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In addition to requiring new labeling on these prescript"...
(morphine sulfate) Extended-Release Liposome Injection
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 (morphine sulfate xr liposome injection) 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 (morphine sulfate xr liposome injection) 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.
What are the precautions when taking morphine sulfate xr liposome injection (DepoDur)?
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain relievers (e.g., hydromorphone, oxymorphone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood clotting problems, brain disorders (e.g., seizure, head injury, increased intracranial pressure), adrenal gland problems (e.g., Addison's disease), difficulty urinating (e.g., enlarged prostate, urethral stricture), current infection, heart problems (e.g., low blood pressure, irregular heartbeat), breathing problems (e.g., asthma,...
Last reviewed on RxList: 10/13/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional DepoDur Information
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