LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- losartan potassium and hydrochlorothiazide tablets tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Sandoz Inc

INN (International Name):

LOSARTAN POTASSIUM

구성:

LOSARTAN POTASSIUM 50 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Losartan potassium and hydrochlorothiazide tablets, USP 50 mg/12.5 mg are white, round, biconvex film-coated debossed with “SZ 349” on one side. Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5206-31, bottle of 30 tablets NDC 0781-5206-92, bottle of 90 tablets NDC 0781-5206-01, bottle of 100 tablets NDC 0781-5206-10, bottle of 1,000 tablets NDC 0781-5206-74, bottle of 4,000 tablets Losartan potassium and hydrochlorothiazide tablets, USP 100 mg/12.5 mg are white, round, biconvex film-coated debossed with “SZ 309” on one side. Each tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5204-31, bottle of 30 tablets NDC 0781-5204-92, bottle of 90 tablets NDC 0781-5204-01, bottle of 100 tablets NDC 0781-5204-10, bottle of 1,000 tablets NDC 0781-5204-74, bottle of 4,000 tablets Losartan potassium and hydrochlorothiazide tablets, USP 100 mg/25 mg are white, round, biconvex film-coated debossed with “SZ 390” on one side. Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. They are supplied as follows: NDC 0781-5207-31, bottle of 30 tablets NDC 0781-5207-92, bottle of 90 tablets NDC 0781-5207-01, bottle of 100 tablets NDC 0781-5207-10, bottle of 1,000 tablets NDC 0781-5207-74, bottle of 4,000 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLETS TABLET, FILM COATED
SANDOZ INC
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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 tablets are a combination
of losartan, an angiotensin II receptor blocker (ARB)
and hydrochlorothiazide, a diuretic indicated for:
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DOSAGE AND ADMINISTRATION
Hype rte nsion
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Hypertensive Patients with Left Ventricular Hypertrophy
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DOSAGE FORMS AND STRENGTHS
Tablets (losartan potassium and hydrochlorothiazide content):
50/12.5 mg; 100/12.5 mg; and 100/25 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,
cough, and back pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at
1-800-525-8747 or FDA at 1-800-FDA-1088 or
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)
Usual starting dose: 50/12.5 mg once daily. (2.1)
Titrate as needed to a maximum dose