Sertraline Hydrochloride Tablets, USP 25 mg, 50 mg & 100 mg

SECTION 2: Hazards identification

OSHA Not considered hazardous when handled under normal conditions. EMERGENCY OVERVIEW Caution Statement: Each Sertraline Hydrochloride Tablet intended for oral administration contains Sertraline Hydrochloride, USP and excipients generally considered to be non-toxic and non- hazardous in small quantities and under conditions of normal occupational exposure. WARNING: 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 Sertraline hydrochloride 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. Sertraline hydrochloride tablets are not approved for the treatment of major depressive disorder in pediatric patients.

Principle Routes of Exposure

Oral Effects of Overexposure: Tablets are intended for human consumption under guidance of a physician. Intact Tablets are not considered hazardous under normal handling procedures.

Medical Conditions Generally Aggravated by Exposure

Selective serotonin reuptake inhibitors (SSRIs), Mental depression, Bipolar disorder, Seizure disorders, Liver impairment, Kidney impairment, Recent or concurrent use of monoamine oxidase (MAO) inhibitors. Carcinogenicity: Sertraline Hydrochloride - Not listed by IARC, NTP and OSHA.