Sertraline

SERTRALINE- sertraline hydrochloride tablet, film coated
RedPharm Drug, Inc.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [See Warnings and Precautions (5.1)].

HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use sertraline hydrochloride tablets safely and effectively. See full prescribing information for sertraline hydrochloride tablets.
SERTRALINE hydrochloride tablets, for oral use
Initial U.S. Approval: 1991

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients (5.1)
Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.1)

INDICATIONS AND USAGE

Sertraline hydrochloride tablet is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):

Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)

DOSAGE AND ADMINISTRATION

Indication
Starting Dosage
Maximum Dosage
MDD (2.1)
50 mg per day
200 mg per day
OCD (2.1)
25 mg per day (ages 6 to 12)
200 mg per day
50 mg per day (ages ≥ 13)
PD, PTSD, SAD (2.1)
25 mg per day
200 mg per day
PMDD (2.2) continuous dosing
50 mg per day
150 mg per day
PMDD (2.2) intermittent dosing
50 mg per day during luteal phase only
100 mg per day during luteal phase only

If inadequate response to starting dosage, titrate in 25 to 50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD (2.1)
See Full Prescribing Information for titration in PMDD (2.2)
Hepatic impairment:

Mild: Recommended starting and maximum dosage is half recommended dosage (2.3)
Moderate or severe: Not recommended (2.4)

When discontinuing sertraline hydrochloride tablets, reduce dose gradually (2.5, 5.4)

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg, 50 mg and 100 mg (3)

CONTRAINDICATIONS

Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4, 7.1)
Concomitant use of pimozide (4, 7.1)
Known hypersensitivity to sertraline or excipients (4, 5.4)

WARNINGS AND PRECAUTIONS

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue sertraline hydrochloride tablets and initiate supportive treatment. (5.2)

Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti- inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. (5.3)
Activation of Mania/Hypomania: Screen patients for bipolar disorder. (5.4)
Seizures: Use with caution in patients with seizure disorders. (5.6)
Angle Closure Glaucoma: Avoid use of antidepressants, including sertraline hydrochloride, in patients with untreated anatomically narrow angles. (5.7)

ADVERSE REACTIONS

Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Protein-bound drugs: Monitor for adverse reactions and reduce dosage of sertraline hydrochloride or other protein-bound drugs (e.g., warfarin) as warranted. (7.1, 12.3)
CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6 (7.1, 12.3)

USE IN SPECIFIC POPULATIONS

Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the neonate (8.1)
Pediatric use: Safety and effectiveness of sertraline hydrochloride in pediatric patients other than those with OCD have not been established (8.4)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 2/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

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 Tablets
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 Tablets
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
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing 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 NONCLINICAL TOXICOLOGY
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.

1 INDICATIONS AND USAGE

Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]:

Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)

2 DOSAGE AND ADMINISTRATION

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

The recommended initial dosage and maximum sertraline hydrochloride dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage.

For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one week.

Table 1: Recommended Daily Dosage of Sertraline Hydrochloride in Patients with MDD, OCD, PD, PTSD, and SAD
Indication
Starting Dose
Therapeutic Range
Adults
MDD
50 mg
OCD
50 mg
50 to 200 mg
PD, PTSD, SAD
25 mg
Pediatric Patients
OCD (ages 6 to 12 years old)
25 mg
50 to 200 mg
OCD (ages 13 to 17 years old)
50 mg

2.2 Dosage in Patients with PMDD

The recommended starting sertraline hydrochloride dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride tablets may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

When dosing continuously , patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
When dosing intermittently , patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first 3 days of dosing followed by 100 mg per day during the remaining days in the dosing cycle.

2.3 Screen for Bipolar Disorder Prior to Starting Sertraline Hydrochloride Tablets

Prior to initiating treatment with sertraline hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [See Warnings and Precautions (5.4)].

2.4 Dosage Modifications in Patients with Hepatic Impairment

Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage [See Dosage and Administration (2.1, 2.2)]. The use of sertraline hydrochloride tablets in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10 to 15) is not recommended [See Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.5 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of sertraline hydrochloride tablets. In addition, at least 14 days must elapse after stopping sertraline hydrochloride tablets before starting an MAOI antidepressant [See Contraindications (4), Warnings and Precautions (5.2)].

2.6 Discontinuation of Treatment with Sertraline Hydrochloride Tablets

Adverse reactions may occur upon discontinuation of sertraline hydrochloride tablets [See Warnings and Precautions (5.5)]. Gradually reduce the dosage rather than stopping sertraline hydrochloride tablets abruptly whenever possible.

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