|
|
DRUG INTERACTIONS Drug Interactions:
Use with Other Central Nervous System Depressants:
The depressant effects of morphine are potentiated by the presence of other CNS depressants such as alcohol, sedatives, antihistaminics, or psychotropic drugs. Use of neuroleptics in conjunction with oral morphine may increase the risk of respiratory depression, hypotension and profound sedation or coma.
|
OVERDOSAGE
| NOTE: THE SUSTAINED RELEASE OF MORPHINE FROM ORAMORPH SR SHOULD BE TAKEN INTO CONSIDERATION IN THE EVENT OF AN OVERDOSAGE. |
Overdosage of morphine is characterized by respiratory depression, with or without concomitant CNS depression. Since respiratory arrest may result either through direct depression of the respiratory center, or as the result of hypoxia, primary attention should be given to the establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted, or controlled, ventilation. The narcotic antagonist, naloxone, is a specific antidote. An initial dose of 0.4 to 2 mg of naloxone should be administered intravenously, simultaneously with respiratory resuscitation. If the desired degree of counteraction and improvement in respiratory function is not obtained, naloxone may be repeated at 2 to 3 minute intervals. If no response is observed after 10 mg of naloxone has been administered, the diagnosis of narcotic-induced, or partial narcotic-induced, toxicity should be questioned. Intramuscular or subcutaneous administration may be used if the intravenous route is not available.
As the duration of effect of naloxone is considerably shorter than that of ORAMORPH SR, repeated administration may be necessary. Patients should be closely observed for evidence of renarcotization.
| NOTE: In an individual physically dependent on opioids, administration of the usual dose of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Use of a narcotic antagonist in such a person should be avoided. If necessary to treat serious respiratory depression in a physically dependent patient, the antagonist should be administered with extreme care and by titration with smaller than usual doses of the antagonist. |
When indicated, gut decontamination should be performed via emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) with cathartic. Since ORAMORPH SR is a sustained release product, absorption may be expected to continue for many hours, particularly following an overdose, combined with decreased peristaltic activity of the gastrointestinal tract.
Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
|
CONTRAINDICATIONS
ORAMORPH SR is contraindicated in patients with respiratory depression in the absence of resuscitative equipment, in patients with acute or severe bronchial asthma and in patients with known hypersensitivity to morphine.
ORAMORPH SR is contraindicated in any patient who has or is suspected of having a paralytic ileus.
|
DRUG ABUSE AND DEPENDENCE
Opioid analgesics may cause psychological and physical dependence (see WARNINGS). Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug, or these symptoms may be precipitated through the administration of drugs with antagonistic activity, e.g., naloxone or mixed agonist/antagonist analgesics (pentazocine, etc.; see also OVERDOSAGE). Physical dependence usually does not occur, to a clinically significant degree, until several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required to produce the same degree of analgesia, is initially manifested by a shortened duration of analgesic effect and, subsequently, by decreases in the intensity of analgesia. In patients with chronic pain, as well as in opioid-tolerant cancer patients, the administration of ORAMORPH SR (morphine sulfate) should be guided by the degree of tolerance manifested. Physical dependence, per se, is not ordinarily a concern when one is dealing with opioid-tolerant patients whose pain and suffering is associated with an irreversible illness.
If ORAMORPH SR is abruptly discontinued, an abstinence syndrome may occur. Withdrawal symptoms, in patients dependent on morphine, begin shortly before the time of the next scheduled dose, reaching a peak at 36 to 72 hours after the last dose, and then slowly subside over a period of 7 to 10 days. Symptoms include yawning, sweating, lacrimation, rhinorrhea, restless sleep, dilated pupils, gooseflesh, irritability, tremor, nausea, vomiting, and diarrhea.
Treatment of the abstinence syndrome is primarily symptomatic and supportive, including maintenance of proper fluid and electrolyte balance. If withdrawal has inadvertently been precipitated in a patient who requires narcotics for pain management, the withdrawal syndrome can be terminated rapidly by the administration of an appropriate dose of a pure agonist opioid, such as morphine. The degree of physical dependence of a patient on ORAMORPH SR can be intentionally reduced by a gradual reduction of dosage and symptomatic treatment of withdrawal symptomatology.
|
|
|
|
-- advertisement --
|
