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PRISTIQ®(desvenlafaxine succinate)
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PRISTIQ® Quick Finder
Highlights
Boxed Warning
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show...
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Indications and Usage
1 INDICATIONS AND USAGE
PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 General Instructions for Use
The recommended dose for PRISTIQ is 50 mg once daily, with or without food. The 50 mg dose is both a...
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Dosage Forms and Strengths
3 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...
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Contraindications
4 CONTRAINDICATIONS
- Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the PRISTIQ formulation. Angioedema has been reported in patients treated with PRISTIQ...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
Patients with MDD, both adult and pediatric, may experience...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label.
- Hypersensitivity [see Contraindications (4)...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Drugs Having Clinically Important Interactions with PRISTIQ
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is...
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Drug Abuse and Dependence
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
PRISTIQ is not a controlled substance.
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Overdosage
10 OVERDOSAGE
10.1 Human Experience with Overdosage
There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. However,...
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Description
11 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...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The exact mechanism of the antidepressant action of desvenlafaxine is unknown, but is thought to be related to the...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
14 CLINICAL STUDIES
Major Depressive Disorder
The efficacy of PRISTIQ as a treatment for depression was established in four 8-week,...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
PRISTIQ® (desvenlafaxine) extended-release tablets are available as follows:
25 mg, tan, square pyramid tablet debossed with "W" (over) "25" on the flat...
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Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: 11/2021 | |||
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