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SERTRALINE Hydrochloride Tablets, Oral Solution (GREENSTONE LLC) Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD

2.2 Dosage in Patients with PMDD

2.3 Screen for Bipolar Disorder Prior to Starting Sertraline Hydrochloride

2.4 Dosage Modifications in Patients with Hepatic Impairment

2.5 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant

2.6 Discontinuation of Treatment with Sertraline Hydrochloride

2.7 Preparation of Sertraline Hydrochloride Oral Solution

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 Increased Risk of Bleeding

5.4 Activation of Mania or Hypomania

5.5 Discontinuation Syndrome

5.6 Seizures

5.7 Angle-Closure Glaucoma

5.8 Hyponatremia

5.9 False-Positive Effects on Screening Tests for Benzodiazepines

5.10 QTc Prolongation

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-marketing Experience

7 DRUG INTERACTIONS

7.1 Clinically Significant Drug Interactions

7.2 Drugs Having No Clinically Important Interactions with Sertraline Hydrochloride

7.3 False-Positive Screening Tests for Benzodiazepines

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICALTOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Major Depressive Disorder

14.2 Obsessive-Compulsive Disorder

14.3 Panic Disorder

14.4 Posttraumatic Stress Disorder

14.5 Social Anxiety Disorder

14.6 Premenstrual Dysphoric Disorder

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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