Embeda (generic: morphine/naltrexone) is a prescription medication used to treat moderate to severe around-the-clock pain. It is formulated in a manner to reduce the potential for abuse. It is a single capsule containing two prescription medications, morphine and naltrexone. By adding naltrexone, a medication that counteracts the effects of morphine, Embeda is less likely to be abused by snorting or injecting it. Morphine belongs to a group of drugs called opioid analgesics, which help relieve pain.
This medication comes in capsule form and is usually taken once or twice daily. Embeda capsules must be swallowed whole.
Common side effects of Embeda include constipation, nausea, and sleepiness. Do not drive or operate heavy machinery or drink alcohol while taking Embeda.
Tell your healthcare provider if you are pregnant or planning to become pregnant. Embeda may harm your unborn baby.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:
- alvimopan (Entereg)
- antidepressant medicines
- antihistamines
- antipsychotic medicines such as aripiprazole (Abilify), clozapine (Clozaril), olanzapine (Zyprexa), pimozide (Orap), ziprasidone (Geodon) and others.
- barbiturates such as amobarbital (Amytal), butalbital (Fioricet, Fiorinal), pentobarbital (Nembutal), phenobarbital (Luminal), secobarbital (Seconal)
- benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium, Limbitrol, Librax), clobazam (Onfi), clonazepam (Klonopin) and others.
- cimetidine (Tagamet)
- diuretics such as amiloride (Midamor), chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (HydroDiuril), metolazone (Zaroxolyn), spironolactone (Aldactone), triamterene (Dyrenium) and others.
- monoamine oxidase inhibitors (MAOIs) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), tranylcypromine (Parnate) and others.
- muscle relaxants such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Flexeril), metaxalone (Skelaxin) and others.
- other narcotics or opiates
- quinidine
- sleep medicines
This is not a complete list of Embeda drug interactions. Ask your doctor or pharmacist for more information.
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
Abuse Potential
Embeda contains pellets of morphine sulfate, an opioid agonist, with a sequestered core of naltrexone hydrochloride, an opioid receptor antagonist. Morphine sulfate is a Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient’s risk for opioid abuse or addiction prior to prescribing Embeda. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving Embeda for signs of misuse, abuse, and addiction during treatment.
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of Embeda, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential and Embeda should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of Embeda or following a dose increase. Instruct patients to swallow Embeda capsules whole or to sprinkle the contents of the capsule on applesauce and swallow immediately without chewing. Crushing, dissolving, or chewing the pellets within the capsule can cause rapid release and absorption of a potentially fatal dose of morphine.
Accidental Exposure
Accidental ingestion of Embeda, especially in children, can result in a fatal overdose of morphine.
Interaction with Alcohol
The co-ingestion of alcohol with Embeda may result in an increase of plasma levels and potentially fatal overdose of morphine. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on Embeda therapy.
When taking Embeda:
- Do not change your dose. Take Embeda exactly as prescribed by your healthcare provider.
- Take your prescribed dose at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take Embeda as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at the same time unless your healthcare provider tells you to.
- Swallow Embeda whole. Do not cut, break, chew, crush, dissolve, or inject Embeda. You should not receive Embeda through a nasogastric tube or gastric tube (stomach tube).
- If you cannot swallow Embeda capsules, see the detailed Instructions for Use.
- Call your healthcare provider if the dose you are taking does not control your pain.
- Do not stop taking Embeda without talking to your healthcare provider.
- After you stop taking Embeda, flush any unused capsules down the toilet.
While taking Embeda Do Not:
- Drive or operate heavy machinery, until you know how Embeda affects you. Embeda can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
Instructions For Use
- If you cannot swallow Embeda capsules, tell your healthcare provider. There may be another way to take Embeda that may be right for you. If your doctor tells you that you can take Embeda using this other way, follow these steps:
- Embeda can be opened and the pellets inside the capsule can be sprinkled over apple sauce, as follows:
- Open the Embeda capsule and sprinkle the pellets over approximately one tablespoon of apple sauce .
- Swallow all of the apple sauce and pellets right away. Do not save any of the apple sauce and pellets for another dose .
- Rinse your mouth to make sure you have swallowed all of the pellets. Do not chew the pellets.
- Flush the empty capsule down the toilet right away.
- You should not receive Embeda through a nasogastric tube or gastric tube (stomach tube).
- Embeda can be opened and the pellets inside the capsule can be sprinkled over apple sauce, as follows:
- Get emergency help right away if you take too much Embeda (overdose). Embeda overdose can cause life threatening breathing problems that can lead to death.
- Never give anyone else your Embeda. They could die from taking it. Store Embeda away from children and in a safe place to prevent stealing or abuse. Selling or giving away Embeda is against the law.
Do not take Embeda if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Do Not:
- Drive or operate heavy machinery, until you know how Embeda affects you. Embeda can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
Embeda is a prescription medication used to treat moderate to severe around-the-clock pain.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Before taking Embeda, tell your healthcare provider if you have a history of:
- head injury, seizures
- problems urinating
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Embeda may harm your unborn baby.
- breastfeeding. Embeda passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
If you take too much Embeda, seek emergency medical attention right away.
Tell your healthcare provider if you are breastfeeding. Embeda passes into breast milk and may harm your baby.
The possible side effects of Embeda are:
- constipation
- nausea
- sleepiness
- vomiting
- tiredness
- headache
- dizziness
- abdominal pain
Call your healthcare provider if you have any of these symptoms and they are severe
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, or you are feeling faint.
These are not all the possible side effects of Embeda. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Store Embeda capsules at room temperature between 15° and 30°C (59° and 86°F).
Keep Embeda and all medicines out of the reach of children.