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BD Rx Announces FDA Approval of High-Demand Injectable for Pain Management
Date:11/4/2013

r/>Use Morphine Sulfate injection in reduced dosages in patients with severe renal or hepatic impairment, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients.  Monitor these patients closely for signs of respiratory and central nervous system depression. 

ADVERSE REACTIONS
Serious adverse reactions associated with Morphine Sulfate Injection USP include, respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest.  Rarely, anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously.

The most frequently observed adverse reactions include sedation, lightheadedness, dizziness, nausea, vomiting, constipation and diaphoresis. 

DRUG INTERACTIONS  

  • CNS depressants: Increased  risk of respiratory depression, hypotension, profound sedation and coma 
  • Muscle relaxants: May enhance the neuromuscular blocking action of skeletal muscle relaxants and produce respiratory depression 
  • Mixed agonist/antagonist opioid analgesics: May reduce the analgesic effect and/or may precipitate withdrawal symptoms 
  • Cimetidine: May increase respiratory and CNS depression
  • Monoamine Oxidase Inhibitors (MAOIs): Potentiate the action of Morphine Sulfate Injection USP 
  • Anticholinergics: May increase the risk of urinary retention, severe constipation, or paralytic ileus

USE IN SPECIFIC POPULATIONS 

  • Pregnancy: Based on animal data, may cause fetal harm
  • Pediatric patients: Safety and effectiveness and the pharmacokinetics of Morphine Sulfate Injection in pediatric patients below the age of 18 have not been established. 
  • Geriatric pati
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SOURCE BD (Becton, Dickinson and Company)
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