LOSARTAN POTASSIUM tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Hikma Pharmaceuticals USA Inc.

INN (International Adı):

LOSARTAN POTASSIUM

Kompozisyon:

LOSARTAN POTASSIUM 25 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Losartan 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, from a vari

Ürün özeti:

Losartan Potassium Tablets, USP 25 mg tablets are supplied as round, green film coated, biconvex, beveled-edge tablets; debossed with product identification “54 277” on one side and plain on the other side. NDC 0054-0123-22: Bottle of 90 Tablets 50 mg tablets are supplied as round, green film coated, biconvex, beveled-edge tablets; debossed with product identification “54 125” on one side and scored on the other side. NDC 0054-0124-22: Bottle of 90 Tablets 100 mg tablets are supplied as round, green film coated, biconvex, beveled-edge tablets; debossed with product identification “54 357” on one side and plain on the other side. NDC 0054-0125-22: Bottle of 90 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep container tightly closed. Protect from light.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET
HIKMA PHARMACEUTICALS USA INC.
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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 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 is an angiotensin II receptor blocker (ARB) indicated for:
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•
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DOSAGE AND ADMINISTRATION
Hypertension
•
•
Hypertensive Patients with Left Ventricular Hypertrophy
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Nephropathy in Type 2 Diabetic Patients
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg and 100 mg. (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)
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)
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)
Usual starting dose: 50 mg once daily. (2.2)
Add hydrochlorothiazide 12.5 mg and/or increase losartan to 100 mg
followed by an increase to
hydrochlorothiazid