Active Ingredient and Strength	PAROXETINE HCL HEMIHYDRATE 14.25 MG EQUV. TO PAROXETIN HCL - 12.5 MG
Dosage Form	TABLET, EXTENDED RELEASE
Manufacturer and Country	BORA PHARMACEUTICAL SERVICES INC. - CANADA
Registration Number	SIN12584P
Licence Holder	GLAXOSMITHKLINE PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	N06AB05

Indications

Adults

Major Depressive Disorder:

SEROXAT CR tablets are indicated for the treatment of major depressive disorder (MDD).

SEROXAT CR has not been systematically evaluated beyond 12 weeks in controlled clinical trials and the physician who elects to use SEROXAT CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patients.

Premenstrual Dysphoric Disorder:

SEROXAT CR tablets are indicated for the treatment of premenstrual dysphoric disorder (PMDD).

The effectiveness of SEROXAT CR in long-term use, i.e. for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use SEROXAT CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Social Anxiety Disorder/Social Phobia:

SEROXAT CR tablets are indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia.

The effectiveness of SEROXAT CR tablets in the long-term treatment of Social Anxiety Disorder/Social Phobia, i.e. for more than 12 weeks, has not been evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe SEROXAT CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Children and adolescents (less than 18 years)

All Indications:

SEROXAT CR is not indicated for use in children or adolescents aged less than 18 years (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The efficacy of SEROXAT CR tablets has not been studied in children or adolescents aged less than 18 years; however, controlled clinical studies with SEROXAT IR (immediate release) tablets in children and adolescents with major depressive disorder failed to demonstrate efficacy, and do not support the use of SEROXAT CR in the treatment of depression in this population (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The safety and efficacy of SEROXAT CR in children aged less than 7 years has not been studied.

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.

Contraindications

Known hypersensitivity to paroxetine and excipients.

SEROXAT CR tablets should not be used in combination with monoamine oxidase (MAO) inhibitors [including linezolid, an antibiotic which is a reversible non-selective MAO inhibitor and methylthioninium chloride (methylene blue)] or within 2 weeks of terminating treatment with MAO inhibitors. Likewise, MAO inhibitors should not be introduced within 2 weeks of cessation of therapy with SEROXAT CR tablets (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

SEROXAT CR should not be used in patients receiving medications that can prolong QT interval and are also metabolised by CYP450 2D6, such as thioridazine or pimozide (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).