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Pronunciation
(OH pee um TING chur)
Generic Available (U.S.)
Yes
Index Terms
Controlled Substance
C-II
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of diarrhea in adults
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal reproduction studies have not been conducted.
Lactation
Enters breast milk/use caution
Breast-Feeding Considerations
Information regarding use while breast-feeding is based on experience with morphine. Refer to morphine monograph.
Contraindications
Hypersensitivity to opium, morphine sulfate, or any component of the formulation; diarrhea caused by poisoning prior to the toxic material being removed from the GI tract
Note: Manufacturer does not recommend use in children.
Warnings/Precautions
Concerns related to adverse effects:
• 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).
• Hypotension: May cause hypotension; use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or with drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics).
Disease-related concerns:
• Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions.
• Adrenal insufficiency: Use with caution in patients with adrenal insufficiency, including Addison's disease.
• Biliary tract impairment: Use with caution in patients with biliary tract dysfunction; acute pancreatitis may cause constriction of sphincter of Oddi.
• CNS depression/coma: Use with caution in patients with CNS depression or coma.
• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use.
• GI Hemorrhage: Use with caution in patients with GI hemorrhage.
• Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure; exaggerated elevation of ICP may occur.
• Hepatic impairment: Use with caution in patients with severe hepatic dysfunction.
• Obesity: Use with caution in patients who are morbidly obese.
• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.
• Respiratory disease: Use with caution in patients with pre-existing respiratory compromise (hypoxia and/or hypercapnia), COPD or other obstructive pulmonary disease, and kyphoscoliosis or other skeletal disorders which may alter respiratory function; critical respiratory depression may occur, even at therapeutic dosages.
• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Concurrent drug therapy issues:
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations:
• Debilitated patients: Use with caution in debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages.
• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Decrease initial dose.
• Pediatrics: Infants <3 months of age are more susceptible to respiratory depression; if used, diluted doses are recommended and use with caution; manufacturer does not recommend use in children.
Dosage form specific issues:
• Sulfites: Some preparations contain sulfites which may cause allergic reactions.
Other warnings/precautions:
• Potential for error: Do not confuse opium tincture with paregoric; opium tincture is 25 times more potent than paregoric; opium shares the toxic potential of opiate agonists, usual precautions of opiate agonist therapy should be observed; opium may mask dehydration by producing fluid retention in the bowel; monitor patients with prolonged or severe diarrhea carefully; abrupt discontinuation after prolonged use may result in withdrawal symptoms
• Withdrawal: Concurrent use of agonist/antagonist analgesics may precipitate withdrawal symptoms and/or reduced analgesic efficacy in patients following prolonged therapy with mu opioid agonists. Abrupt discontinuation following prolonged use may also lead to withdrawal symptoms.
Adverse Reactions
Frequency not defined.
Cardiovascular: Palpitation, hypotension, bradycardia, peripheral vasodilation
Central nervous system: Drowsiness, dizziness, restlessness, headache, malaise, CNS depression, intracranial pressure increased, insomnia, mental depression
Gastrointestinal: Nausea, vomiting, constipation, anorexia, stomach cramps, biliary tract spasm
Genitourinary: Urination decreased, urinary tract spasm
Neuromuscular & skeletal: Weakness
Ocular: Miosis
Respiratory: Respiratory depression
Miscellaneous: Histamine release, physical and psychological dependence
Metabolism/Transport Effects
None known.
Drug Interactions
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
Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Analgesics (Opioid). 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
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
Pegvisomant: Analgesics (Opioid) may diminish the therapeutic effect of Pegvisomant. Risk C: Monitor therapy
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 Interactions
Ethanol: May increase CNS depression; monitor for increased effects with coadministration. Caution patients about effects.
Storage
Store at 68° to 77°F (20° to 25°C). Protect from light.
Mechanism of Action
Contains many narcotic alkaloids including morphine; its mechanism for gastric motility inhibition is primarily due to this morphine content; it results in a decrease in digestive secretions, an increase in GI muscle tone, and therefore a reduction in GI propulsion
Pharmacodynamics/Kinetics
Duration: 4-5 hours
Absorption: Variable
Metabolism: Hepatic
Excretion: Urine
Dosage
Oral: Note: Opium tincture 10% contains morphine 10 mg/mL. Use caution in ordering, dispensing, and/or administering. The following doses are expressed in mg (milligram) dosing units of morphine.
Adults: Diarrhea: Usual: 6 mg of undiluted opium tincture (10 mg/mL) 4 times daily
Administration: Oral
May administer with food to decrease GI upset.
Monitoring Parameters
Observe patient for excessive sedation, respiratory depression, implement safety measures, assist with ambulation
Test Interactions
Increased aminotransferase [ALT/AST] (S)
Patient Education
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. May cause hypotension, dizziness, drowsiness, impaired coordination, blurred vision, or dry mouth. Report chest pain, slow or rapid heartbeat, dizziness, or persistent headache; confusion or respiratory difficulties; or severe constipation.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Dizziness and drowsiness are common; may cause restlessness; may rarely cause insomnia or depression
Mental Health: Effects on Psychiatric Treatment
Concurrent use with psychotropics may alter the analgesic effects of opioids; monitor for altered response
Nursing: Physical Assessment/Monitoring
If being used to control diarrhea, monitor stools. Assess patient's physical and/or psychological dependence. For inpatients, implement safety measures to prevent falls. Discontinue slowly after prolonged use.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tincture, oral: Anhydrous morphine 10 mg/mL (118 mL, 473 mL) [0.6 mL equivalent to morphine 6 mg; contains ethanol 19%]
References
Kraus DM and Pham JT, “Neonatal Therapy,” Applied Therapeutics: The Clinical Use of Drugs, 9th ed, Koda-Kimble MA, Young LY, Kradjan WA, et al, eds, Baltimore, MD: Lippincott Williams & Wilkins, 2009.
Levine SR, Cohen MR, Blanchard MR, et al, “Guidelines for Preventing Medication Errors in Pediatrics,” J Pediatr Pharmacol Ther, 2001, 6:427-43.
Levy M and Spino M, “Neonatal Withdrawal Syndrome: Associated Drugs and Pharmacologic Management,” Pharmacotherapy, 1993, 13(3):202-11.
Mokhlesi B, Leikin JB, Murray P, et al, “Adult Toxicology in Critical Care: Part II: Specific Poisonings,” Chest, 2003, 123(3):897-922.
Lexi-Comp.com
Last full review/revision March 2012
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