Uses

Pain Associated with Ureteral Spasm

Used rectally in combination with belladonna extract for the relief of moderate to severe pain associated with ureteral spasm unresponsive to nonopiate analgesics.

Used when the analgesic, sedative, and antispasmodic effects of the combination may be useful (i.e., when pain and smooth-muscle spasm are present concurrently) and to space intervals between opiate injections.

Diarrhea

Paregoric or opium tincture are used principally for the treatment of diarrhea.

Should not be used for treatment of diarrhea caused by poisoning until the toxic material is eliminated from the GI tract by gastric lavage or cathartics. (See Contraindications.)

Opiate Withdrawal

Used as a tincture (e.g., paregoric or diluted opium tincture) to treat opiate withdrawal† symptoms (e.g., generalized tremors, hypertonicity with any form of tactile stimuli, hyperalertness, sleeplessness, excessive crying, vomiting, diarrhea, yawning, fever) in neonates† born to women addicted to opiates.

Diluted opium tincture is preferred by some clinicians to paregoric tincture for the treatment of opiate withdrawal symptoms in neonates, since paregoric contains camphor and benzoic acid which may cause potential adverse effects.

Dosage and Administration

Administration

Administer orally as a solution.

Administer rectally as a suppository.

Oral Administration

Paregoric and opium tincture are administered orally as a solution.

Opium tincture contains 25 times more morphine than does paregoric and should never be confused with the latter preparation. (See Concentrated Opium Solutions and also Possible Prescribing and Dispensing Errors, under Cautions.)

Dilution

For treatment of opiate withdrawal symptoms in neonates, opium tincture must be diluted and administered as a 1:25 dilution in water.

Rectal Administration

Opium is administered rectally as a suppository in combination with belladonna extract.

Moisten finger and rectal suppository containing belladonna and opium with water prior to rectal insertion.

Dosage

Tincture: Available as opium and paregoric; dosage is expressed in terms of anhydrous morphine alkaloid.

Opium tincture is an alcoholic solution containing 50 mg of anhydrous morphine (as granulated or sliced opium) per 5 mL.

Paregoric contains 2 mg of anhydrous morphine (usually as opium), anise oil, benzoic acid, glycerin, and sufficient diluted alcohol to make 5 mL.

Rectal suppository: Available as a fixed combination containing opium and belladonna; dosage expressed in terms of opium and belladonna.

Should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence.

Pediatric Patients

Diarrhea

Paregoric

Oral

Usually, 0.25–0.5 mL/kg 1–4 times daily.

Opiate Withdrawal

Paregoric or 1:25 Dilution of Opium Tincture

Oral

To prevent potential overdose, opium tincture must be diluted and administered as a 1:25 dilution in water. (See Concentrated Opium Solutions and also Possible Prescribing and Dispensing Errors, under Cautions.) †

Neonates†: Usually, 3–6 drops every 3–6 hours as needed; adjust dosage to control withdrawal symptoms. Alternatively, initially, 0.2 mL every 3 hours and increase, if necessary, by approximately 0.05 mL every 3 hours until withdrawal symptoms are controlled; rarely necessary to exceed 0.7 mL per dose. After withdrawal symptoms have stabilized for 3–5 days, gradually decrease dosage over a 2- to 4-week period.†

Adults

Pain Associated with Ureteral Spasm

Opium Combination Suppository

Rectal

Usually, 1 suppository once or twice daily, or as directed by a clinician.

Diarrhea

Paregoric

Oral

Usually, 5–10 mL 1–4 times daily.

Opium Tincture

Oral

Opium tincture contains 25 times more morphine than does paregoric and should never be confused with the latter preparation. (See Concentrated Opium Solutions and also Possible Prescribing and Dispensing Errors, under Cautions.)

Usually, 0.6 mL 4 times daily; may range from 0.3–1 mL 4 times daily.

Prescribing Limits

Pediatric Patients

Opiate Withdrawal

Paregoric or 1:25 Dilution of Opium Tincture

Oral

Neonates†: Rarely necessary to exceed 0.7 mL per dose. †

Adults

Pain Associated with Ureteral Spasm

Opium Combination Suppository

Rectal

Maximum 1 suppository 4 times daily.

Diarrhea

Opium Tincture

Oral

Maximum 1 mL as a single dose or 6 mL daily.

Special Populations

Hepatic Impairment

Use with caution and reduce initial dosage in patients with hepatic cirrhosis or insufficiency.

Renal Impairment

Use with caution and reduce initial dosage in patients with renal impairment.

Geriatric and Debilitated Patients

Administer with caution and reduce dosage in geriatric or debilitated patients.