国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
dorzolamide hydrochloride, Quantity: 22.26 mg/mL (Equivalent: dorzolamide, Qty 20 mg/mL)
Mundipharma Pty Ltd
Eye Drops, solution
Excipient Ingredients: mannitol; sodium citrate dihydrate; benzalkonium chloride; hyetellose; water for injections; sodium hydroxide
Ophthalmic
5mL
(S4) Prescription Only Medicine
Trusopt eye drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open- angle glaucoma.
Visual Identification: Clear, colourless to nearly colourless, slightly viscous solution, practically free from particles.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Restricted flow insert
Licence status A
1996-04-18
TRUSOPT ® EYE DROPS 1 TRUSOPT ® Dorzolamide hydrochloride Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about TRUSOPT. 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 TRUSOPT 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 TRUSOPT is used for TRUSOPT 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 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 TRUSOPT 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. TR 完全なドキュメントを読む
TRUSOPT® EYE DROPS Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION – TRUSOPT ® (DORZOLAMIDE (AS HYDROCHLORIDE)) EYE DROPS 1 NAME OF THE MEDICINE Dorzolamide hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of TRUSOPT contains 20 mg (2%) dorzolamide (22.3 mg of dorzolamide hydrochloride). List of excipient(s) with known effect: benzalkonium chloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless to nearly colourless, slightly viscous, sterile, isotonic, buffered solution, practically free from particles. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TRUSOPT eye drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. 4.2 D OSE AND METHOD OF ADMINISTRATION When used as monotherapy, the dose is one drop of TRUSOPT in the affected eye(s) three times daily. When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of TRUSOPT in the affected eye(s) two times daily. When substituting TRUSOPT for another ophthalmic antiglaucoma agent, discontinue the other agent after usual dosing on one day, and start TRUSOPT on the next day. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. Systemic absorption of drugs from ophthalmic solutions may be minimised by pressure on the tear-duct immediately after application. TRUSOPT® EYE DROPS Page 2 of 9 4.3 C ONTRAINDICATIONS TRUSOPT is contraindicated in patients who are hypersensitive to any component of this product. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE General The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. TRUSOPT has not been studied in patients with acute angle-closure glaucoma. TRUSOPT is a sulphonamide and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions th 完全なドキュメントを読む