LOSARTAN POTASSIUM tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)

Disponible des:

Cardinal Health 107, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal 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. 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

Resumen del producto:

Losartan Potassium Tablets USP, 25 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z" on one side and "2"on other side and are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-2326-0 Losartan Potassium Tablets USP, 50 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z16" on one side and lip type breakline on other side and are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-2327-0 Losartan Potassium Tablets USP, 100 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z18" on one side and plain on other side and are supplied as follows: Overbagged with 10 tablets per bag, NDC 55154-2333-0 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
Cardinal Health 107, LLC
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Patient Information
Losartan Potassium (loe-SAR-tan poe-TASS-ee-um) Tablets, USP
Read the Patient Information that comes with losartan potassium
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 tablets?
•
Losartan potassium 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 tablets, tell your
doctor right away.
What are losartan potassium tablets?
Losartan potassium tablets are a prescription medicine called an
angiotensin receptor blocker (ARB). It is
used:
•
alone or with other blood pressure medicines to lower high blood
pressure (hypertension).
•
to lower the chance of stroke in patients with high blood pressure and
a heart problem called left
ventricular hypertrophy. Losartan potassium tablets may not help Black
patients with this problem.
•
to slow the worsening of diabetic kidney disease (nephropathy) in
patients with type 2 diabetes who
have or had high blood pressure.
Losartan potassium tablets have not been studied in children less than
6 years old or in children with
certain kidney problems.
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. Losartan
potassium tablets can help your blood vessels relax so your blood
pressure is lower.
Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of
the left chamber of the heart (the
heart's main pumping chamber). LVH can happen from several things.
High blood pressure is the most
common cause of LVH.
Type 2 Diabetes with Nephropathy

Fitxa tècnica

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOSARTAN POTASSIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LOSARTAN POTASSIUM
TABLETS.
LOSARTAN POTASSIUM 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 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 Hyperkalemia (5.4)
10/2018
INDICATIONS AND USAGE
Losartan potassium tablets are an angiotensin II receptor blocker
(ARB) indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
Hypertension
•
•
Hypertensive Patients with Left Ventricular Hypertrophy
•
•
Nephropathy in Type 2 Diabetic Patients
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg; 50 mg; and 100 mg. (3) (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥2% and greater than
placebo) are: dizziness, upper
respiratory infection, nasal congestion, and back pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ZYDUS PHARMACEUTICALS
USA INC. AT 1-
877-993-8779 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
•
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 5/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: FETAL TOXICITY
1 INDICATIONS AND USAGE
1.1 Hypertension
1.2 Hypertensive Patients with Left Ventricular Hypertrophy
1.3 Nephropathy in Type 2 Diabetic Patients
2 DOSAGE AND ADMINISTRATION
2.1 Hypertension
2.2 Hypertensive Patients with Left Ventricular Hypertrophy
2.3 Nephropathy in Type 2 Diabetic Patients
2.4 Dosage Modifications in Patients with Hepatic Impairment
2.5 Prepar