LOSARTAN POTASSIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson Corporation dba SKY Packaging

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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: Boxes of 10x10 UD 100, NDC 63739-698-10 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
McKesson Corporation dba SKY Packaging
----------
Patient Information
Losartan Potassium (loe sar' tan poe tas' 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 w

Summary of Product characteristics

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED
MCKESSON CORPORATION DBA SKY PACKAGING
----------
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:
Treatment of hypertension, to lower blood pressure in adults and
children greater than 6 years old.
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)
Treatment of diabetic nephropathy with an elevated serum creatinine
and proteinuria in patients with
type 2 diabetes and a history of hypertension. ( 1.3)
DOSAGE AND ADMINISTRATION
Hypertension
Usual adult dose: 50 mg once daily. ( 2.1)
Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg).
( 2.1)
Hypertensive Patients with Left Ventricular Hypertrophy
Usual starting dose: 50 mg once daily. ( 2.2)
Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium to
100 mg followed by an
increase to hydrochlorothiazide 25 mg if further blood pressure
response is needed. ( 2.2, 14.2)
Nephropathy in Type 2 Diabetic Patients
Usual dose: 50 mg once daily. ( 2.3)
Increase dose to 100 mg once daily if further blood pressure response
is needed. ( 2.3)
DOS