VALSARTAN- valsartan tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 160 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Valsartan tablets 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 tablets. 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,

Product summary:

Valsartan tablets, USP, are available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles as described below. 40 mg tablets are scored on one side and biconvex and capsule-shaped. 80 mg, 160 mg, and 320 mg tablets are unscored and biconvex and capsule-shaped as well. Store at 20-25o C (68-77o F); excursions permitted to 15-30o C (59-86o F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VALSARTAN- VALSARTAN TABLET
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Valsartan Tablets (val-SAR-tan), USP
Read the Patient Information that comes with valsartan 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, ask your doctor or pharmacist.
What is the most important information I should know about valsartan?
Valsartan 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, tell your
doctor right away.
What is valsartan?
Valsartan is 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 may lower
the need for hospitalization that
happens from heart failure.
•
improve the chance of living longer after a heart attack (myocardial
infarction) in adults.
Valsartan is 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 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 ca

Summary of Product characteristics

VALSARTAN- VALSARTAN TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VALSARTAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VALSARTAN.
VALSARTAN (VALSARTAN) TABLET 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 AS SOON AS POSSIBLE.
(5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS. (5.1)
INDICATIONS AND USAGE
Valsartan tablets are 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-IV); valsartan tablets
significantly reduced hospitalization for heart failure
(1.2)
Reduction of cardiovascular mortality in clinically stable patients
with left ventricular failure or left ventricular
dysfunction FOLLOWING MYOCARDIAL INFARCTION (1.3)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
STARTING DOSE
DOSE RANGE
TARGET MAINTENANCE
DO SE*
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)
40 mg twice daily
40-160 mg twice daily
160 mg twice daily
Post-Myocardial Infarction
(2.4)
20 mg twice daily
20-160 mg twice daily
160 mg twice daily
* 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 in patients with diabetes (4)
WARNINGS AND PRECAUTIONS
Observe for signs and symptoms of hypotension (5.2)
Monitor renal function and potassium in susceptible patients (