PRISTIQ Extended-release tablet Ref.[10909] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

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 disorder.

Desvenlafaxine is designated RS4[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.

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 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively.

Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.

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.

Dosage Forms and Strengths
  • 25 mg Tablet: tan, square pyramid tablet debossed with “W” over “25” on the flat side.
  • 50 mg Tablet: light pink, square pyramid tablet debossed with “W” over “50” on the flat side.
  • 100 mg Tablet: reddish-orange, square pyramid tablet debossed with “W” over “100” on the flat side.
How Supplied

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 43063-262-30, bottle of 30 tablets.

Drugs

Drug Countries
PRISTIQ Australia, Brazil, Canada, Ecuador, Spain, Hong Kong, Mexico, Singapore, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.