2 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 6-12) 50 mg per day (ages ≥ 13) 200 mg per day 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 25-50 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 ( 2.4 ) Moderate or severe: Not recommended ( 2.4 ) When discontinuing sertraline, reduce dose gradually ( 2.6 , 5.4 ) 2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD The recommended initial dosage and maximum sertraline 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, the recommended interval between dose changes is one week. Table 1: Recommended Daily Dosage of Sertraline 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 6-12 years old) 25 mg 50 to 200 mg OCD (ages 13-17 years old) 50 mg 2.2 Dosage in Patients with PMDD The recommended starting sertraline dosage in adult women with PMDD is 50 mg per day. Sertraline 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 Prior to initiating treatment with sertraline 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 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. In addition, at least 14 days must elapse after stopping sertraline before starting an MAOI antidepressant [See Contraindications (4) , Warnings and Precautions (5.2) ]. 2.6 Discontinuation of Treatment with Sertraline Adverse reactions may occur upon discontinuation of sertraline [See Warnings and Precautions (5.5) ]. Gradually reduce the dosage rather than stopping sertraline abruptly whenever possible.