Basic Information
SEROXAT CR TABLET 12.5 mg
TABLET, EXTENDED RELEASE
Regulatory Information
SIN12584P
August 30, 2004
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XN06AB05
Company Information
Active Ingredients
Strength: 12.5 mg
Detailed Information
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_).
Indication Information
**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.