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U.S. Department of Health and Human Services

Safety

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Morphine Sulfate Oral Solution, 10 mg/5 mL, 20 mg/5 mL, and 100 mg/5 mL

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012

 

Summary View

5 WARNINGS AND PRECAUTIONS

5.3 Misuse, Abuse and Diversion of Opioids
  • Morphine sulfate may be abused by inhaling or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death. [See DRUG ABUSE AND DEPENDENCE (9)]

6 ADVERSE REACTIONS

Digestive System: anorexia, biliary pain, dyspepsia, dysphagia, gastroenteritis, abnormal liver function tests, rectal disorder, thirst

Endocrine: hypogonadism

Hemic and Lymphatic System: anemia, thrombocytopenia Metabolic and Nutritional Disorders: edema, weight loss

Musculoskeletal: skeletal muscle rigidity, decreased bone mineral density

Nervous System: abnormal dreams, abnormal gait, agitation, amnesia, anxiety, ataxia, confusion, convulsions, coma, delirium, depression, dry mouth, euphoria, hallucinations, lethargy, nervousness, abnormal thinking, tremor, vasodilation, vertigo, headache

Urogenital System: abnormal ejaculation, dysuria, impotence, decreased libido, oliguria, urinary retention or hesitancy, anti-diuretic effect, amenorrhea

8.0 USE IN SPECIAL POPULATIONS

8.1 Pregnancy

Teratogenic Effects (Pregnancy Category C)

  • No formal studies to assess the teratogenic effects of morphine in animals have been conducted. It is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Morphine should be given to a pregnant woman only if clearly needed.

17 PATIENT COUNSELING INFORMATION

  • Instruct patients not to combine morphine sulfate with central nervous system depressants (such as sleep aids, tranquilizers, antihistamines, general anesthetics, phenothiazines, other opioids, and monoamine oxidase [MAO] inhibitors) except by the orders of the prescribing physician, and not to combine with alcohol because dangerous additive effects may occur, resulting in serious injury or death.
  • If patients have been receiving treatment with morphine sulfate for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose as abrupt discontinuation of the medication could precipitate withdrawal symptoms. Provide a dose schedule to accomplish a gradual discontinuation of the medication.

MEDICATION GUIDE

  • Do not take the strongest dose of Morphine Sulfate Oral Solution, 100 mg per 5 mL (20 mg/mL), unless you have been using opioid medicine every day for several weeks or longer and your body is used to it.
  • Do not take any new medicine while using Morphine Sulfate until you have talked with your healthcare provider orpharmacist. They will tell you if it is safe to take other medicines with Morphine Sulfate. Ask your healthcare provider if you are not sure if your medicine is one listed above.
  • Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • There is a risk of abuse or addiction with Morphine Sulfate. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.