LOSARTAN POTASSIUM TABLETS, 100 MG- losartan potassium tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Losartan Potassium (UNII: 3ST302B24A) (Losartan - UNII:JMS50MPO89)

Beschikbaar vanaf:

Aphena Pharma Solutions - Tennessee, LLC

INN (Algemene Internationale Benaming):

Losartan Potassium

Samenstelling:

Losartan Potassium 100 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Losartan potassium is 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 drugs, f

Product samenvatting:

Losartan potassium Tablets USP, 25 mg Green, oval, film coated tablet debossed with "C" on one side and "333" on other side. Bottles of 30 tablets with Child Resistant Closure, NDC 59746-333-30 Bottles of 90 tablets with Child Resistant Closure, NDC 59746-333-90 Bottles of 100 tablets with Child Resistant Closure, NDC 59746-333-01 Bottles of 1000 tablets with Plain Closure, NDC 59746-333-10 Losartan potassium Tablets USP, 50 mg Green, oval, film coated tablet debossed with "C" and scored on one side and "334" on other side. Bottles of 30 tablets with Child Resistant Closure, NDC 59746-334-30 Bottles of 90 tablets with Child Resistant Closure, NDC 59746-334-90 Bottles of 100 tablets with Child Resistant Closure, NDC 59746-334-01 Bottles of 1000 tablets with Plain Closure, NDC 59746-334-10 Losartan potassium Tablets USP, 100 mg Green, oval, film coated tablet debossed with "C" on one side and "335" on other side. Bottles of 30 tablets with Child Resistant Closure, NDC 59746-335-30 Bottles of 90 tablets with Child Resistant Closure, NDC 59746-335-90 Bottles of 100 tablets with Child Resistant Closure, NDC 59746-335-01 Bottles of 1000 tablets with Plain Closure, NDC 59746-335-10 Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

LOSARTAN POTASSIUM TABLETS, 100 MG - LOSARTAN POTASSIUM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 USP, 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 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 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 10