This medication is used to treat pain after major surgery. It acts on certain centers in the brain to give you pain relief. This drug is a long-acting narcotic pain reliever (opiate-type).

This medication is approved only for single epidural use. Giving it by any other routes may lead to serious breathing problems (e.g., very slow and shallow breathing).

This drug should be given only by a trained healthcare professional. It is given by injection into the epidural space of the spine with a needle or through a catheter at the lower back (lumbar) level. It can be given before surgery or after clamping the umbilical cord during a cesarean section delivery.

This medication is a suspension of fat-soluble particles containing morphine. Before using, gently invert the vial to re-suspend the particles. Inspect the vial for any discoloration. Do not use the vial if it has been or appears frozen. This medication should not be given through a filter or mixed with any other medications.

Dosage is based on your medical condition and the type of surgical procedure.

If you have been using other pain medications before surgery, withdrawal reactions (e.g., anxiety, irritability, sweating, trouble sleeping, diarrhea) may occur. Report any such reactions to your doctor immediately.

Inform your doctor if your pain persists or worsens.

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.

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 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 medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding during the first 48 hours after using this drug is not recommended. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: naltrexone.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin, heparin, enoxaparin), other epidural medications (e.g., local anesthetics), corticosteroids (e.g., hydrocortisone, methylprednisolone), other pain medications (e.g., butorphanol, pentazocine, tramadol), anti-seizure drugs (e.g., carbamazepine, phenobarbital, phenytoin), drugs that lower blood pressure (e.g., diuretics such as hydrochlorothiazide, furosemide), muscle relaxants (e.g., carisoprodol, cyclobenzaprine), pyridostigmine, sodium oxybate.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness, such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), medicine for sleep (e.g., sedatives), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclic antidepressants such as amitriptyline), tranquilizers.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slowed/shallow breathing, excessive drowsiness, slowed heartbeat, persistent dizziness/fainting, or loss of consciousness.

Do not share this medication with others. It is against the law.

This medication is intended only for one-time use following surgery.

Refrigerate between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted for up to 7 days if the vial is unopened.

After the medication is removed from the vial, it may be stored between 59-86 degrees F (15-30 degrees C) for up to 4 hours. Throw away any unused drug properly.

Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.