Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3497
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DepoDur (Injection, Lipid Complex)
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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 . 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 interactionof 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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morphine sulfate
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DepoDur (Injection, Lipid Complex)
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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.
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DepoDur
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