opium tincture, deodorized (laudanum)

opium tincture, camphorated (paregoric)

Pharmacologic classification: opiate
Therapeutic classification: antidiarrheal
Pregnancy risk category B (D for high doses or long term)
Controlled substance schedule II (deodorized), III (camphorated) Controlled substance schedule II (deodorized), III (camphorated)

Available forms
Available by prescription only
opium tincture, deodorized
Alcoholic solution: Equivalent to morphine 10 mg/ml
opium tincture, camphorated
Alcoholic solution: Each 5 ml contains morphine, 2 mg; anise oil, 0.2 ml; benzoic acid, 20 mg; camphor, 20 mg; glycerin, 0.2 ml; and ethanol to make 5 ml

Indications and dosages
 Acute, nonspecific diarrhea. Adults: 0.6 ml opium tincture (range, 0.3 to 1 ml) P.O. q.i.d. (maximum dose, 6 ml daily). Or, 5 to 10 ml camphorated opium tincture daily, b.i.d., t.i.d., or q.i.d. until diarrhea subsides.
Children: 0.25 to 0.5 ml/kg camphorated opium tincture daily, b.i.d., t.i.d., or q.i.d. until diarrhea subsides.
 Severe opiate withdrawal symptoms in neonates. Neonates: Camphorated opium tincture or a 1:25 dilution of opium tincture in water, given as 0.2 ml P.O. q 3 hours. Adjust dosage to control withdrawal symptoms. Increase by 0.05 ml q 3 hours until symptoms are controlled. Once symptoms are stabilized for 3 to 5 days, gradually decrease dosage over a 2- to 4-week period.

Pharmacodynamics
Antidiarrheal action: Opium contains several ingredients. The most active, morphine, increases GI smooth-muscle tone, inhibits motility and propulsion, and diminishes secretions. By inhibiting peristalsis, the drug delays passage of intestinal contents, increasing water resorption and relieving diarrhea.

Pharmacokinetics
Absorption: Absorbed variably from the gut.
Distribution: Although opium alkaloids are distributed widely in the body, the low doses used to treat diarrhea act primarily in the GI tract. Camphor crosses the placental barrier.
Metabolism: Metabolized rapidly in the liver.
Excretion: Opium is excreted in urine; opium alkaloids (especially morphine) enter breast milk.

Route Onset Peak Duration
P.O. Unknown Unknown 4-5 hr


Contraindications and precautions
Contraindicated in patients with acute diarrhea caused by poisoning until toxic material is removed from GI tract or in those with diarrhea caused by organisms that penetrate intestinal mucosa. Use cautiously in patients with asthma, prostatic hyperplasia, hepatic disease, or history of opium dependence.

Interactions
Drug-drug. Other CNS depressants: Causes additive effect. Use together cautiously.
Metoclopramide: May antagonize effects of metoclopramide. Avoid use together.
Drug-herb. St. John’s wort: Increases narcotic-induced sleeptime. Discourage use together.
Drug-lifestyle. Alcohol use: Causes additive effects. Discourage alcohol use.

Adverse reactions
CNS: dizziness, light-headedness.
GI: nausea, vomiting.
Other: physical dependence (after long-term use).

Effects on lab test results
• May increase amylase and lipase levels.

Overdose and treatment
Signs and symptoms of overdose include drowsiness, hypotension, seizures, and apnea.
 Empty stomach by induced emesis or gastric lavage; maintain patent airway. Use naloxone to treat respiratory depression. Monitor patient for signs and symptoms of CNS or respiratory depression.

Special considerations
• Mix drug with sufficient water to ensure passage to stomach.
 ALERT Deodorized opium tincture (laudanum) is 25 times more potent than camphorated form (paregoric); take care not to confuse these drugs. Camphorated form is more dilute, and teaspoon doses are easier to measure than dropper quantities of opium tincture.
• When camphorated opium tincture is added to water, a milky fluid forms.
• Risk of physical dependence on drug increases with long-term use.
• Don’t refrigerate drug.
• Opium tincture and camphorated tincture may prevent delivery of technetium-99m disofenin to the small intestine during hepatobiliary imaging tests; delay test until 24 hours after last dose.
Breast-feeding patients
• Because opium alkaloids, especially morphine, appear in breast milk, risks must be weighed against benefits.
Pediatric patients
• Opium tincture has been used to treat withdrawal symptoms in infants whose mothers are narcotic addicts.

Patient education
• Warn patient that physical dependence may result from long-term use.
• Advise patient to use caution when performing hazardous tasks because drug may cause drowsiness, dizziness, and blurred vision.
• Instruct patient to report diarrhea that persists longer than 48 hours because drug is indicated only for short-term use.
• Advise patient to take drug with food if it causes nausea, vomiting, or constipation.
• Instruct patient to call immediately if he has difficulty breathing or shortness of breath.
• Instruct patient to drink adequate fluids while diarrhea persists.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use