Teva UK Limited Launches Generic Losartan

By Teva Uk Ltd, PRNE
Sunday, February 28, 2010

CASTLEFORD, England, March 2, 2010 - We are pleased to announce the launch of losartan potassium film-coated
tablets available in 25mg, 50mg and 100mg strengths, in packs of 28. Losartan
is indicated for the treatment of essential hypertension(1).

It is a generic version of Cozaar(R) Black Triangle Drug (losartan)
from MSD and is available immediately in the award-winning Teva 360 livery,
which is designed to aid patient safety.

The Teva retail prices for the product are:

    - 25mg = GBP6.47
    - 50mg = GBP5.12
    - 100mg = GBP6.47

Kim Innes, Commercial Director at Teva UK Limited said, "We are pleased
to add this product straight into our portfolio on the first day it is off
patent."

References

1. Losartan potassium film-coated tablets - Abbreviated Prescribing
Information

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

Losartan Film-coated Tablets

Prescribing Information:

Presentation: Film-coated tablets containing 25mg, 50mg, 100mg losartan
(as potassium salt). Indications: Treatment of essential hypertension. Dosage
and administration: To be swallowed with a glass of water in the morning with
or without food. Adults: Usual starting and maintenance dose is 50mg once
daily, some patients may receive an additional benefit from increasing the
dose to 100 mg daily. Elderly patients: Dosage adjustment is not usually
necessary for the elderly. Consideration should be given to initiating
therapy with 25 mg in patients over 75 years of age. Children: Not
recommended in children under 6 years old. 25 mg once daily in patients >20
to <50kg and 50 mg in patients >50kg. Not recommended in children with
hepatic impairment or a glomerular filtration rate <30ml/min/1.73m2. Hepatic
impairment: Lower dose should be considered in patients with a history of
hepatic impairment. Contraindicated in severe hepatic impairment.
Intravascular volume depletion: Consider starting dose of 25 mg once daily.
Contraindications: Hypersensitivity to losartan or any of the excipients.
Second and third trimesters of pregnancy. Severe hepatic impairment.
Precautions and warnings: Patients with history of angioedema should be
closely monitored. Electrolyte and fluid imbalance should be corrected prior
to administration of Losartan. Plasma concentrations of potassium and
creatine clearance values should be closely monitored. Use with caution in
patients with bilateral renal artery stenosis or stenosis of the artery to a
solitary kidney. Renal function in children should be regularly monitored
during treatment with losartan as it may deteriorate. Not recommended in
patients with primary aldosteronism. Use with caution in patients with
coronary heart disease, cerebrovascular disease, heart failure, aortic and
mitral valve stenosis and obstructive hypertrophic cardiomyopathy. Patients
with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
Losartan is less effective in lowering blood pressure in black people than
non-black people. Interactions: Antihypertensive agents, tricyclic
antidepressants, antipsychotics , baclofen and amifostine may increase the
risk of hypotension. Fluconazole and rifampicin may reduces the plasma
concentration of the active metabolite of Losartan. Other angiotensin II
blockers, potassium sparing diuretics, heparin, potassium supplements or salt
substitutes containing potassium may lead to an increase in serum potassium.
Co-administration of lithium and losartan should be undertaken with caution.
If this combination proves essential, serum lithium level monitoring is
recommended. Combination with NSAIDs should be administered with caution,
especially in the elderly. Patients should be adequately hydrated and
consideration should be given to monitoring renal function. Pregnancy and
lactation: Not recommended during the first trimester of pregnancy or while
breast feeding. Not to be used during the 2nd and 3rd trimesters of
pregnancy. Effects on ability to drive and use machines: Dizziness or
drowsiness may occur, if affected do not drive or operate machinery. Adverse
reactions: Serious: anaphylaxis, hepatitis, oedema, palpitations, angina
pectoris, atrial fibrillation, cerebrovascular accident, syncope. Common:
dizziness, vertigo, asthenia/fatigue, hypotension, hypoglycaemia,
hyperkalaemia. Overdose: No experience with overdose in man is available so
far. Most likely symptoms are hypotension, tachycardia, and possibly
bradycardia. NHS Price: 25mg tablets 28s GBP6.47, 50 mg tablets 28s GBP5.12,
100 mg tablets 28s GBP6.47 Legal category: POM Marketing Authorisation
Number: PL 00289/0963-5 Marketing Authorisation Holder: Teva UK Limited,
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG. Date of
preparation: January 2010

29/COP/10

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

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