Sertraline

Preview FDA label, Dr. Reddy's Laboratories Inc., oral, effective 2026-01-20. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Renal Impairment No dose adjustment is necessary in patients with mild (eGFR 60 to 89 mL/minute/1.73 m 2 ), moderate (eGFR 30 to 59 mL/minute/1.73 m 2 ), or severe renal impairment (eGFR 15 to 29 mL/minute/1.73 m 2 ). Sertraline exposure does not appear to be affected by renal impairment [see Clinical Pharmacology] .

Dosing in liver impairment

Hepatic Impairment Sertraline hydrochloride capsules are not recommended in patients with mild (Child-Pugh score 5 or 6), moderate (Child-Pugh score 7 to 10), or severe (Child-Pugh score 10 to 15) hepatic impairment. The effect of sertraline hydrochloride capsules in patients with mild, moderate, or severe hepatic impairment was not studied.

Sertraline plasma exposure was higher in patients with mild hepatic impairment, compared with those with normal hepatic function [see Clinical Pharmacology]. Dosage adjustments are not possible with the available strengths of sertraline hydrochloride capsules.

Preparation and administration

Administration Instructions Administer sertraline hydrochloride capsules orally. Swallow capsules whole; do not open, crush, or chew.