Diovan (Valsartan) Tablets ------DOSAGE FORMS and STRENGTHS------Initial U.S
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HIGHLIGHTS OF PRESCRIBING INFORMATION without food. In heart failure patients, consideration should be given to These highlights do not include all the information needed to use Diovan reducing the dose of concomitant diuretics. Following myocardial safely and effectively. See full prescribing information for Diovan. infarction, consideration should be given to a dosage reduction if symptomatic hypotension or renal dysfunction occurs. Diovan (valsartan) Tablets -----------DOSAGE FORMS AND STRENGTHS------------ Initial U.S. Approval: 1996 Tablets (mg): 40 (scored), 80, 160, 320 WARNING: USE IN PREGNANCY ---------------------CONTRAINDICATIONS------------------- When pregnancy is detected, discontinue Diovan as soon as possible. None Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus (5.1) ---------------WARNINGS AND PRECAUTIONS------------ • Avoid fetal or neonatal exposure (5.1) -----------------RECENT MAJOR CHANGES----------------- • Observe for signs and symptoms of hypotension (5.2) Indications and Usage: Benefits of lowering blood pressure (1) 12/2011 • Use with caution in patients with impaired hepatic (5.3) or renal (5.4) function --------------INDICATIONS AND USAGE--------------------- Diovan is an angiotensin II receptor blocker (ARB) indicated for: -------------------ADVERSE REACTIONS ----------------- • Treatment of hypertension, to lower blood pressure. Lowering blood Hypertension: Most common adverse reactions are headache, dizziness, pressure reduces the risk of fatal and nonfatal cardiovascular events, viral infection, fatigue and abdominal pain (6.1) primarily strokes and myocardial infarctions (1.1) Heart Failure: Most common adverse reactions are dizziness, hypotension, • Treatment of heart failure (NYHA class II-IV); Diovan significantly diarrhea, arthralgia, back pain, fatigue and hyperkalemia (6.1) reduced hospitalization for heart failure (1.2) Post-Myocardial Infarction: Most common adverse reactions which caused • Reduction of cardiovascular mortality in clinically stable patients with patients to discontinue therapy are hypotension, cough and increased blood left ventricular failure or left ventricular dysfunction following creatinine (6.1) myocardial infarction (1.3) To report SUSPECTED ADVERSE REACTIONS, contact Novartis ------------DOSAGE AND ADMINISTRATION------------- Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch. Indication Starting Dose Dose Range Target Maintenance -------------------DRUG INTERACTIONS---------------------- Dose* • Potassium sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, Adult 80 or 160 mg 80-320 mg once --- increases in serum creatinine (7) Hypertension (2.1) once daily daily • NSAID use may lead to increased risk of renal impairment and loss of Pediatric 1.3 mg/kg 1.3-2.7 mg/kg --- antihypertensive effect (7) Hypertension (6 once daily (up once daily (up to 16 years) (2.1) to 40 mg total) 40-160 mg total) -------------USE IN SPECIFIC POPULATIONS------------- Heart Failure (2.2) 40 mg twice 40-160 mg twice 160 mg twice Nursing Mothers: Nursing or drug should be discontinued (8.3); Pediatrics: daily daily daily Efficacy and safety data support use in 6-16 year old patients (8.4); Geriatrics: No overall difference in efficacy or safety vs. younger patients, Post-Myocardial 20 mg twice 20-160 mg twice 160 mg twice but greater sensitivity of some older individuals cannot be ruled out (8.5) Infarction (2.3) daily daily daily See 17 for PATIENT COUNSELING INFORMATION and FDA- * as tolerated by patient approved patient labeling No initial dosage adjustment is required for elderly patients, for patients with Revised: 12/2011 mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Diovan in patients with hepatic or severe renal impairment. Diovan may be administered with or FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy WARNING: USE IN PREGNANCY 8.3 Nursing Mothers 1 INDICATIONS AND USAGE 8.4 Pediatric Use 1.1 Hypertension 8.5 Geriatric Use 1.2 Heart Failure 10 OVERDOSAGE 1.3 Post-Myocardial Infarction 11 DESCRIPTION 2 DOSAGE AND ADMINISTRATION 12 CLINICAL PHARMACOLOGY 2.1 Adult Hypertension 12.1 Mechanism of Action 2.2 Pediatric Hypertension 6-16 years of age 12.2 Pharmacodynamics 2.3 Heart Failure 12.3 Pharmacokinetics 2.4 Post-Myocardial Infarction 13 NONCLINICAL TOXICOLOGY 3 DOSAGE FORMS AND STRENGTHS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 4 CONTRAINDICATIONS 13.2 Animal Toxicology and/or Pharmacology 5 WARNINGS AND PRECAUTIONS 14 CLINICAL STUDIES 5.1 Fetal/Neonatal Morbidity and Mortality 14.1 Hypertension 5.2 Hypotension 14.2 Heart Failure 5.3 Impaired Hepatic Function 14.3 Post-Myocardial Infarction 5.4 Impaired Renal Function 16 HOW SUPPLIED/STORAGE AND HANDLING 6 ADVERSE REACTIONS 17 PATIENT COUNSELING INFORMATION 6.1 Clinical Studies Experience 6.2 Post-Marketing Experience * Sections or subsections omitted from the full prescribing information are not 7 DRUG INTERACTIONS listed 7.1 Clinical Laboratory Test Findings Reference ID: 3056827 FULL PRESCRIBING INFORMATION WARNING: USE IN PREGNANCY When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Diovan should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality (5.1) 1 INDICATIONS AND USAGE 1.1 Hypertension Diovan® (valsartan) is 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 this drug principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Diovan. 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, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Diovan may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure Diovan is indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Diovan significantly reduced hospitalizations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor. [See Clinical Studies (14.2)] 1.3 Post-Myocardial Infarction In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality. [See Clinical Studies (14.3)] Reference ID: 3056827 2 DOSAGE AND ADMINISTRATION 2.1 Adult Hypertension The recommended starting dose of Diovan (valsartan) is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Diovan may be used over a dose range of 80 mg to 320 mg daily, administered once a day. The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic