| Initial U.S. Approval: 2008
PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.
Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2•C4H6O4•H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48.
Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21.
PRISTIQ is formulated as an extended-release tablet for once-a-day oral administration.
Each tablet contains 76 or 152 mg of desvenlafaxine succinate equivalent to 50 or 100 mg of desvenlafaxine, respectively.
Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.
Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6.
| CLINICAL PHARMACOLOGY
Mechanism of Action
| INDICATIONS AND USAGE
PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder [MDD]
USE IN SPECIFIC POPULATIONS
There is an increased incidence of orthostatic hypotension in PRISTIQ treated patients >/= 65 years.
For elderly patients, the possibility of reduced renal clearance of desvenlafaxine should be considered when determining dose.
Only administer PRISTIQ to pregnant or breastfeeding women if the expected benefits outweigh the possible risks.
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation.
Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI
| WARNINGS AND PRECAUTIONS
| ADVERSE REACTIONS
Adverse reactions in patients in short-term fixed-dose studies (incidence >/= 5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.
To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc., at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
| 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.
2.2 Special Populations
Pregnant women during the third trimester
Patients with renal impairment
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
2.3 Maintenance/Continuation/Extended Treatment
2.4 Discontinuing PRISTIQ
2.5 Switching Patients From Other Antidepressants to PRISTIQ
2.6 Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI)
| DOSAGE FORMS AND STRENGTHS
PRISTIQ tablets are available as 50 and 100 mg tablets.
Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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