LOSARTAN POTASSIUM tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

losartan potassium (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

Disponible desde:

Preferred Pharmaceuticals Inc.

Designación común internacional (DCI):

losartan potassium

Composición:

losartan potassium 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Losartan potassium 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. 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

Resumen del producto:

Losartan potassium tablets USP, 50 mg, are white to off-white, round, convex, beveled edge, film-coated, scored tablets, debossed with S on one side and 112 on the other side with the score line between 11 and 2. They are supplied as follows: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOSARTAN POTASSIUM TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOSARTAN
POTASSIUM TABLETS.
LOSARTAN POTASSIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE LOSARTAN POTASSIUM AS SOON AS
POSSIBLE. DRUGS THAT ACT DIRECTLY
ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE
DEVELOPING FETUS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions
Hyperkalemia (5.4) 10/2018
INDICATIONS AND USAGE
Losartan potassium is an angiotensin II receptor blocker (ARB)
indicated for:
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DOSAGE AND ADMINISTRATION
Hype rte nsion
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Hypertensive Patients with Left Ventricular Hypertrophy
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Nephropathy in Type 2 Diabetic Patients
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg; 50 mg; and 100 mg. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Treatment of hypertension, to lower blood pressure in adults and
children greater than 6 years old. Lowering blood
pressure reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial infarctions.
(1.1)
Reduction of the risk of stroke in patients with hypertension and left
ventricular hypertrophy. There is evidence that
this benefit does not apply to Black patients. (1.2)
Treatment of diabetic nephropathy with an elevated serum creatinine
and proteinuria in patients with type 2 diabetes
and a history of hypertension. (1.3)
Usual adult dose: 50 mg once daily. (2.1)
Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg).
(2.1)
Usual starting dose: 50 mg once daily. (2.2)
Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium to
100 mg followed by an increase to
hydrochlorothiazide 25 mg if further blood pressure response is
needed. (2