WARNING: ADDICTION, ABUSE, MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse – Belladonna and opium suppositories expose users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor regularly for the development of these conditions

Life-Threatening Respiratory Depression – Serious, life-threatening, or fatal respiratory depression may occur with use. Monitor for respiratory depression, especially during initiation or following a dose increase.