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June 24, 2016


Company: Rowex Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Losartan K+ 50mg, 100mg.
Description: 50mg: White oblong tablet with 1 notch on each side, embossed with 3 on one side. 100mg: White oblong tablet with 3 notches on both sides, embossed with 5 on one side.
Presentation: 50mg-28, €11.73; 100mg-28, €19.71.
Indications: Hypertension. Heart failure (HF), when treatment with ACE inhibitors is no longer appropriate; patients with HF stable with an ACE inhibitor should not be switched to Lotanos. Renal disease in type 2 diabetes patients with proteinuria, to delay disease progression and to reduce proteinuria.

Pharmacology: Losartan is an oral specific angiotensin-II receptor (type AT1) antagonist. Angiotensin II, a potent vasoconstrictor, is the primary active hormone of the renin-angiotensin system and an important determinant of the pathophysiology of hypertension.
Dosage: Adult: Hypertension: 50mg once daily. Maximal antihypertensive effect attained after 3-6 weeks. If necessary, increase to 100mg once daily. May be administered with other antihypertensive agents. Patients with intravascular volume depletion: 25mg once daily initially. Hepatic impairment: Consider a lower dose. HF: Initially 12.5mg once daily. Recommended titration: 7 days at 12.5mg daily, followed by 25mg daily for a further 7 days and then increase to 50mg daily. Renal protection: Initially 50mg once daily. May be increased to 100mg according to BP response. May be administered with other antihypertensive agents as well as with insulin and other commonly used hypoglycaemic agents.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy, lactation.
Special precautions: Volume depletion may cause symptomatic hypotension. Caution: Hepatic impairment (dose adjustment), renal impairment (hyperkalaemia risk). May occur: Angioedema, changes in renal function. No data on use in haemodynamically significant obstructive valvular disease. Contains lactose.
Drug interactions: Caution: Rifampicin, fluconazole, K+ sparing diuretics, K+ supplements or salt substitutes containing K+, indomethacin.
Adverse drug reactions: Hypertension: Dizziness. Hypertensive patients with left ventricular hypertrophy: Dizziness, vertigo, asthenia/fatigue. Heart Failure: Dizziness, hypotension. Type 2 diabetes patients with proteinuria: Dizziness, hypotension, asthenia/fatigue, hyperkalaemia.
Full prescribing information and references available from Rowex Ltd. Telephone: 1800 304400. Fax: (027) 50417. E-mail: rowex@rowa-pharma.ie