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 tablets is an angiotensin II receptor blocker (ARB) indicated for: (1)
-
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)
DOSAGE AND ADMINISTRATION
|
Indication |
Starting Dose |
Dose Range |
Target Maintenance Dose* |
Adult Hypertension (2.1) |
80 or 160 mg once daily |
80 to 320 mg once daily |
--- |
|
Pediatric Hypertension (6-16 years) (2.2) |
1.3 mg/kg once daily (up to 40 mg total) |
1.3 to 2.7 mg/kg once daily (up to 40-160 mg total) |
--- |
|
Heart Failure (2.3) |
40 mg twice daily |
40 to 160 mg twice daily |
160 mg twice daily |
* as tolerated by patient (2)
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) (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 dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Qualitest Pharmaceuticals, LLC at 1-800-444-4011 or FDA at 1-800-FDA-1088, or http://www.fda.gov/medwatch
DRUG INTERACTIONS
-
Potassium sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine (7
-
NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect (7)
-
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7)
-
Lithium: Increases in serum lithium concentrations and lithium toxicity
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Nursing or drug should be discontinued (8.3);
Pediatrics: Efficacy and safety data support use in 6 to 16 year old patients(8.4); use is not recommended in patients <6 years old (6.1, 8.4) (8)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2014
