"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
DepoDur Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
DepoDur Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular/shallow breathing, dizziness upon standing, slow/fast/irregular heartbeat, mental/mood changes, severe stomach/abdominal pain, change in the amount of urine, seizures.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for DepoDur (Morphine Sulfate XR Liposome Injection)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
DepoDur FDA Prescribing Information: 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 entire FDA prescribing information for DepoDur (Morphine Sulfate XR Liposome Injection) »
Additional DepoDur Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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