LOSARTAN POTASSIUM 25 MG- losartan potassium tablet, film coated LOSARTAN POTASSIUM 50 MG- losartan potassium tablet, film coat

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Losartan Potassium Tablets, USP are available as follows: 25 mg – Each white, round, biconvex film coated tablets debossed with “11” on one side and plain on other side contains 25 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 23155-644-03), 90 (NDC 23155-644-09), 1000 (NDC 23155-644-10). 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 23155-645-03), 90 (NDC 23155-645-09), 1000 (NDC 23155-645-10). 100 mg – Each white, oval, biconvex film coated tablets debossed with “13” on one side and plain on other side contains 100 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 23155-646-03), 90 (NDC 23155-646-09), 1000 (NDC 23155-646-10).

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LOSARTAN POTASSIUM 25 MG- LOSARTAN POTASSIUM TABLET, FILM COATED
LOSARTAN POTASSIUM 50 MG- LOSARTAN POTASSIUM TABLET, FILM COATED
LOSARTAN POTASSIUM 100 MG- LOSARTAN POTASSIUM TABLET, FILM COATED
HERITAGE PHARMACEUTICALS INC. D/B/A AVET 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)
INDICATIONS AND USAGE
Losartan potassium tablets are an angiotensin II receptor blocker
(ARB) indicated for: (1)
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
Hypertension (2)
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 (2)
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. (2.2, 14.2)
Nephropathy in Type 2 Diabetic Patients (2)
Usual dose: 50 mg once daily