Directions for use conveyed in the sponsor’s proposed labeling are as follows:

Citalopram should be administered at a dose of 20 mg once daily. Clinical trials demonstrating antidepressant effectiveness studied the recommended therapeutic dose range of 20-60 mg/day. Patients not responding to 20 mg may benefit from dose increases, in 20 mg/day increments, up to a maximum of 60 mg/day. Dose changes should occur at intervals of at least one week.

Citalopram should be administered once daily, in the morning or evening, with or without food.

In elderly patients, dosage should not exceed 40 mg/day. In patients with hepatic impairment, dosage should not exceed 40 mg/day. No dosage adjustment is necessary for patients with mild or moderate renal impairment, but should be used with caution in patients with severe renal impairment.

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