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 after initiation of therapy onwards. 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 paediatric 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 with a glass of water. Losartan tablets may be administered with or without food.

1) In these clinical trials, the most common adverse reaction was dizziness. The frequency of adverse reactions 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) Table 1.

The frequency of adverse reactions identified from placebo-controlled clinical studies and post marketing experience Adverse reaction Frequency of adverse reaction by indication Other Hypertension Hypertensive patients with left- ventricular hypertrophy Chronic Heart Failure Hypertension and type 2 diabetes with renal disease Post- marketing experience Blood and lymphatic system disorders anaemia common frequency not known thrombocytopenia frequency not known Immune system disorders Hypersensitivity reactions, anaphylactic reactions, angioedema*, and vasculitis** rare Psychiatric disorders depression frequency not known Nervous system disorders dizziness common common common common somnolence uncommon headache uncommon uncommon sleep disorders uncommon paraesthesia rare migraine frequency not known dysgeusia frequency not known Ear and labyrinth disorders vertigo common common tinnitus frequency not known Cardiac disorders palpitations uncommon angina pectoris uncommon syncope rare atrial fibrillation rare cerebrovascular accident rare Vascular disorders (orthostatic) hypotension (including dose- related orthostatic effects) ║ uncommon common common Respiratory, thoracic and mediastinal disorders dyspnoea uncommon cough uncommon frequency not known Gastrointestinal disorders abdominal pain uncommon obstipation uncommon diarrhoea uncommon frequency not known nausea uncommon vomiting uncommon intestinal angioedema rare Hepatobiliary disorders pancreatitis frequency not known hepatitis rare liver function abnormalities frequency not known Skin and subcutaneous tissue disorders urticaria uncommon frequency not known pruritus uncommon frequency not known rash uncommon uncommon frequency not known photosensitivity frequency not known Musculoskeletal and connective tissue disorders myalgia frequency not known arthralgia frequency not known rhabdomyolysis frequency not known Renal and urinary disorders renal impairment common renal failure common Reproductive system and breast disorders erectile dysfunction / impotence frequency not known General disorders and administration site conditions asthenia uncommon common uncommon common fatigue uncommon common uncommon common oedema uncommon malaise frequency not known Investigations hyperkalaemia common uncommon† common‡ increased alanine aminotransferase (ALT) § rare increase in blood urea, serum creatinine, and serum potassium common hyponatraemia frequency not known hypoglycaemia common ∗Including swelling of the larynx, glottis, face, lips, pharynx, and/or tongue (causing airway obstruction); in some of these patients angioedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors.

∗∗Including Henoch-Schönlein purpura. g. patients with severe heart failure or under treatment with high dose diuretics. † Common in patients who received 150 mg losartan instead of 50 mg. 4% of patients treated with placebo. § Usually resolved upon discontinuation.

The following additional adverse reactions occurred more frequently in patients who received losartan than placebo (frequencies not known): back pain, urinary tract infection, and flu-like symptoms. 4) Paediatric population The adverse reaction profile for paediatric patients appears to be similar to that seen in adult patients.

Data in the paediatric population are limited. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Hypersensitivity Angioedema. 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). 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). 8). These patients presented with abdominal pain, nausea, vomiting and diarrhoea. Symptoms resolved after discontinuation of angiotensin II receptor antagonists. If intestinal angioedema is diagnosed, losartan should be discontinued and appropriate monitoring should be initiated until complete resolution of symptoms has occurred.

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 medicinal products 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 medicinal products 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 medicinal products 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 Losartan potassium contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total 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. When pregnancy is diagnosed, treatment with losartan should be stopped immediately, and, if appropriate, alternative therapy should be started (see […]

1. 6). - Severe hepatic impairment. 1).