CASTLEFORD, England, January 28 /PRNewswire/ -- We are pleased to announce the launch of dorzolamide 2% eye drops solution available in a 5ml bottle. Dorzolamide solution is indicated as adjunctive therapy to beta-blockers, as monotherapy in patients unresponsive to beta-blockers or in whom beta-blockers are contraindicated. Dorzolamide solution is also used in the treatment of elevated intra-ocular pressure in ocular hypertension, open-angle glaucoma and pseudo-exfoliative glaucoma.
It is a generic version of Trusopt(R) from MSD and is available immediately in the award-winning Teva 360 livery, which is designed to aid patient safety, as dorzolamide 2% eye drops solution 5ml in a single pack.
The Teva list price for the product is GBP6.33.
Kim Innes, Commercial Director at Teva UK Limited said We are pleased to add this product to our ever expanding product portfolio.
1. Dorzolamide 2% eye drops solution - Summary of Product Characteristics
About Teva UK Limited: Teva UK Limited is one of the UK's top ten pharmaceutical manufacturers, with a presence in the generics, branded respiratory and hospitals markets. It has the widest range of any UK generic pharmaceutical company and markets solid and liquid dose, injectable and respiratory medicines to healthcare professionals. The company is part of Teva Pharmaceutical Industries Ltd which has 38,000 employees based in 70 countries around the world.
Adverse events should be reported. Reporting forms and information can be found at http://www.yellowcard.gov.uk. Adverse events should also be reported to Teva UK Limited.
Dorzolamide 2% eye drops solution Prescribing Information:
Presentation: Each 1 ml contains 20 mg dorzolamide as dorzolamide hydrochloride. Indications: Adjunctive therapy to beta-blockers. Monotherapy in patients unresponsive to beta-blockers. Monotherapy when beta-blockers are contraindicated. Treatment of elevated intra-ocular pressure in ocular hypertension, open-angle glaucoma, and pseudo-exfoliative glaucoma. Dosage and administration: If more than one topical ophthalmic drug is being used , they should be administered at least ten minutes apart. When substitutuing for another ophthalmic anti-glaucoma agent, discontinue other agent after proper dosing on one day and start dorzolamide on the following day. Wash hands before use and don't let the tip of the bottle touch the eye or surrounding structures. Ensure correct handling of the bottle to prevent contamination. Instil drops into the conjunctival sac of the affected eye(s) Adults: Monotherapy-one drop three times daily. Adjunctive therapy-one drop two times daily. Children: Limited clinical data with administration three times a day. Dorzolamide has not been studied in patients less than 36 weeks gestational age and less than one week of age. Contraindications: Hypersensitivity to benzalkonium chloride or to any of the excipients. Severe renal impairment. Hyperchloraemic acidosis. Warnings and Precautions: Hepatic impairment. Dorzolamide has not been studied in patients with acute angle-closure glaucoma. Dorzolamide contains a sulfonamido group therefore the same types of adverse reactions that are attributable to sulphonamides may occur and if serious reactions of hypersensitivity occur, it should be discontinued. Patients with a history of renal calculi may be at increased risk of urolithiasis. Use with caution in patients with pre-existing corneal defects and/or a history of intra-ocular surgery. Contains the preservative benzalkonium chloride which is known to discolour soft contact lenses and may cause eye irritation. Remove contact lenses prior to administration and wait at least 15 minutes before reinsertion. Interactions: Concomitant administration of dorzolamide and oral carbonic anhydrase inhibitors is not recommended as there is potential for an additive effect on the known systemic effects. Specific drug interaction studies have not been performed. Pregnancy and lactation: Should not be used during pregnancy. If treatment with dorzolamide is required, then lactation is not recommended. Effects on ability to drive and use machines: Dizziness and visual disturbances may affect the ability to drive and use machines. Adverse reactions: Very common: Burning and stinging. Common: Headache, superficial punctuate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision, nausea, bitter taste, asthenia and fatigue. Serious: Systemic allergic reactions including angioedema, urticaria and pruritis, rash, shortness of breath and rarely bronchospasm. Rare: Corneal oedema, ocular hypotony, choroidal detachment following filtration surgery. Urolithiasis. Paraesthesia. Prescribers should consult the Summary of Product Characteristics in relation to other side-effects. Overdosage: Somnolence has been reported with oral ingestion and nausea, dizziness, headache, fatigue, abnormal dreams, and dysphagia with topical application. NHS Price: 5ml GBP6.33 Legal category: POM. Marketing Authorisation Numbers: PL 00289/1116. Marketing Authorisation Holder: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG. Date of preparation: January 2010. 18/COP/10
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SOURCE: Teva UK Ltd
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