Depodur
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Questions & Answers
Side Effects & Adverse Reactions
Due to the risk of severe adverse events when the epidural route of administration is employed, patients must be observed in a fully equipped and staffed environment for at least 48 hours after administration. The facility must be equipped to resuscitate patients with severe opiate overdosage, and the personnel must be familiar with the use and limitations of specific narcotic antagonists (naloxone, naltrexone) in such cases.
No clinical studies have evaluated the safety of administration of DepoDur into the intrathecal space. DepoDur is intended for administration by the epidural route only. However, cases of intrathecal administration of DepoDur have been reported during post-marketing experience. In all cases, signs of prolonged respiratory depression were observed requiring narcotic antagonist (naloxone) administration or ventilatory support.
Prolonged and serious respiratory depression or apnea has occurred when administration of epidural DepoDur was associated with subarachnoid puncture. In these cases, respiratory depression has occurred within 12 hours of DepoDur administration following apparent recovery from anesthesia. Respiratory depression resulting from DepoDur can be treated successfully with a naloxone bolus or, more commonly, a naloxone infusion; intubation and mechanical ventilation may be necessary in some cases.
Because intrathecal leakage from the epidural space may occur through a breached dural membrane, especially when the epidural drug is administered in a bolus, DepoDur should not be administered to a patient following a recent dural puncture without vigilant monitoring of respiratory function for a prolonged period (48 hours) with provision for emergency mechanical ventilation to minimize the risk of serious respiratory depression.
DepoDur should be administered by or under the direction of a physician experienced in the techniques associated with epidural drug administration and familiar with patient management following epidural opiate administration, including the management of respiratory depression.
Prior to drug administration, the physician should be familiar with patient conditions (such as infection at the injection site, bleeding diathesis, current and anticipated anticoagulant therapy, etc.) that call for special evaluation of the benefit versus risk potential.
Respiratory depression is the chief hazard of all opiate preparations. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia or hypercapnia in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation.
Administration of opiates with or without coadministration of other sedative or hypnotic drugs can worsen airway obstruction in patients with obstructive sleep-apnea syndrome. Patients who are obese are at particular risk for this syndrome, which may be undiagnosed prior to administration.
Respiratory depression can occur with DepoDur. Four percent of the patients who received DepoDur required treatment with narcotic antagonists for respiratory depression. Ninety percent of events of respiratory depression started within the first 24 hours after dosing with DepoDur. However, the incidence of respiratory depression starting after 48 hours, potentially related to DepoDur, was 0.6% (5 of 900 patients). Patients at increased risk of respiratory depression such as those with impaired respiratory drive, sleep apnea, concomitant sedation or the elderly, may require monitoring for periods longer than 48 hours.
Because of the risk of respiratory depression, the facility must be equipped to resuscitate patients. Patients must be closely monitored in a fully equipped and staffed environment for a minimum of 48 hours.
If the surgical procedure is cancelled after the administration of DepoDur, the risk of respiratory depression may be increased, and patients should be monitored with a high level of vigilance.
Epidural local anesthetics should not be used before or after DepoDur, except in the form of a test dose. (See PRECAUTIONS – Drug Interactions) Do not mix or co-administer DepoDur with any other medications including local anesthetics. Once DepoDur has been administered, no other medication should be administered into the epidural space for at least 48 hours.
The active ingredient of DepoDur is morphine, a μ-opiate agonist. DepoDur is a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty. DepoDur can be abused in a manner similar to other opiate agonists, legal or illicit.
Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
DepoDur, like all other opiates, may cause severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or concurrent administration of drugs such as phenothiazines or general anesthetics (see also PRECAUTIONS – Drug Interactions). DepoDur may produce orthostatic hypotension and syncope in ambulatory patients.
In a patient who progresses to circulatory shock, DepoDur may make resuscitation more difficult due to vasodilatation.
DepoDur should not be administered to patients with gastrointestinal obstruction, especially paralytic ileus, because DepoDur diminishes propulsive peristaltic waves in the gastrointestinal tract and may prolong the obstruction.
The central nervous depressant effects of morphine are potentiated by the presence of other CNS depressants such as alcohol, other opiates, sedatives, antihistaminics or psychotropic drugs. Use of neuroleptics or general anesthetics in conjunction with epidural morphine may increase the risk of respiratory depression.
DepoDur should not be administered to women for vaginal labor and delivery. DepoDur has only been administered to women undergoing cesarean section following clamping of the umbilical cord.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
DepoDur is an extended-release liposome injection of morphine sulfate intended for single-dose administration by the epidural route, at the lumbar level, for the treatment of pain following major surgery. DepoDur is administered prior to surgery or after clamping the umbilical cord during cesarean section.
DepoDur is not intended for intrathecal, intravenous, or intramuscular administration. Administration of DepoDur into the thoracic epidural space or higher has not been evaluated and therefore is not recommended.
History
There is currently no drug history available for this drug.
Other Information
DepoDur (morphine sulfate extended-release liposome injection) is a sterile suspension of multivesicular liposomes using proprietary DepoFoam® formulation technology containing morphine sulfate, intended for epidural administration.
Chemically, morphine sulfate is 7, 8-didehydro-4, 5α-epoxy-17-methylmorphinan-3, 6α -diol sulfate (2:1) (salt) pentahydrate with a molecular weight of 758. Morphine sulfate pentahydrate has the following structural formula:
Morphine base has a pKa of 7.9, with an octanol/water partition coefficient of 1.42 at physiologic pH 7.4. At this pH, morphine’s tertiary amino group is mostly ionized, making the molecule water-soluble.
DepoDur is a sterile, non-pyrogenic, white to off-white, preservative-free suspension of multivesicular lipid-based particles containing Morphine Sulfate, USP. The median diameter of the liposome particles is in the range of 17 to 23 μm. The liposomes are suspended in a 0.9% sodium chloride solution. Each vial contains morphine sulfate (expressed as the pentahydrate) at a nominal concentration of 10 mg/mL. Inactive ingredients and their approximate concentrations are: 1,2-dioleoyl-sn-glycero-3‑phosphocholine (DOPC), 4.2 mg/mL; cholesterol, 3.3 mg/mL; 1,2-dipalmitoyl-sn-glycero-3‑phospho-rac-(1-glycerol) (DPPG), 0.9 mg/mL; tricaprylin, 0.3 mg/mL; and triolein, 0.1 mg/mL. The pH of DepoDur is in the range of 5.0 to 8.0.
After the administration of DepoDur into the epidural space, morphine sulfate is released from the multivesicular liposomes over a period of time.
Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. DO NOT SUBSTITUTE.
Sources
Depodur Manufacturers
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Pacira Pharmaceuticals Inc.
![Depodur (Morphine Sulfate) Injection, Lipid Complex [Pacira Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Depodur | Pacira Pharmaceuticals Inc.
DepoDur is intended only for lumbar epidural administration prior to surgery or after clamping of the umbilical cord during cesarean section. DepoDur may be administered via needle or catheter at the lumbar level. Administration of DepoDur at the thoracic level or higher is not recommended because it has not been studied. DepoDur may be administered undiluted or may be diluted up to 5 mL total volume with PRESERVATIVE-FREE 0.9% normal saline.
Vials of DepoDur should be gently inverted to re-suspend the particles immediately prior to withdrawal from the vial. Avoid aggressive agitation. No further reconstitution or dilution is required.
For major orthopedic surgery of the lower extremity the recommended dose of DepoDur is 15 mg. For lower abdominal or pelvic surgery, the recommended dose of DepoDur is 10-15 mg. Some patients may benefit from a 20-mg dose of DepoDur, but the incidence of serious adverse respiratory events was dose-related in clinical trials. For cesarean section, the recommended dose is 10 mg.
DepoDur should be administered to elderly patients (>65 years) after careful evaluation of their underlying medical condition and consideration of the risks associated with DepoDur. Vigilant perioperative monitoring should be exercised for elderly patients receiving DepoDur. In general, as with all opiates, the dose for elderly or debilitated patients should be at the low end of the dosing range.
While DepoDur is indicated for women undergoing cesarean section following clamping of the umbilical cord, DepoDur should not be administered to women for vaginal labor and delivery.
The safety and effectiveness of DepoDur in pediatric patients below the age of 18 years have not been established and use in this population is not recommended.
DepoDur should be administered by or under the direct supervision of a physician experienced in the technique of epidural administration and who is thoroughly familiar with the risks associated with the drug product. It should be administered only in settings where there is adequate patient monitoring. Resuscitative equipment and a specific antagonist (naloxone injection) should be immediately available for the management of respiratory depression. Patient monitoring should be continued for at least 48 hours after dosing, as delayed respiratory depression may occur (see WARNINGS).
Improper placement of a needle or catheter in the epidural space should be ruled out before DepoDur is injected. Techniques to detect improper placement of a needle or catheter include: a) aspiration to check for the presence of blood or cerebrospinal fluid and/or b) administration of a 3-mL test dose of 1.5% PRESERVATIVE-FREE lidocaine and epinephrine (1:200,000). If a test dose is administered, the patient should be observed for tachycardia or sudden onset of segmental anesthesia, indicating that intrathecal injection has occurred. To minimize a pharmacokinetic interaction of DepoDur with the test dose, flush the epidural catheter with 1 mL of PRESERVATIVE-FREE 0.9% normal saline and wait at least 15 minutes after administration of the test dose.
Do not mix DepoDur with any other medications. Once DepoDur has been administered, no other medication should be administered into the epidural space for at least 48 hours.
Do not use an in-line filter during administration of DepoDur.
Although DepoDur is a sterile agent, it does not contain any bacteriostatic agents. Therefore, DepoDur must be administered within 4 hours after withdrawal from the vial. Do not heat-sterilize or gas-sterilize.
Discard any unused portion in a manner appropriate for Schedule II substances.
PROTECT DEPODUR FROM FREEZING. DO NOT ADMINISTER DEPODUR IF IT IS SUSPECTED THAT THE VIAL HAS BEEN FROZEN.
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