Indications And Usage
Hypertension: Losartan tablets are 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. 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.
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.
Losartan tablets may be administered with other antihypertensive agents.
Hypertensive Patients with Left Ventricular Hypertrophy: Losartan tablets are 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: Losartan tablets are 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, Losartan tablet 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)
The usual starting dose of losartan tablets 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).
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 .
Losartan tablets are 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 losartan tablets once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan tablets 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 losartan tablets is 25 mg once daily. Losartan tablet has not been studied in patients with severe hepatic impairment .
- In patients who are hypersensitive to any component of this product.
For coadministration with aliskiren in patients with diabetes.
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue losartan as soon as possible .
Hypotension in Volume-or Salt-Depleted Patients:
In patients with an activated renin-angiotensin system, such as volume-or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan. Correct volume or salt depletion prior to administration of losartan tablets .
Renal Function Deterioration:
Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on losartan. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on losartan .
Monitor serum periodically and treat appropriately. Dosage reduction or discontinuation of losartan may be required.
Blood and lymphatic system disorders: Anemia.
Psychiatric disorders: Depression.
Nervous system disorders: Somnolence, headache, sleep disorders, paresthesia, migraine.
Ear and labyrinth disorders: Vertigo, tinnitus.
Cardiac disorders: Palpitations, syncope, atrial fibrillation, CVA.
Respiratory: thoracic and mediastinal disorders: Dyspnea.
Gastrointestinal disorders: Abdominal pain, constipation, nausea, vomiting.
Skin and subcutaneous tissue disorders: Urticaria, pruritus, rash, photosensitivity. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Reproductive system and breast disorders: Impotence.
General disorders and administration site conditions: Edema.Hypertensive Patients with Left Ventricular Hypertrophy
In the Losartan Intervention for Endpoint (LIFE) study, adverse reactions with losartan were similar to those reported previously for patients with hypertension.
Nephropathy in Type 2 Diabetic Patients
General Disorders and Administration Site Conditions: Malaise.
Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported. Anaphylactic reactions have been reported.
Metabolic and Nutrition: Hyponatremia.
Nervous system disorders: Dysgeusia.
Pregnancy and lactation
|pregnancy category D |
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Renal and liver Impairment
Renal impairment, renal failure, BUN increased, serum creatinine increased
Hepatitis, liver enzymes increased, serum bilirubin increased,pancreatitis, liver function abnormalities
Within 1 to 2 weeks after initiation, reassess BP (including postural blood pressure changes), renal function, and serum; follow closely after dose changes. Patients with systolic BP <80 mm Hg, low serum sodium, diabetes mellitus, and impaired renal function should be closely monitored.
Baseline and periodic BP, electrolytes, renal function.