LOSARTAN POTASSIUM

Posology Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning).

g. 1). 5 g/day The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on blood pressure response from one month onwards after initiation of therapy. g. g. sulfonylureas, glitazones and glucosidase inhibitors).

5 mg once daily. e. 5 mg daily, 25 mg daily, 50 mg daily, 100 mg daily, up to a maximum dose of 150 mg once daily) as tolerated by the patient. Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG The usual starting dose is 50 mg of losartan once daily.

A low dose of hydrochlorothiazide should be added and/or the dose of losartan should be increased to 100 mg once daily based on blood pressure response. g. 4).

Use in patients with renal impairment and haemodialysis patients:

No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.

Use in patients with hepatic impairment:

A lower dose should be considered for patients with a history of hepatic impairment. There is no therapeutic experience in patients with severe hepatic impairment. 4). Paediatric population 6 months – less than 6 years The safety and efficacy of children aged 6 months to less than 6 years has not been established.

2 but no recommendation on posology can be made. 6 years to 18 years For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients >20 to <50 kg. In exceptional cases the dose can be increased to a maximum of 50 mg once daily.

Dosage should be adjusted according to blood pressure response. In patients >50 kg, the usual dose is 50 mg once daily. In exceptional cases the dose can be adjusted to a maximum of 100 mg once daily. 4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients.

Losartan is not recommended for use in children under 6 years old, as limited data are available in these patient groups. 4). 4). Use in Elderly Although consideration should be given to initiating therapy with 25 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.

Method of administration Losartan tablets should be swallowed whole with a glass of water. Losartan tablets may be administered with or without food.

Losartan has been evaluated in clinical studies as follows: • In a controlled clinical trial in > 3,000 adult patients 18 years of age and older for essential hypertension. 1) In these clinical trials, the most common adverse event was dizziness.

The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

In controlled clinical trials for essential hypertension, hypertensive patients with left ventricular hypertrophy, chronic heart failure as well as for hypertension and type 2 diabetes mellitus with renal disease, the most common adverse event was dizziness.

Hypertension In controlled clinical trials for essential hypertension with losartan the following adverse events were reported: Nervous system disorders Common: dizziness Uncommon: somnolence, headache, sleep disorders Ear and labyrinth disorders Common: vertigo Cardiac disorder Uncommon: palpitations, angina pectoris Vascular disorders Uncommon: (orthostatic) hypotension (dose-related orthostatic effects) ║, Skin and subcutaneous tissue disorders Uncommon: rash Gastrointestinal disorders Uncommon: abdominal pain, obstipation Rare: Intestinal angioedema.

General disorders and administration site conditions Uncommon: asthenia, fatigue, oedema Investigations Common: hyperkalaemia Rare: increased alanine aminotransferase (ALT) § Hypertensive patients with left ventricular hypertrophy In a controlled clinical trial in hypertensive patients with left ventricular hypertrophy the following adverse events were reported: Nervous system disorders Common: dizziness Ear and labyrinth disorders common: vertigo General disorders and administration site conditions Common: asthenia,fatigue Chronic heart failure In a controlled clinical trial in patients with cardiac insufficiency the following adverse events were reported: Blood and lymphatic system disorders Common: anaemia Nervous system disorders Common: dizziness Uncommon: headache Rare: paraesthesia Cardiac disorders Rare: syncope, artrial fibrillation, cerebrovascular accident Vascular disorders Common: (orthostatic) hypotension (including dose- related orthostatic effects) ║ Respiratory, thoracic and mediastinal disorders Uncommon: dyspnoea, cough Gastrointestinal disorders Uncommon: diarrhoea, nausea, vomiting Rare: Intestinal angioedema.

g. 4% of patients treated with placebo §Usually resolved upon discontinuation The following adverse events occurred more often in patients receiving losartan than placebo: Muscoskeletal and connective tissue disorders Not known: back pain Renal and urinary disorders Not known: urinary tract infections General disorders and administration site conditions Not known: flu-like symptoms Renal and urinary disorders As a […]

Hypersensitivity Angiooedema. 8). Hypotension and Electrolyte/Fluid Imbalance Symptomatic hypotension, especially after the first dose and after increasing of the dose, may occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.

2). This also applies to children 6 to 18 years of age. Electrolyte imbalances Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. 8, 'Hypertension and type 2 diabetes with renal disease - Investigations’ and ‘Post- marketing experience - Investigations’ Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored, especially patients with heart failure and a Creatinine Clearance between 30-50 ml/min should be closely monitored.

5). Hepatic impairment Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment.

There is no therapeutic experience with losartan in patients with severe hepatic impairment. 2). 2). Renal Impairment As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported (in particular, in patients whose renal function is dependent on the renin angiotensin aldosterone system such as those with severe cardiac insufficiency or pre-existing renal dysfunction).

As with other drugs that affect the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; these changes in renal function may be reversible upon discontinuation of therapy.

Losartan should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. 2). Renal function should be regularly monitored during treatment with losartan as it may deteriorate.

This applies particularly when losartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function. Concomitant use of losartan and ACE-inhibitors has shown to impair renal function. 5). Renal transplantation There is no experience in patients with recent kidney transplantation.

Primary hyperaldosteronism Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Losartan is not recommended. Coronary heart disease and cerebrovascular disease As with any antihypertensive agents, excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke.

Heart failure In patients with heart failure, with or without renal impairment, there is - as with other drugs acting on the renin-angiotensin system - a risk of severe arterial hypotension, and (often acute) renal impairment. There is no sufficient therapeutic experience with losartan in patients with heart failure and concomitant severe renal impairment, in patients with severe heart failure (NYHA class IV) as well as in patients with heart failure and symptomatic life threatening cardiac arrhythmias.

Therefore, losartan should be used with caution in these patient groups. 1). Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Excipients This medicinal product contains Lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pregnancy Losartan should not be initiated during pregnancy.

Unless continued losartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. 6). Other warnings and precautions As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, […]

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