Paroxetine

Preview FDA label, Apotex Corp, oral, effective 2026-09-16. 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

Dosage Modifications for Elderly Patients, Patients with Severe Renal Impairment and Patients with Severe Hepatic Impairment The recommended initial dose of Paroxetine HCL CR is 12.5 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Reduce initial dose and increase up-titration intervals if necessary.

Dosage should not exceed 50 mg per day for MDD or PD and should not exceed 37.5 mg per day for SAD [see Use in Specific Populations ( 8.5 , 8.6 )].

Dosing in liver impairment

Renal and/or Hepatic Impairment Increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. The initial dosage of Paroxetine HCL CR, should be reduced in patients with severe renal impairment and patients with severe hepatic impairment [see Dosage and Administration and Clinical Pharmacology].

Preparation and administration

Important Administration Instructions Administer Paroxetine HCL CR as a single daily dose in the morning, with or without food. Swallow tablets whole and do not chew or crush.

Calculators for paroxetine