LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

थमां उपलब्ध:

ACETRIS HEALTH, LLC

INN (इंटरनेशनल नाम):

LOSARTAN POTASSIUM

रचना:

LOSARTAN POTASSIUM 50 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 and hydrochlorothiazide. 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

उत्पाद समीक्षा:

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘48’ on the other side.             Bottles of 30  NDC 52343-116-30             Bottles of 90  NDC 52343-116-90             Bottles of 1,000          NDC 52343-116-99 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg are white, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘F’ on one side and ‘74’ on the other side.             Bottles of 30  NDC 52343-117-30             Bottles of 90  NDC 52343-117-90             Bottles of 1,000          NDC 52343-117-99 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘49’ on the other side.             Bottles of 30  NDC 52343-118-30             Bottles of 90  NDC 52343-118-90             Bottles of 1,000          NDC 52343-118-99 Storage  Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE - LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
ACETRIS HEALTH, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LOSARTAN
POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS.
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 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 AND
HYDROCHLOROTHIAZIDE 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 and hydrochlorothiazide is a combination of
losartan, an angiotensin II receptor blocker (ARB) and
hydrochlorothiazide, a diuretic indicated for:
Treatment of hypertension, to lower blood pressure. 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)
DOSAGE AND ADMINISTRATION
Hype rte nsion
Usual starting dose: 50 mg/12.5 mg once daily. (2.1)
Titrate as needed to a maximum dose of 100 mg/25 mg. (2.1)
Hypertensive Patients with Left Ventricular Hypertrophy
Not controlled on monotherapy: Initiate with 50 mg/12.5 mg. Titrate as
needed to a maximum of 100 mg/25 mg. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets (losartan potassium/hydrochlorothiazide content): 50 mg/12.5
mg; 100 mg/12.5 mg; and 100 mg/25 mg. (3)
CONTRAINDICATIONS
Hypersensitivity to any component of losartan potassium and
hydrochlorothiazide tablets. (4)
Anuria. (4)
Coadministration with aliskiren in patients with diabetes. (4)
WARNINGS AND PRECAUTIONS
Hypotension: Co