LOSARTAN POTASSIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Losartan potassium tablets USP, 25 mg, are pink, round, biconvex, film-coated with debossed “SZ 210” on one side. They are supplied (with dessicant) as follows: NDC 0781-5700-92, bottle of 90 tablets NDC 0781-5700-01, bottle of 100 tablets NDC 0781-5700-10, bottle of 1,000 tablets Losartan potassium tablets USP, 50 mg, are pink, round, biconvex, film-coated with debossed “SZ 213” on one side and scored on the other side. They are supplied (with dessicant) as follows: NDC 0781-5701-31, bottle of 30 tablets NDC 0781-5701-92, bottle of 90 tablets NDC 0781-5701-01, bottle of 100 tablets NDC 0781-5701-10, bottle of 1,000 tablets NDC 0781-5701-74, bottle of 4,000 tablets Losartan potassium tablets USP, 100 mg, are pink, round, biconvex, film-coated with debossed “SZ 214” on one side. They are supplied (with dessicant) as follows: NDC 0781-5702-31, bottle of 30 tablets NDC 0781-5702-92, bottle of 90 tablets NDC 0781-5702-01, bottle of 100 tablets NDC 0781-5702-10, bottle of 1,000 tablets 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 and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
SANDOZ 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
INDICATIONS AND USAGE
Losartan potassium tablets are an angiotensin II receptor blocker
(ARB) indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
Hype rte nsion
•
•
Hypertensive Patients with Left Ventricular Hypertrophy
•
•
Nephropathy in Type 2 Diabetic Patients
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg; 50 mg; and 100 mg. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
Hyperkalemia ( 5.4 ) 10/2018
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
tablets to 100 mg followed by an increase to
hydrochlorothiazide 25 mg if further blood pressure response is
nee