VALSARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

VALSARTAN

Composition:

VALSARTAN 320 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 320 mg. 320 mg tablets are unscored and biconvex and capsule-shaped. 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
Proficient Rx LP
----------
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 can make you short of breath, so

Summary of Product characteristics

VALSARTAN- VALSARTAN TABLET
PROFICIENT RX LP
----------
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._
•
•
INDICATIONS AND USAGE
Valsartan tablets are an angiotensin II receptor blocker (ARB)
indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
INDIC ATIO N
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
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
•
•
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 dizziness,
hypotension, diarrhea, arthralgia, back pain, fatigue and
hyperkalemia (6.1)
POST-MYOCARDIAL INFARCTION: Most common adverse reactions which caused
patients to discontinue therapy are
hypotension, cough and increased blood creatinine (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US,
LLC AT 1-866-257-2597 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
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)
Treatment of HYPERTENSION,