HYZAAR- losartan potassium and hydrochlorothiazide tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

PD-Rx Pharmaceuticals, Inc.

INN (nemzetközi neve):

LOSARTAN POTASSIUM

Összetétel:

LOSARTAN POTASSIUM 100 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

HYZAAR ® 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 variety of pharmacolog

Termék összefoglaló:

HYZAAR is supplied as a film-coated tablet. Losartan/Hydrochlorothiazide 100/25mg , light yellow, oval, engraved with 747. Bottles of 30 tablets.NDC 55289-522-30 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.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

HYZAAR- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYZAAR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYZAAR.
HYZAAR (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 HYZAAR 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
HYZAAR 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
Hypertension
Usual starting dose: 50/12.5 mg once daily. ( 2.1)
Titrate as needed to a maximum dose of 100/25 mg. ( 2.1)
Hypertensive Patients with Left Ventricular Hypertrophy
Not controlled on monotherapy: Initiate with 50/12.5 mg. Titrate as
needed to a maximum of 100/25
mg. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Tablets (losartan potassium/hydrochlorothiazide content): 50/12.5 mg;
100/12.5 mg; and 100/25 mg. ( 3)
CONTRAINDICATIONS
Hypersensitivity to any component of HYZAAR. ( 4)
Anuria. ( 4)
Coadministration with aliskiren in patients with diabetes. ( 4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume or salt depletion prior to administration
of HYZAAR. ( 5.2)
Monitor renal function and potassium in susceptible patients. ( 5.3)
Observe for clinical signs of fluid or electrolyte imbalance. ( 5.5)
Acute angle-closure glaucoma. ( 5