1.2. Pediatrics
Risperidone is FDA-approved to manage symptoms of irritability in autistic children greater than 5 years of age and adolescents, and is approved for bipolar mania in children and adolescents 10 to 17 years of age and schizophrenia in adolescents 13 to 17 years of age1,6. Aripiprazole is FDA approved for treating Tourette’s disorder in pediatric patients 6 to 18 years of age, and is also FDA-approved for managing schizophrenia in adolescents 13 to 17 years of age, bipolar disorder with or without psychotic features in children 10 to 17 years of age, and irritability associated with autistic disorder in children 6 to 17 years of age1,9. Olanzapine is FDA approved for bipolar disorder and schizophrenia in adolescents 13 years of age and older.1,10 Olanzapine is also FDA approved to treat depressive episodes associated with bipolar 1 disorder in patients 10 years of age and older when used in combination with fluoxetine1,18. Quetiapine is FDA approved for acute treatment of bipolar disorder mania episodes in children and adolescents 10 to 17 years of age and schizophrenia management in adolescents 13 to 17 years of age1,11,12. Paliperidone is approved FDA for the management of schizophrenia in adolescents 12 to 17 years of age1,8. Lurasidone is approved for the management of depressed phase bipolar disorder in children 10 to 17 years of age, and it is approved for the management of schizophrenia in patients 13 to 17 years of age1,13. Cariprazine, clozapine, iloperidone, lumateperone, ziprasidone, and aripiprazole tablets with sensors (Abilify MyCite) are not recommended for use in pediatric patients as safety and efficacy have not been established in this patient population. Additionally, pimavanserin is not approved for use in pediatric patients as Parkinson’s disease is typically not observed in pediatric patients, and safety and efficacy data are not available for pimavanserin in the pediatric population1-3,5,7,15-17,20.
Atypical antipsychotic pediatric dosages are summarized in Table 3. An additional column reflecting literature-based dosing included in the Texas Health and Human Services Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version) is included in Tables 3 and 422.
Drug Name | Available Dosage Strengths | Treatment Indication | Literature Based Maximum Dosage | FDA Approved Maximum Recommended Dosage |
---|---|---|---|---|
Aripiprazole (Abilify,generics) |
| Schizophrenia |
| 13-17 years of age: 30 mg once daily |
BD | 10-17 years of age: 30 mg once daily | |||
Tourette’s disorder | 6-18 years of age:
| |||
Irritability associated with autism | 6-17 years of age: 15 mg/day as a single dose | |||
Asenapine (Saphris®) | 2.5 mg, 5 mg, 10 mg sublingual tablets | BD | Age greater than or equal to 10 years: 10 mg twice daily | 10-17 years of age: 20 mg/day, in two divided doses |
Brexpiprazole (Rexulti) | 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg tablets | Schizophrenia | Age 13-17 years: 4 mg/ day | |
Clozapine (Clozaril, generics, Versacloz) |
| Reserved for treatment resistant psychosis, following two failed trials of antipsychotic therapy with adequate dose/ duration |
| Not approved for children or adolescents |
Lurasidone (Latuda®) | 20 mg, 40 mg, 60 mg, 80 mg IR tablets | Schizophrenia, BD |
| 13 to 17 years of age: 80 mg/day, with food (at least 350 calories) |
Olanzapine (Zyprexa®, Zyprexa Zydis®, generics) |
| Schizophrenia, BD |
| 13 to 17 years of age: 20 mg once daily |
Paliperidone (Invega®) | 1.5 mg, 3 mg, 6 mg, 9 mg extended-release (ER) tablets | Schizophrenia | Adolescents (age greater than or equal to 12 years), schizophrenia:
| 12-17 years of age:
|
Quetiapine (Seroquel, generics, Seroquel XR) |
| BD - acute manic episodes |
| 10 to 17 years of age: 600 mg daily, once daily (ER tablets) or in 2 to 3 divided doses (IR tablets) |
Schizophrenia | 13 to 17 years of age: 800 mg daily, once daily (ER tablets) or in 2 to 3 divided doses (IR tablets) | |||
Risperidone (Risperdal, generics) |
| Bipolar mania |
| 10-17 years of age: 6 mg daily |
Schizophrenia | 13-17 years of age: 6 mg daily | |||
Irritability in autistic disorder | 5-17 years of age: 3 mg/day (no dosing data available for pediatric patients less than 15 kg) | |||
Ziprasidone (Geodon, generics) | 20 mg, 40 mg, 60 mg, 80 mg IR capsules | BP | Bipolar Disorder (age10-17 years)
| Not approved for children or adolescents |
The olanzapine/fluoxetine combination has been approved for use in pediatric patients 10-17 years of age with depression associated with BD1,18. Recommended pediatric dosages are summarized in Table 4.
Drug Name | Available Dosage Strengths | Literature Based Maximum Dosage | Treatment Indication | Maximum Recommended Dosage per Age Group |
---|---|---|---|---|
Olanzapine/ fluoxetine (Symbyax, generics) |
| Age 10-17 years: 12 mg olanzapine/50 mg fluoxetine once daily | Bipolar depression | 10-17 years of age: olanzapine 12 mg/ fluoxetine 50 mg once daily in evening, without regard to meals |