HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
PRISTIQ®(desvenlafaxine succinate)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
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...
Did you find an answer to your question?
Yes
No
Indications and Usage
1 INDICATIONS AND USAGE
PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label.
- Hypersensitivity [see Contraindications (4)...
Did you find an answer to your question?
Yes
No
Drug Interactions
7 DRUG INTERACTIONS
7.1 Drugs Having Clinically Important Interactions with PRISTIQ
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is...
Did you find an answer to your question?
Yes
No
Drug Abuse and Dependence
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
PRISTIQ is not a controlled substance.
Did you find an answer to your question?
Yes
No
Overdosage
10 OVERDOSAGE
10.1 Human Experience with Overdosage
There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. However,...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
Major Depressive Disorder
The efficacy of PRISTIQ as a treatment for depression was established in four 8-week,...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: 11/2021 | |||
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.