Losartan Potassium Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Losartan potassium 10mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Clear colourless solution. Therapeutic Indications: Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age. Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment. Treatment of chronic heart failure in adult patients when treatment with Angiotensin converting enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been stabilised with an ACE inhibitor should not be switched to losartan. Patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure. For reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG. Posology and Method of Administration: For oral administration with or without food, using the dosing syringe provided. The product should be taken with a glass of water. 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). Losartan may be administered with other antihypertensive agents, especially with diuretics (e.g. hydrochlorothiazide). Hypertensive type II diabetic patients with proteinuria ≥ 0.5 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. Losartan may be administered with other antihypertensive agents (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used hypoglycaemic agents (e.g. sulfonylureas, glitazones and glucosidase inhibitors). Heart Failure: The usual initial dose of losartan in patients with heart failure is 12.5 mg once daily. The dose should generally be titrated at weekly intervals (i.e. 12.5 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. Use in patients with intravascular volume depletion: For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. 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. Therefore, losartan is contraindicated in patients with severe hepatic impairment. 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. 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. 6 years to 18 years: 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. Doses above 1.4 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. It is not recommended in children with a glomerular filtration rate < 30 ml/min/1.73 m2 and hepatic impairment, as no data are available. Contra-indications: Hypersensitivity to the active substance or to any of the excipients, 2nd and 3rd trimester of pregnancy, severe hepatic impairment and the concomitant use of losartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2). Special Warnings and Precautions for use: Patients with a history of angioedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored. Intestinal angioedema has been reported in patients treated with angiotensin II receptor antagonists, including losartan. These patients presented with abdominal pain, nausea, vomiting and diarrhoea. If intestinal angioedema is diagnosed, losartan should be discontinued, and appropriate monitoring should be initiated until complete resolution of symptoms has occurred. 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. These conditions should be corrected prior to administration of losartan, or a lower starting dose should be used. This also applies to children 6 to 18 years of age. Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. 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. The concomitant use of potassium-sparing diuretics, potassium supplements, potassium- containing salt substitutes, or other drugs that may increase serum potassium (e.g., trimethoprim-containing products) with losartan is not recommended. 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. Hence, must not be administered in patients with severe hepatic 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. The use of losartan is not recommended in primary aldosteronism. Excessive blood pressure decrease in patients with ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction or stroke. 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. The combination of losartan with a beta-blocker should be used with caution. As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Losartan should not be initiated during pregnancy and should not be continued if diagnosed with pregnancy. Losartan is less effective in black patients because of higher prevalence of low-renin states in the black hypertensive population. The concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia, and decreased renal function (including acute renal failure). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy. Losartan oral solution contains glycerol, sodium benzoate, propylene glycol sodium and potassium. A dose of 9 ml or more may cause headache, stomach upset and diarrhoea due to its glycerol content. The potassium level in losartan is to be taken into consideration for patients with reduced kidney function or patients on a controlled potassium diet. Any warning from the MC, CHM CSM or MHRA: Not Applicable. Black Triangle notice: Not Applicable. A list of common and serious adverse reactions: Common adverse reactions: anaemia, dizziness, vertigo, (orthostatic) hypotension (may be dose-related), renal impairment, renal failure, asthenia, fatigue, increase in blood urea, increased serum creatinine, increased serum potassium, hypoglycaemia, and hyperkalaemia. Serious adverse reactions include palpitations, angina pectoris, increased alanine aminotransferase, atrial fibrillation, dyspnoea, cerebrovascular accident, thrombocytopenia, hypersensitivity reaction, anaphylactic reactions, angioedema 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. Vasculitis including Henoch-Schönlein purpura, intestinal angioedema, pancreatitis, hepatitis, liver function abnormalities, photosensitivity, rhabdomyolysis, erectile dysfunction/impotence, and hyponatraemia. Consult the SmPC for full details of adverse reactions. Pack Size and NHS Price: 150ml – £218.  Marketing Authorisation Number: PL 00427/0319. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Legal Category: POM. Date of Preparation: 24-Nov-2025.