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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 43063-491-30, bottle of 30 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLETS TABLET, FILM COATED
PD-RX 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:
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 and hydrochlorothiazide content):
50/12.5 mg; 100/12.5 mg; and 100/25 mg. ( 3)
CONTRAINDICATIONS
Hypersensitivity to any component of losartan potassium and
hydrochlorothiazide. ( 4)
Anuria. ( 4)
Coadministration with aliskiren in patients with diabetes. ( 4)
WARNINGS AND PRECAUTIONS
Hypoten