Pristiq Extended-Release Tablet 50mg

TABLET, EXTENDED RELEASE

**2 DOSAGE AND ADMINISTRATION** **2.1 Initial Treatment of Major Depressive Disorder** The recommended dose for PRISTIQ is 50 mg once daily, with or without food. In clinical studies, doses of 50 to 400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur gradually and at intervals of not less than 7 days. The maximum dose should not exceed 200 mg/day. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms \[see _Dosage and Administration (2.4)_ and _Warnings and Precautions (5.9)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. PRISTIQ should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. **2.2 Special Populations** Pregnant women during the third trimester Neonates exposed to SNRIs or Selective Serotonin Reuptake Inhibitors (SSRIs) late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding \[see _Use in Specific Populations (8.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. When treating pregnant women with PRISTIQ during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. Patients with renal impairment No dosage adjustment is necessary in patients with mild renal impairment (24-hr CrCl = 50–80 mL/min). The recommended dose in patients with moderate renal impairment (24-hr CrCl = 30–50 mL/min) is 50 mg/day. The recommended starting dose in patients with severe renal impairment (24-hr CrCl <30 mL/min) or end-stage renal disease (ESRD) is 50 mg every other day. Because of individual variability in clearance in these patients, individualization of dosage may be desirable. Supplemental doses should not be given to patients after dialysis. The doses should not be escalated in patients with moderate or severe renal impairment, or ESRD \[see _Warnings and Precautions (5.10)_, _Use in Specific Populations (8.6)_ and _Clinical Pharmacology (12.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Patients with hepatic impairment The recommended dose in patients with hepatic impairment is 50 mg/day. Dose escalation above 100 mg/day is not recommended \[see _Clinical Pharmacology (12.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Elderly patients No dosage adjustment is required solely on the basis of age; however, the possibility of reduced renal clearance of PRISTIQ should be considered when determining the dose \[see _Use in Specific Populations (8.5)_ and _Clinical Pharmacology (12.5)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. **2.3 Maintenance/Continuation/Extended Treatment** It is generally agreed that acute episodes of MDD require several months or longer of sustained pharmacologic therapy. However, the longer-term efficacy of PRISTIQ at a dose of 50 mg/day that was effective in short-term, controlled studies has not been studied. Patients should be periodically reassessed to determine the need for continued treatment. **2.4 Discontinuing PRISTIQ** Symptoms associated with discontinuation of PRISTIQ, other SNRIs and SSRIs have been reported \[see _Warnings and Precautions (5.9)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended. 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. In some patients, discontinuation may need to occur over periods of months or longer. **2.5 Switching Patients from Other Antidepressants to PRISTIQ** Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to PRISTIQ. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms. **2.6 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders** At least 14 days should elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with PRISTIQ. Conversely, at least 7 days should be allowed after stopping PRISTIQ before starting a MAOI intended to treat psychiatric disorders \[see _Contraindications (4.2)_\]. **Use of PRISTIQ with reversible MAOIs such as Linezolid or Methylene Blue** Do not start PRISTIQ in a patient who is being treated with a reversible MAOI such as linezolid or in whom intravenous methylene blue has been administered because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered \[see _Contraindications (4.2)_\]. In some cases, a patient already receiving PRISTIQ therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, PRISTIQ should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with PRISTIQ may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue \[see _Warnings and Precautions (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with PRISTIQ is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use \[see _Warnings and Precautions (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].