盐酸氟西汀片说明书(美国-FDA-英文).pdf

SARAFEM®

fluoxetine hydrochloride tablets
Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and
behavior (suicidality) in children, adolescents, and young adults in short-term studies of
major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the
use of SARAFEM or any other antidepressant in a child, adolescent, or young adult must
balance this risk with the clinical need. Short-term studies did not show an increase in the
risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there
was a reduction in risk with antidepressants compared to placebo in adults aged 65 and
older. Depression and certain other psychiatric disorders are themselves associated with
increases in the risk of suicide. Patients of all ages who are started on antidepressant
therapy should be monitored appropriately and observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and caregivers should be advised of
the need for close observation and communication with the prescriber. SARAFEM is not
approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide
Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)
DESCRIPTION
SARAFEM® (fluoxetine hydrochloride tablets) is a selective serotonin reuptake inhibitor (SSRI)
for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p­
tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NO•HCl. Its
molecular weight is . The structural formula is:



Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL
in water.

Each SARAFEM tablet contains fluoxetine hydrochloride equivalent to 10 mg ( µmol), 15