LOSARTAN POTASSIUM 50 MG- losartan potassium tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

Disponível em:

Proficient Rx LP

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Losartan Potassium Tablets, USP are available as follows: 50 mg – Each white, round, biconvex, film coated tablets debossed with "12" on scoreline side and plain on other side contains 50 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 71205-598-30), 60 (NDC 71205-598-60) and 90 (NDC 71205-598-90). Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light Dispense in a tight, light-resistant container as defined in USP.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

LOSARTAN POTASSIUM 50 MG- LOSARTAN POTASSIUM TABLET, FILM COATED
PROFICIENT RX LP
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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 TABLETS 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
Warning and Precautions
Hyperkalemia (5.4) 10/2018
INDICATIONS AND USAGE
Losartan potassium tablets are an angiotensin II receptor blocker
(ARB) indicated for: (1)
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DOSAGE AND ADMINISTRATION
Hypertension (2)
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Hypertensive Patients with Left Ventricular Hypertrophy (2)
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Nephropathy in Type 2 Diabetic Patients (2)
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg; 50 mg; and 100 mg. (3) (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 pressu