Venlafaxine Dosage

Usual Adult Dose for Depression

Immediate release:
Initial dose: 37.5 mg orally twice a day or 25 mg orally 3 times a day
Maintenance dose: May increase in daily increments of up to 75 mg at intervals of no less than 4 days
Maximum dose: (moderately depressed outpatients): 225 mg/day
Maximum dose (severely depressed inpatients): 375 mg/day
Daily dosage may be divided in 2 or 3 doses/day

Extended release:
Initial dose: 75 mg orally once daily
Maintenance dose: May increase in daily increments of up to 75 mg at intervals of no less than 4 days
Maximum dose (moderately depressed outpatients): 225 mg/day
Maximum dose (severely depressed inpatients): 375 mg/day

Usual Adult Dose for Anxiety

For generalized anxiety disorder or social anxiety disorder:
Extended release:
Initial dose: 75 mg orally once daily
Maintenance dose: May increase in daily increments of 75 mg at intervals of no less than 4 days
Maximum dose: 225 mg/day

Usual Adult Dose for Panic Disorder

Extended-release:
Initial dose: 37.5 mg once a day
Maintenance dose: May increase dose in daily increments of 75 mg at intervals of no less than 7 days
Maximum dose: 225 mg/day

Renal Dose Adjustments

CrCl 10 to 70 mL/min: Dosage should be reduced by 25% to 50%.
CrCl <10 mL/min: Dosage should be reduced by at least 50%.

Liver Dose Adjustments

Dosage should be reduced by at least 50%.

Precautions

Children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder and other psychiatric disorders may be at an increased risk of suicidal thinking and suicidality with antidepressant use, particularly during the first few months of treatment. Medical evidence has not shown this increased risk to exist in adults older than 24 years of age, but adults 65 years of age and older taking antidepressants appear to have a decreased risk of suicidality. The results of a meta-analysis indicate an overall favorable risk-to-benefit profile for the use of antidepressants (i.e., selective serotonin and/or norepinephrine reuptake inhibitors) in the treatment of pediatric patients (less than 19- years- old) with major depressive disorders (MDD), obsessive-compulsive disorder (OCD), or non- OCD anxiety disorders. Although this study also reports an overall increased risk of suicidal ideation/suicide attempt associated with the use of antidepressants in pediatric patients, the risk may be less than originally estimated. Additional prospective studies are warranted in order to confirm these findings.

Worsening of depression and/or increased suicidal thinking or behavior may always be a possibility in patients treated with antidepressant medications, particularly those being treated for depression. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. It is unknown if these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses; however, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Although the FDA has not concluded that antidepressant drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

Health care providers should carefully monitor patients receiving antidepressants for possible and/or persistent worsening of depression or emergent suicidality, especially at the beginning of therapy or when the dose either increases or decreases. If symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms, the health care provider will need to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated. Prescriptions should be written for small quantities of drug to reduce the risk of an attempt to overdose. Health care providers should instruct patients, their families and their caregivers to be alert for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.

Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Suicide related events have been reported in 7.6% of venlafaxine treated children and adolescents in controlled clinical trials versus 0.55% reported in placebo- treated patients. Hostility, manic reaction, overdose, and suicidal thoughts were the commonest reasons or discontinuation due to an adverse event in the venlafaxine group. One percent of the venlafaxine patients discontinued due to a suicide attempt. In addition, the FDA reports antidepressants may increase suicidal thoughts and actions in about 1 out of 50 pediatric patients (18 years and younger).

The manufacturer sent a letter to physicians (on August 22, 2003) that venlafaxine is not effective in treating depression among children and teens, and that the drug may increase hostility and suicidal thoughts and behavior in children from 6 to 17 years of age.

When discontinuing after >1 week of therapy, it is recommended that the dose be tapered to minimize the risk of discontinuation symptoms. At least 14 days should lapse between discontinuation of MAOI and starting venlafaxine. When starting an MAOI allow 7 days after stopping venlafaxine.

Dialysis

The dose should be withheld until the dialysis treatment is completed (4 hrs) in patients undergoing hemodialysis.

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for venlafaxine. It includes a Medication Guide. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

Administer with food.

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