Indications, Dosing & Safety
This section can provide you with quick reference information about prescribing EFFEXOR XR. For more information, please refer to the Prescribing Information.
- EFFEXOR XR should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day2
- Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water, or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce; this drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets2
- Flexibility in dosing for depression
- Patients not responding to the initial dose of 75 mg/day may benefit from increases to a maximum of approximately 225 mg/day2
- When increasing the dosage, incremental increases of up to 75 mg/day should be made at intervals of no less than 4 days2
- Experience with EFFEXOR XR doses higher than 225 mg/day is very limited2
- Dosing for special populations may vary; click here for more information.
Available in the Following Strengths
Find out more about dosing in the Prescribing Information.
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%).
Low incidence of treatment-emergent weight gain, decreased libido, and agitation2,4
In trials for major depressive disorder, EFFEXOR XR was associated with a low incidence of treatment-emergent weight gain, decreased libido, and agitation.
Find out more about EFFEXOR XR adverse events in the Prescribing Information.
EFFEXOR has little or no impact on cytochrome P4502
0 = minimal or zero inhibition.
+ = weak inhibition.
- EFFEXOR XR is minimally protein-bound (27%)2
- Potential exists for a drug interaction between EFFEXOR XR and drugs that inhibit cytochrome P4502
- Caution is advised if a patient's therapy includes a CYP3A4 inhibitor and venlafaxine concomitantly2
- Concomitant use of EFFEXOR XR in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated2
- Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, including herbal preparations and nutritional supplements, since there is a potential for interactions.2
- Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of EFFEXOR XR and triptans, tryptophan supplements, or other serotonergic agents2
Find out more about EFFEXOR XR drug interactions in the Prescribing Information.
Indications
EFFEXOR XR (venlafaxine hydrochloride) Extended-Release Capsules are indicated for the treatment of Depression, Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia.
Important Safety Information for EFFEXOR XR
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults
in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of
EFFEXOR XR® (venlafaxine HCl)
or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an
increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants
compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the
risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical
worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication
with the prescriber. EFFEXOR XR is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information
for Patients, and Precautions: Pediatric Use.)
- 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.
- 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.
- 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.
- 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%).
- 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.