Buspirone hydrochloride tablets (adults) - selected U.S. labeling
- Product / population
- Adult anxiety treatment with oral buspirone hydrochloride tablets; severe renal impairment requires special avoidance review.
- Renal measure
- Indexed ClCr in the pharmacokinetic study; severe-impairment warning is qualitative.
Labeled basic dosing
Start 7.5 mg orally twice daily. If needed, increase total daily dosing by 5 mg at 2-3 day intervals; maximum 60 mg/day. Take consistently with respect to food.
Renal information and dialysis
The label does not recommend use in severe renal impairment. Exposure was approximately fourfold greater in a study spanning ClCr 10-70 mL/min/1.73 m2. No validated numeric renal-dose algorithm is provided; dialysis removal is undetermined.
Selected warnings and limits
Review CYP3A4 interactions and serotonin syndrome. MAOI antidepressants require separation; do not start with linezolid or intravenous methylene blue.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff02c7cb-f96a-4a3b-99a2-812cd78b345c