LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- losartan potassium and hydrochlorothiazide tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

West-Ward Pharmaceuticals Corp.

INN:

LOSARTAN POTASSIUM

composition:

LOSARTAN POTASSIUM 50 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Losartan potassium and hydrochlorothiazide is 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, from a var

leaflet_short:

Losartan Potassium and Hydrochlorothiazide Tablets USP 50 mg/12.5 mg tablets are supplied as round, yellow film coated, biconvex, beveled-edge tablets debossed with product identification “54 717” on one side and plain on the other side. NDC 0054-0126-22: Bottle of 90 Tablets 100 mg/12.5 mg tablets are supplied as round, white film coated, biconvex, beveled-edge tablets debossed with product identification “54 931” on one side and plain on the other side. NDC 0054-0277-22: Bottle of 90 Tablets 100 mg/25 mg tablets are supplied as round, yellow film coated, biconvex, beveled-edge tablets debossed with product identification “54 557” on one side and plain on the other side. NDC 0054-0127-22: Bottle of 90 Tablets Storage Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Keep container tightly closed. Protect from light.

authorization_status:

Abbreviated New Drug Application

SPC

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET
WEST-WARD PHARMACEUTICALS CORP.
REFERENCE LABEL SET ID: EEC68255-439F-4738-ABC3-D19B0A0B92C8
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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._
RECENT MAJOR CHANGES
Warnings and Precautions
INDICATIONS AND USAGE
Losartan potassium and hydrochlorothiazide is a combination of
losartan, an angiotensin II receptor blocker (ARB) and
hydrochlorothiazide, a diuretic indicated for:
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DOSAGE AND ADMINISTRATION
_Hypertension_
•
•
_Hypertensive Patients with Left Ventricular Hypertrophy_
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DOSAGE FORMS AND STRENGTHS
Losartan Potassium and Hydrochlorothiazide Tablets USP: 50 mg/12.5 mg;
100 mg/12.5 mg; and 100 mg/25 mg. (3)
CONTRAINDICATIONS
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•
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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,
Electrolyte and Metabolic Effects ( 5.5 ) 10/2018
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 of 100/25 mg. (2.1)
Not Controlled on Monotherapy: Initiate with 50/12.5 mg. Titrate as
needed to a maximum of 100/25 mg. (2.2)
Hypersensitivity to any component of losartan potassium and
hydrochlorothiazid