SERTRALINE HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE- sertraline hydrochloride solution
Bryant Ranch Prepack

chemical-structure

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 oral solution is 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 oral solution 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 oral solution, the recommended interval between dose changes is one week.

Table 1: Recommended Daily Dosage of Sertraline Hydrochloride oral solution in Patients with MDD, OCD, PD, PTSD, and SAD

Indication

Starting Dose

Therapeutic Range

Adults

MDD

50 mg

50-200 mg

OCD

50 mg

PD,PTSD, SAD

25 mg

Pediatric Patients

OCD (ages 6-12 years old)

25 mg

50-200 mg

OCD (ages 13-17 years old)

50 mg

2.2 Dosage in Patients with PMDD

The recommended starting sertraline hydrochloride oral solution dosage in adult women with PMDD is 50 mg per day. Sertraline hydrochloride oral solution 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 Oral Solution

Prior to initiating treatment with sertraline hydrochloride oral solution 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 oral solution in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10-15) 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 oral solution. In addition, at least 14 days must elapse after stopping sertraline hydrochloride oral solution before starting an MAOI antidepressant [See Contraindications (4), Warnings and Precautions (5.2)].

2.6 Discontinuation of Treatment with Sertraline Hydrochloride Oral solution

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

2.7 Preparation of Sertraline Hydrochloride Oral Solution

Sertraline hydrochloride oral solution must be diluted before use.

  • Use the supplied calibrated dispensing dropper to measure the amount of sertraline hydrochloride oral solution needed
  • Note: The supplied calibrated dispensing dropper has 25 mg and 50 mg graduation marks only
  • Mix with 4 ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. After mixing, a slight haze may appear, which is normal.

Instruct patients or caregivers to immediately take the dose after mixing.

3 DOSAGE FORMS AND STRENGTHS

Sertraline Hydrochloride Oral solution USP is a clear, colorless solution liquid containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL. It is supplied as a 60 bottle with an accompanying calibrated dispensing dropper.

4 CONTRAINDICATIONS

Sertraline hydrochloride oral solution is contraindicated in patients:

5 WARNINGS AND PRECAUTIONS

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