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DepoDur

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DepoDur

DepoDur

SIDE EFFECTS

In controlled and open label clinical studies with DepoDur (morphine sulfate xr liposome injection) , the majority of the adverse events were typical of opiate medications and would be expected in the surgical populations studied. The most common adverse events (greater than 10%) reported at least once during therapy in patients treated with DepoDur (morphine sulfate xr liposome injection) were decreased oxygen saturation, hypotension, urinary retention, vomiting, constipation, nausea, pruritus, pyrexia, anemia, headache, and dizziness. Adverse events occurring in 5-10% of study patients were hypoxia, tachycardia, insomnia, and flatulence. Other less common side effects (seen in 2-5% of patients receiving DepoDur (morphine sulfate xr liposome injection) ) included respiratory depression, hypercapnia, paralytic ileus, somnolence, bladder spasm, abdominal distension, hypoesthesia, hypertension, oliguria, bradycardia, anxiety, back pain, increased sweating, dyspepsia, rigors, dyspnea, hypokalemia, paresthesia, and decreased hematocrit.

Of the patients treated with DepoDur (morphine sulfate xr liposome injection) in clinical trials, 4% exhibited signs of respiratory depression requiring treatment with narcotic antagonists. In clinical trials, 90% of respiratory depression occurred within 24 hours after administration of DepoDur (morphine sulfate xr liposome injection) . However, onset of respiratory depression occurred in 0.6% of patients after more than 48 hours.

During post-marketing experience, central nervous system (CNS) depression, including obtunded feeling, non-arousable condition, unresponsiveness, confusion, and lethargy, has been reported following epidural administration of DepoDur (morphine sulfate xr liposome injection) . In most of these cases with CNS depression, there was concomitant administration of different narcotics or hypnotic/sedative medications in the post operative period.

During post-marketing experience, severe respiratory depression, involving apnea or respiratory arrest, and cardiac arrest have been reported following administration of labeled doses of DepoDur (morphine sulfate xr liposome injection) .

Prolonged respiratory depression or apnea may occur when administration of epidural DepoDur (morphine sulfate xr liposome injection) is associated with subarachnoid puncture.

Drug Abuse And Dependence

DepoDur (morphine sulfate xr liposome injection) is a n-agonist opiate and is a Schedule II controlled substance. Morphine, as with other opiates used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm.

As with all potent µ-agonist opiates, tolerance as well as psychological and physical dependence to morphine may develop irrespective of the route of administration (intravenous, intramuscular, intrathecal, epidural or oral). Tolerance is a condition in which previous exposure to an opiate results in the necessity for increasingly larger doses of the drug in order to produce the same degree of analgesia. Withdrawal symptoms, indicating the presence of psychophysiological dependence, may occur when morphine is discontinued abruptly after chronic administration for analgesia, or upon administration of a drug with full or partial opiate antagonist effects. Care must be taken to avert withdrawal in patients who have been maintained on parenteral/oral opiates prior to epidural administration of DepoDur (morphine sulfate xr liposome injection) .

Individuals with a history of opiate or other substance abuse would be considered to be at greater risk of addiction or abuse, given that they are more apt to respond to the euphorigenic and reinforcing properties of morphine. However, concerns about abuse, addiction or diversion of opiates should not prevent proper management of pain.

DepoDur (morphine sulfate xr liposome injection) is intended for epidural use only. Abuse of DepoDur (morphine sulfate xr liposome injection) may pose a hazard of overdose and death when administered through other routes. This risk is increased with concurrent use of other medications or illicit drugs.

Read the DepoDur (morphine sulfate xr liposome injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Local Anesthetics (test dose – lidocaine 1.5% and epinephrine 1:200,000): Administration of DepoDur (morphine sulfate xr liposome injection) three minutes after a 3 mL test-dose (lidocaine 1.5% and epinephrine 1:200,000) increases peak serum concentrations of morphine (See CLINICAL PHARMACOLOGY). Increasing the interval between the test dose and DepoDur (morphine sulfate xr liposome injection) administration to at least 15 minutes minimizes this pharmacokinetic interaction.

Local Anesthetics (analgesic dose – bupivacaine 0.25%, 20 mL): Administration of DepoDur (morphine sulfate xr liposome injection) after an analgesic dose of bupivacaine increases peak serum concentrations of morphine (See CLINICAL PHARMACOLOGY). Increasing the interval between the analgesic dose and DepoDur (morphine sulfate xr liposome injection) administration to greater than 30 minutes reduces this pharmacokinetic interaction.

Safety and efficacy of DepoDur (morphine sulfate xr liposome injection) when used in conjunction with analgesic epidural doses of lidocaine with epinephrine (for conduction anesthesia) have not been studied in clinical trials.

CNS Depressants: The concurrent use of other central nervous system (CNS) depressants including sedatives, hypnotics, general anesthetics, droperidol, phenothiazines or other tranquilizers, or alcohol increases the risk of respiratory depression, hypotension, profound sedation, or coma. Use with caution and with vigilant monitoring in patients taking these agents.

Monoamine Oxidase Inhibitors (MAOIs): MAOIs markedly potentiate the action of morphine. DepoDur (morphine sulfate xr liposome injection) should not be used in patients taking MAOIs or within 14 days of stopping such treatment.

Muscle Relaxants: Respiratory depression associated with morphine may delay recovery of spontaneous pulmonary ventilation when neuromuscular blocking agents are coadministered.

Last reviewed on RxList: 10/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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