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Opium

RxNorm 830196· MORPHINE· ORAL

Opioid Agonist [EPC] · Genus Lifesciences Inc.

Indications and usage

INDICATIONS AND USAGE Opium tincture is useful for the treatment of diarrhea.

Dosage and administration

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

Warnings

WARNINGS Addiction can result from opium usage. Opium preparations should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence.

Contraindications

CONTRAINDICATIONS This preparation is not recommended for use in children. It should not be used in diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract.

Drug interactions

Drug Interactions When preparations containing opium are administered in combination with other drugs, the cautions applicable to each ingredient should be borne in mind. Reduced dosage is indicated in poor-risk patients, in the very young or very old patient, and in those who are receiving other central-nervous system depressants.

Pregnancy

Usage in Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Opium Tincture, USP (Deodorized). It is also not known whether Opium Tincture, USP (Deodorized), can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Opium Tincture, USP (Deodorized), should be given to a pregnant woman only if clearly needed.

Nursing mothers

Nursing Mothers Caution should be exercised when Opium Tincture, USP (Deodorized), is administered to a nursing woman.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • drug dependence33,888
  • pain26,904
  • overdose25,373
  • death21,628
  • emotional distress17,595
  • toxicity to various agents15,834
  • drug withdrawal syndrome14,586
  • drug hypersensitivity12,453
  • nausea10,742
  • drug ineffective9,565
  • vomiting8,092
  • fatigue7,739
  • off label use6,675
  • drug abuse6,517
  • diarrhoea6,369
  • headache6,150

Adverse reactions (label)

ADVERSE REACTIONS Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed.