Overview
11 DESCRIPTION Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60): Belladonna (16.2 mg) and Opium (30 mg): Powdered belladonna extract 16.2 mg and powdered opium 30 mg (Warning: May be habit forming). Belladonna (16.2 mg) and Opium (60 mg): Powdered belladonna extract 16.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Belladonna/opium rectal suppository is a combination narcotic analgesic/antispasmodic agent. The belladonna extract component of the rectal suppository provides the active alkaloids atropine and scopolamine, while the opium component provides primarily morphine (among more than 20 alkaloids). The atropine alkaloid is parasympatholytic, exerting antispasmodic activity by relaxation of smooth muscle that is stimulated by the parasympathetic nervous system. The atropine alkaloid is also the dl isomer of l-hyoscyamine and exerts the same pharmacologic activity; however, it exerts about one-half the activity peripherally as l-hyoscyamine. Atropine activity also counteracts morphine induced smooth muscle spasm without affecting the analgesia.
Indications
- 1 INDICATIONS AND USAGE Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1) ], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g.
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1) • Individualize dosing based on the severity of pain, patient response, and prior analgesic experience, and risk factor for addiction, abuse, and misuse. (2.1) • Initiate dosing with one suppository once or twice daily as needed for pain. (2.2) • Do not stop belladonna and opium suppositories abruptly in a physically dependent patient. (2.4) 2.
Black Box Warning
WARNING: ADDICTION, ABOUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOD WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH ALCOHOL, BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Belladonna and opium suppositories expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing belladonna and opium suppositories, and monitor all patients regularly for the development of these behaviors or conditions [ see Warnings...
Contraindications
- 4 CONTRAINDICATIONS • Belladonna and opium suppositories are contraindicated in patients with: • Significant respiratory depression [ see Warnings and Precautions (5.2) ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions (5.5) ] • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [ see Warnings and Precautions (5.7), Drug Interactions (7) ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions (5.
Side Effects
- 6 ADVERSE REACTIONS Belladonna may cause drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision 7 . Opium usage may result in constipation, nausea or vomiting. Pruritis and urticaria may occasionally occur. Hypersensitivity to opium or belladonna may occur. The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [ see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [ see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with belladonna and opium suppositories. Table 1: Clinically Significant Drug Interactions with Belladonna and Opium Suppositories Alcohol, Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact : Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.