Paregoric

Pronunciation

(par e GOR ik)

Synonyms

Camphorated Tincture of Opium

Generic Available

Yes

Use

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

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

Use with caution in patients with respiratory, hepatic or renal dysfunction, severe prostatic hyperplasia, or history of narcotic abuse; opium shares the toxic potential of opiate agonists, and usual precautions of opiate agonist therapy should be observed; some preparations contain sulfites which may cause allergic reactions; infants <3 months of age are more susceptible to respiratory depression, use with caution and generally in reduced doses in this age group; tolerance or drug dependence may result from extended use

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

Overdosage/Toxicology

Symptoms of overdose include hypotension, drowsiness, seizures, and respiratory depression. Naloxone, 2 mg I.V. with repeat administration as necessary up to a total of 10 mg, can be used to reverse opiate effects.

Drug Interactions

Increased effect/toxicity with CNS depressants (eg, alcohol, narcotics, benzodiazepines, TCAs, MAO inhibitors, phenothiazine)

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may increase CNS depression).

Stability

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 nursing, 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

Dosage Forms

Liquid, oral: Morphine equivalent 2 mg/5 mL (473 mL) [equivalent to opium 20 mg powder; contains alcohol 45% and benzoic acid]

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.

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