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.
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 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:
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:
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any type of breathing problem or lung disease;
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a history of head injury, brain tumor, or seizures;
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a history of drug abuse, alcohol addiction, or mental illness;
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enlarged prostate, urination problems;
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liver or kidney disease;
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curvature of the spine that affects your breathing;
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Addison"s disease (an adrenal gland disorder);
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problems with your gallbladder, pancreas, or thyroid.
It is not known whether Embeda will harm an unborn baby. If you use morphine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
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.
Do not keep leftover Embeda capsules. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused capsules 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:
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weak or shallow breathing;
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a light-headed feeling, like you might pass out;
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seizure (convulsions); or
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agitation, hallucinations, fast heart rate, overactive reflexes, loss of coordination.
Morphine and naltrexone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
Common Embeda side effects may include:
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constipation, nausea, vomiting, stomach pain;
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drowsiness, dizziness; or
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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.
