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Examiné médicalement par Oliinyk Elizabeth Ivanovna, Pharmacie Dernière mise à jour le 30.03.2022
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- 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 Losartic. 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.
- 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.
Hypertension
Losartic® is indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Losartic may be administered with other antihypertensive agents.
Hypertensive Patients With Left Ventricular Hypertrophy
Losartic is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients.
Nephropathy In Type 2 Diabetic Patients
Losartic is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, Losartic reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation).
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.
Losartic potassium tablets are available in 25 mg, 50 mg and 100 mg.
Method of administration
Losartic tablets should be swallowed with a glass of water.
Losartic potassium may be administered with or without food.
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.
Losartic tablets are available in 25 mg, 50 mg and 100 mg.
Method of administration
Losartan tablets should be swallowed with a glass of water.
Losartic may be administered with or without food.
Hypertension
Adult Hypertension
The usual starting dose of Losartic is 50 mg once daily. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure. A starting dose of 25 mg is recommended for patients with possible intravascular depletion (e.g., on diuretic therapy).
Pediatric Hypertension
The usual recommended starting dose is 0.7 mg per kg once daily (up to 50 mg total) administered as a tablet or a suspension. Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg per kg (or in excess of 100 mg) daily have not been studied in pediatric patients.
Losartic is not recommended in pediatric patients less than 6 years of age or in pediatric patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m².
Hypertensive Patients With Left Ventricular Hypertrophy
The usual starting dose is 50 mg of Losartic once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of Losartic should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response.
Nephropathy In Type 2 Diabetic Patients
The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response.
Dosage Modifications In Patients With Hepatic Impairment
In patients with mild-to-moderate hepatic impairment the recommended starting dose of Losartic is 25 mg once daily. Losartic has not been studied in patients with severe hepatic impairment.
Preparation Of Suspension (for 200 mL of a 2.5 mg/mL suspension)
Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg Losartic tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-Plus™ and Ora-Sweet SF™. Add 190 mL of the 50/50 Ora-Plus™/Ora- Sweet SF™ mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.
2nd and 3rd trimester of pregnancy.
Severe hepatic impairment.
The concomitant use of Losartic potassium with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).
2nd and 3rd trimester of pregnancy.
Severe hepatic impairment.
The concomitant use of Losartic with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).
Losartic is contraindicated:
- In patients who are hypersensitive to any component of this product.
- For coadministration with aliskiren in patients with diabetes.
However, we will provide data for each active ingredient