morphine and naltrexone

Pronunciation

Generic Name: morphine and naltrexone (MOR feen and nal TREX one)
Brand Name: Embeda

What is morphine and naltrexone?

Morphine is an opioid pain medication. An opioid is sometimes called a narcotic.

Naltrexone is a special narcotic drug that blocks the effects of other narcotic medicines and alcohol.

Morphine and naltrexone is a combination medicine used to treat moderate to severe pain when around-the-clock pain relief is needed for a long time period.

Morphine and naltrexone is an extended-release opioid pain medicine that is not for use on an as-needed basis for pain.

Morphine and naltrexone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about morphine and naltrexone?

You should not use morphine and naltrexone if you have severe asthma or breathing problems, or a bowel obstruction called paralytic ileus.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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Morphine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose. Morphine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tell your doctor if you are pregnant. Morphine and naltrexone may cause life-threatening addiction and withdrawal symptoms in a newborn.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with morphine and naltrexone.

What should I discuss with my healthcare provider before taking morphine and naltrexone?

Do not use morphine and naltrexone if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use morphine and naltrexone if you have ever had an allergic reaction to a narcotic medicine, or if you have:

  • severe asthma or breathing problems; or

  • a bowel obstruction called paralytic ileus.

You should not use morphine and naltrexone unless you are already using a similar opioid medicine and are tolerant to it. Opioid medicines include codeine (Tylenol #3), fentanyl (Abstral, Actiq, Fentora, Duragesic, Lazanda, Onsolis), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid, Palladone), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Combunox, Roxicodone, Percocet), and many others. Ask your doctor if you are not sure you are opioid-tolerant.

To make sure morphine and naltrexone is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • a history of head injury, brain tumor, or seizures;

  • a history of drug abuse, alcohol addiction, or mental illness;

  • enlarged prostate, urination problems;

  • liver or kidney disease;

  • curvature of the spine that affects your breathing;

  • Addison's disease (an adrenal gland disorder);

  • problems with your gallbladder, pancreas, or thyroid.

Morphine and naltrexone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

FDA pregnancy category C. It is not known whether morphine and naltrexone will harm an unborn baby. Morphine and naltrexone may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

Morphine and naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using morphine and naltrexone.

How should I use morphine and naltrexone?

Follow all directions on your prescription label. Morphine can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Morphine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away morphine and naltrexone is against the law.

Stop taking all other around-the-clock narcotic pain medications when you start taking morphine and naltrexone.

You may take morphine and naltrexone with or without food. Morphine and naltrexone is usually taken 1 or 2 times each day. Each dose should be spaced at least 12 hours apart. Follow your doctor's instructions.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

To make swallowing easier, you may open the extended-release capsule and sprinkle the medicine into a spoonful of applesauce. Mix only one dose and swallow this mixture right away without chewing. Drink a glass of water to make sure all the medicine has been swallowed. Flush the empty capsule down a toilet.

Do not stop using morphine and naltrexone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using morphine and naltrexone.

Never crush or break a morphine and naltrexone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of morphine and naltrexone and similar prescription drugs.

Store at room temperature away from moisture, heat, and light. Keep track of the amount of medicine used from each new bottle. Morphine and naltrexone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety. Throw away any unused liquid morphine and naltrexone that is older than 90 days.

What happens if I miss a dose?

Since morphine and naltrexone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Morphine and naltrexone is not for use on an as-needed basis for pain.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A morphine and naltrexone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while using morphine and naltrexone?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with morphine and naltrexone. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how morphine and naltrexone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Morphine and naltrexone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; chest pain, anxiety, pounding heartbeats, fainting; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • weak or shallow breathing;

  • a light-headed feeling, like you might pass out;

  • seizure (convulsions); or

  • agitation, hallucinations, fast heart rate, overactive reflexes, loss of coordination.

Common side effects may include:

  • constipation, nausea, vomiting, stomach pain;

  • drowsiness, dizziness; or

  • headache, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Morphine and naltrexone dosing information

Usual Adult Dose for Pain:

It is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In selecting an initial dose, attention should be given to:
1) the total daily dose, potency, and kind of opioid the patient has been taking previously;
2) the reliability of the relative potency estimate used to calculate the equivalent dose of morphine needed;
3) the patient's degree of opioid experience and opioid tolerance;
4) the general condition and medical status of the patient;
5) concurrent medication(s);
6) the type and severity of the patient's pain.

The following dosing recommendations can be considered approaches to what is actually a series of clinical decisions over time in the management of the pain of an individual patient.

Care should be taken to use low initial doses in patients who are not already opioid tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications. Patients may subsequently be titrated to a once a day or twice a day dosage which adequately maintains their pain.

Other oral morphine formulations may be converted to morphine-naltrexone by administering one-half of the patient's total daily oral morphine dose as morphine-naltrexone every 12 hours or by administering the total daily oral morphine dose as morphine-naltrexone once every 24 hours. Morphine-naltrexone should not be given more frequently than every 12 hours. It is better to underestimate the patient's 24 hour oral morphine requirement and provide rescue medication than to overestimate and manage an adverse event.

Morphine-naltrexone can be administered to patients previously receiving treatment with parenteral morphine or other opioids.
Parenteral to Oral Morphine Ratio:
It may take anywhere from 2 to 6 mg of oral morphine to provide analgesia equivalent to 1 mg of parenteral morphine. A dose of oral morphine three times the daily parenteral morphine requirement may be sufficient in chronic use settings.
Other Oral or Parenteral Opioids to Oral Morphine Sulfate:
There is a lack of systematic evidence available on these types of analgesic substitutions. Therefore, specific recommendations are not possible.

The first dose of morphine-naltrexone may be taken with the last dose of any immediate release (short acting) opioid medication due to the extended release characteristics of morphine-naltrexone.

What other drugs will affect morphine and naltrexone?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking morphine and naltrexone with a sleeping pill, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with morphine and naltrexone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about morphine and naltrexone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2014-01-13, 5:51:22 PM.

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