LOSARTAN POTASSIUM — losartan potassium tablet
Lupin Pharmaceuticals, Inc.
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue losartan potassium tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNINGS AND PRECAUTIONS (5.1)].
1 INDICATIONS AND USAGE
Losartan potassium tablets USP 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. 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.
Losartan potassium tablets USP may be administered with other antihypertensive agents.
1.2 Hypertensive Patients with Left Ventricular Hypertrophy
Losartan potassium tablets USP 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 [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
1.3 Nephropathy in Type 2 Diabetic Patients
Losartan potassium tablets USP 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 potassium tablets USP 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) [see CLINICAL STUDIES (14.3)].
2 DOSAGE AND ADMINISTRATION
The usual starting dose of losartan potassium tablets USP are 50 mg once daily. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure [see CLINICAL STUDIES (14.1)]. 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 [see DOSAGE AND ADMINISTRATION (2.5)]. 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 [see CLINICAL PHARMACOLOGY (12.3), CLINICAL STUDIES (14.1), and WARNINGS AND PRECAUTIONS (5.2)].
Losartan potassium 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 [see USE IN SPECIFIC POPULATIONS (8.4), CLINICAL PHARMACOLOGY (12.3), and CLINICAL STUDIES (14)].
2.2 Hypertensive Patients with Left Ventricular Hypertrophy
The usual starting dose is 50 mg of losartan potassium tablets once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan potassium 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 [see CLINICAL STUDIES (14.2)].
2.3 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 [see CLINICAL STUDIES (14.3)].
2.4 Dosage Modifications in Patients with Hepatic Impairment
In patients with mild-to-moderate hepatic impairment the recommended starting dose of losartan potassium tablet USP is 25 mg once daily. Losartan potassium tablet USP has not been studied in patients with severe hepatic impairment [see USE IN SPECIFIC POPULATIONS (8.8) and CLINICAL PHARMACOLOGY (12.3)].
2.5 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 losartan potassium 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-PlusTM and Ora-Sweet SFTM. Add 190 mL of the 50/50 Ora-PlusTM /Ora- Sweet SFTM 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 to 8°C (36 to 46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.
3 DOSAGE FORMS AND STRENGTHS
- Losartan potassium tablets, 25 mg, are white, capsule shaped, biconvex, film-coated tablets, debossed with ‘LU’ on one side and ‘P21’ on the other side.
- Losartan potassium tablets, 50 mg, are white, capsule shaped, biconvex, film-coated tablets, debossed with ‘L’ and ‘U’ on either side of breakline on one side and ‘P22’ on the other side.
- Losartan potassium tablets, 100 mg, are white, capsule shaped, biconvex, film-coated tablets, debossed with ‘LU’ on one side and ‘P23’ on the other side.
Losartan potassium tablets are contraindicated:
- In patients who are hypersensitive to any component of this product.
- For coadministration with aliskiren in patients with diabetes.
5 WARNINGS AND PRECAUTIONS
5.1 Fetal Toxicity
Losartan Potassium Tablets can cause fetal harm when administered to a pregnant woman. 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 potassium as soon as possible [see USE IN SPECIFIC POPULATIONS (8.1)].
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