Nefazodone Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Depression

Nefazodone sold under the trade name of Serzone was voluntarily withdrawn from the U.S. market in June 2004. The manufacturer blamed a decline in sales as the reason for the withdrawal of the drug. However, some feel the withdrawal of this drug may have actually been because nefazodone has been linked to dozens of cases of liver failure and injury, including at least 20 deaths. Canadian regulators had banned the drug in the fall of 2003 because of the liver risk associated with it. Serzone has also been pulled off the market in many other countries and the manufacturer had been under mounting pressure from lawsuits in the U.S. However, generic versions of nefazodone are still available in the U.S.

Initial dose: 100 mg orally twice a day.
Maintenance dose: 150 to 300 mg orally twice a day. The dose may be increased in 100 to 200 mg increments at intervals of no less than 1 week.

Usual Pediatric Dose for Depression

Nefazodone sold under the trade name of Serzone was voluntarily withdrawn from the U.S. market in June 2004. The manufacturer blamed a decline in sales as the reason for the withdrawal of the drug. However, some feel the withdrawal of this drug may have actually been because nefazodone has been linked to dozens of cases of liver failure and injury, including at least 20 deaths. Canadian regulators had banned the drug in the fall of 2003 because of the liver risk associated with it. Serzone has also been pulled off the market in many other countries and the manufacturer had been under mounting pressure from lawsuits in the U.S. However, generic versions of nefazodone are still available in the U.S.

<7 years: Safety and efficacy have not been established.
7 to 12 years:
Initial dose: 50 mg orally twice a day (investigational).
Maintenance dose: 100 to 150 mg orally twice a day. The dose may be increased in 50 mg increments at intervals of no less than 1 week.

12 to 18 years:
Initial dose: 50 mg orally twice a day (investigational).
Maintenance dose: 100 to 300 mg orally twice a day. The dose may be increased in 50 to 100 mg increments at intervals of no less than 1 week.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Nefazodone should be discontinued and not restarted if patients develop signs of liver dysfunction (AST or ALT >= 3 times ULN).

Dose Adjustments

Dose increases should occur in increments of 100 to 200 mg/day at intervals of no less than 1 week.

Precautions

At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with nefazodone. At least 7 days should be allowed after stopping nefazodone starting an MAOI.

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.

Dialysis

Hemodialysis, hemoperfusion and exchange transfusion are not expected to remove nefazodone.

Other Comments

Several weeks on treatment may be required to obtain a full antidepressant response. Pharmacological treatment for acute episodes of depression should continue for up to 6 months or longer.

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