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:

Camber Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

LOSARTAN POTASSIUM

Composição:

LOSARTAN POTASSIUM 25 mg

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 antihy

Resumo do produto:

Losartan potassium tablets USP, 25 mg are white to off-white, film coated, oval shaped tablets debossed with 'I' on one side and '5' on the other side.     Bottles of 30 tablets     (NDC 31722-700-30) Bottles of 60 tablets     (NDC 31722-700-60) Bottles of 90 tablets     (NDC 31722-700-90) Bottles of 500 tablets    (NDC 31722-700-05) Bottles of 1000 tablets   (NDC 31722-700-10) Losartan potassium tablets USP, 50 mg are white to off-white, film coated, oval shaped tablets debossed with 'I' on one side and '6' on the other side with score line. Bottles of 30 tablets     (NDC 31722-701-30) Bottles of 60 tablets     (NDC 31722-701-60) Bottles of 90 tablets     (NDC 31722-701-90) Bottles of 500 tablets    (NDC 31722-701-05) Bottles of 1000 tablets   (NDC 31722-701-10) Losartan potassium tablets USP, 100 mg are white to off-white, film coated, tear drop shaped tablets debossed with 'H' on one side and '145' on the other side. Bottles of 30 tablets      (NDC 31722-702-30) Bottles of 60 tablets      (NDC 31722-702-60) Bottles of 90 tablets      (NDC 31722-702-90) Bottles of 500 tablets     (NDC 31722-702-05) Bottles of 1000 tablets    (NDC 31722-702-10) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

LOSARTAN POTASSIUM - LOSARTAN POTASSIUM TABLET, FILM COATED
CAMBER 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 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
Warnings and Precautions
Hyperkalemia (5.4) 10/2018
INDICATIONS AND USAGE
Losartan Potassium tablets are an angiotensin II receptor blocker
(ARB) indicated for:
• 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)
DOSAGE AND ADMINISTRATION
Hype rte nsion
• 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)
Hypertensive Patients with Left Ventricular Hypertrophy
• Usual starting dose: 50 mg once daily. (2.2)
• Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium
tablets to 100 mg followed by an increase to
hydrochlorothiazide 25 mg if further blood pressure response is
needed. (2.2, 14.2)
Nephropathy in Type 2 Diabetic Patients
• Usual dose: 50 mg once daily. (2.3)
• Increase dose to 100 mg once daily if further blood pre