Dosing and uses of opium paregoric, paregoric (opium tincture)
Adult dosage forms and strengths
oral liquid
- 2mg/5mL: Schedule III
- 50mg/5mL: Schedule II
Acute Diarrhea
Tincture (50 mg/5 mL): 6 mg (0.6 mL) PO q6hr; not to exceed 6 mL/day
Paregoric (2 mg/5 mL): 2-4 mg (5-10 mL) PO qDay-q6hr PRn
Amounts in mg based on anhydrous morphine content
Opium tincture is 25 times the strength of paregoric
Should not be used in diarrhea caused by poisoning until toxin is eliminated
Chronic Diarrhea (Orphan)
Orphan designation for treatment of chronic diarrhea in short bowel syndrome patients with an inadequate response to antidiarrheal treatment
Orphan sponsor
- Marathon Pharmaceuticals, LLC; Nine Parkway Blvd North; Deerfield, IL 60015
Pediatric dosage forms and strengths
oral liquid
- 2mg/5mL: Schedule III
- 50mg/5mL: Schedule II
Acute Diarrhea
Tincture (50 mg/5 mL): 0.05-0.1 mg/kg PO q3-4hr PRn
Paregoric (2 mg/5 mL): 0.1-0.2 mg/kg PO qDay-q6hr PRn
Maximum 6 doses/24 hours
Amounts in mg based on anhydrous morphine content
Opium tincture is 25 times the strength of paregoric
Should not be used in diarrhea caused by poisoning until toxin is eliminated
Neonatal Abstinence Syndrome (Off-label)
Using 25-fold dilution of tincture (0.4 mg/mL morphine): 0.1 mL/kg PO q3-4hr
Increase up to 0.7 mL of dilution PRN to control symptoms
Stabilize for 3-5 days, THEN gradually decrease over 2-4 weeks
Amounts in mg based on anhydrous morphine content
Opium tincture is 25 times the strength of paregoric
Should not be used in diarrhea caused by poisoning until toxin is eliminated
Geriatric dosage forms and strengths
Acute Diarrhea
Tincture (50 mg/5 mL): 6 mg (0.6 mL) PO q6hr; not to exceed 6 mL/day
Paregoric (2 mg/5 mL): 2-4 mg (5-10 mL) PO qDay-q6hr PRn
Amounts in mg based on anhydrous morphine content
Opium tincture is 25 times the strength of paregoric
Should not be used in diarrhea caused by poisoning until toxin is eliminated
opium paregoric, paregoric (opium tincture) adverse (side) effects
Frequency not defined
CNS depression
Physical/psychological dependence
Sedation
Hypotension
Respiratory depression
Constipation
Nausea
Vomiting
Urinary retention
Miosis
Histamine release
Warnings
Contraindications
Hypersensitivity
Respiratory disease/depression, diarrhea due to poison, pseudomembranous colitis, glaucoma, severe hepatic disease, convulsive disorders
Cautions
Caution in asthma, severe prostatic hypertrophy, thyroid dysfunction, hepatic disease, history of opioid dependence, patients morbidly obese, and concurrent CNS depressants
Caution in patients with head trauma
Opium tincture contains 25 times more morphine than paregoric & should never be confused with the latter
Caution in patients with acute adrenal insuficiency (eg, Addison's disease)
Caution in patients with bilieary tract dysfunction
Caution in patients with GI hemorrhage
Pregnancy and lactation
Pregnancy category: B; D if used for prolonged periods or near term
Lactation: Long-term effect unknown, AAP Committee states morphine compatible w/nursing
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of opium paregoric, paregoric (opium tincture)
Mechanism of action
Opium, because of its morphine content, inhibits GI motility & propulsion, diminishes digestive secretion; increases GI muscle tone
Pharmacokinetics
Duration: 4-5 hr
Metabolism: Extensively metabolized in liver, undergoes conjugation with glucuronic acid
Metabolites: Morphine-3-glucuronide, morphine-3-6-diglucuronide
Excretion: Mainly by kidney, small amount in bile
