LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 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:

St. Marys Medical Park Pharmacy

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 100 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).

Product summary:

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘49’ on the other side. NDC 60760-472-90 BOTTLES OF 90 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
ST. MARYS MEDICAL PARK PHARMACY
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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 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
Hype rte nsion
Usual starting dose: 50 mg/12.5 mg once daily. ( 2.1)
Titrate as needed to a maximum dose of 100 mg/25 mg. ( 2.1)
Hypertensive Patients with Left Ventricular Hypertrophy
Not controlled on monotherapy: Initiate with 50 mg/12.5 mg. Titrate as
needed to a maximum of 100 mg/25 mg. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Tablets (losartan potassium/hydrochlorothiazide content): 50 mg/12.5
mg; 100 mg/12.5 mg; and 100 mg/25 mg. ( 3)
CONTRAINDICATIONS
Hypersensitivity to any component of losartan potassium and
hydrochlorothiazide tablets. ( 4)
Anuria. ( 4)
Coadministration with aliskiren in patients with diabetes. ( 4)
WARNINGS AND PRECA