Desvenlafaxine Succinate (2 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET, EXTENDED RELEASE.
Routes of administration: ORAL.
Brand Names
- DESVENLAFAXINE SUCCINATE
- PRISTIQ
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 an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS (5.1)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see WARNINGS AND PRECAUTIONS (5.1)]. Desvenlafaxine extended-release tablets are not approved for use in pediatric patients [see USE IN SPECIFIC POPULATIONS (8.4) ].
Indications and Usage
Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].
Contraindications
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine formulation. Angioedema has been reported in patients treated with desvenlafaxine [see ADVERSE REACTIONS (6.1)]. The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine is contraindicated because of an increased risk of serotonin syndrome. The use of desvenlafaxine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see DOSAGE AND ADMINISTRATION (2.7) and WARNINGS AND PRECAUTIONS (5.2)]. Starting desvenlafaxine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see DOSAGE AND ADMINISTRATION (2.8) and WARNINGS AND PRECAUTIONS (5.2)].
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see CONTRAINDICATIONS (4)] Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see WARNINGS AND PRECAUTIONS (5.1)] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.2)] Elevated Blood Pressure [see WARNINGS AND PRECAUTIONS (5.3)] Increased Risk of Bleeding [see WARNINGS AND PRECAUTIONS (5.4)] Angle Closure Glaucoma [see WARNINGS AND PRECAUTIONS (5.5)] Activation of Mania/ Hypomania [see WARNINGS AND PRECAUTIONS (5.6)] Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS (5.7)] Seizure [see WARNINGS AND PRECAUTIONS (5.8)] Hyponatremia [see WARNINGS AND PRECAUTIONS (5.9)] Interstitial Lung Disease and Eosinophilic Pneumonia [see WARNINGS AND PRECAUTIONS (5.10)] Sexual Dysfunction [see Warnings and Precautions [see WARNINGS AND PRECAUTIONS (5.11)]