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EFFEXOR XR®Index Section (venlafaxine HCl)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

1 INDICATIONS AND USAGE

1.1 Major Depressive Disorder

1.2 Generalized Anxiety Disorder

1.3 Social Anxiety Disorder

1.4 Panic Disorder

2 DOSAGE AND ADMINISTRATION

2.1 Major Depressive Disorder

2.2 Generalized Anxiety Disorder

2.3 Social Anxiety Disorder (Social Phobia)

2.4 Panic Disorder

2.5 Switching Patients from Effexor Tablets

2.6 Specific Populations

2.7 Maintenance Treatment

2.8 Discontinuing Effexor XR

2.9 Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Hypersensitivity

4.2 Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs)

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults

5.2 Serotonin Syndrome

5.3 Elevations in Blood Pressure

5.4 Abnormal Bleeding

5.5 Angle-Closure Glaucoma

5.6 Activation of Mania/Hypomania

5.7 Discontinuation Syndrome

5.8 Seizures

5.9 Hyponatremia

5.10 Weight and Height Changes in Pediatric Patients

5.11 Appetite Changes in Pediatric Patients

5.12 Interstitial Lung Disease and Eosinophilic Pneumonia

5.13 Sexual Dysfunction

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Vital Sign Changes

6.3 Laboratory Changes

6.4 Pediatric Patients

6.5 Adverse Reactions Identified During Postapproval Use

7 DRUG INTERACTIONS

7.1 Central Nervous System (CNS)-Active Drugs

7.2 Monoamine Oxidase Inhibitors

7.3 Serotonergic Drugs

7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)

7.5 Weight Loss Agents

7.6 Effects of Other Drugs on Effexor XR

7.7 Effects of Effexor XR on Other Drugs

7.8 Drug-Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Age and Gender

8.7 Use in Patient Subgroups

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

10.1 Human Experience

10.2 Management of 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

14 CLINICAL STUDIES

14.1 Major Depressive Disorder

14.2 Generalized Anxiety Disorder

14.3 Social Anxiety Disorder (also known as Social Phobia)

14.4 Panic Disorder

14.5 Pediatric Patients

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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