DOSAGE AND ADMINISTRATION
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 50-400 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.
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) ].
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.
Pregnant women during the third trimester
Neonates exposed to SNRIs or SSRIs late in the third trimester havedeveloped complications requiring prolonged hospitalization, respiratory support, and tube feeding [ see Use in Specific Populations (8.1) ]. When treating pregnant women with Pristiq during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Pristiq in the third trimester.
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 per day. The recommended 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. Supplemental doses should not be given to patients after dialysis [ see Use in Specific Populations (8.6) and Clinical Pharmacology (12.6) ].
Patients with hepatic impairment
No adjustment of the starting dosage is necessary for patients with hepatic impairment. However, dose escalation above 100 mg/day is not recommended [ see Clinical Pharmacology (12.6) ].
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 (12.6) ].
It is generally agreed that acute episodes of major depressive disorder 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.
Symptoms associated with discontinuation of Pristiq, other SNRIs and SSRIs have been reported [ see Warnings and Precautions (5.9) ]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose (by giving 50 mg of Pristiq less frequently) rather than abrupt cessation is recommended whenever possible. 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.
Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI)
At least 14 days must elapse between discontinuation of an MAOI and initiation of therapy with Pristiq. In addition, at least 7 days must be allowed after stopping Pristiq before starting an MAOI [ see Contraindications (4.2) ].
DOSAGE FORMS AND STRENGTHS
PristiqTM (desvenlafaxine) Extended-Release Tablets are available as 50 and 100 mg tablets.
50 mg, light pink, square pyramid tablet debossed with “W” over “50” on the flat side
100 mg, reddish-orange, square pyramid tablet debossed with “W” over “100” on the flat side