Maximum Dose of Citalopram
The maximum recommended dose of citalopram is 40 mg/day for adults under 60 years of age, and 20 mg/day for adults 60 years and older, patients with hepatic impairment, CYP2C19 poor metabolizers, or those taking CYP2C19 inhibitors (such as omeprazole or cimetidine). 1
Standard Adult Dosing (Age <60 Years)
- Start at 20 mg once daily (morning or evening, with or without food) for most adult patients 2, 1
- The dose can be increased to a maximum of 40 mg/day after at least one week if clinical response is insufficient 2, 1
- Doses above 40 mg/day are not recommended due to the risk of QT interval prolongation 2, 1
- Importantly, the only dose-response study did not demonstrate any advantage for 60 mg/day over 40 mg/day, further supporting the 40 mg maximum 1
Mandatory Dose Reductions to 20 mg/day Maximum
The following populations require a maximum dose of 20 mg/day 1:
- Elderly patients (>60 years of age): Due to 23-30% increased AUC and 30-50% increased half-life compared to younger patients, plus greater risk of QT prolongation and hyponatremia 2, 1
- Hepatic impairment: Start at 10 mg/day with a maximum of 20 mg/day 2, 1
- CYP2C19 poor metabolizers: Significantly reduced citalopram clearance necessitates dose reduction 2, 1
- Patients taking CYP2C19 inhibitors (omeprazole, cimetidine): These medications significantly reduce citalopram clearance 2, 1
Renal Impairment Considerations
- No dosage adjustment is necessary for patients with mild or moderate renal impairment 1
- Use with caution in severe renal impairment, though specific dose adjustments are not mandated 1
Cardiac Safety Rationale
- The maximum dose restrictions are based on dose-dependent QT interval prolongation risk 2, 1
- QT prolongation is particularly concerning at doses above 40 mg/day 2
- Regular monitoring for signs of QT prolongation is recommended, especially when initiating treatment or adjusting doses 2
- While one critical evaluation questioned the clinical significance of the QT prolongation findings from the thorough QT/QTc study, the FDA maintains these restrictions based on both study data and post-marketing reports of torsade de pointes 3
Dose Titration and Timing
- When increasing the dose, wait at least 1-2 weeks before escalating, as full therapeutic response requires 4-8 weeks 2
- For anxious or sensitive patients, consider starting at a lower dose of 10 mg/day initially 2
- If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered 1