DESVENLAFAXINE SUCCINATE

Major Depressive Disorder The efficacy of desvenlafaxine as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies (at doses of 50 mg per day to 400 mg per day) in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. In the first study, patients received 100 mg (n = 114), 200 mg (n = 116), or 400 mg (n = 113) of desvenlafaxine extended-release tablets once daily, or placebo (n = 118). In a second study, patients received either 200 mg (n = 121) or...

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 PRECAUTI...

• 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 ...

• Serotonin Syndrome: Increased risk when co-adminstered with other serotonergic agents, but also when taken alone. If it occurs, discontinue desvenlafaxine and serotonergic agents and initiate supportive treatment ( 5.2 ).
• Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( 5.3 ).
• Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase ...

7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with Desvenlafaxine

Table 8Clinically Important Drug Interactions with Desvenlafaxine Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SSRIs and SNRIs including desvenlafaxine with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of desvenlafaxine is contraindicated: ● Wit...