DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

MORPHINE SULFATE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIR concern

Severity Score:4

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

OVERDOSAGE
Acute overdosage with morphine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, rhabdomyolysis progressing to renal failure, and, sometimes, bradycardia, hypotension and death.
The nature of the controlled-release morphine should also be taken into account when treating the overdose. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects. Deaths due to overdose may occur with abuse and misuse of morphine sulfate extended-release tablets.
In the treatment of morphine overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. 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.
The pure opioid antagonists, such as naloxone, are specific antidotes against respiratory depression which results from opioid overdose. Naloxone (usually should be administered intravenously; however, because its duration of action is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. If the response to naloxone is suboptimal or not sustained, additional naloxone may be administered, as needed, or given by continuous infusion to maintain alertness and respiratory function; however, there is no information available about the cumulative dose of naloxone that may be safely administered.
Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose. Such agents should be administered cautiously to persons who are known, or suspected to be physically dependent on morphine sulfate extended-release tablets. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

130

42782

Other ADRs

22246

14095033

Odds Ratio = 1.926

Drug Property Information

ATC Code(s):

N02AA01 - morphine sulfate

N02AA - Natural opium alkaloids
N02A - OPIOIDS
N02 - ANALGESICS
N - NERVOUS SYSTEM

A07DA52 - morphine sulfate

A07DA - Antipropulsives
A07D - ANTIPROPULSIVES
A07 - "ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE "
A - ALIMENTARY TRACT AND METABOLISM

N02AA51 - morphine sulfate

N02AA - Natural opium alkaloids
N02A - OPIOIDS
N02 - ANALGESICS
N - NERVOUS SYSTEM

N02AG01 - morphine sulfate

N02AG - Opioids in combination with antispasmodics
N02A - OPIOIDS
N02 - ANALGESICS
N - NERVOUS SYSTEM

Active Ingredient:morphine sulfate

Active Ingredient UNII:X3P646A2J0

Drugbank ID:DB00295

PubChem Compound:5288826

CAS Number:57-27-2

Dosage Form(s):tablet, film coated, extended release

Route(s) Of Administrator:oral

Daily Dose:

100.0 mg/day N02AA01

Chemical Structure:

SMILE Code:
CN1CC[C@]23[C@@H]4[C@H]1CC5=C2C(=C(C=C5)O)O[C@H]3[C@H](C=C4)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: When pain is out of proportion.

[Johnson David E]
Emerg Med Serv.2003 Sep;32(9):115-9. PMID: 14503162

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