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:

Preferred 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 antihypertensiv

Product summary:

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘48’ on the other side. Bottles of 30                                                      NDC 68788-6329-3 Bottles of 60                                                      NDC 68788-6329-6 Bottles of 90                                                      NDC 68788-6329-9 Bottles of 100                                                     NDC 68788-6329-1 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
PREFERRED 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 is a combination of
losartan, an angiotensin II receptor
blocker (ARB) and hydrochlorothiazide, a diuretic indicated for:
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DOSAGE AND ADMINISTRATION
Hypertension
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Hypertensive Patients with Left Ventricular Hypertrophy
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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
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•
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥2% and greater than
placebo) are dizziness, upper
respiratory infection, cough, and back pain. (6.1)
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)
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)
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)
Not controlled on monotherapy: Initiate with 50 mg/12.5 mg. Titrate as
ne