LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- losartan potassium and hydrochlorothiazide tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

AvPAK

INN (इंटरनेशनल नाम):

HYDROCHLOROTHIAZIDE

रचना:

HYDROCHLOROTHIAZIDE 12.5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

Losartan potassium and hydrochlorothiazide tablets, USP are supplied as film-coated tablets. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg are light yellow colored, oval shaped, biconvex film coated tablets, debossed with "116" on one side and plain on other side. NDC 50268-513-15 (10 Tablets per card, 5 cards per carton) Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg are white to off white colored, oval shaped, biconvex film coated tablets, debossed with "1117" on one side and plain on other side. NDC 50268-514-15 (10 Tablets per card, 5 cards per carton) Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg are yellow colored, oval shaped, biconvex film coated tablets, debossed with "1118" on one side and plain on other side. NDC 50268-515-15 (10 Tablets per card, 5 cards per carton) Store at 20° to 25°C (68° to 77°F) (See USP controlled room temperature). Protect from light. Keep container tightly closed. Dispensed in Unit Dose package. For Institutional Use Only.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET
AvPAK
----------
PATIENT INFORMATION
Losartan Potassium and Hydrochlorothiazide (loe SAR tan poe TASS ee um
and HYE droe KLOR oh THYE
a zide) Tablets, USP 50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg Rx
only
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 tabletscan 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

उत्पाद विशेषताएं

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- LOSARTAN POTASSIUM AND
HYDROCHLOROTHIAZIDE TABLET
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
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)
RECENT MAJOR CHANGES
Warnings and Precautions
Electrolyte and Metabolic Effects (5.5) 10/2018
INDICATIONS AND USAGE
Losartan potassium and hydrochlorothiazide tablets are 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)
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 (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)
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)
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
hydrochloroth