Recommended Topic Related To:

DepoDur

"Types (classes) of pain medication

Pain medications are drugs used to relieve discomfort associated with disease, injury, or surgery. Because the pain process is complex, there are many types of pain drugs that provide relief by acting "...

DepoDur

Indications
Dosage
How Supplied

INDICATIONS

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 (morphine sulfate xr liposome injection) is administered prior to surgery or after clamping the umbilical cord during cesarean section.

DepoDur (morphine sulfate xr liposome injection) is not intended for intrathecal, intravenous or intramuscular administration. Administration of DepoDur (morphine sulfate xr liposome injection) into the thoracic epidural space or higher has not been evaluated and therefore is not recommended.

DOSAGE AND ADMINISTRATION

DepoDur (morphine sulfate xr liposome injection) is intended only for lumbar epidural administration prior to surgery or after clamping of the umbilical cord during cesarean section. DepoDur (morphine sulfate xr liposome injection) may be administered via needle or catheter at the lumbar level. Administration of DepoDur (morphine sulfate xr liposome injection) at the thoracic level or higher is not recommended because it has not been studied. DepoDur (morphine sulfate xr liposome injection) may be administered undiluted or may be diluted up to 5 mL total volume with PRESERVATIVE-FREE 0.9% normal saline.

Vials of DepoDur (morphine sulfate xr liposome injection) 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 (morphine sulfate xr liposome injection) is 15 mg. For lower abdominal or pelvic surgery, the recommended dose of DepoDur (morphine sulfate xr liposome injection) is 10-15 mg. Some patients may benefit from a 20-mg dose of DepoDur (morphine sulfate xr liposome injection) , but the incidence of serious adverse respiratory events was dose-related in clinical trials. For cesarean section, the recommended dose is 10 mg.

For any given level of pain, patients differ widely in their opiate requirements. It is critical to adjust the dose of DepoDur (morphine sulfate xr liposome injection) 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.

DepoDur (morphine sulfate xr liposome injection) should be administered to elderly patients ( > 65 years) after careful evaluation of their underlying medical condition and consideration of the risks associated with DepoDur (morphine sulfate xr liposome injection) . Vigilant perioperative monitoring should be exercised for elderly patients receiving DepoDur (morphine sulfate xr liposome injection) . 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 (morphine sulfate xr liposome injection) is indicated for women undergoing cesarean section following clamping of the umbilical cord, DepoDur (morphine sulfate xr liposome injection) should not be administered to women for vaginal labor and delivery.

The safety and effectiveness of DepoDur (morphine sulfate xr liposome injection) in pediatric patients below the age of 18 years have not been established and use in this population is not recommended.

DepoDur (morphine sulfate xr liposome injection) 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 (morphine sulfate xr liposome injection) 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 (morphine sulfate xr liposome injection) 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. To minimize a pharmacokinetic interaction of DepoDur (morphine sulfate xr liposome injection) with a previously administered analgesic dose of bupivacaine (0.25%, 20 mL), flush the epidural catheter with 1 mL of PRESERVATIVE-FREE 0.9% normal saline and wait at least 30 minutes after administration of the bupivacaine.

Do not mix DepoDur (morphine sulfate xr liposome injection) with any other medications. Once DepoDur (morphine sulfate xr liposome injection) 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 (morphine sulfate xr liposome injection) .

Although DepoDur (morphine sulfate xr liposome injection) is a sterile agent, it does not contain any bacteriostatic agents. Therefore, DepoDur (morphine sulfate xr liposome injection) 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 (morphine sulfate xr liposome injection) FROM FREEZING. DO NOT ADMINISTER DEPODUR (morphine sulfate xr liposome injection) IF IT IS SUSPECTED THAT THE VIAL HAS BEEN FROZEN.

SAFETY AND HANDLING INSTRUCTIONS

DepoDur (morphine sulfate xr liposome injection) consists of morphine encapsulated in multivesicular lipid-based particles that pose no known risk of handling to healthcare workers. Vials of DepoDur (morphine sulfate xr liposome injection) should be gently inverted to re-suspend the particles immediately prior to withdrawal from the vial. Each vial of DepoDur (morphine sulfate xr liposome injection) contains a potent opiate that has been associated with abuse and dependence among health care providers. Appropriate measures should be taken to control this product within the hospital or clinic including rigid accounting, rigorous control of wastage, and restricted access.

Protect DepoDur (morphine sulfate xr liposome injection) from freezing. Do not administer DepoDur (morphine sulfate xr liposome injection) if it is suspected that the vial has been frozen. Each carton of DepoDur (morphine sulfate xr liposome injection) includes a freeze indicator that should be checked prior to administration of the product. Do not administer DepoDur (morphine sulfate xr liposome injection) , if the bulb of the freeze indicator has changed from clear to pink or purple, as this indicates that the product may have frozen. Freezing may adversely affect the modified release mechanism of DepoDur (morphine sulfate xr liposome injection) .

As a convenience to the hospital pharmacist, each carton of DepoDur (morphine sulfate xr liposome injection) includes pharmacy stickers for noting when each vial has been removed from refrigeration and advising to resuspend just prior to use. Following withdrawal from the vial DepoDur (morphine sulfate xr liposome injection) may be held at 15° to 30°C (59° to 86°F) for up to 4 hours prior to administration.

HOW SUPPLIED

Preservative-free DepoDur (morphine sulfate extended- release liposome injection) is available in 10 mg/mL single-use, amber vials for epidural administration.

10 mg/1 mL vial packaged in cartons of 5 (NDC 24477-020-04)

15 mg/1.5 mL vial packaged in cartons of 5 (NDC 24477-020-05)

Storage

Protect from freezing. DepoDur (morphine sulfate xr liposome injection) should be routinely stored in the refrigerator at 2° to 8°C (36° to 46°F). Keep DepoDur (morphine sulfate xr liposome injection) vials in carton during refrigeration. DepoDur (morphine sulfate xr liposome injection) may be held at controlled room temperature for up to 30 days in sealed, intact (unopened) vials. Vials stored at controlled room temperature may be separated from the carton, but should not be returned to a refrigerator. Discard vials that have been stored at room temperature for over 30 days

Manufactured for: EKR Therapeutics, Inc. Bedminster NJ 07921. Manufactured by: Pacira Pharmaceuticals, San Diego, CA 92121. November, 2008

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

Indications
Dosage
How Supplied
A A A

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.


Chronic Pain/Back Pain

Find tips and advances in treatment.