Drug Information

Belladonna and opium

Belladonna and opium Belladonna opium Analgesic Combination Antispasmodic Agent Urinary
Belladonna and opium Belladonna opium Analgesic Combination Antispasmodic Agent Urinary

Belladonna and opium

Pharmacologic Category

  • Analgesic Combination (Opioid);
  • Antispasmodic Agent, Urinary

Dosing: AdultPain: Rectal: 1 suppository 1-2 times/day, up to 4 doses/day

Dosing: PediatricPain: Children >12 years: Refer to adult dosing.

Dosing: GeriatricRefer to adult dosing.

Dosage Forms: U.S.Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suppository: Belladonna extract 16.2 mg and opium 30 mg; belladonna extract 16.2 mg and opium 60 mg

Generic Equivalent Available: U.S.Yes

AdministrationPrior to rectal insertion, the finger and suppository should be moistened. Assist with ambulation.

UseRelief of moderate-to-severe pain associated with ureteral spasms not responsive to nonopioid analgesics and to space intervals between injections of opiates

Medication Safety Issues

Sound-alike/look-alike issues:

B&O may be confused with beano®

BEERS Criteria medication:

This drug may be inappropriate for use in geriatric patients (high severity risk).

Adverse Reactions SignificantFrequency not defined.

Cardiovascular: Palpitation

Central nervous system: Dizziness, drowsiness

Dermatologic: Pruritus, urticaria

Gastrointestinal: Constipation, nausea, vomiting, xerostomia

Genitourinary: Urinary retention

Ocular: Blurred vision, photophobia

ContraindicationsHypersensitivity to belladonna, opium, or any component of the formulation; glaucoma; severe renal or hepatic disease; bronchial asthma; respiratory depression; convulsive disorders; acute alcoholism; premature labor

Warnings/Precautions Concerns related to adverse effects:

• Atropine idiosyncrasy: Use with caution in patients with known idiosyncrasy to atropine or atropine-like compounds.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Phenanthrene hypersensitivity: Use with caution in patients with hypersensitivity reactions to other phenanthrene-derivative opioid agonists (codeine, hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone).

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease.

• Drug abuse: Use with caution in patients with a history of opiate drug abuse or acute alcoholism; potential for drug dependency exists.

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• Increased intracranial pressure: Use with caution in patients with increased intracranial pressure; exaggerated elevation of ICP may occur.

• Prostatic hyperplasia: Use with caution in patients with prostatic hyperplasia; may cause urinary retention.

• Psychosis: Use with caution in patients with toxic psychosis; may exacerbate condition.

• Thyroid dysfunction: Use with caution in patients with myxedema; may exacerbate condition.

Concurrent drug therapy issues:

• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.

Special populations:

• Elderly: Avoid long-term use in this age group due to anticholinergic adverse effects and uncertain effectiveness (Beers Criteria).

• Pediatrics: Not recommended for use in children ≤12 years of age.

Other warnings/precautions:

• Appropriate use: Usual precautions of opiate agonist therapy should be observed.

Controlled SubstanceC-II

Drug Interactions
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Risk C: Monitor therapyAcetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alvimopan: Analgesics (Opioid) may enhance the adverse/toxic effect of Alvimopan. This is most notable for patients receiving long-term (i.e., more than 7 days) opiates prior to alvimopan initiation. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation. Risk D: Consider therapy modification

Ammonium Chloride: May increase the excretion of Analgesics (Opioid). Risk C: Monitor therapy

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Amphetamines: May enhance the analgesic effect of Analgesics (Opioid). Risk C: Monitor therapy

Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy

Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Analgesics (Opioid). Risk C: Monitor therapy

Cannabinoids: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoids. Risk C: Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Risk C: Monitor therapy

Desmopressin: Analgesics (Opioid) may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MAO Inhibitors: May enhance the orthostatic hypotensive effect of Orthostatic Hypotension Producing Agents. Risk C: Monitor therapy

Mixed Agonist / Antagonist Opioids: May diminish the analgesic effect of Analgesics (Opioid). Management: Seek alternatives to mixed agonist/antagonist opioids in patients receiving pure opioid agonists, and monitor for symptoms of therapeutic failure/high dose requirements (or withdrawal in opioid-dependent patients) if patients receive these combinations. Risk D: Consider therapy modification

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Risk C: Monitor therapy

Pegvisomant: Analgesics (Opioid) may diminish the therapeutic effect of Pegvisomant. Risk C: Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Risk D: Consider therapy modification

Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Risk C: Monitor therapy

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Secretin: Anticholinergic Agents may diminish the stimulatory effect of Secretin. Risk D: Consider therapy modification

Selective Serotonin Reuptake Inhibitors: Analgesics (Opioid) may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Risk C: Monitor therapy

Succinylcholine: May enhance the bradycardic effect of Analgesics (Opioid). Risk C: Monitor therapy

Thiazide Diuretics: Analgesics (Opioid) may enhance the orthostatic hypotensive effect of Thiazide Diuretics. Risk C: Monitor therapy

Ethanol/Nutrition/Herb InteractionsEthanol: Avoid ethanol (may increase sedation).

Pregnancy Risk Factor

Pregnancy ImplicationsReproduction studies have not been conducted with this product. Refer to Atropine and Morphine Sulfate monographs for additional information.

LactationExcretion in breast milk unknown/use caution

Breast-Feeding ConsiderationsIt is not known if/how much morphine or atropine may be found in breast milk following rectal administration of this product. Refer to Atropine and Morphine Sulfate monographs for additional information.

Mechanism of ActionThe pharmacologically active agents present in the belladonna component are atropine and scopolamine. Atropine blocks the action of acetylcholine at parasympathetic sites in smooth muscle, secretory glands, and the CNS causing a relaxation of smooth muscle and drying of secretions. The principle agent in opium is morphine. Morphine binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain.

Pharmacodynamics/KineticsAbsorption: Rectal absorption is dependent upon body hydration, not temperature

REFERENCES

  1. Mokhlesi B, Leikin JB, Murray P, et al, “Adult Toxicology in Critical Care: Part II: Specific Poisonings,” Chest, 2003, 123(3):897-922.

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