LOSARTAN POTASSIUM tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

NuCare Pharmaceuticals,Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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).

Produkto santrauka:

Losartan Potassium Tablets USP, 50 mg are green colored, oval shaped, biconvex film-coated tablets debossed with E on one side and 4 and 6 separated by scoreline on other side. NDC 68071-5040-3 BOTTLES OF 30 Store at 20° to 25°C (68° to 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.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
----------
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 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
Hypertension
• 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 pressure
response