Table I-2, FDA-approved adult medications (prescribed off label in pediatric patients) included in literature review - Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents

Drug	FDA Approved Adult Indication	Boxed Warning	Contraindications	Warnings/ Precautions
Ziprasidone ⁹	Treatment of schizophrenia. Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate. Acute treatment of agitation in schizophrenic patients.	---	Do not use in patients with a known history of QT prolongation. Do not use in patients with recent acute myocardial infarction Do not use in patients with uncompensated heart failure Do not use in combination with other drugs that have demonstrated QT prolongation.	QT Interval Prolongation: should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation Neuroleptic Malignant Syndrome (NMS): Potentially fatal symptom complex has been reported with antipsychotic drugs. Manage with immediate discontinuation of drug and close monitoring. Tardive Dyskinesia - May develop acutely or chronically Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. Rash: Discontinue in patients who develop a rash without an identified cause Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease Leukopenia, Neutropenia, and Agranulocytosis has been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue at the first sign of a decline in WBC in the absence of other causative factors. Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold Potential for Cognitive and Motor impairment: Patients should use caution when operating machinery Suicide Closely supervise high-risk patients

Drug

FDA Approved Adult Indication

Boxed Warning

Contraindications

Warnings/ Precautions

Ziprasidone ⁹

Treatment of schizophrenia.
Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder
Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.
Acute treatment of agitation in schizophrenic patients.

---

Do not use in patients with a known history of QT prolongation.
Do not use in patients with recent acute myocardial infarction
Do not use in patients with uncompensated heart failure
Do not use in combination with other drugs that have demonstrated QT prolongation.

QT Interval Prolongation: should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation
Neuroleptic Malignant Syndrome (NMS): Potentially fatal symptom complex has been reported with antipsychotic drugs. Manage with immediate discontinuation of drug and close monitoring.
Tardive Dyskinesia - May develop acutely or chronically
Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.
Rash: Discontinue in patients who develop a rash without an identified cause
Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease
Leukopenia, Neutropenia, and Agranulocytosis has been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue at the first sign of a decline in WBC in the absence of other causative factors.
Seizures: Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold
Potential for Cognitive and Motor impairment: Patients should use caution when operating machinery
Suicide Closely supervise high-risk patients

From: Appendix I, Pharmacologic Approval Status, Harms, and Indications

Cover of Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents

Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents [Internet].

Comparative Effectiveness Reviews, No. 154.

Epstein R, Fonnesbeck C, Williamson E, et al.

Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Oct.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Table I-2FDA-approved adult medications (prescribed off label in pediatric patients) included in literature review