LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Alembic Pharmaceuticals Inc.

INN (mednarodno ime):

LOSARTAN POTASSIUM

Sestava:

LOSARTAN POTASSIUM 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Losartan Potassium and Hydrochlorothiazide Tablets USP are supplied as. Losartan Potassium and Hydrochlorothiazide Tablets USP 50 mg/12.5 mg: Yellow coloured, tear drop shaped, biconvex film coated tablets debossed with ‘L146’ on one side and plain on other side. NDC 62332-048-30                bottle of 30 tablets  NDC 62332-048-90                bottle of 90 tablets NDC 62332-048-91                bottle of 1000 tablets NDC 62332-048-10                carton of 10 blisters of 10 tablets  Losartan Potassium and Hydrochlorothiazide Tablets USP 100 mg/12.5 mg: White coloured, oval shaped, biconvex film coated tablets debossed with ‘L144’ on one side and plain on other side. NDC 62332-049-30                bottle of 30 tablets  NDC 62332-049-90                bottle of 90 tablets NDC 62332-049-91                bottle of 1000 tablets NDC 62332-049-10                carton of 10 blisters of 10 tablets   Losartan Potassium and Hydrochlorothiazide Tablets USP 100 mg/25 mg: Yellow coloured, tear drop shaped, biconvex film coated tablets debossed with ‘L145’ on one side and plain on other side.   NDC 62332-050-30                bottle of 30 tablets  NDC 62332-050-90                bottle of 90 tablets NDC 62332-050-91                bottle of 1000 tablets NDC 62332-050-10                carton of 10 blisters of 10 tablets   Storage Store at 25°C (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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE - LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS 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: (1)
· 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) (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 (2)
· Usual starting dose: 50/12.5 mg once daily. (2.1) (2)
· Titrate as needed to a maximum dose of 100/25 mg. (2.1) (2)
Hypertensive Patients with Left Ventricular Hypertrophy (2)
· 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) (4)
· Anuria. (4) (4)
· Coadministration with aliskiren in pati