LOSARTAN POTASSIUM tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Major Pharmaceuticals

Designación común internacional (DCI):

LOSARTAN POTASSIUM

Composición:

LOSARTAN POTASSIUM 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Losartan potassium tablets, USP 25 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "25" on one side and "113" on the other side. Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6391-61 Losartan potassium tablets, USP 50 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "114" on one side and breakline on the other side. Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6390-61 Losartan potassium tablets, USP 100 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "100" on one side and "115" on the other side. Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6389-61

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET
MAJOR PHARMACEUTICALS
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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
RX ONLY
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)
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DOSAGE AND ADMINISTRATION
Hypertension (2)
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Hypertensive Patients with Left Ventricular Hypertrophy (2)
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Nephropathy in Type 2 Diabetic Patients (2)
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg; 50 mg; and 100 mg. (3) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥2% and greater than
placebo) are: dizziness, upper respiratory infection,
nasal congestion, and back pain. (6.1) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENT PHARMA INC. AT
1-269-544-2299 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH (6)
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: FETAL TOXICITY
1 INDICATIONS AND USAGE
1.1 Hypertension
1.2 Hypertensive Patients with Left Ventricular Hypertrophy
1.3 Nephropathy in Type 2 Diabetic Patients
2 DOSAGE AND ADMINISTRATION
2.1 Hypertension
2.2 Hypertensive Patients with Left Ventricular Hypertrophy
2.3 Nephropathy in Type 2 Diabetic Patients
2.4 Dosage Modifications in Patients with Hepatic Impairment
2.5 Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension)
3 DOSAGE FORMS AND STR