Post 20 mg twice 20 160 mg twice daily - Food and Drug ...

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 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)

-----------------RECENT MAJOR CHANGES-----------------

Indications and Usage: Benefits of lowering blood pressure (1) Dosage and Administration: Pediatric Hypertension 6-16 years of age (2.2) Contraindications: Known hypersensitivity (4) Boxed Warning: Fetal Toxicity Warnings and Precautions: Fetal Toxicity (5.1)

12/2011

2/2012 7/2012 1/2012 1/2012

--------------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

Adult Hypertension (2.1)

Pediatric Hypertension (616 years) (2.2)

80 or 160 mg once daily

1.3 mg/kg once daily (up to 40 mg total)

80-320 mg once daily

1.3-2.7 mg/kg once daily (up to 40-160 mg total)

Target Maintenance Dose* ---

---

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 6-16 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 Post-Marketing Experience 7 DRUG INTERACTIONS 7.1 Clinical Laboratory Test Findings 8 USE IN SPECIFIC POPULATIONS

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

-----------DOSAGE FORMS AND STRENGTHS------------

Tablets (mg): 40 (scored), 80, 160, 320

---------------------CONTRAINDICATIONS-------------------

Known hypersensitivity to any component (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-FDA1088 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)

-------------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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