Opium Tincture

Opium Tincture is useful for the treatment of diarrhea.

Usual Adult Dose – 0.6 mL orally 4 times a day.

Opium Tincture, USP (Deodorized), is supplied as:
NDC 62559-153-04

Bottles of 4 fl oz

Dispense in tightly closed containers.
Store at controlled room temperature, 68° to 77°F (20° to 25°C) (see USP).

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623

571-15304-0 Rev 11-10

Opium Tincture USP (Deodorized), 10 mg/mL of anhydrous morphine, CII
NDC 62559-153-04
Rx only
118 mL (4 fl. oz.)

• Deodorized Tincture of Opium (error-prone synonym)
• DTO (error-prone abbreviation)
• Opium Tincture, Deodorized
• Tincture of Opium

Contains many opioid alkaloids including morphine; its mechanism for gastric motility inhibition is primarily due to this morphine content; it results in a decrease in digestive secretions, an increase in GI muscle tone, and therefore a reduction in GI propulsion

Absorption

Variable

Metabolism

Hepatic

Excretion

Urine

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Hypotension: May cause hypotension; use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or with drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics).

Disease-related concerns:

• Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions.

• Adrenal insufficiency: Use with caution in patients with adrenal insufficiency, including Addison's disease. Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis (Brennan, 2013).

• Biliary tract impairment: Use with caution in patients with biliary tract dysfunction, including acute pancreatitis; may cause constriction of sphincter of Oddi.

• CNS depression/coma: Avoid use in patients with CNS depression or coma as these patients are susceptible to intracranial effects of CO2 retention.

• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use.

• GI Hemorrhage: Use with caution in patients with GI hemorrhage.

• Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure; exaggerated elevation of ICP may occur.

• Hepatic impairment: Use with caution in patients with hepatic dysfunction.

• Obesity: Use with caution in patients who are morbidly obese.

• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.

• Respiratory disease: Use with caution in patients with pre-existing respiratory compromise (hypoxia and/or hypercapnia), COPD or other obstructive pulmonary disease, and kyphoscoliosis or other skeletal disorders which may alter respiratory function; critical respiratory depression may occur, even at therapeutic dosages.

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Debilitated patients: Use with caution in debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages.

• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects. Decrease initial dose.

• Pediatric: Infants <3 months of age are more susceptible to respiratory depression; if used (off-label), diluted doses are recommended and use with caution; contraindicated for use in children according to the manufacturer.

Dosage form specific issues:

• Ethanol: Product contains alcohol.

Other warnings/precautions:

• Potential for error: Do not confuse opium tincture with paregoric; opium tincture is 25 times more potent than paregoric; opium shares the toxic potential of opioid agonists, usual precautions of opioid agonist therapy should be observed.

• Withdrawal: Concurrent use of agonist/antagonist analgesics may precipitate withdrawal symptoms and/or reduced analgesic efficacy in patients following prolonged therapy with mu opioid agonists. Abrupt discontinuation following prolonged use may also lead to withdrawal symptoms.

• Appropriate use: Opium tincture is not routinely used as a source of morphine to treat neonatal abstinence syndrome in infants exposed to chronic opioids in utero. If used, then dilution is necessary. In addition, use for this purpose may increase the risk of drug error and morphine overdose in the infant (AAP, 1998; Dow, 2012; Hudack, 2012).

Observe patient for excessive sedation, respiratory depression, implement safety measures, assist with ambulation; signs or symptoms of hypogonadism or hypoadrenalism (Brennan, 2013)