Indications

EFFEXOR XR (venlafaxine HCl) Extended-Release Capsules are indicated for the treatment, in adults, of Depression, Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia.

Important Safety Information for EFFEXOR XR

• Effexor XR is contraindicated in patients with a known hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation.
• EFFEXOR XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). EFFEXOR XR should not be used in combination with an MAOI or within at least 14 days of discontinuing treatment with an MAOI because of potential for serious adverse reactions. Based on the half-life of EFFEXOR XR, at least 7 days should be allowed after stopping EFFEXOR XR before starting an MAOI.
• Adult and pediatric patients with MDD can experience worsening of their depression and/or the emergence of suicidal ideation and behavior, whether or not they are taking antidepressants. All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms.
• Development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including EFFEXOR XR treatment, but particularly with concomitant use of serotonergic drugs (including triptans), with drugs that impair the metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. If concomitant use with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Concomitant use of EFFEXOR XR with serotonin precursors is not recommended.
• Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Three percent of EFFEXOR XR patients in MDD studies (doses of 75 to 375 mg/day), 0.5% in generalized anxiety disorder (GAD) studies (doses of 37.5 to 225 mg/day), 0.6% in social anxiety disorder (SAD) studies (doses of 75 to 225 mg/day), and 0.9% in panic disorder (PD) studies (doses of 75 to 225 mg/day) had sustained BP elevations. Experience with immediate-release venlafaxine in MDD studies showed that sustained hypertension was dose related, increasing from 3% to 7% at doses of 100 to 300 mg/day, to 13% at doses above 300 mg/day. Postmarketing cases of elevated BP requiring immediate treatment have been reported. Pre-existing hypertension should be controlled. Regular BP monitoring is recommended. For patients who experience a sustained increase in BP, either dose reduction or discontinuation should be considered.
• SSRIs and SNRIs, including EFFEXOR XR, may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to this risk.
• Mydriasis has been reported in association with venlafaxine; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
• Effexor XR is not approved for use in bipolar depression. Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder.
• As with all antidepressants, EFFEXOR XR should be used cautiously in patients with a history or family history of mania or hypomania, or with a history of seizure disorder.
• Clinically relevant increases in serum cholesterol were observed in clinical studies in 5.3% of venlafaxine patients
• Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually. See the PRECAUTIONS section of the Prescribing Information.
• For patients with renal or hepatic impairment, dosage adjustment may be required.
• Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy have been rarely reported.
• Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including EFFEXOR XR. Discontinuation of EFFEXOR XR should be considered in patients with symptomatic hyponatremia
• The most commonly observed adverse reactions in patients taking EFFEXOR XR vs placebo in short-term placebo-controlled studies (incidence ≥10% and at least twice the rate of placebo) of MDD were nausea (31% vs 12%), dizziness (20% vs 9%), somnolence (17% vs 8%), abnormal ejaculation (16% vs <1%), sweating (14% vs 3%), dry mouth (12% vs 6%), and nervousness (10% vs 5%); of GAD were nausea (35% vs 12%), dry mouth (16% vs 6%), abnormal ejaculation (11% vs <1%), sweating (10% vs 3%), and constipation (10% vs 4%); of SAD were nausea (31% vs 9%), dizziness (16% vs 8%), somnolence (20% vs 8%), abnormal ejaculation (19% vs <1%), sweating (13% vs 4%), dry mouth (17% vs 4%), nervousness (10% vs 5%), insomnia (24% vs 8%), asthenia (19% vs 9%), and anorexia (17% vs 2%); of panic disorder were somnolence (12% vs 6%), sweating (10% vs 2%), and dry mouth (12% vs 6%). [ Note: If speaking to only one indication, then list only AEs assoctiated with that indication ]
• As with any psychotropic drug, EFFEXOR XR may impair judgment, thinking, or motor skills; patients should be advised to exercise caution until they have adapted to therapy.