Belladonna and Opium (Lexi-Drugs Multinational)

Pronunciation

(bel a DON a & OH pee um)

Anatomic Therapeutic Chemical (ATC) Classification

A03DB04

Pharmacologic Category
Dosing: Adult

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

Pain: Rectal: One suppository 1 to 2 times daily; maximum: 4 doses/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Pain: Adolescents: Refer to adult dosing.

Use: Labeled Indications

Relief of moderate-to-severe pain associated with ureteral spasms not responsive to nonopioid

analgesics and to space intervals between injections of opioids

Administration: Rectal
Storage/Stability

Prior to rectal insertion, the finger and suppository should be moistened with water.

Store at room temperature. Do not refrigerate.

Medication Safety Issues

Sound-alike/look-alike issues:
B&O may be confused with beano
High alert medication:
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes which have a
heightened risk of causing significant patient harm when used in error.
Geriatric Patients: High-Risk Medication:
Beers Criteria: Belladonna alkaloids are identified in the Beers Criteria as potentially inappropriate medications to be avoided in
patients 65 years and older (independent of diagnosis or condition) due to its highly anticholinergic properties and
uncertain effectiveness as an antispasmodic (Beers Criteria [AGS 2015]).

Contraindications

Glaucoma; severe renal or hepatic disease; bronchial asthma; opioid idiosyncrasies; respiratory depression;

convulsive disorders; acute alcoholism; delirium tremens; 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:
Adrenal insufficiency: Use with caution in patients with adrenal insufficiency, including Addison disease. Long-term opioid use may
cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis (Brennan,
2013).
Biliary tract impairment: Use opium with caution in patients with biliary tract dysfunction, including acute pancreatitis; may cause

constriction of sphincter of Oddi.

Cardiovascular disease: Use with caution in patients with cardiovascular disease.
Drug abuse: Use with caution in patients with a history of opioid drug abuse or acute alcoholism; potential for drug dependency
exists.
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:
Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring,
and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
Debilitated patients: Use with caution in debilitated patients; there is a greater potential for critical respiratory depression, even at
therapeutic dosages.
Other warnings/precautions:
Appropriate use: Usual precautions of opioid agonist therapy should be observed.

Pregnancy Risk Factor: US

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. See individual agents.

Breast-Feeding Considerations

It is not known if morphine or atropine is excreted in breast milk following rectal

administration of this combination. The manufacturer recommends that caution be exercised when administering to breast-feeding women.
See individual agents.

Briggs' Drugs in Pregnancy & Lactation

Belladonna
Opium

Adverse Reactions

Frequency not defined.

Cardiovascular: Palpitations
Central nervous system: Dizziness, drowsiness
Dermatologic: Pruritus, urticaria
Gastrointestinal: Constipation, nausea, vomiting, xerostomia
Genitourinary: Urinary retention
Ophthalmic: Blurred vision, photophobia
Postmarketing and/or case reports: Hypogonadism (Brennan, 2013; Debono, 2011)

Allergy and Idiosyncratic Reactions

Belladonna Alkaloid Allergy

Metabolism/Transport Effects
Drug Interactions

None known.

Drug Interactions

Open Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Risk C: Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the
therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
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
Amphetamines: May enhance the analgesic effect of Analgesics (Opioid). Risk C: Monitor therapy
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for
constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Exceptions: Levocabastine (Nasal). Risk C:
Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary
retention may be increased with this combination. Risk C: Monitor therapy
Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Analgesics (Opioid). Risk C: Monitor therapy
Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Risk X: Avoid combination
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Risk D: Consider therapy modification
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Cannabis: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
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
Diuretics: Analgesics (Opioid) may enhance the adverse/toxic effect of Diuretics. Risk C: Monitor therapy
Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis
(doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended.
Risk C: Monitor therapy
Dronabinol: May enhance the CNS depressant effect of CNS Depressants. 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
Eluxadoline: Analgesics (Opioid) may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic).
Risk C: Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse
effects may be increased. Risk X: Avoid combination

Glycopyrrolate: Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate. Risk X: Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X:
Avoid combination
Hydrocodone: CNS Depressants may enhance the CNS depressant effect of Hydrocodone. Management: Consider starting with a 20% to
30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may
also be warranted. Risk D: Consider therapy modification
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy
Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance
the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of
concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically
effective methotrimeprazine dose is established. Risk D: Consider therapy modification
Metyrosine: CNS Depressants may enhance the sedative effect of Metyrosine. Risk C: Monitor therapy
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Minocycline: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy
Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. 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 X: Avoid combination
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Naltrexone: May diminish the therapeutic effect of Analgesics (Opioid). Management: Seek therapeutic alternatives to opioids. See full
drug interaction monograph for detailed recommendations. Risk D: Consider therapy modification
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Risk C: Monitor therapy
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined
with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone
starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Risk D: Consider therapy
modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination
Pegvisomant: Analgesics (Opioid) may diminish the therapeutic effect of Pegvisomant. Risk C: Monitor therapy
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug
that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require
alertness and coordination, until they have experience using the combination. Risk D: Consider therapy modification
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs
with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid
combination

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk D: Consider
therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
Ramosetron: Analgesics (Opioid) may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Risk C: Monitor therapy
ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy
Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C:
Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial
anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely
for a diminished response to 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
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake
Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy
Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use.
When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative
hypnotics is contraindicated. Risk D: Consider therapy modification
Succinylcholine: May enhance the bradycardic effect of Analgesics (Opioid). Risk C: Monitor therapy
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or
any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with
any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification
Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to onehalf of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for
evidence of excessive CNS depression. Risk D: Consider therapy modification
Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like
Diuretics. Risk C: Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual
zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for
women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Nursing: Physical Assessment/Monitoring

Monitor for signs of overdose. May cause physical and/or psychological

dependence. For inpatients, implement safety measures to prevent falls.

Controlled Substance
Dosage Forms

C-II

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 Available (US)

Yes

Pricing: US
Suppository (Belladonna Alkaloids-Opium Rectal)
16.2-60 mg (12): $401.43
Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic
product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or
adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.

Genes of Interest
Catechol-O-Methyltransferase

Mechanism of Action

The 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/Kinetics
Onset of action: Opium: Within 30 minutes
Absorption: Rectal absorption is dependent upon body hydration, not temperature
Metabolism: Hepatic

Local Anesthetic/Vasoconstrictor Precautions

Effects on Dental Treatment

No information available to require special precautions

Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal

salivary flow resumes upon discontinuation), and dry throat and nose.

Effects on Bleeding

No information available to require special precautions

Related Information
Beers Criteria Potentially Inappropriate Medications for Geriatrics

Index Terms

B&O; Opium and Belladonna

References
American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for
potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi:10.1111/jgs.13702[PubMed
26446832]
Belladonna and opium [prescribing information]. Minneapolis, MN: Perrigo; March 2012.
Brennan MJ. The effect of opioid therapy on endocrine function. Am J Med. 2013;126(3)(suppl 1):S12-S18. doi:
10.1016/j.amjmed.2012.12.001.[PubMed 23414717]
Debono M, Chan S, Rolfe C, Jones TH. Tramadol-induced adrenal insufficiency. Eur J Clin Pharmacol. 2011;67(8):865-867. [PubMed
21243342]

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