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:

Contract Pharmacy Services-PA

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 50 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).

Product summary:

Losartan potassium tablets USP are supplied as follows: 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. Blisterpacks of 30 NDC 67046-455-30 Losartan Potassium Tablets USP, 100 mg are green colored, oval shaped, biconvex film-coated tablets debossed with ‘E’ on one side and ‘47’ on other side. Blisterpacks of 30 NDC 67046-449-30 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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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 449 455
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)
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 pressure response
is needed. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg; 50 mg; and 100 mg. ( 3)