- Approval Id
- 32270e25e9821db4
- Drug Name
- SEROXAT CR TABLET 25 mg
- Product Name
- SEROXAT CR TABLET 25 mg
- Approval Number
- SIN12583P
- Approval Date
- 2004-08-30
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, EXTENDED RELEASE
- Dosage
- **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.
- Route Of Administration
- ORAL
- Indication Info
- **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.
- Contraindications
- **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_).
- Atc Code
- N06AB05
- Atc Item Name
- paroxetine
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/glaxosmithkline-pte-ltd
