LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Zydus Pharmaceuticals USA Inc.

INN:

HYDROCHLOROTHIAZIDE

composition:

HYDROCHLOROTHIAZIDE 12.5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/ 12.5 mg, are white to off-white, capsule-shaped, film-coated tablets debossed with "ZD18" on one side and plain on other side and are supplied as follows: NDC 68382-142-06 in bottle of 30 tablets with child-resistant closure NDC 68382-142-16 in bottle of 90 tablets with child-resistant closure NDC 68382-142-10 in bottle of 1,000 tablets NDC 68382-142-40 in bottle of 5,000 tablets Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/ 25 mg, are white to off-white, capsule-shaped, film-coated tablets debossed with "ZD19" on one side and plain on other side and are supplied as follows: NDC 68382-143-06 in bottle of 30 tablets with child-resistant closure NDC 68382-143-16 in bottle of 90 tablets with child-resistant closure NDC 68382-143-10 in bottle of 1,000 tablets NDC 68382-143-23 in bottle of 4,000 tablets Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container.

authorization_status:

Abbreviated New Drug Application

PIL

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
Zydus Pharmaceuticals (USA) Inc.
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Patient Information
Losartan Potassium and Hydrochlorothiazide (loe-SAR-tan poe-TASS-ee-um
and hye dro klor o THY a zide)
Tablets, USP
Read the Patient Information that comes with losartan potassium and
hydrochlorothiazide tablets before you
start taking it and each time you get a refill. There may be new
information. This leaflet does not take the
place of talking with your doctor about your condition and treatment.
What is the most important information I should know about losartan
potassium and hydrochlorothiazide
tablets?
•
Losartan potassium and hydrochlorothiazide tablets can cause harm or
death to an unborn baby.
•
Talk to your doctor about other ways to lower your blood pressure if
you plan to become pregnant.
•
If you get pregnant while taking losartan potassium and
hydrochlorothiazide tablets tell your doctor
right away.
What are losartan potassium and hydrochlorothiazide tablets?
Losartan potassium and hydrochlorothiazide tablets contain 2
prescription medicines, an angiotensin receptor
blocker (ARB) and a diuretic (water pill). It is used to:
•
lower high blood pressure (hypertension). Losartan potassium and
hydrochlorothiazide tablets are not
usually the first medicine used to treat high blood pressure.
•
lower the chance of stroke in patients with high blood pressure and a
heart problem called left
ventricular hypertrophy (LVH). Losartan potassium and
hydrochlorothiazide tablets may not help
Black patients with this problem.
Losartan potassium and hydrochlorothiazide tablets have not been
studied in children less than 18 years old.
High Blood Pressure (hypertension). Blood pressure is the force in
your blood vessels when your heart beats
and when your heart rests. You have high blood pressure when the force
is too much. The losartan ingredient
in losartan potassium and hydrochlorothiazide tablets can help your
blood vessels relax so your blo

SPC

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE - LOSARTAN POTASSIUM
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
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
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/hydrochlorothiazide content): 50/12.5 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
Hypotension: Correct volume or salt depletion p