DepoDur

Morphine epidural injection is used to relieve pain following a major surgery. It is given right before a surgery or during a cesarean section delivery right after the baby's umbilical cord is clamped.

Morphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

This medicine is available only with your doctor's prescription and will be given by or under the immediate supervision of your doctor.

• If you have an allergy to morphine or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Very bad asthma, trouble breathing, recent head injury, growths or tumors in the brain, raised pressure in the brain, or very bad bowel or stomach problems like bowel block.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking DepoDur within 14 days of those drugs can cause very bad high blood pressure.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take DepoDur with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Slow heartbeat.
• Trouble breathing, slow breathing, or shallow breathing.
• A burning, numbness, or tingling feeling that is not normal.
• Seizures.
• Trouble passing urine.
• Very bad belly pain.
• Very hard stools (constipation).
• Feeling very tired or weak.
• Fever or chills.
• Very bad headache.
• Sweating a lot.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• Taking an opioid drug like DepoDur may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Headache.
• Not able to sleep.
• Gas.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with morphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Caution is recommended. Dosage reductions should be considered.

The dosing regimen of this drug should be adjusted for each patient individually, taking into account prior analgesic treatment experience. In the selection of the initial dose consider the following:
-Different formulations of this drug are not bioequivalent. When switching a patient from one form to another, consult the product labeling or local protocol.
-The total daily dose and potency of the opioid the patient took previously.
-The degree of opioid tolerance of the patient
-The general condition and medical status of the patient
-Concurrent medications
-Type and severity of the pain
-Risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.

-As needed "rescue doses" of immediate release oral formulations may be needed for patients with cancer pain. The need for more than 2 rescue doses per day may require a review of the controlled release dose.
-The parenteral morphine tartrate and sulfate salt formulations contain almost an equivalent amount of morphine base per milligram, and may be used interchangeably.
-Morphine sulfate controlled release oral formulations have not been shown to be bioequivalent; adjustment between these formulations should be done with caution and careful titration.
-This drug should be used with caution in patients greater than 50 years of age, debilitated patients, and patients with impaired respiratory function; doses may need to be reduced by up to half of the usual daily adult dose.
-Titrate dosage slowly upward, taking into consideration the dosages received for breakthrough pain, to meet the specific needs of the patient.
-Factors such as age, disease state, concomitant drug therapy, analgesic history, and tolerance to narcotics can have variable but important effects on dose and response. In some patients with severe, chronic pain, it may be necessary to exceed the usual dose. Doses should be maintained at the lowest effective dose.
-Dosage reductions may be required with concomitant CNS depressant therapy.
-Patients may initially experience drowsiness or increased sedation due to exhaustion that may be mistaken as excessive analgesia. Initial doses should be maintained for at least 3 days before any dose reduction, as long as sedation is not excessive or associated with unsteadiness, and confusion, and that respiratory activity and other vital signs are adequate.
-The daily dose should be gradually tapered to minimize or prevent withdrawal symptoms.
-Caution and reduced doses are recommended with concomitant use of other narcotic analgesics, general anesthetics, phenothiazines, and other tranquillizers, sedatives/hypnotics, tricyclic antidepressants, and other CNS depressants, including alcohol.
-Continual reevaluation of the patient receiving this drug is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for non-cancer related pain, the continued need for the use of opioid analgesics should be periodically reassessed.

• Morphine is an analgesic (pain-reliever) that binds to mu opioid receptors in the brain and stomach. Morphine has very strong pain relieving effects and it may be used to relieve moderate-to-severe pain that is unresponsive to other, less potent, pain-relieving medicines.
• Morphine belongs to the group of medicines known as narcotic analgesics. It may also be called an opioid analgesic.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nausea, vomiting, dizziness, blurred vision, rashes and sweating. Constipation caused by morphine may be severe and laxatives are typically required.
• Drowsiness which may affect a person's ability to drive or operate machinery. Avoid alcohol at all times (alcohol can increase blood levels of the drug leading to fatal overdosage).
• Rarely, serious, life-threatening, breathing problems may occur. The risk is greater with slow-release forms, in people with pre-existing respiratory disease, in seniors or the frail, or in those taking other medications that cause respiratory depression (such as benzodiazepines).
• There is a large variability in the way different people respond to morphine.
• Known to cause addiction and dependence and may be misused or sought after by drug addicts. The risk is higher in people with psychiatric disorders. Legitimate supplies of products containing morphine may be sought out by drug seekers.
• Abrupt discontinuation of any morphine-containing medication in a person who has become physically dependent on it may lead to a withdrawal syndrome and symptoms such as restlessness, pupil dilation, watery eyes and a runny nose, sweating, muscle aches, insomnia, irritability and gastrointestinal complaints. Babies born to mothers who are physically dependent on morphine will also be physically dependent.
• Interaction or overdosage may also cause serotonin syndrome. Symptoms include mental status changes such as agitation, hallucinations, coma, or delirium; a fast heart rate; dizziness; flushing; muscle tremor or rigidity; and stomach symptoms (including nausea, vomiting, and diarrhea).
• May not be suitable for people with pre-existing respiratory depression or respiratory disease, with seizure disorders or a head injury, people with gastrointestinal obstruction, or recent use of monoamine oxidase inhibitors.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

• The pain-relieving effects of morphine are usually seen within 60 minutes and may last up to 15 hours. The onset of effect and the duration of action depends on the formulation of morphine used.

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Applies to morphine liposomal: epidural suspension

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Slow heartbeat.
• Trouble breathing, slow breathing, or shallow breathing.
• A burning, numbness, or tingling feeling that is not normal.
• Seizures.
• Trouble passing urine.
• Very bad belly pain.
• Very hard stools (constipation).
• Feeling very tired or weak.
• Fever or chills.
• Very bad headache.
• Sweating a lot.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• Taking an opioid drug like this drug may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.

Morphine is excreted into human milk in trace amounts. Adverse effects in the nursing infant are unlikely. Morphine is considered compatible with breast-feeding by the American Academy of Pediatrics.