Table 4: Schedule of Selected FDA-approved Psychotropic Medications for Children (Continued) Generic and Brand Names FDA-Approved Indications and Dosing
Zyprexa, Zyprexa Relprevv, Zyprexa Zydis, olanzapine
Bipolar I disorder (manic or mixed episodes): <13 years: Safety and efficacy not established; 13–17 years: 2.5–5 mg/day PO initially; target dosage, 10 mg/day; adjust by increments/decrements of 2.5–5 mg; dosage range: 2.5–20 mg/day Schizophrenia : <13 years: Safety and efficacy not established; 13–17 years: 2.5–5 mg/day PO initially; target dosage: 10 mg/day; adjust by increments/decrements of 2.5–5 mg; dosage range: 2.5–20 mg/day Schizophrenia: <13 years: Safety and efficacy not established; >13 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5–1 mg/day at intervals ≥24 hr to recommended dosage of 3 mg/day; dosage range: 1–6 mg/day (dosages >3 mg/day have not been proved more effective and are associated with increased incidence of adverse effects); if persistent somnolence occurs, daily dose may be divided q12hr Bipolar mania : <10 years: Safety and efficacy not established; >10 years: 0.5 mg/day PO in morning or evening initially; may be increased in increments of 0.5–1 mg/day at intervals ≥24 hr to recommended dosage of 2.5 mg/day; dosage range: 0.5–6 mg/day (dosages >2.5 mg/day have not been proved more effective and are associated with increased incidence of adverse effects); if persistent somnolence occurs, the daily dose may be divided q12hr Autism: Irritability associated with autistic disorder in children ages 5–16 years; <5 years: Safety and efficacy not established; 5–16 years (<20 kg): 0.25 mg/day PO initially; may be increased after ≥4 days to recommended dosage of 0.5 mg/day; 5–16 years (≥20 kg): 0.5 mg/day PO initially; may be increased after ≥4 days to recommended dosage of 1 mg/day Bipolar disorder: Indicated as monotherapy for acute treatment of manic or mixed episodes associated with bipolar, I disorder; <10 years: Safety and efficacy not established; 10–17 years: 2.5 mg SL q12hr initially; may increase to 5 mg SL q12hr after 3 days and to 10 mg SL q12hr after 3 additional days Anxiety: 6 years: 0.5 mg/kg/day divided PO q6– 8hr, or 5 mg PO q6–12hr; may increase dose to 10 mg PO q8–12hr; >12 years: 25–50 mg IV/IM q6–8hr Sedative/muscle relaxant: Potentially toxic dose in patients 0.5 mg/kg; 12 years: 0.12–0.8 mg/ kg/day PO divided q6–8hr, or 0.04–0.2 mg/kg IV/IM q2–4hr; no more than 0.6 mg/kg within 8 hr Anxiety: <6 years old: Not recommended; 6–12 years: 100–200 mg PO q8–12hr; >12 years old: 1,200–1,600 mg/day PO divided q8–12hr; not to exceed 2.4 g/day Anxiety: <6 years: Not recommended; 6–12 years: Not established—use with caution; >12 years—mild/moderate: 10–15 mg PO q6–8hr PRN; severe agitation or associated with depression: 15–30 mg PO q6–8hr PRN Generalized anxiety disorder: <7 years: Safety and efficacy not established; 7–17 years: 30 mg PO qDay initially; after 2 weeks, may consider increasing dose to 60 mg/day; recommended dosage range: 30–60 mg/day; some patients may benefit from doses >60 mg/ day; if increased beyond 60 mg/day, use increments of 30 mg/day; maximum dose studied was 120 mg/day; safety of doses >120 mg/day has not been evaluated
Risperdal, Risperdal Consta, Risperdal M-Tab, (Risperidone)
Saphris (Asenapine)
Antianxiety Agents Librium (Chlordiazepoxide)
Valium, Diastat (Diazepam)
Meprobamate
Serax (Oxazepam)
Cymbalta, duloxetine
Hypnotics Amytal Sodium, amobarbital Valium, Diastat (Diazepam)
Sedative: <6 years: Safety and effectiveness not established; 6–12 years: 65–500 mg IV/IM
Sedative: <6 years: Safety and effectiveness not established; 6–12 years: 65–500 mg IV/IM; >12 years: 3050 mg IV q8–12hr Hypnotic: Used as a hypnotic, for short-term treatment of insomnia; effectiveness for sleep induction and sleep maintenance is lost after 2 weeks; <6 years: Safety and effectiveness not established; 6–12 years: 2–3 mg/kg; not to exceed 500 mg IV/IM; >12 years: 65–200 mg IV qHS
Nembutal (Pentobarbital) Seconal (Secobarbital)
Hypnotic: 2–6 mg/kg IM once; not to exceed 100 mg
Sedative: 6 mg/kg PO divided q8hr
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Book Code: PYFL4024
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