LOSARTAN POTASSIUM 25 MG- losartan potassium tablet, film coated LOSARTAN POTASSIUM 50 MG- losartan potassium tablet, film coat

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Strides Pharma Science Limited

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 are available as follows: 25 mg – Each white, round, biconvex film coated tablets debossed with "11" on one side and plain on other side contains 25 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 64380-933-04), 90 (NDC 64380-933-05) and 1000 (NDC 64380-933-08). 50 mg – Each white, round, biconvex, film coated tablets debossed with "12" on scoreline side and plain on other side contains 50 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 64380-934-04), 90 (NDC 64380-934-05) and 1000 (NDC 64380-934-08). 100 mg – Each white, oval, biconvex film coated tablets debossed with "13" on one side and plain on other side contains 100 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 64380-935-04), 90 (NDC 64380-935-05) and 1000 (NDC 64380-935-08). 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 Dispense in a tight, light-resistant container as defined in USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM 25 MG- LOSARTAN POTASSIUM TABLET, FILM COATED
LOSARTAN POTASSIUM 50 MG- LOSARTAN POTASSIUM TABLET, FILM COATED
LOSARTAN POTASSIUM 100 MG- LOSARTAN POTASSIUM TABLET, FILM COATED
STRIDES PHARMA SCIENCE 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 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 tablets are 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)
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 (2)
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 (2)
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 (2)
Usual dose: 50 mg once daily. (2.3)
Increase dose to 100