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Opium Tincture Drug Information Provided by Lexi-Comp

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Medication Safety Issues

Sound-alike/look-alike issues:

Opium tincture may be confused with camphorated tincture of opium (paregoric)

High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Use care when prescribing opium tincture; each mL contains the equivalent of morphine 10 mg; paregoric contains the equivalent of morphine 0.4 mg/mL

DTO is an error-prone abbreviation (mistaken as Diluted Tincture of Opium; dose equivalency of paregoric)

Pronunciation

(OH pee um TING chur)

Index Terms

  • DTO (error-prone abbreviation)
  • Opium Tincture, Deodorized

Generic Available

Yes

Pharmacologic Category

  • Analgesic, Opioid
  • Antidiarrheal

Pharmacologic Category Synonyms

  • Narcotic Analgesic
  • Opiate Analgesic

Use: Labeled Indications

Treatment of diarrhea or relief of pain

Restrictions

C-II

Pregnancy Risk Factor

B/D (prolonged use or high doses at term)

Lactation

Enters breast milk/use caution

Contraindications

Hypersensitivity to morphine sulfate or any component of the formulation; increased intracranial pressure; severe respiratory depression; severe hepatic or renal insufficiency; pregnancy (prolonged use or high dosages near term)

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.

• 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; use with caution and generally in reduced doses in this age group.

Dosage form specific issues:

• Sulfites: Some preparations contain sulfites which may cause allergic reactions.

Other warnings/precautions:

• Not paregoric: This is not paregoric, dose accordingly.

• 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

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. 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

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 effect of Thiazide Diuretics. Risk C: Monitor therapy

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase CNS depression).

Storage

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.

Children:

Diarrhea: 0.005-0.01 mL/kg/dose every 3-4 hours for a maximum of 6 doses/24 hours

Analgesia: 0.01-0.02 mL/kg/dose every 3-4 hours

Adults:

Diarrhea: 0.3-1 mL/dose every 2-6 hours to maximum of 6 mL/24 hours

Analgesia: 0.6-1.5 mL/dose every 3-4 hours

Monitoring Parameters

Observe patient for excessive sedation, respiratory depression, implement safety measures, assist with ambulation

Test Interactions

Increased aminotransferase [ALT/AST] (S)

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. May cause hypotension, dizziness, drowsiness, impaired coordination, or blurred vision (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); or dry mouth (frequent mouth care, small frequent meals, chewing gum, or sucking lozenges may help). Report slow or rapid heartbeat, acute dizziness, or persistent headache; changes in mental status; swelling of extremities or unusual weight gain; changes in urinary elimination or pain on urination; acute headache; trembling or muscle spasms; blurred vision; skin rash; or shortness of breath. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant.

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

Assess other medications patient may be taking for additive or adverse interactions. Monitor vital signs, effectiveness of pain relief, adverse reactions, and signs of overdose 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. Discontinue slowly after prolonged use.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Liquid: 10% (120 mL, 480 mL) [0.6 mL equivalent to morphine 6 mg; contains alcohol 19%]

References

Kraus DM and Hatzopoulos FK, “Neonatal Therapy,” Applied Therapeutics: The Clinical Use of Drugs, 6th ed, Young LY and Koda-Kimble MA, eds, Vancouver, WA: Applied Therapeutics, Inc, 1995.

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 July 2009

Content last modified July 2009

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