VALSARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Solco Healthcare US, LLC

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 Education

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. The 40 mg tablets are scored on one side and biconvex and capsule-shaped. The 80 mg, 160 mg, and 320 mg tablets are unscored and biconvex and capsule-shaped as well. Side 1 Side 2 Bottle of 30 90 500 1000 40 mg Yellow HH 341 367-03 367-09 367-50 367-11 80 mg Brown HH 342 368-03 368-09 368-50 368-11 160 mg Yellow HH 343 369-03 369-09 369-50 369-11 320 mg Brown HH 344 370-03 370-09 370-50 370-11 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 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
Solco Healthcare US, LLC
----------
PATIENT INFORMATION
Valsartan Tablets (val-SAR-tan), USP
What is the most important information I should know about valsartan?
Valsartan can cause harm or death to an unborn baby.
•
Talk to your healthcare provider about other ways to lower your blood
pressure if you plan to become
pregnant.
•
If you become pregnant during treatment with valsartan, stop taking
valsartan and tell your healthcare
provider right away.
What is valsartan?
Valsartan is a prescription medicine used in:
•
adults and children 6 years of age and older to lower high blood
pressure (hypertension). Valsartan may
be used alone or in combination with other blood pressure medicines.
•
adults to treat heart failure. Valsartan may help decrease your need
for hospitalization that happens
with heart failure.
•
adults with certain types of heart failure, to increase the chance of
living longer after a heart attack
(myocardial infarction).
Valsartan should not be used to treat high blood pressure in children
less than 1 year of age.
It is not known if Valsartan is safe and effective in children with
certain kidney problems.
Do not takevalsartan if you:
•
are allergic to any of the ingredients in valsartan. See the end of
this leaflet for a complete list of
ingredients in valsartan.
•
have diabetes and are also taking aliskiren. Talk to your healthcare
provider if you are not sure.
Before takingvalsartan, tell your healthcare provider about all of
your medical conditions including, if you:
•
have heart problems
•
have kidney problems
•
are pregnant or plan to become pregnant. See “What is the most
important information I should know
about valsartan?”
•
are breastfeeding or plan to breastfeed. It is not known if valsartan
passes into your breast milk. You
should not breastfeed during treatment with valsartan. Talk with your
healthcare provider about the
best way to feed your baby during your treatment with valsartan.
Tell your healthcare provider about all the medi

Summary of Product characteristics

VALSARTAN- VALSARTAN TABLET
SOLCO HEALTHCARE US, LLC
----------
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._
•
•
INDICATIONS AND USAGE
Valsartan tablets are an angiotensin II receptor blocker (ARB)
indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
INDICATION (2)
STARTING DOSE (2)
DOSE RANGE (2)
Hypertension Adult (2.2)
(2)
80-160 mg once daily (2)
80-320 mg once daily (2)
6-16 years (2.3) (2)
1 mg/kg once daily Up to
40 mg daily (2)
Up to 160 mg daily (2)
Heart Failure (2.4) (2)
40 mg twice daily (2)
40-160 mg twice daily (2)
Post-Myocardial Infarction
(2.5) (2)
20 mg twice daily (2)
20-160 mg twice daily (2)
* As tolerated by patient (2)
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
(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
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)
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 reduce hospitalization for