SEROXAT CR TABLET 12.5 mg

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

TABLET, EXTENDED RELEASE

**Dosage and Administration** Pharmaceutical form: Controlled release tablets **Adults** _SEROXAT_ CR tablets should be administered as a single daily dose, usually in the morning, with or without food. Patients should be informed that _SEROXAT_ CR tablets should not be chewed or crushed, and should be swallowed whole. **Major Depressive Disorder:** The recommended initial dose is 25 mg/day. Some patients not responding to a 25 mg dose may benefit from dose increases in 12.5 mg/day increments, up to a maximum of 62.5 mg/day according to patient response. Dose changes should occur at intervals of at least 1 week. As with all antidepressant drugs, dosage should be reviewed and adjusted if necessary within 2 to 3 weeks of initiation of therapy and thereafter as judged clinically appropriate. Patients with depression should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months. **Premenstrual Dysphoric Disorder:** The recommended initial dose is 12.5 mg/day. Some patients not responding to a 12.5 mg dose may benefit from having their dose increased to 25 mg/day. Dose changes should occur at intervals of at least 1 week. Patients with PMDD should be periodically assessed to determine the need for continual treatment. _SEROXAT_ CR may be administered either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle (by starting **14** days prior to the anticipated onset of menstruation through to the first full day of menses and repeating with each cycle), depending on physician assessment. The recommended initial dose is **12.5** mg/day. **Social Anxiety Disorder/Social Phobia:** The recommended initial dose is 12.5 mg daily. Some patients not responding to a 12.5 mg dose may benefit from having dose increases in 12.5 mg/day increments as required, up to a maximum of 37.5 mg/day according to the patient’s response. Dose changes should occur at intervals of at least 1 week. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment. **General Information** **_Other Populations_** _**Elderly:**_ Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects. Dosing should commence at 12.5 mg/day and may be increased up to 50 mg/day. **_Children and adolescents (less than 18 years):_** _SEROXAT_ CR is not indicated for use in children or adolescents aged less than 18 years ( _see Indications, Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Renal/hepatic impairment:**_ Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance <30 mL/min) or in those with hepatic impairment. The dosage should be restricted to the lower end of the range. **DISCONTINUATION OF _SEROXAT_ CR** As with other psychoactive medications, abrupt discontinuation should generally be avoided ( _see Warnings and Precautions and Adverse Reactions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The taper phase regimen used in recent clinical trials involved a decrease in the daily dose by 10 mg/day (equivalent to 12.5 mg/day CR tablets) at weekly intervals. When a daily dose of 20 mg/day (equivalent to 25 mg/day CR tablets) was reached, patients were continued on this dose for 1 week before treatment was stopped. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.