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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.
Panic Disorder: Patients should begin treatment on 12.5 mg/day and the dose increased weekly in 12.5 mg/day increments according to patient response. Some patients may benefit from having their dose increased up to a maximum of 75 mg/day.
A low initial starting dose is recommended to minimise the potential worsening of panic symptomatology which is generally recognised to occur early in the treatment of this disorder.
Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms. This period may be several months or even longer.
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.
SEROXAT CR may be administered daily throughout the menstrual cycle or limited to intermittent dosing in the luteal phase of the menstrual cycle, depending on physician assessment.
Patients with PMDD should be periodically assessed to determine the need for continual treatment.
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.
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 and Precautions).
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: As with other psychoactive medications, abrupt discontinuation should generally be avoided (see Precautions & Adverse Reactions). 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.
