Sertraline

SERTRALINE- sertraline hydrochloride tablet, film coated
Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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.

3 DOSAGE FORMS AND STRENGTHS

25 mg Tablets

Green colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘D01’ on the other side.

50 mg Tablets

Blue colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘D02’ on the other side.

100 mg Tablets

Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with ‘L’and ‘U’ on either side of the breakline on one side and ‘D03’ on the other side.

4 CONTRAINDICATIONS

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)] .