LOSARTAN POTASSIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

LOSARTAN POTASSIUM

Composition:

LOSARTAN POTASSIUM 25 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 25 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "25" on one side and "113" on the other side. NDC 50268-516-15 (10 Tablets per card, 5 cards per carton) Losartan potassium tablets, USP 50 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "114" on one side and breakline on the other side. NDC 50268-517-15 (10 Tablets per card, 5 cards per carton) Losartan potassium tablets, USP 100 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "100" on one side and "115" on the other side. NDC 50268-518-15 (10 Tablets per card, 5 cards per carton) Dispensed in Unit Dose package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° - 86°F). [see USP Controlled Room Temperature]. Protect from light. Manufactured For: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 09/16 AV Rev. 09/18 (P) AvPAK

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET
AvPAK
----------
PATIENT INFORMATION
Losartan Potassium (loe SAR tan poe TASS ee um)Tablets, USP
25 mg, 50 mg, 100 mg
Rx only
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 potassiumtabletscan 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 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. Type 2

Summary of Product characteristics

LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
LOSARTAN POTASSIUM TABLETS USP
RX ONLY
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
RX ONLY
INITIAL U.S. APPROVAL: 1995
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE LOSARTAN POTASSIUM 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 tablets are an angiotensin II receptor blocker
(ARB) indicated for: (1)
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 (2)
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 (2)
Usual starting dose: 50 mg once daily. (2.2)
Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium
tablets 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 (2)
Usual dose: 50 mg once daily. (2.3)
Increase dose to 100 mg once daily if further blood pressure response
is needed. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg; 50 mg; and