LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Macleods Pharmaceuticals Limited

INN (Rahvusvaheline Nimetus):

LOSARTAN POTASSIUM

Koostis:

LOSARTAN POTASSIUM 50 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

Losartan potassium and hydrochlorothiazide tablets, USP are supplied as a film-coated tablet. Storage Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE - LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
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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, USP 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:
• 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) (1)
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) (2)
DOSAGE FORMS AND STRENGTHS
Tablets (losartan potassium/hydrochlorothiazide content): 50/12.5 mg;
100/12.5 mg; and 100/25 mg. (3)
(3)
CONTRAINDICATIONS
• Hypersensitivity to any component of losartan potassium and
hydrochlorothiazide tablets. (4)
• Anuria. (4)
• Anuria. (4)
• Coadministration with aliskiren in pat