Sertralinedosage

­Indication Starting Dosage Maximum Dosage MDD 50 mg per day 200 mg per day OCD 25 mg per day (ages 6 to 12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD 25 mg per day 200 mg per day PMDD continuous dosing 50 mg per day 150 mg per day PMDD 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 See Full Prescribing Information for titration in PMDD Hepatic impairment: Mild: Recommended starting and maximum dosage is half recommended dosage Moderate or severe: Not recommended When discontinuing sertraline hydrochloride oral solution, reduce dose gradually Oral solution: Must be diluted before 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 to 200 mg OCD 50 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 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.

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. 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 to 15) is not recommended.

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.

2.6 Discontinuation of

Treatment with Sertraline Hydrochloride Oral Solution Adverse reactions may occur upon discontinuation of sertraline hydrochloride oral solution. 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 syringe to measure the amount of sertraline hydrochloride oral solution needed Note: The supplied calibrated dispensing syringe 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.