Name of the medicinal product
Cozaar® 50 mg film-coated tablets
Cozaar® 100 mg film-coated tablets
Qualitative and quantitative composition
Each COZAAR 50 mg tablet contains 25.5 mg lactose monohydrate.
Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate.
Pharmaceutical form
Blue, oval film-coated tablets marked 11 on one side and plain on the other.
COZAAR 50 mg tablet
White, oval film-coated tablets marked 952 on one side and scored on the other.
The score line is not intended for breaking the tablet.
COZAAR 100 mg tablet
White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other.
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. The patients should have a left ventricular ejection fraction ≤ 40% and should be clinically stable and on an established treatment regimen for chronic heart failure.
• Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG.
Posology and method of administration
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).
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.
Method of administration
Losartan tablets should be swallowed whole with a glass of water.
Losartan tablets may be administered with or without food.
Contraindications
• Hypersensitivity to the active substance or to any of the excipients.
• 2nd and 3rd trimester of pregnancy.
• Severe hepatic impairment.
• The concomitant use of losartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60>
Overdose
Symptoms of intoxication
Limited data are available with regard to overdose in humans. The most likely manifestation of overdose would be hypotension and tachycardia. Bradycardia could occur from parasympathetic (vagal) stimulation.
Treatment of intoxication
If symptomatic hypotension should occur, supportive treatment should be instituted.
Measures are depending on the time of medicinal product intake and kind and severity of symptoms. Stabilisation of the cardiovascular system should be given priority. After oral intake, the administration of a sufficient dose of activated charcoal is indicated. Afterwards, close monitoring of the vital parameters should be performed. Vital parameters should be corrected if necessary.
Neither losartan nor the active metabolite can be removed by haemodialysis.
