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Pristiq (Desvenlafaxine Succinate) - Indications and Dosage



PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies ( 14 ) and Dosage and Administration ( 2.1 )]. The efficacy of PRISTIQ has been established in four 8-week, placebo-controlled studies of outpatients who met DSM-IV criteria for major depressive disorder.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.


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.

Special Populations

Pregnant women during the third trimester

Neonates exposed to SNRIs or SSRIs late in the third trimester have developed 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. 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 ( 12.6 )].

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 ( 12.6 )].

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 ( 12.6 )].

Maintenance/Continuation/Extended Treatment

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.

Discontinuing PRISTIQ

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 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 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 [see Contraindications ( 4.2 )].

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 )].


PRISTIQ® (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


PRISTIQ® (desvenlafaxine) Extended-Release Tablets are available as follows:

50 mg, light pink, square pyramid tablet debossed with “W” (over) “50” on the flat side

     NDC 0008-1211-14, bottle of 14 tablets in unit-of-use package

     NDC 0008-1211-30, bottle of 30 tablets in unit-of-use package

     NDC 0008-1211-01, bottle of 90 tablets in unit-of-use package

     NDC 0008-1211-50, 10 blisters of 10 (HUD)

100 mg, reddish-orange, square pyramid tablet debossed with “W” (over) “100” on the flat side

     NDC 0008-1222-14, bottle of 14 tablets in unit-of-use package

     NDC 0008-1222-30, bottle of 30 tablets in unit-of-use package

     NDC 0008-1222-01, bottle of 90 tablets in unit-of-use package

     NDC 0008-1222-50, 10 blisters of 10 (HUD)

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each tablet contains 76 or 152 mg of desvenlafaxine succinate equivalent to 50 or 100 mg of desvenlafaxine, respectively.

The unit-of-use package is intended to be dispensed as a unit.

The appearance of these tablets is a trademark of Wyeth Pharmaceuticals.

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