Press Release

CASTLEFORD, England, January 28 /PRNewswire/ -- We are pleased to announce the launch of dorzolamide 2% eye dropssolution available in a 5ml bottle. Dorzolamide solution is indicated asadjunctive therapy to beta-blockers, as monotherapy in patients unresponsiveto beta-blockers or in whom beta-blockers are contraindicated. Dorzolamidesolution is also used in the treatment of elevated intra-ocular pressure inocular hypertension, open-angle glaucoma and pseudo-exfoliative glaucoma[1].

It is a generic version of Trusopt(R) from MSD and is availableimmediately in the award-winning Teva 360 livery, which is designed to aidpatient 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 toadd this product to our ever expanding product portfolio."

References

1. Dorzolamide 2% eye drops solution - Summary of Product Characteristics

About Teva UK Limited: Teva UK Limited is one of the UK's top tenpharmaceutical manufacturers, with a presence in the generics, brandedrespiratory and hospitals markets. It has the widest range of any UK genericpharmaceutical company and markets solid and liquid dose, injectable andrespiratory medicines to healthcare professionals. The company is part ofTeva Pharmaceutical Industries Ltd (NASDAQ: TEVA) which has 38,000 employeesbased in 70 countries around the world.

Adverse events should be reported. Reporting forms and information can befound at http://www.yellowcard.gov.uk. Adverse events should also be reportedto Teva UK Limited.

Dorzolamide 2% eye drops solution Prescribing Information:

Presentation: Each 1 ml contains 20 mg dorzolamide as dorzolamidehydrochloride. Indications: Adjunctive therapy to beta-blockers. Monotherapyin patients unresponsive to beta-blockers. Monotherapy when beta-blockers arecontraindicated. Treatment of elevated intra-ocular pressure in ocularhypertension, open-angle glaucoma, and pseudo-exfoliative glaucoma. Dosageand administration: If more than one topical ophthalmic drug is being used ,they should be administered at least ten minutes apart. When substitutuingfor another ophthalmic anti-glaucoma agent, discontinue other agent afterproper dosing on one day and start dorzolamide on the following day. Washhands before use and don't let the tip of the bottle touch the eye orsurrounding structures. Ensure correct handling of the bottle to preventcontamination. Instil drops into the conjunctival sac of the affected eye(s)Adults: Monotherapy-one drop three times daily. Adjunctive therapy-one droptwo times daily. Children: Limited clinical data with administration threetimes a day. Dorzolamide has not been studied in patients less than 36 weeksgestational age and less than one week of age. Contraindications:Hypersensitivity to benzalkonium chloride or to any of the excipients. Severerenal impairment. Hyperchloraemic acidosis. Warnings and Precautions: Hepaticimpairment. Dorzolamide has not been studied in patients with acuteangle-closure glaucoma. Dorzolamide contains a sulfonamido group thereforethe same types of adverse reactions that are attributable to sulphonamidesmay occur and if serious reactions of hypersensitivity occur, it should bediscontinued. Patients with a history of renal calculi may be at increasedrisk of urolithiasis. Use with caution in patients with pre-existing cornealdefects and/or a history of intra-ocular surgery. Contains the preservativebenzalkonium chloride which is known to discolour soft contact lenses and maycause eye irritation. Remove contact lenses prior to administration and waitat least 15 minutes before reinsertion. Interactions: Concomitantadministration of dorzolamide and oral carbonic anhydrase inhibitors is notrecommended as there is potential for an additive effect on the knownsystemic effects. Specific drug interaction studies have not been performed.Pregnancy and lactation: Should not be used during pregnancy. If treatmentwith dorzolamide is required, then lactation is not recommended. Effects onability to drive and use machines: Dizziness and visual disturbances mayaffect 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: Systemicallergic reactions including angioedema, urticaria and pruritis, rash,shortness of breath and rarely bronchospasm. Rare: Corneal oedema, ocularhypotony, choroidal detachment following filtration surgery. Urolithiasis.Paraesthesia. Prescribers should consult the Summary of ProductCharacteristics in relation to other side-effects. Overdosage: Somnolence hasbeen reported with oral ingestion and nausea, dizziness, headache, fatigue,abnormal dreams, and dysphagia with topical application. NHS Price: 5mlGBP6.33 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

For media enquiries, telephone the Teva Communications team on+44(0)1977-628500, or email media.enquiries@tevauk.com.

Last updated on: 27/08/2010 11:40:18