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PRISTIQ®Index Section (desvenlafaxine succinate)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 General Instructions for Use

2.2 Dosage Recommendations for Patients with Renal Impairment

2.3 Dosage Recommendations for Patients with Hepatic Impairment

2.4 Maintenance/Continuation/Extended Treatment

2.5 Discontinuing PRISTIQ

2.6 Switching Patients From Other Antidepressants to PRISTIQ

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

2.8 Use of PRISTIQ with other MAOIs such as Linezolid or Methylene Blue

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients

5.2 Serotonin Syndrome

5.3 Elevated Blood Pressure

5.4 Increased Risk of Bleeding

5.5 Angle Closure Glaucoma

5.6 Activation of Mania/Hypomania

5.7 Discontinuation Syndrome

5.8 Seizure

5.9 Hyponatremia

5.10 Interstitial Lung Disease and Eosinophilic Pneumonia

5.11 Sexual Dysfunction

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with PRISTIQ

7.2 Drugs Having No Clinically Important Interactions with PRISTIQ

7.3 Alcohol

7.4 Drug-Laboratory Test Interactions

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

10 OVERDOSAGE

10.1 Human Experience with Overdosage

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

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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