DIOVAN® (valsartan) tablets, for oral use
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use DIOVAN safely and effectively. See full prescribing information for DIOVAN.
DIOVAN? (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 Diovan 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---------------------------Diovan 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-IV); Diovan significantly reduced hospitalization for heart failure (1.2) ? Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction (1.3)
-----------------------DOSAGE AND ADMINISTRATION ----------------------
Indication
Starting Dose Dose Range
Target Maintenance Dose*
Adult
80 or 160 mg 80-320 mg once --
Hypertension (2.1) once daily
daily
Pediatric
1.3 mg/kg
1.3-2.7 mg/kg
--
Hypertension (6 once daily (up once daily (up to
16 years) (2.2)
to 40 mg total) 40-160 mg total)
Heart Failure (2.3) 40 mg twice daily
40-160 mg twice daily
160 mg twice daily
Post-Myocardial 20 mg twice
Infarction (2.4)
daily
* as tolerated by patient
20-160 mg twice daily
160 mg twice daily
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: FETAL TOXICITY 1 INDICATIONS AND USAGE
1.1 Hypertension 1.2 Heart Failure 1.3 Post-Myocardial Infarction 2 DOSAGE AND ADMINISTRATION 2.1 Adult Hypertension 2.2 Pediatric Hypertension 6 to 16 Years of Age 2.3 Heart Failure 2.4 Post-Myocardial Infarction 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Fetal Toxicity 5.2 Hypotension 5.3 Impaired Renal Function 5.4 Hyperkalemia 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Clinical Laboratory Test Findings 8 USE IN SPECIFIC POPULATIONS
--------------------- DOSAGE FORMS AND STRENGTHS--------------------- Tablets (mg): 40 (scored), 80, 160, 320
------------------------------ CONTRAINDICATIONS ----------------------------- Known hypersensitivity to any component; Do not coadminister aliskiren with Diovan 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 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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA 1088 or 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 (7)
----------------------- USE IN SPECIFIC POPULATIONS ---------------------- Nursing Mothers: Nursing or drug should be discontinued (8.3); Pediatrics: Efficacy and safety data support use in 6-16 year old patients; use is not recommended in patients ................
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