Medication Guide App

Embeda

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

What is Embeda?

Embeda contains a combination of 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.

Embeda is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long time period.

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

Embeda may also be used for purposes not listed in this medication guide.

Important information

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

Do not use Embeda 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.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Embeda can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take Embeda 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.

Embeda may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN 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. Embeda 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.

Before taking this medicine

Do not use Embeda 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 Embeda 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 Embeda 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.

Morphine may be habit-forming. Never share Embeda 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. Selling or giving away Embeda to any other person is against the law.

To make sure Embeda 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.

Embeda 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 Embeda 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.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

How should I use Embeda?

Take Embeda exactly as prescribed. Follow all directions on your prescription label. Embeda can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take 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.

Embeda may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Stop taking all other around-the-clock narcotic pain medications when you start taking Embeda.

You may take this medicine with or without food. Embeda 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 Embeda suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Never crush or break a tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store at room temperature away from moisture, heat, and light. Keep track of the amount of medicine used from each new bottle. Embeda 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.

What happens if I miss a dose?

Since Embeda 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.

Embeda 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 Embeda 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?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Embeda. 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 Embeda will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Embeda side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Embeda: 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 Embeda 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)

What other drugs will affect Embeda?

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 Embeda with a sleeping pill, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with Embeda, 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 Embeda.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine 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 1996-2014 Cerner Multum, Inc. Version: 5.01. Revision Date: 2014-01-13, 5:51:22 PM.

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