called an ophthalmic carbonic anhydrase and timolol maleate called a beta-blocker. cosopt is used to lower high pressure in the eye in people with open-angle glaucoma or ocular hypertension when a beta-blocking medicine alone does not work to control the eye pressure. it is not known if cosopt is safe and effective in children 2 years of age and younger. do not use cosopt if you: - have or have had asthma. - have chronic obstructive pulmonary disease (copd) which emphysema, chronic bronchitis or both. - have heart problems including a slow heartbeat, heart block, heart failure, or your heart muscle suddenly becomes weak due to a severe heart attack or other heart problem that caused heart damage (cardiogenic shock). - are allergic to any of the ingredients in cosopt. see the end of this patient information leaflet for a complete list of ingredients in cosopt. before using cosopt, tell your healthcare provider about all your medical conditions, including if you: - have or have had allergies to sulfa drugs - have a history of anaphylactic reactions to allergens - have atopy (genetic disposition to develop allergic reactions) - have or have had muscle weakness or myasthenia gravis - have diabetes - have thyroid disease - have or have had kidney or liver problems - plan to have any type of surgery - wear contact lenses - are using any other eye drops - have an eye infection or eye trauma - are pregnant or plan to become pregnant. it is not know if cosopt will harm your unborn baby. tell your healthcare provider right away if you become pregnant while using cosopt. you and your healthcare provider will decide if you should use cosopt while you are pregnant. - are breastfeeding or plan to breastfeed. it is not known if cosopt passes into breastmilk. talk to your healthcare provider about the best way to feed your baby while using cosopt. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. cosopt may affect the way medicines work, and other medicines may affect how cosopt works. do not start a new medicine without first talking to your healthcare provider. ask your healthcare provider or pharmacist for a list of medicines you are using, if you are not sure. know the medicines you take. keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. how should i use cosopt? - see the complete instructions for use at the end of this patient information leaflet for detailed instructions about the right way to use cosopt. - use cosopt exactly as your healthcare provider tells you. - use 1 drop of cosopt in the affected eye or both eyes if needed, 2 times each day. 1 drop in the morning and 1 drop in the evening. - if you are using cosopt with another eyedrop, wait at least 5 minutes before or after using cosopt. - if you have eye surgery or have any problems with your eye such as trauma or an infection, talk to your healthcare provider about continuing to use the bottle (multidose) that contains cosopt. - cosopt contains a preservative called benzalkonium chloride. the preservative may be absorbed by soft contact lenses. if you wear contact lenses, remove them before using cosopt. the lenses can be placed back into your eyes 15 minutes after using cosopt. - do not touch your eye or eyelid with the dropper tip. eye medicines, not handled the right way, can become contaminated by bacteria that can cause eye infections. serious damage to the eye and followed by loss of vision may happen from using contaminated eye medicines. if you think your cosopt medicine may be contaminated, or if you develop an eye infection, contact your healthcare provider right away about continuing to use your bottle of cosopt. - if you use too much cosopt you may have dizziness, headaches, shortness of breath, slow heartbeats, or problems breathing. if you have any of these symptoms call your healthcare provider or go to the nearest hospital emergency room right away. what are the possible side effects of cosopt? cosopt may cause serious side effects, including: - severe breathing problems. these breathing problems can happen in people who have asthma, chronic obstructive pulmonary disease, or heart failure and can cause death. tell your healthcare provider right away if you have breathing problems while using cosopt. - heart failure. this can happen in people who already have heart failure and in people who have never had heart failure before. tell your healthcare provider right away if you get any of these symptoms of heart failure while taking cosopt: shortness of breath irregular heartbeat (palpitations) swelling of your ankles or feet sudden weight gain - shortness of breath - irregular heartbeat (palpitations) - swelling of your ankles or feet - sudden weight gain - serious sulfa (sulfonamide) reactions. serious reactions including death can happen in people who are allergic to sulfonamide medicines like one of the medicines in cosopt. other serious reactions can include: severe skin reactions liver problems blood problems stop using cosopt and call your healthcare provider or get emergency help right away if you get any of these symptoms of an allergic reaction: swelling of your face, lips, mouth, or tongue trouble breathing wheezing severe itching skin rash, redness, or swelling dizziness or fainting fast heartbeat or pounding in your chest sweating - severe skin reactions - liver problems - blood problems - swelling of your face, lips, mouth, or tongue - trouble breathing - wheezing - severe itching - skin rash, redness, or swelling - dizziness or fainting - fast heartbeat or pounding in your chest - sweating - increased allergic reactions. people who have a genetic history of developing allergies (atopy) or who have a history of severe anaphylactic reactions from different allergens may have increased allergic reactions while taking beta-blockers, like one of the medicines in cosopt. your usual dose of epinephrine used to treat your anaphylactic reactions may not work as well. stop using cosopt and call your healthcare provider or get emergency help right away if you get any of these symptoms of an allergic reaction: swelling of your face, lips, mouth or tongue trouble breathing wheezing severe itching skin rash, redness, or swelling dizziness or fainting fast heartbeat or pounding in your chest sweating - swelling of your face, lips, mouth or tongue - trouble breathing - wheezing - severe itching - skin rash, redness, or swelling - dizziness or fainting - fast heartbeat or pounding in your chest - sweating - worsening muscle weakness. muscle weakness symptoms including double vision or drooping eyelids can happen while using cosopt. muscle weakness can get worse in people who already have problems with muscle weakness like myasthenia gravis. - swelling of eye. some people with low counts of certain types of cells in the eye have developed corneal edema when using cosopt. call your healthcare provider if you have swelling in your eyes. the most common side effects of cosopt include: - eye burning - eye stinging - eye redness - blurred vision - eye tearing - eye itching - a bitter, sour, or unusual taste after putting in your eyedrops these are not all the possible side effects of cosopt. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088. how should i store cosopt? - store at 68° to 77°f (20° to 25°c). - protect from light. - do not use cosopt after the expiration date on the bottle. keep cosopt and all medicines out of the reach of children. general information about the safe and effective use of cosopt. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not use cosopt for a condition for which it was not prescribed. do not give cosopt to other people, even if they have the same symptoms that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about cosopt that is written for health professionals. what are the ingredients in cosopt? active ingredients: dorzolamide hydrochloride and timolol maleate inactive ingredients: sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, water for injection and benzalkonium chloride added as a preservative. this patient package information has been approved by the u.s. food and drug administration | 11/2020 read this instructions for use before you start using cosopt and each time you get a refill. there may be new information. this leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. important information: - cosopt is for use in the eye. - if you are using cosopt with another eyedrop, wait at least 5 minutes before or after using cosopt. - if you wear contact lenses, remove them before using cosopt. the lenses can be placed back into your eyes 15 minutes after using cosopt. - do not touch your eye or eyelid with the dropper tip. eye medicines, not handled the right way, can become contaminated by bacteria that can cause eye infections. serious damage to the eye and followed by loss of vision may happen from using contaminated eye medicines. if you think your cosopt medicine may be contaminated, or if you develop an eye infection, contact your healthcare provider right away about continuing to use your bottle of cosopt. - wash your hands before each use to make sure you do not infect your eyes while using cosopt. - before using the eyedrops for the first time, be sure the safety seal around the cap is not broken. if the safety seal is broken, call your pharmacist to get a new bottle of cosopt. - the dropper tip is made to give a single drop of cosopt. do not enlarge the hole of the dropper tip. - after you have used all of your doses of cosopt, there will be some cosopt left in the bottle. - there is an extra amount of cosopt that has been added to the bottle. you will get the full amount of cosopt that your doctor prescribed. - do not try to remove the extra cosopt medicine from the bottle. this instructions for use has been approved by the u.s. food and drug administration | 11/2020 manufactured for: thea pharma inc. waltham, ma 02451 made in switzerland © 2023. thea pharma inc. all rights reserved the cosopt trademarks are owned by merck sharp & dohme corp. and are being used with permission. rev. 05/2023 revised: 5/2023 thea pharma inc.

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

a-s medication solutions - 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

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

arrow pharma pty ltd - dorzolamide hydrochloride,timolol maleate -

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

apotex pty ltd - dorzolamide hydrochloride -

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

viatris pty ltd - dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops - excipient ingredients: water for injections; benzalkonium chloride; hyetellose; mannitol; sodium citrate dihydrate; sodium hydroxide - trusamide eye drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.