VALSARTAN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)

Available from:

AvPAK

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Valsartan are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan. 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 one 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

Product summary:

Valsartan, USP is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in unit dose blister packages as described below. Valsartan Tablets USP, 40 mg are yellow coloured, capsule shaped, biconvex, film coated tablets, debossed with 'H' on one side and '182' on the other side, 18 and 2 separated by a score line. Supplied as followed: NDC 50268-783-15 (10 tablets per card, 5 card per carton). 10 tablets per card, 5 cards per carton Valsartan Tablets USP, 80 mg are pink coloured, round shaped, biconvex, film coated tablets, debossed with '183' on one side and 'H' on the other side. Supplied as followed: NDC 50268-784-15 (10 tablets per card, 5 card per carton). 10 tablets per card, 5 cards per carton Valsartan Tablets USP, 160 mg are yellowish brown coloured, oval shaped, biconvex, film coated tablets, debossed with '184' on one side and 'H' on the other side. Supplied as followed: NDC 50268-785-15 (10 tablets per card, 5 card per carton). 10 tablets per card, 5 cards per carton Valsartan Tablets USP, 320 mg are dark grey-violet colored, capsule shaped, biconvex, film coated tablets, debossed with '185' on one side and 'H' on the other side. Supplied as followed: NDC 50268-786-13 (5 tablets per card, 6 card per carton). 10 tablets per card, 3 cards per carton Dispensed in Unit Dose package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AvPAK
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SPL MEDGUIDE SECTION
Valsartan Tablets, USP
(val SAR tan)
Read the Patient Information that comes with valsartan tablets before
you take 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 medical condition or treatment. If you have any questions about
valsartan tablets, ask your doctor or
pharmacist.
What is the most important information I should know about valsartan
tablets?
Valsartan 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 valsartan tablets, tell
your doctor right away.
What are valsartan tablets?
Valsartan tablets are a prescription medicine called an angiotensin
receptor blocker (ARB). It is used in
adults to:
• lower high blood pressure (hypertension) in adults and children, 6
to 16 years of age.
• treat heart failure in adults. In these patients, valsartan
tablets may lower the need for hospitalization that
happens from heart failure.
Valsartan tablets are not for children under 6 years of age or
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. Valsartan tablet can
help your blood vessels relax so your blood pressure is lower.
Medicines that lower your blood pressure
lower your chance of having a stroke or heart attack.
High blood pressure makes the heart work harder to pump blood
throughout the body and causes damage to
the blood vessels. If high blood pressure is not treated, it can lead
to stroke, heart attack, heart failure, kidney
failure and vision problems.
Heart Failure occurs when the heart is weak and cannot pump enough
blood to your lungs and the rest of
your body. Just walking or moving can make you short of breath, so you
may have to rest a lot.
What should I tell my

Summary of Product characteristics

VALSARTAN- VALSARTAN TABLET, FILM COATED
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
VALSARTAN TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN
TABLETS.
VALSARTAN TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _
• WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN TABLETS AS SOON
AS POSSIBLE. (
5.1)
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND EVEN
DEATH TO THE DEVELOPING FETUS. ( 5.1)
INDICATIONS AND USAGE
Valsartan Tablet is an angiotensin II receptor blocker (ARB) 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)
• Treatment of HEART FAILURE (NYHA class II to IV); valsartan
tablets significantly reduced hospitalization
for heart failure ( 1.2)
• POST-MYOCARDIAL INFARCTION: for the reduction of cardiovascular
mortality in clinically stable patients
with left ventricular failure or left ventricular dysfunction
following myocardial infrarction (1.3)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSE
DOSE RANGE
TARGET
MAINTENANCE
DOSE*
Adult Hypertension ( 2.1)
80 or 160 mg once daily
80-320 mg once daily
---
Pediatric Hypertension (6-
16 years) ( 2.2)
1.3 mg/kg once daily (up
to 40 mg total)
1.3-2.7 mg/kg once daily (up to
40-160 mg total)
---
Heart Failure ( 2.3)
Post-Myocardial Infraction
(2.4)
40 mg twice daily
20mg twice daily
40-160 mg twice daily
20-160mg twice daily
160 mg twice daily
160 mg twice daily
* as tolerated by patient
* as tolerated by patient
DOSAGE FORMS AND STRENGTHS
Tablets (mg): 40 (scored), 80, 160, 320 (3)
CONTRAINDICATIONS
Known hypersensitivity to any component; Do not coadminister aliskiren
with valsartan tablets in patients
with diabetes ( 4)
WARNINGS AND PRECAUTIONS
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