Starting Pediatric Dose of Prozac (Fluoxetine)
Start with 10 mg daily in the morning for pediatric patients (children and adolescents aged 7-17 years), then increase to 20 mg daily after one week. 1
Initial Dosing Protocol
- Begin with 10 mg/day for the first week, administered in the morning 1, 2
- Increase to 20 mg/day after the initial week, which is the target therapeutic dose for most pediatric patients 1, 2
- Lower weight children may remain at 10 mg/day as their starting and target dose due to higher plasma drug levels 1
Dose Titration Beyond Initial Phase
- After several weeks at 20 mg/day, consider increasing the dose by 20 mg increments if insufficient clinical improvement is observed 1, 3
- Maximum dose is 60 mg/day for pediatric patients, though the FDA label notes adult doses can go up to 80 mg/day 1, 3
- Dose increases should occur at approximately 3-4 week intervals due to fluoxetine's long half-life 4
Critical Monitoring Requirements
- Monitor closely for suicidal ideation, behavioral activation, or manic switch, particularly in the first 24-48 hours after any dose change 4, 5
- Full therapeutic effect may be delayed until 4 weeks of treatment or longer, so avoid premature dose escalation 1
- Watch for activating side effects including insomnia, nervousness, and agitation, which are more common with fluoxetine than other SSRIs 4, 5
Important Clinical Considerations
- If anxiety or agitation is a concern, consider starting with the 10 mg dose and advancing more slowly, as these can be initial adverse effects 4
- Fluoxetine's very long half-life means side effects may not manifest for several weeks, requiring patience before making dosing adjustments 4
- The drug is generally well-tolerated in pediatric patients, with most adverse events involving the CNS or gastrointestinal system 2, 3
Evidence Base
The dosing recommendations are supported by two placebo-controlled trials demonstrating efficacy at 20 mg/day in pediatric major depressive disorder 2, 6 and OCD 3. In the pivotal depression trial, patients received 10 mg/day for one week followed by 20 mg/day for 8 weeks, with 41% achieving remission compared to 20% on placebo 2.