Pronunciation (bel a DON a & OH pee um)
U.S. Brand Names B&O Supprettes® [DSC]
Pharmacologic Category Analgesic Combination (Opioid); Antispasmodic Agent, Urinary
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 opiates
Dosing: Adults Pain: Rectal: 1 suppository 1-2 times/day, up to 4 doses/day
Dosing: Elderly Refer to adult dosing.
Dosing: Pediatric Pain: Children >12 years: Refer to adult dosing.
Administration: Other Prior to rectal insertion, the finger and suppository should be moistened. Assist with ambulation.
Storage Store at 15°C to 30°C. Do not refrigerate.
Restrictions C-II
Contraindications Hypersensitivity 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
Allergy Considerations Belladonna Alkaloid Allergy
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.
• 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: Use with caution in the elderly; may be more sensitive to adverse effects.
• 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.
Pregnancy Risk Factor C
Pregnancy Considerations Reproduction studies have not been conducted with this product. Refer to Atropine and Morphine Sulfate monographs for additional information.
Lactation Excretion in breast milk unknown/use caution
Breast-Feeding Considerations It 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.
Adverse Reactions Frequency not defined.
Cardiovascular: Palpitation
Central nervous system: Dizziness, drowsiness
Dermatologic: Pruritus, urticaria
Gastrointestinal: Constipation, nausea, vomiting, xerostomia
Genitourinary: Urinary retention
Ocular: Blurred vision, photophobia
Drug Interactions Acetylcholinesterase 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
Amphetamines: May enhance the analgesic effect of Analgesics (Opioid). Risk C: Monitor therapy
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: 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. Risk C: Monitor therapy
Desmopressin: Analgesics (Opioid) may enhance the adverse/toxic effect of Desmopressin. 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
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
Ethanol/Nutrition/Herb Interactions Ethanol: Avoid ethanol (may increase sedation).
Nursing: Physical Assessment/Monitoring Assess other medications patient may be taking for additive or adverse interactions. Monitor therapeutic effectiveness, signs of overdose, and adverse effects at beginning of therapy and at regular intervals with long-term use. May cause physical and/or psychological dependence. For inpatients, implement safety measures. Assess knowledge/teach patient appropriate use if self-administered. Teach patient to monitor for adverse reactions, adverse reactions to report, and appropriate interventions to reduce side effects.
Patient Education If self-administered, use exactly as directed; do not increase dose or frequency. Drug may cause physical and/or psychological dependence. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause hypotension, dizziness, or drowsiness; use caution when driving, climbing stairs, or changing position (rising from sitting or lying to standing) or when engaging in tasks requiring alertness (until response to drug is known); dry mouth or throat (frequent mouth care, frequent sips of fluids, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, fruit, or fiber may help; if unresolved, consult prescriber about use of stool softeners); photosensitivity (use sunscreen, wear protective clothing and eyewear, and avoid direct sunlight); or decreased perspiration (avoid extremes in temperature or excessive activity in hot environments). Report chest pain or palpitations; persistent dizziness; changes in mentation; changes in gait; blurred vision; shortness of breath or respiratory difficulty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.
Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suppository: Belladonna extract 16.2 mg and opium 30 mg; belladonna extract 16.2 mg and opium 60 mg
B&O Supprettes® #15 A: Belladonna extract 16.2 mg and opium 30 mg [DSC]
B&O Supprettes® #16 A: Belladonna extract 16.2 mg and opium 60 mg [DSC]
Generic Available Yes
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 Absorption: Rectal absorption is dependent upon body hydration, not temperature
Dental Health: Effects on Dental Treatment Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation), and dry throat and nose.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions No information available to require special precautions
Mental Health: Effects on Mental Status None reported
Mental Health: Effects on Psychiatric Treatment Constipation and dry mouth are common; use with low potency antipsychotics and TCAs will likely result in additive effects
Index Terms Opium and Belladonna
References Mokhlesi B, Leikin JB, Murray P, et al, “Adult Toxicology in Critical Care: Part II: Specific Poisonings,†Chest, 2003, 123(3):897-922.[PubMed 12628894]
Copyright (c) Lexi-Comp, Inc. 1978-2008 All Rights Reserved. Sources : Drug Information Handbook, 17th Edition
.jpg)
No comments:
Post a Comment