Each film coated tablet contains : Losartan Potassium 25 mg and 50 mg.
Losartan Potassium is indicated for the treatment of hypertension.
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximum antihypertensive effect is achieved 3-6 weeks after initiation of therapy.
The dose may be increase to 100 mg once daily.
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.
No initial dosage adjustment is necessary for the elderly patients or for patients with renal impairment, including patients on dialysis. A lower dose should be considered for patients with a history of hepatic impairment.
Losartan Potassium may be administered with other antihypertensive agents of a different class.
Losartan Potassium may be administered with or without food.
The symptoms of an overdosage of Losartan Potassium would be hypotension and tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Neither Losartan Potassium nor the active metabolite can be removed by haemodialysis.
Patients who are hypersensitive to any component of this product.
The use of Losartan Potassium during pregnancy and lactation Is contra-indicated.
Losartan Potassium should be discontinued as soon as possible, when pregnancy is suspected.
Safety and efficacy has not been established In children.
Women of childbearing age should ensure adequate contraception.
Losartan Potassium is contra-indicated in pregnancy and should be used with care, if at all, during breast-feeding.
Losartan Potassium should be used with caution in patients with bilateral renal artery stenosis or stenosis of an artery to a single kidney, aortic valve stenosis, and hypertrophic obstructive cardiomyopathy.
Symptomatic hypotension may occur after initiation of Losartan Potassium.
Reduced doses must be considered in patients with hepatic impairment.
Patients with volume-depletion (e.g. those treated with high-dose diuretics) may experience hypotension, which may be minimised by initiating treatment with a low dose of Losartan Potassium. Halving of the dose should be considered for patients with a history of hepatic impairment (see Dosage & Administration).
Since hyperkalemia may occur, serum-potassium concentrations should be monitored, especially in the elderly and patients with renal impairment and the concomitant use of potassium-sparing diuretics should generally be avoided (see Interactions).
When impaired renal function is present, changes in renal function as a consequence of inhibiting the renin-angiotensin system including renal failure have been reported in susceptible individuals. These changes in renal function may be reversible upon discontinuation of Losartan Potassium therapy, in some patients.
In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors has been associated with oliguria and/or progressive azotemia and (less frequently) with acute renal failure and/or death. Similar outcomes are likely with Losartan Potassium therapy.
Agents affecting the renin-angiotensin system may increase blood urea and serum creatinine 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 Losartan Potassium therapy.
Pregnancy: See Contraindications.
Losartan Potassium should be discontinued as soon as possible, when pregnancy is suspected.
Losartan Potassium should not be used in pregnancy as teratogenicity has been shown in experimental animals.
Lactation: Safety has not been established.
The following side-effect may occur: Hypersensitivity: The following side effects have been reported and frequencies are unknown: Angioedema (involving swelling of the face, lips, and/or tongue) has been reported in patients treated with Losartan Potassium.
Gastrointestinal: Less Frequent: Diarrhoea, dyspepsia, nausea.
Buccal: Less Frequent: Taste disturbances, complete taste loss.
Skin: Less Frequent: Urticaria, rash, atypical cutaneous lymphoid infiltrates.
Cardiovascular: Less Frequent: Palpitation, tachycardia.
The following side effects have been reported and frequencies are unknown: Hypotension.
Musculoskeletal: Less Frequent: Back pain, muscle cramps, leg pain.
The following side effects have been reported and frequencies are unknown: Myalgia.
Nervous/Psychiatric: Frequent: Headache.
Less Frequent: Dizziness, insomnia, migraine.
Respiratory: Less Frequent: Cough, nasal congestion, pharyngitis, sinus disorder, upper respiratory infection.
Hepatic: Less Frequent: Raised liver enzymes values, severe acute hepatotoxicity.
The following side effects have been reported and frequencies are unknown: Cholestasis.
Haematological: Less Frequent: Symptomatic anaemia, decreased haemoglobin concentrations.
The following side effects have been reported and frequencies are unknown: Neutropenia.
Pancreatic: Less Frequent: Acute pancreatitis.
Body as a Whole: Less Frequent: Abdominal pain, asthenia/fatigue, chest pain, fatigue and oedema/swelling.
Renal: The following side effects have been reported and frequencies are unknown: Impaired renal function.
Combinations containing any of the following medications, depending on the amount present, may also interact with Losartan Potassium :
Non-steroidal anti-inflammatory drugs (NSAIDs) may antagonise the antihypertensive effect of Losartan Potassium.
Concurrent use with sympathomimetics may reduce the antihypertensive effects of Losartan Potassium.
Potassium-sparing diuretics, potassium containing medication or potassium supplements used concurrently with Losartan Potassium may result in hyperkalemia since reduction of aldosterone production induced by Losartan Potassium may lead to elevation of serum potassium.
Store below 30°C in a dry place.
Protect from light and moisture.
C09CA01 - losartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
FC tab 25 mg x 10 x 10's. 50 mg x 10 x 10's.
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