Fluoxetine daily capsules (adults) - selected U.S. labeling
- Product / population
- Adult major depressive disorder; daily oral immediate-release fluoxetine capsules. Excludes weekly delayed-release products and olanzapine combinations.
- Renal measure
- Qualitative renal guidance, supported by a small dialysis pharmacokinetic study; no CrCl dose table.
Labeled basic dosing
Start 20 mg orally each morning. Consider escalation after several weeks when response is insufficient. Doses above 20 mg/day may be once daily or divided morning/noon; maximum 80 mg/day.
Renal information and dialysis
The label does not routinely require a lower dose or longer interval for renal impairment. In 12 dialysis patients, 20 mg/day produced parent/metabolite concentrations comparable to normal renal function; possible accumulation of other renally eliminated metabolites is acknowledged.
Selected warnings and limits
Review suicidality, serotonin syndrome and interacting medicines. Delayed steady state and the prolonged elimination of fluoxetine/norfluoxetine matter when adjusting or switching treatment.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8609ed02-0b30-4c82-bab1-4d51d92ec224