HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use EFFEXOR XR safely and effectively. See full prescribing information for EFFEXOR XR.
EFFEXOR XR® (venlafaxine Extended-Release) Capsules
Initial U.S. Approval: 1997
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
- Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants (5.1)
- Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1)
- Effexor XR is not approved for use in pediatric patients (8.4)
INDICATIONS AND USAGE
Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: (1)
- Major Depressive Disorder (MDD)
- Generalized Anxiety Disorder (GAD)
- Social Anxiety Disorder (SAD)
- Panic Disorder (PD)
DOSAGE AND ADMINISTRATION
|Indication||Starting Dose||Target Dose ||Maximum Dose|
|MDD (2.1)||37.5 –75 mg/day||75 mg/day||225 mg/day|
|GAD (2.2)||37.5 –75 mg/day||75 mg/day||225 mg/day|
|SAD (2.3)||75 mg/day||75 mg/day||75 mg/day|
|PD (2.4)||37.5 mg/day||75 mg/day||225 mg/day|
- Take once daily with food (2). Capsules should be taken whole; do not divide, crush, chew, or dissolve (2).
- When discontinuing treatment, reduce the dose gradually (2.8, 5.7).
- Renal impairment: reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment (2.6).
- Hepatic impairment: reduce the daily dose by 50% in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% (2.6).
DOSAGE FORMS AND STRENGTHS
- Effexor XR capsules are available as 37.5 mg, 75 mg and 150 mg strengths (3).
- Each capsule contains venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg or 150 mg of venlafaxine (3).
- Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the Effexor XR formulation (4.1).
- Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping Effexor XR before starting an MAOI, because of the risk of serotonin syndrome (4.2, 5.2, 7.3).
WARNINGS AND PRECAUTIONS
- Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk (5.1).
- Serotonin Syndrome: Risk increases with concomitant use of other serotonergic drugs. Discontinue Effexor XR and initiate supportive treatment if serotonin syndrome occurs (4.2, 5.2, 7.3).
- Elevations in Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
- Abnormal Bleeding: Effexor XR may increase risk of bleeding events. Caution patients about the risk of bleeding associated with the concomitant use of Effexor XR and NSAIDs, aspirin, or other drugs that affect coagulation (5.4).
- Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (5.5).
- Activation of Mania/Hypomania: Use cautiously in patients with bipolar disorder. Caution patients about the risk of activation of mania/hypomania (5.6).
Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal ejaculation, anorexia, constipation, erectile dysfunction, and libido decreased (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Serotonergic Drugs (e.g., MAOIs, triptans, SSRIs, other SNRIs, linezolid, lithium, tramadol, or St. John's wort): Potential for serotonin syndrome. Careful patient observation is advised (4.2, 5.2, 7.3).
USE IN SPECIFIC POPULATIONS
- Pregnancy: Based on animal data, may cause fetal harm (8.1).
- Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother (8.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.