1.2. Pediatrics

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The FDA requires that all antidepressant drugs display a black box warning describing the potential for increased suicidal thinking and behavior when prescribed to children and adolescents with MDD and other psychiatric disorders. In short-term clinical trials, the suicide risk occurred twice as frequently with antidepressant-treated children/adolescents compared to those receiving placebo (4% vs. 2%, respectively) in the first few months of treatment. Pediatric patients prescribed antidepressant drugs should be closely monitored for changes in behavior.

Citalopram and paroxetine are not FDA-approved for use in pediatric patients as safety and effectiveness in this age group have not been well established. The olanzapine/fluoxetine combination is FDA-approved in pediatric patients.

Maximum pediatric recommended doses for SSRI antidepressants approved for use as monotherapy and combination therapy are summarized in Tables 3 and 4, respectively. 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 4. Dosages exceeding these recommendations will be reviewed.

Table 3: Recommended SSRI Antidepressant Drug Dosages for Pediatric Patients – Monotherapy ^1-18
Drug Name	Available Dosage Strengths	Treatment Indication	Literature Based Maximum Dosage	FDA Approved Maximum Recommended Dosage
citalopram (Celexa®)	10 mg, 20 mg, 40 mg tablets; 30 mg capsule; 10 mg/ 5 mL oral solution		Greater than or equal to 6 years of age: 40 mg/ day	Not FDA approved for children & adolescents
escitalopram (Lexapro®, generics)	5 mg, 10 mg, 20 mg tablets; 5 mg/5 mL oral solution	MDD	6-11 years of age: 20 mg/ day Greater than or equal to 12 years of age: 30 mg/day	12 to 17 years of age: 20 mg/day
fluoxetine (Prozac®, generics)	10 mg, 20 mg, 40 mg capsules; 10 mg, 20 mg, 60 mg tablets; 20 mg/5 mL solution	MDD	Greater than or equal to 6 years of age: 60 mg/ day	8 to 17 years of age: 20 mg/day
		OCD	Greater than or equal to 6 years of age: 60 mg/ day	7 to 17 years of age: lower weight children: 30 mg/day higher weight children: 60 mg/day
fluoxetine (Prozac Pulvules®)	10 mg, 20 mg, 40 mg pulvules	BD		10 to 17 years of age: 50 mg/ day^
		MDD	8 to 18 years of age: 20 mg/day	8 to 18 years: 20 mg/day
		OCD	7 to 17 years of age: 60 mg/day	7 to 17 years: 60 mg/day
fluvoxamine (generics)	IR: 25 mg, 50 mg, 100 mg tablets	OCD	Age 8-11 years: 200 mg/day Age 12-17 years: 300 mg/day	8-11 years of age: 200 mg/day# 12 to 17 years of age: 300 mg/day#
Fluvoxamine controlled release (Luvox CR®, generics)	CR: 100 mg, 150 mg	OCD	Age 8-11 years: 200 mg/day Age 12-17 years: 300 mg/day	8-11 years of age: 200 mg/day 12 to 17 years of age: 300 mg/day
sertraline (Zoloft®, generics)	25 mg, 50 mg, 100 mg tablets; 20 mg/mL oral concentrate	OCD	Age greater than or equal to 6 years: 200 mg/day	6 to 17 years of age: 200 mg/day

Legend:

BD = bipolar I disorder
IR = immediate-release
MDD = major depressive disorder
OCD = obsessive-compulsive disorder
# Fluvoxamine IR doses > 50 mg daily should be administered in divided doses, if the two doses are unequal the larger dose should be given at bedtime
^ In combination with olanzapine

Table 4: Recommended SSRI Antidepressant Drug Dosages for Pediatric Patients – Combination Therapy^{1-2, 17-18}
Treatment Indication	Drug Name	Available Dosage Strengths	Literature Based Maximum Dosage	FDA Approved Maximum Recommended Dosage
BD	olanzapine/ fluoxetine (Symbyax®, generics)	3 mg/ 25 mg, 6 mg/ 25 mg, 12 mg/25 mg, 6 mg/ 50 mg, 12 mg/ 50 mg capsules	Age 10-17 years: 12 mg olanzapine/50 mg fluoxetine once daily	10 to 17 years of age: 12 mg/50 mg per day

Legend:

BD = bipolar I disorder