SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated
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)].
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 tablets 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 mg 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 Tablets in Patients with MDD, OCD, PD, PTSD, and SAD|
|Indication||Starting Dose||Therapeutic Range|
|MDD||50 mg||50 mg to 200 mg|
|PD, PTSD, SAD||25 mg|
|OCD (ages 6 to 12 years old)||25 mg||50 mg to 200 mg|
|OCD (ages 13 to 17 years old)||50 mg|
2.2 Dosage in Patients with PMDD
The recommended starting sertraline hydrochloride tablets 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.
3 DOSAGE FORMS AND STRENGTHS
Sertraline hydrochloride tablets, USP having functional scoring containing sertraline hydrochloride equivalent to 25 mg , 50 mg and 100 mg of sertraline, are available as:
25 mg: light green to green colored, round, biconvex, film coated tablets, debossed with “S1” on one side and breakline on other side.
50 mg: light blue to blue colored, round, biconvex, film coated tablets, debossed with “S2” on one side and breakline on other side.
100 mg: yellow colored, round biconvex, film coated tablets, debossed with “S3” on one side and breakline on other
Sertraline hydrochloride tablets are contraindicated in patients:
- Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)] .
- Taking pimozide [See Drug Interactions (7.1)] .
- With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1, 6.2)].
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