VALSARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Valsartan (UNII: 80M03YXJ7I) (Valsartan - UNII:80M03YXJ7I)

Available from:

Jubilant Cadista Pharmaceuticals Inc.

INN (International Name):

Valsartan

Composition:

Valsartan 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. 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 Educat

Product summary:

Valsartan Tablets USP are available as follows:   40 mg tablets are yellow colored, capsule shaped, biconvex, film coated tablets, with a scoreline on one side, debossed with 'C' on one side of scoreline and 'I' on the other side of scoreline and plain on the other side.             Bottle of 30’s (child-resistant closure)                       NDC 59746-360-58             Bottle of 90’s (child-resistant closure)                       NDC 59746-360-62 80 mg tablets are peach colored, round, biconvex, film coated tablets, debossed with 'C3' on one side and 'C' on other side.             Bottle of 90’s (child-resistant closure)                       NDC 59746-361-62              160 mg tablets are yellow colored, oval shaped, biconvex, film coated tablets, debossed with 'C4' on one side and 'C' on other side.              Bottle of 90’s (child-resistant closure)                       NDC 59746-362-62 320 mg tablets are yellow colored, oval shaped, biconvex, film coated tablets, debossed with 'C5' on one side and 'C' on other side.               Bottle of 90’s (child-resistant closure)                      NDC 59746-363-62 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F and  86°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
Jubilant Cadista Pharmaceuticals Inc.
----------
PATIENT INFORMATION
Valsartan Tablets
(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 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
tablets 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 bre

Summary of Product characteristics

VALSARTAN - VALSARTAN TABLET
JUBILANT CADISTA PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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, 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 angiotensin II receptor blocker (ARB) indicated
for:
Hypertension, to lower blood pressure in adults and children 6 years
and older. Lowering blood pressure
reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial
infarctions (1.1)
Heart failure (NYHA class II-IV), to reduced hospitalization for heart
failure in adults (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 infarction in adults(1.3)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSE
DOSE RANGE*
Hypertension Adults(2.2)
80-160 mg once daily
80-320mg once daily
6-16 years (2.3)
1.3 mg/kg once daily (up to 40 mg
total)
1-4 mg/kg once daily Up to 160 mg
daily
Heart Failure (2.4)
40 mg twice daily
40-160 mg twice daily
Post-Myocardial Infarction
(2.5)
20 mg twice daily
20-160 mg twice daily
DOSAGE FORMS AND STRENGTHS
Tablets (mg): 40 (scored), 80, 160, 320 (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to any component.
Do not coadminister aliskiren with valsartan in patients with
diabetes_ [see Drug Interactions (7.3)]_. (4)
WARNINGS AND PRECAUTIONS
Observe for signs and symptoms of hypotension (5.2)
Monitor renal function and potassium in susceptible patients (5.3,
5.4)
ADVERSE REACTIONS
Hypertension: Most common adverse react