Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
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)
Viatris Pty Ltd
Dorzolamide hydrochloride,Timolol maleate
Eye Drops
Excipient Ingredients: mannitol; benzalkonium chloride; hyetellose; water for injections; sodium citrate dihydrate; sodium hydroxide
Ophthalmic
1
(S4) Prescription Only Medicine
COSDOR is indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.
Visual Identification: Clear, slightly viscous, colorless aqueous solution; Container Type: Bottle; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-09-25
COSDOR _Dorzolamide hydrochloride/Timolol maleate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about COSDOR. 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 COSDOR 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 COSDOR IS USED FOR COSDOR 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 COSDOR 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. COSDOR c Read the complete document
AUSTRALIAN PRODUCT INFORMATION COSDOR _(dorzolamide hydrochloride and timolol maleate) eye drops _ 1 NAME OF THE MEDICINE Dorzolamide hydrochloride and timolol maleate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION COSDOR is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution. Each millilitre of COSDOR contains 20.00 mg (2.0% w/v) dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5.00 mg (0.5% w/v) timolol (6.83 mg of timolol maleate) as the active ingredients. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, slightly viscous, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COSDOR is indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate. 4.2 DOSE AND METHOD OF ADMINISTRATION For individual patient use only. The dose is one drop of COSDOR in the affected eye(s) two times daily. When substituting COSDOR for another ophthalmic antiglaucoma agent(s), discontinue the other agent(s) after proper dosing on one day, and start COSDOR on the next day. If another topical ophthalmic agent is being used, COSDOR and the other agent should be administered at least ten minutes apart. Efficacy in paediatric patients has not been established. Safety in paediatric patients below the age of 2 years has not been established (For information regarding safety in paediatric patients ≥2 and < 6 years of age see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – PAEDIATRIC USE). 4.3 CONTRAINDICATIONS COSDOR is contraindicated in patients with: • reactive airway disease, bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease • sinus bradycardia, sino-atrial block, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock • hypersensitivity to any component of this product The above are based on the components and a Read the complete document