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Medication Safety Issues
Sound-alike/look-alike issues:
Camphorated tincture of opium is an error-prone synonym (mistaken as opium tincture)
Paregoric may be confused with Percogesic®
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.
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
Pronunciation
(par e GOR ik)
Index Terms
Generic Available
Yes
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of diarrhea or relief of pain; neonatal opiate withdrawal
Restrictions
C-III
Pregnancy Risk Factor
B/D (prolonged use or high doses)
Lactation
Enters breast milk/use caution
Breast-Feeding Considerations
Information regarding use while breast-feeding is based on experience with morphine. Probably safe with low doses and by administering dose after breast-feeding to further minimize exposure to the drug. Monitor the infant for possible side effects related to opiates.
Contraindications
Hypersensitivity to opium or any component of the formulation; diarrhea caused by poisoning until the toxic material has been removed; pregnancy (prolonged use or high doses)
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 drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics).
• Opioid agonist toxicities: Opium shares the toxic potentials of opiate agonists, and precautions of opiate agonist therapy should be observed.
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 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.
• Renal impairment: Use with caution in patients with renal dysfunction.
• 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 disorder which may alter respiratory function; critical respiratory depression may occur, even at therapeutic dosages.
• Seizures: Use with caution in patients with a history of seizure disorders.
• 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.
Dosage form specific issues:
• Sulfites: Some preparations contain sulfites which may cause allergic reactions
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.
Other warnings/precautions:
• 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: Hypotension, peripheral vasodilation
Central nervous system: Drowsiness, dizziness, insomnia, CNS depression, mental depression, increased intracranial pressure, restlessness, headache, malaise
Gastrointestinal: Constipation, anorexia, stomach cramps, nausea, vomiting, biliary tract spasm
Genitourinary: Ureteral spasms, decreased urination, urinary tract spasm
Hepatic: Increased liver function tests
Neuromuscular & skeletal: Weakness
Ocular: Miosis
Respiratory: Respiratory depression
Miscellaneous: Physical and psychological dependence, histamine release
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
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
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase CNS depression).
Storage
Store in light-resistant, tightly-closed container.
Mechanism of Action
Increases smooth muscle tone in GI tract, decreases motility and peristalsis, diminishes digestive secretions
Pharmacodynamics/Kinetics
In terms of opium:
Metabolism: Hepatic
Excretion: Urine (primarily as morphine glucuronide conjugates and unchanged drug - morphine, codeine, papaverine, etc)
Dosage
Oral:
Neonatal opiate withdrawal: 3-6 drops every 3-6 hours as needed, or initially 0.2 mL every 3 hours; increase dosage by approximately 0.05 mL every 3 hours until withdrawal symptoms are controlled; it is rare to exceed 0.7 mL/dose. Stabilize withdrawal symptoms for 3-5 days, then gradually decrease dosage over a 2- to 4-week period.
Children: 0.25-0.5 mL/kg 1-4 times/day
Adults: 5-10 mL 1-4 times/day
Patient Education
Take exactly as directed; do not increase dosage. May cause dependence with prolonged or excessive use. Avoid alcohol or any other prescription and OTC medications that may cause sedation (sleeping medications, some cough/cold remedies, antihistamines, etc). You may experience drowsiness, dizziness, or impaired judgment (use caution when driving or engaging in tasks that require alertness until response to drug is known) or postural hypotension (use caution when rising from sitting or lying position or when climbing stairs). You may experience nausea or loss of appetite (small frequent meals may help) or constipation (a laxative may be necessary). Report unresolved nausea, vomiting, respiratory difficulty (shortness of breath or decreased respirations), chest pain, or palpitations. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. If breast-feeding, take immediately after feeding or 4-6 hour before next feeding.
Additional Information
Contains morphine 0.4 mg/mL and alcohol 45%. Do not confuse this product with opium tincture which is 25 times more potent; each 5 mL of paregoric contains 2 mg morphine equivalent, 0.02 mL anise oil, 20 mg benzoic acid, 20 mg camphor, 0.2 mL glycerin and alcohol; final alcohol content 45%; paregoric also contains papaverine and noscapine; because all of these additives may be harmful to neonates, a 25-fold dilution of opium tincture is often preferred for treatment of neonatal abstinence syndrome (opiate withdrawal).
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
Drowsiness and dizziness are common; may cause restlessness; may rarely cause insomnia or depression
Mental Health: Effects on Psychiatric Treatment
Concurrent use with psychotropics may produce additive sedation
Nursing: Physical Assessment/Monitoring
Monitor for excessive sedation, respiratory depression, or hypotension. For inpatients, implement safety measures (eg, side rails up, call light within reach, patient instructions to call for assistance). Has potential for psychological or physiological dependence
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Liquid, oral: Morphine equivalent 2 mg/5 mL (473 mL) [equivalent to opium 20 mg powder; contains alcohol 45% and benzoic acid]
Pricing: U.S. (www.drugstore.com)
Tincture (Paregoric)
2 mg/5 mL (240): $69.98
References
Calabrese JR and Gulledge AD, “The Neonatal Narcotic Abstinence Syndrome: A Brief Review,” Can J Psychiatry, 1985, 30(8):623-6.
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 August 2008
Content last modified August 2008
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