Pristiq Extended-release

Pristiq Extended-release

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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. The structural formula is shown below.

Chemical Structure

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.

Pristiq Extended-release Manufacturers


  • Pd-rx Pharmaceuticals, Inc.
    Pristiq Extended-release (Desvenlafaxine Succinate) Tablet, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Pristiq Extended-release (Desvenlafaxine Succinate) Tablet, Extended Release [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Physicians Total Care, Inc.
    Pristiq Extended-release (Desvenlafaxine Succinate) Tablet, Extended Release [Physicians Total Care, Inc.]
  • Cardinal Health
    Pristiq Extended-release (Desvenlafaxine Succinate) Tablet, Extended Release [Cardinal Health]
  • Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
    Pristiq Extended-release (Desvenlafaxine Succinate) Tablet, Extended Release [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]

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