LOSARTAN POTASSIUM tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Alembic Pharmaceuticals Inc.

INN (Nome Internazionale):

LOSARTAN POTASSIUM

Composizione:

LOSARTAN POTASSIUM 25 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Losartan potassium tablets USP, 25 mg are green color, circular, biconvex, film-coated tablets debossed with “L143” on one side and plain on other side.  They are supplied as follows:   NDC 62332-027-30                bottles of 30 tablets NDC 62332-027-90                bottles of 90 tablets NDC 62332-027-31                bottles of 100 tablets NDC 62332-027-91                bottles of 1000 tablets   Losartan potassium tablets USP, 50 mg are green color, circular, biconvex, film-coated tablets debossed with “L142” on one side and breakline on other side. They are supplied as follows:   NDC 62332-028-30                bottles of 30 tablets NDC 62332-028-90                bottles of 90 tablets NDC 62332-028-31                bottles of 100 tablets NDC 62332-028-91                bottles of 1000 tablets Losartan potassium tablets USP, 100 mg are green color, circular, biconvex, film-coated tablets debossed with “L126” on one side and plain on other side.  They are supplied as follows: NDC 62332-029-30                bottles of 30 tablets NDC 62332-029-90                bottles of 90 tablets NDC 62332-029-31                bottles of 100 tablets NDC 62332-029-91                bottles of 1000 tablets   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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

LOSARTAN POTASSIUM - LOSARTAN POTASSIUM TABLET, FILM COATED
ALEMBIC 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 tablet is 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) (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) (1)
· Treatment of diabetic nephropathy with an elevated serum creatinine
and proteinuria in patients
with type 2 diabetes and a history of hypertension. (1.3) (1)
DOSAGE AND ADMINISTRATION
Hypertension (2)
· Usual adult dose: 50 mg once daily. (2.1) (2)
· Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50
mg). (2.1) (2)
Hypertensive Patients with Left Ventricular Hypertrophy (2)
· Usual starting dose: 50 mg once daily. (2.2) (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)
(2)
Nephropathy in Type 2 Diabetic Patients (2)
· Usual dose: 50 mg once daily. (2.3) (2)
· Increase dose to 100 mg once daily if further blood pressure
response is needed. (2.3) (2)
D