Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
timolol
Mundipharma Pty Ltd
Medicine Registered
Registered
TENOPT ® _Timolol maleate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TENOPT. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using TENOPT against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TENOPT IS USED FOR TENOPT is used to lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure. Also, some people with raised eye pressure may not have glaucoma. Glaucoma is usually caused by a build-up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye. There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems. You may have no symptoms but eventually glaucoma can lead to total blindness. In fact, untreated glaucoma is one of the most common causes of blindness. Although TENOPT helps control your glaucoma it does not cure it. For more information about glaucoma, contact Glaucoma Australia Inc., PO Box 420, Crows Nest 1585, telephone 1800 500 880, or at www.glaucoma.org.au. TENO Aqra d-dokument sħiħ
TENOPT- Product Information Page 1 of 11 PRODUCT INFORMATION TENOPT ® STERILE Ophthalmic Solution NAME OF THE MEDICINE TENOPT ® (timolol maleate) 0.25% and 0.5% CAS NUMBER 26921-17-5 CHEMICAL STRUCTURE Timolol maleate is described chemically as (S)-1-((1,1-dimethylethyl)amino)-3-((4-(4- morpholinyl)-1,2,5-thiadiazol-3-yl)oxy)-2-propanol, (Z)-butenedioate(1:1)salt. Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo isomer. The empirical formula is C 13 H 24 N 4 O 3 S . C 4 H 4 O 4 and the structural formula is: DESCRIPTION Timolol maleate has a molecular weight of 432.50. It is a white, odourless, crystalline powder which is soluble in water, methanol and alcohol. TENOPT is stable at room temperature. TENOPT is a clear, colourless to light yellow solution. Each mL of TENOPT 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of TENOPT 0.5% contains 5.0 mg of timolol (6.8 mg of timolol maleate). TENOPT also contains the following inactive ingredients: monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, sodium hydroxide and water for injections. Benzalkonium chloride 0.01% is added as preservative. PHARMACOLOGY Timolol maleate is a non-selective beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic (membrane-stabilising) activity. Timolol maleate combines reversibly with a part of the cell membrane, the beta-adrenergic receptor, and thus inhibits the usual biological response that would occur with stimulation of that receptor. This specific competitive antagonism blocks stimulation of the beta-adrenergic receptors by catecholamines having beta-adrenergic stimulating (agonist) activity, whether these originate from an endogenous or exogenous O N N N S OCH 2 CCH 2 NHC H OH CH 3 CH 3 CH 3 . HC HC COOH COOH TENOPT- Product Information Page 2 of 11 source. Reversal of this blockade can be accomplished by increasing the concentration of t Aqra d-dokument sħiħ