DepoDur^®

(morphine sulfate extended-release liposome injection)

Description:
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.

Indication:
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.

Additional information about DepoDur^® is available at www.depodur.com

Full Prescribing Information

Important Safety Information
DepoDur (morphine sulfate extended-release liposome injection) is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. DepoDur, as with all opiates, is contraindicated in patients with respiratory depression, acute or severe bronchial asthma, and upper airway obstruction. Any contraindications for an epidural injection preclude the administration of DepoDur. DepoDur, as with all opiates, is contraindicated in any patient who has or is suspected of having paralytic ileus. DepoDur should not be used in patients with suspected or known head injury or increased intracranial pressure.

DepoDur is an opiate analgesic which causes vasodilatation that may exacerbate hypotension and hypoperfusion and, therefore, is contraindicated in circulatory shock.

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.

It is critical to adjust the dose of DepoDur for each individual patient, taking into account the patient’s age, body mass, physical status, prior experience with opiate analgesics, risk factors for respiratory depression, and medications to be co-administered before or during surgery.

Epidural local anesthetics should not be used before or after DepoDur, except in the form of a test dose of lidocaine and epinephrine or an analgesic dose of bupivacaine. 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.

Patients must be observed in a fully equipped and staffed environment for at least 48 hours after administration, as delayed respiratory depression may occur. 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.

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. 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.

The most common adverse events (greater than 10%) reported at least once during clinical trials in patients treated with DepoDur were decreased oxygen saturation, hypotension, urinary retention, vomiting, constipation, nausea, pruritus, pyrexia, anemia, headache, and dizziness.

Protect DepoDur from freezing. Do not administer DepoDur if it is suspected that the vial has been frozen. DepoDur is a Schedule II controlled substance and is subject to abuse and diversion.

DepoDur^® is a licensed trademark of EKR Therapeutics, Inc., Bedminster, NJ, USA.
DepoDur is manufactured for EKR Therapeutics, Inc., by Pacira Pharmaceuticals, Inc., of San Diego, CA.