A phenylpiperazine antidepressant - It is used to treat depression
FDA Alerts
Special Alerts:
[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Major Depressive Disorder
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Effective in both inpatient and outpatient settings.
Schizophrenic Disorder
Has been used for the short-term management of depressive episodes in patients with schizophrenia†.
Alcohol Dependence
Has been used as adjunctive therapy for the management of alcohol dependence†.
Anxiety States
Has been used for the management of anxiety states†.
Dosage and Administration
General
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Individualize dosages according to individual requirements and response.
Monitor for possible worsening of depression or suicidality, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required; use lowest effective dose and monitor periodically for need for continued therapy.
Administration
Oral Administration
Administer orally after a meal or a light snack.
If drowsiness occurs, administer a major portion of the daily dosage at bedtime or reduce dosage.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Oral
Initially, 150 mg daily, given in divided doses. Daily dosage may be increased in 50-mg increments every 3 or 4 days based on patient’s response and tolerance.
Prescribing Limits
Adults
Major Depressive Disorder
Outpatients
Oral
Maximum 400 mg daily.
Hospitalized Patients
Oral
Maximum 600 mg daily.
Cautions
Contraindications
Known hypersensitivity to trazodone or any ingredient in the formulation.
Warnings/Precautions
Warnings
Worsening of Depression and Suicidality Risk
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) in both adult and pediatric patients; may persist until clinically important remission occurs with therapy. Closely supervise pediatric patients receiving trazodone for any reason and adult patients with major depressive disorder or other psychiatric illness with comorbid depression during initiation of therapy and during periods of dosage adjustments. (See Boxed Warning.)
If anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and/or mania occur, consider changing or discontinuing therapy, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.
Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.
Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.
Bipolar Disorder
May unmask bipolar disorder. Trazodone is not approved for use in treating bipolar depression.
Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.
Priapism
Risk of developing priapism; may require surgical or pharmacologic (e.g., epinephrine) intervention and result in impotence or permanent impairment of erectile function.
Perform pharmacologic or surgical interventions under the supervision of a urologist or a physician familiar with the procedure; procedures should not be initiated without a urologic consultation if priapism persists for >24 hours.
Discontinue immediately if prolonged or inappropriate erections occur.
Hypotension, including orthostatic hypotension and syncope, reported.
Concomitant administration of antihypertensive therapy may require a reduction in dosage of the antihypertensive agent(s).
General Precautions
Elective Surgery
Discontinue several days prior to surgery requiring general anesthesia whenever possible.
CNS Effects
Drowsiness reported in up to 50% of patients.
Performance of activities requiring mental alertness and physical coordination may be impaired.
Electroconvulsive Therapy (ECT)
Effects of concomitant use with ECT have not been systematically evaluated; avoid concomitant use.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether trazodone is distributed into milk; caution advised.
Pediatric Use
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Safety and efficacy not established in children <18 years of age.
Greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder, or other psychiatric disorders based on pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others). No suicides occurred in these trials. If considering use of trazodone in a child or adolescent, balance potential risks with clinical need. (See Worsening of Depression and Suicidality Risk under Cautions.)
Common Adverse Effects
Drowsiness, dry mouth, dizziness or lightheadedness, headache, blurred vision, nausea or vomiting.
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