DepoDur: Safety Profile 14

Safety and tolerability in clinical studies

The majority of adverse events were typical of opioids
The most common adverse events (greater than 10%) were decreased oxygen saturation, hypotension, urinary retention, vomiting, constipation, nausea, pruritus, pyrexia, anemia, headache, and dizziness
As with all opioids, the most serious side effect of morphine sulfate is respiratory depression, especially in elderly and debilitated patients, and in those with compromised respiratory function
Due to the extended release of morphine, patients receiving DepoDur should be monitored for 48 hours
Overall incidence of respiratory depression was dose related—10 mg (0.7%), 15 mg (5%) 13

DepoDur is a Schedule II controlled substance and is subject to abuse and diversion.

DepoDur: Monitoring

Monitoring following opioid administration

The American Society of Anesthesiologists (ASA) recommends that all patients receiving neuraxial opioids be monitored for adequacy of ventilation, oxygenation, and level of consciousness 15

Type of
Administration
Duration of Monitoring Hours
1-12
Hours
12-24
After
24 Hours
DepoDur A minimum of 48 hours At least 1x per hour At least
1x every
2 hours
At least
1x every
4 hours
Single-Injection
Hydrophilic
Opioid
(not extended-release
epidural morphine)
A minimum of 24 hours At least 1x per hour At least
1x every
2 hours
Monitoring based on patient’s clinical condition and concurrent medications
Continuous
Infusion


or

Patient-Controlled
Epidural Analgesia
For duration of infusion and post-
infusion based on patient’s clinical condition
At least 1x per hour At least
1x every
2 hours
At least
1x every
4 hours

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