VALSARTAN- 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:

Preferred Pharmaceuticals Inc.

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 320 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Valsartan tablets, USP 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, USP. 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, D

Product summary:

Valsartan, USP is available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages as described below. 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. They are supplied as Bottle of 20 Tablets (NDC 68788-6882-2) Bottle of 30 Tablets (NDC 68788-6882-3) Bottle of 60 Tablets (NDC 68788-6882-6) Bottle of 90 Tablets (NDC 68788-6882-9) Bottle of 10 Tablets (NDC 68788-6882-1) Bottle of 120 Tablets (NDC 68788-6882-8) 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

Preferred Pharmaceuticals Inc.
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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 l

Summary of Product characteristics

VALSARTAN- VALSARTAN TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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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 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, USP 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, USP significantly reduced hospitalization for heart
failure (1.2)
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)
40 mg twice daily
40-160 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 tablets 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 (5.3,
5.4)
ADVERSE REACTIONS
HYPERTENSION: Most common adverse reactions are headache, dizziness,
viral infection, fatigue and abdominal pain (6.1)
HEART FAILURE: Most common adverse reactions are dizzine