DepoDur

DRUG 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.

Chemically, morphine sulfate is 7, 8-didehydro-4, 5?-epoxy-17-methylmorphinan-3, 6? -diol sulfate (2:1) (salt) pentahydrate with a molecular weight of 758. Morphine sulfate pentahydrate has the following structural formula:

DepoDur (morphine sulfate) Structural Formula Illustration

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: serious breathing problems (e.g., severe asthma, respiratory depression, upper airway obstruction), certain bowel diseases (e.g., paralytic ileus), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or...

Read All Potential Precautions of DepoDur »


DepoDur Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, headache, mild itching, drowsiness, or lightheadedness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular/shallow breathing, dizziness upon standing, slow/fast/irregular heartbeat, mental/mood changes, severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: serious breathing problems (e.g., severe asthma, respiratory depression, upper airway obstruction), certain bowel diseases (e.g., paralytic ileus), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

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), lung diseases (e.g., chronic obstructive pulmonary disease, hypercapnia, hypoxia), metabolic disorders (e.g., dehydration), disease of the pancreas (pancreatitis), psychiatric problems (e.g., toxic psychosis), sleep apnea, spinal problems (kyphoscoliosis), stomach/intestinal problems (e.g., gallbladder disease, obstruction), underactive thyroid (hypothyroidism), personal or family history of regular use/abuse of drugs/alcohol/other substances.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects (e.g., slow/shallow breathing and drowsiness).

This medication should be used only when clearly needed during pregnancy. It is not recommended for use near or at the time of vaginal delivery. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.



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