Applies to the following strength(s): 100 mg ; 150 mg ; 200 mg ; 50 mg ; 250 mg
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Usual Adult Dose for:
Usual Geriatric Dose for:
Additional dosage information:
Usual Adult Dose for Depression
Initial dose: 200 mg orally per day in two divided doses
Maintenance dose: 300 to 600 mg orally per day
-Dose increases should occur in increments of 100 mg per day to 200 mg per day, on a BID schedule, at intervals of no less than 1 week.
Use: Treatment of depression
Usual Geriatric Dose for Depression
Elderly or debilitated patients:
Initial dose: 100 mg orally per day administered in two divided doses
-Since these patients often have reduced drug clearance and/or increased sensitivity to the side effects, it may be appropriate to modify the rate of subsequent dose titration.
Use: Treatment of depression
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
This drug should be discontinued and not restarted if patients develop signs of liver dysfunction (AST or ALT greater than or equal to 3 times the upper limit of normal).
-Dose adjustments may be required on the basis of clinical response when this drug is coadministered with buspirone, propanolol, and desipramine.
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 this drug 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.
-This drug is not approved for use in pediatric patients.
-Cases of life-threatening hepatic failure have been reported in patients treated with this drug.
-The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 to 300,000 patient-years of treatment. The total patient-years is a summation of each patient's duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc.
-Ordinarily, treatment should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.
-Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.
-This drug should be discontinued if clinical signs or symptoms suggest liver failure. Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels equal to 3 times the upper limit of normal, while on this drug should be withdrawn from treatment. These patients should be presumed to be at increased risk for liver injury if this drug is reintroduced. Accordingly, such patients should not be considered for re-treatment.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis is not expected to remove this drug.
-Hepatic: Patients should be monitired for elevated baseline serum transaminases.
-Psychiatric: Patients should be monitored for worsening and emergence of suicidal thoughts.
-Patients should be cautioned accordingly since this drug may impair the mental and/or physical abilities required for the performance of operating an automobile or machinery.
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Other brands: Serzone