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Paregoric
Pronunciation
Generic Available
Synonyms
Pharmacological Index
Use
Restrictions
Pregnancy Risk Factor
Contraindications
Warnings/Precautions
Adverse Reactions
Overdosage/Toxicology
Drug Interactions
Stability
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Dietary Considerations
Mental Health: Effects on Mental Status
Mental Health: Effects on Psychiatric Treatment
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Nursing Implications
Dosage Forms
References

Pronunciation
(par e GOR ik)

Generic Available

Yes


Synonyms
Camphorated Tincture of Opium

Pharmacological Index

Analgesic, Narcotic


Use

Treatment of diarrhea or relief of pain; neonatal opiate withdrawal


Restrictions

C-III


Pregnancy Risk Factor

B/D (when used long-term or in high doses)


Contraindications

Hypersensitivity to opium or any component; diarrhea caused by poisoning until the toxic material has been removed


Warnings/Precautions

Use with caution in patients with respiratory, hepatic or renal dysfunction, severe prostatic hypertrophy, 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

>10%:

Cardiovascular: Hypotension

Central nervous system: Drowsiness, dizziness

Gastrointestinal: Constipation

Neuromuscular & skeletal: Weakness

1% to 10%:

Central nervous system: Restlessness, headache, malaise

Genitourinary: Ureteral spasms, decreased urination

Miscellaneous: Histamine release

<1%: Peripheral vasodilation, insomnia, CNS depression, mental depression, increased intracranial pressure, anorexia, stomach cramps, nausea, vomiting, biliary tract spasm, urinary tract spasm, miosis, respiratory depression, physical and psychological dependence, increased liver function tests


Overdosage/Toxicology

Symptoms of overdose include hypotension, drowsiness, seizures, respiratory depression

Naloxone 2 mg I.V. (0.01 mg/kg for children) with repeat administration as necessary up to a total of 10 mg


Drug Interactions

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


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

Elimination: In urine, primarily as morphine glucuronide conjugates and as parent compound (morphine, codeine, papaverine, etc)


Usual Dosage

Oral:

Children: 0.25-0.5 mL/kg 1-4 times/day

Adults: 5-10 mL 1-4 times/day


Dietary Considerations

Alcohol: Additive CNS effect, avoid use


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


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

No effects or complications reported


Patient Information

Take exactly as directed; do not increase dosage. May cause dependence with prolonged or excessive use. Avoid alcohol and all 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 (frequent small 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. Breast-feeding precautions: If nursing, take immediately after feeding or 4-6 hour before next feeding.


Nursing Implications

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


Dosage Forms

Liquid: 2 mg morphine equivalent/5 mL [equivalent to 20 mg opium powder] (5 mL, 60 mL, 473 mL, 4000 mL)


References

Calabrese JR and Gulledge AD, "The Neonatal Narcotic Abstinence Syndrome: A Brief Review," Can J Psychiatry, 1985, 30(8):623-6.

Levy M and Spino M, "Neonatal Withdrawal Syndrome: Associated Drugs and Pharmacologic Management," Pharmacotherapy, 1993, 13(3):202-11.


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