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:

Micro Labs Limited

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 USP 25 mg tablets are white to off-white, oval shaped, film-coated tablets with “A” engraved on one side and “25” on the other side. They are supplied as follows:   NDC 42571-110-30 unit of use bottles of 30 NDC 42571-110-90 unit of use bottles of 90 NDC 42571-110-10 unit of use bottles of 1000 Losartan Potassium USP 50 mg tablets are white to off-white, oval shaped, film-coated tablets with “A50” engraved on one side and break line on the other side. They are supplied as follows:   NDC 42571-111-30 unit of use bottles of 30 NDC 42571-111-90 unit of use bottles of 90 NDC 42571-111-10 unit dose packages of 1000 Losartan Potassium USP 100 mg tablets are white to off-white, oval shaped, film-coated tablets with “A100” engraved on one side and plain on the other side. They are supplied as follows:   NDC 42571-112-30 unit of use bottles of 30 NDC 42571-112-90 unit of use bottles of 90 NDC 42571-112-10 unit dose packages of 1000 Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [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
MICRO LABS LIMITED
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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 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:
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 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)
CONTRAINDICATIONS
Hypersensitiv