Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
timolol maleate, Quantity: 6.8 mg/mL (Equivalent: timolol, Qty 5 mg/mL)
Micro Labs Pty Ltd
Eye Drops, solution
Excipient Ingredients: benzalkonium chloride; water for injections; dibasic sodium phosphate dodecahydrate; sodium hydroxide; monobasic sodium phosphate dihydrate
Ophthalmic
5 mL
(S4) Prescription Only Medicine
Timolol ophthalmic solution is indicated for the reduction of elevated intraocular pressure.,In clinical trials it has been shown to reduce intraocular pressure in:,Patients with ocular hypertension,Patients with chronic open-angle glaucoma,Aphakic patients with glaucoma
Visual Identification: Clear colorless to pale yellow liquid, practically free from visible particles.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2018-07-03
TIMOLOL MLPL 0.25% AND 0.5% EYE DROPS SOLUTION _TIMOLOL MALEATE_ CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING TIMOLOL MLPL? TIMOLOL MLPL 0.25% contains 3.4 mg of timolol maleate as Timolol. TIMOLOL MLPL 0.5% contains 6.8 mg of timolol maleate as Timolol. TIMOLOL MLPL is used to lower raised pressure in the eye and to treat glaucoma. For more information, see Section 1. Why am I using TIMOLOL MLPL? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TIMOLOL MLPL? Do not use if you have ever had an allergic reaction to TIMOLOL MLPL or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use TIMOLOL MLPL? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TIMOLOL MLPL and affect how it works. A list of these medicines is in Section 3.What if I am taking other medicines? in the full CMI. 4. HOW DO I USE TIMOLOL MLPL? Your doctor will tell you how many drops to take each day. The usual dose for adults is one drop of TIMOLOL MLPL twice a day, in either one or both eyes. More instructions can be found in Section 4. How do I use TIMOLOL MLPL? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TIMOLOL MLPL? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using TIMOLOL MLPL THINGS YOU SHOULD NOT DO Do not give TIMOLOL MLPL to anyone else, even if they have the same condition as you. Do not stop using TIMOLOL MLPL without first talking to your doctor. DRIVING OR USING MACHINES Be careful driving or operating machinery until you know how TIMOLOL MLPL affects you. LOOKING AFTER YOUR Keep your eye drops in a cool place where the temperature stays below MEDICINE 30ºC. Do not store it o Read the complete document
PRODUCT INFORMATION TIMOLOL MLPL 0.25% AND 0.5% EYE DROPS SOLUTION NAME OF THE MEDICINE AUSTRALIAN APPROVED NAME Timolol maleate 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 or almost white, crystalline powder or colourless crystals which is soluble in water, and ethanol(96%). TIMOLOL MLPL is stable at room temperature TIMOLOL MLPL eye drops is clear colorless to pale yellow liquid, practically free from visible particles. The inactive ingredients are: benzalkonium chloride as preservative agent, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, sodium hydroxide for pH adjustment, water for injections. 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 source. Reversal of this blockade can be accomplished by increasing the concentration of the agonist, which will restore the usual biological response. Ophthalmic Solution timolol (timolol maleate) reduces elevated and normal intraocular pressure whether or not associated with glaucoma. Elevated intraocular pressure is a major r Read the complete document