TOP

Valsartan Tablets, USP

2015-06-25 12:55:07 来源: 作者: 【大中小】浏览:358次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Valsartan safely and effectively. See full prescribing information for Valsartan.

Valsartan Tablets, USP
Initial U.S. Approval: 1996
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.

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)

INDICATIONS AND USAGE

Valsartan Tablets, USP are 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); Valsartan Tablets, USP 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 Hypertension (2.1)	80 or 160 mg once daily	80-320 mg once daily	---
Pediatric Hypertension (6-16 years) (2.2)	1.3 mg/kg once daily (up to 40 mg total)	1.3-2.7 mg/kg once daily (up to 40-160 mg total)	---
Heart Failure (2.3)	40 mg twice daily	40-160 mg twice daily	160 mg twice daily
Post-Myocardial Infarction (2.4)	20 mg twice daily	20-160 mg twice daily	160 mg twice daily

* as tolerated by patient

DOSAGE FORMS AND STRENGTHS

Tablets (mg): 40 (scored), 80, 160, 320 (3)
CONTRAINDICATIONS

Known hypersensitivity to any component; Do not coadminister aliskiren with valsartan 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 Sandoz Inc at 1-800-525-8747 or FDA at 1-800-FDA-1088 or 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 (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 <6 years old (6.1, 8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2014

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

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Hypertension

14.2 Heart Failure

14.3 Post-Myocardial Infarction

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

1.1 Hypertension

Valsartan Tablets, USP are 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 valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with Valsartan Tablets, USP.

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, eva luation, 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 (e.g., 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.

Valsartan Tablets, USP may be used alone or in combination with other antihypertensive agents.

1.2 Heart Failure

Valsartan Tablets, USP are indicated for the treatment of heart failure (NYHA class II-IV). In a controlled clinical trial, Valsartan Tablets, USP significantly reduced hospitalizations for heart failure. There is no evidence that Valsartan Tablets, USP 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, Valsartan Tablets, USP is indicated to reduce cardiovascular mortality [see Clinical Studies (14.3)].

2 DOSAGE AND ADMINISTRATION