Drug Notebook

FDA Alerts

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Amoxapine is not approved for use in pediatric patients <16 years of age. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on amoxapine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk and Pediatric Use under Cautions.)

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amoxapine
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(a MOX a peen)

Uses

Depressive Disorders

Symptomatic management of neurotic or reactive depressive disorders, endogenous depression, or psychotic depression.

Treatment of depression accompanied by anxiety or agitation.

Dosage and Administration

General

Depressive Disorders

  • Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of amoxapine and vice versa. Also allow at least 5 weeks to elapse when switching from fluoxetine.
  • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
  • Duration of therapy depends on the condition being treated; during maintenance therapy, administer lowest effective dosage and periodically reassess need for continued therapy.

Administration

Oral Administration

Administer orally in up to 3 divided doses or as a single daily dose (if daily dosage ≤300 mg) at bedtime to avoid daytime sedation. Daily dosages >300 mg daily should be administered in divided doses.

Dosage

Individualize dosage carefully according to individual requirements and response.

Adults

Depressive Disorders

Outpatients
Oral

Initially, 50 mg 2 or 3 times daily; initial dosage of 300 mg daily may be given, but considerable sedation may occur during the first few days. Dosage may be increased to 100 mg 2 or 3 times daily by the end of the first week.

Usual dosage: 200–300 mg daily. Dosage may be further increased to a maximum of 400 mg daily if a satisfactory response is not achieved at a dosage of 300 mg daily for at least 2 weeks and if tolerated.

After symptoms are controlled, gradually reduce dosage to the lowest level that will maintain relief of symptoms.

Hospitalized Patients
Oral

Initially, 50 mg 2 or 3 times daily; initial dosage of 300 mg daily may be given, but considerable sedation may occur during the first few days. Dosage may be increased to 100 mg 2 or 3 times daily by the end of the first week.

Usual dosage: 200–300 mg daily. Dosage may be further increased to a maximum of 600 mg daily if a satisfactory response is not achieved at a dosage of 300 mg daily for at least 2 weeks in patients without a history of seizure disorders and if tolerated.

After symptoms are controlled, gradually reduce dosage to the lowest level that will maintain relief of symptoms.

Prescribing Limits

Adults

Depressive Disorders

Outpatients
Oral

Maximum 400 mg daily.

Hospitalized Patients
Oral

Maximum 600 mg daily.

Special Populations

Geriatric Patients

Select dosage at the lower end of recommended range since decreased hepatic and renal function are more frequent; increase dosage more gradually and monitor closely. (See Geriatric Use under Cautions.)

Initially, 25 mg 2 or 3 times daily. Increase dosage to 50 mg 2 or 3 times daily by the end of the first week if tolerated. Usual dosage: 100–150 mg daily; some patients may require a higher dosage (up to a maximum of 300 mg daily).

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