País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
PD-Rx Pharmaceuticals, Inc.
LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 100 mg
ORAL
PRESCRIPTION DRUG
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
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 43063-483-30, bottle of 30 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.
Abbreviated New Drug Application
LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- 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 1. Hyperkalemia ( 5.4 ) 10/2018 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 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 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. Llegiu el document complet