Teva UK Limited Launches Dorzolamide 2% Eye Drops Solution

By Teva Uk Ltd, PRNE
Wednesday, January 27, 2010

CASTLEFORD, England, January 28 - 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[1].

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."

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 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 (NASDAQ: TEVA) 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 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

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

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

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