Quetiapine immediate-release tablets (adults) - selected U.S. labeling
- Product / population
- Adult bipolar depression dosing orientation with oral immediate-release quetiapine tablets. Excludes extended-release tablets and other indication-specific titrations.
- Renal measure
- Indexed ClCr in the renal study; no labeled numeric renal reduction.
Labeled basic dosing
For adult bipolar depression, the label gives once-nightly doses of 50 mg on day 1, 100 mg on day 2, 200 mg on day 3 and 300 mg on day 4; recommended dose 300 mg/day.
Renal information and dialysis
At ClCr 10-30 mL/min/1.73 m2, mean clearance was about 25% lower, but exposures remained within the normal-subject range. The label therefore does not require renal adjustment for those patients. A separate dialysis regimen is not established here.
Selected warnings and limits
Older adults and hepatic impairment have separate dosing considerations. Review orthostasis, sedation, metabolic adverse effects, suicidality and the boxed warning about mortality in elderly patients with dementia-related psychosis.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=235f367b-544a-4523-a7bf-a9e2b3aa6fa0