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 in a group of drugs called narcotic pain relievers. 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 not for treating pain just after surgery unless you were already taking morphine and naltrexone before the surgery.

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

Important information about Embeda

Do not use Embeda if you have ever had an allergic reaction to a narcotic medicine, if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Before taking Embeda, tell your doctor if you have a breathing disorder, liver or kidney disease, underactive thyroid, curvature of the spine, a history of head injury or brain tumor, gallbladder or pancreas disorders, a blockage in your stomach or intestines, Addison's disease, enlarged prostate, urination problems, a seizure disorder, a debilitating condition, mental illness, or a history of drug or alcohol addiction.

Do not drink alcohol while you are using Embeda. Dangerous side effects or death can occur.

Never take more than your prescribed dose of Embeda. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Before using Embeda

You may not be able to take Embeda unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not use Embeda if you have ever had an allergic reaction to a narcotic medicine. Opioid medicines include codeine (Tylenol #3), hydrocodone (Vicodin), oxycodone (OxyContin, Percocet), propoxyphene (Darvon, Darvocet), morphine (Kadian, MS Contin, Oramorph), and many others.

You should also not take Embeda if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Do not use Embeda if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use Embeda before the MAO inhibitor has cleared from your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Embeda:

• asthma, COPD, sleep apnea, or other breathing disorders;

• liver or kidney disease;

• underactive thyroid;

• curvature of the spine;

• a history of head injury or brain tumor;

• gallbladder or pancreas disorders;

• a blockage in your stomach or intestines;

• Addison's disease or other adrenal gland disorders;

• enlarged prostate, urination problems;

• epilepsy or other seizure disorder;

• any type of debilitating condition; or

• mental illness or a history of drug or alcohol addiction.

Embeda may be habit-forming and should be used only by the person it was prescribed for. Embeda should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

FDA pregnancy category C. Embeda may cause addiction or withdrawal symptoms in a newborn. Before you receive Embeda, tell your doctor if you are pregnant. This medicine should not be used during labor and delivery. Morphine and naltrexone can pass into breast milk and may harm a nursing baby. Do not use Embeda without telling your doctor if you are breast-feeding a baby.

See also: Embeda pregnancy and breastfeeding warnings (in more detail)

Older adults may be more sensitive to the effects of this medicine.

How should I use Embeda?

Use Embeda exactly as it was prescribed for you. Never take Embeda in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Each dose should be spaced at least 12 hours apart.

Do not crush, chew, or dissolve the medicine pellets inside an Embeda extended-release capsule. If possible, swallow the pill whole. Crushing or chewing the medicine pellets would cause too much of the drug to be released at one time, which may cause a life-threatening overdose.

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. Talk to your doctor about how to avoid withdrawal symptoms.

Store Embeda at room temperature, away from heat, moisture, and light.

Keep track of how many pills have been used from each new bottle of this medicine. Embeda is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet. Throw away any unused liquid Embeda that is older than 90 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly 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 if you think you have used too much of this medicine. An overdose of Embeda can be fatal. Overdose symptoms may include extreme drowsiness or limp feeling, pinpoint or dilated pupils, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while using Embeda?

Do not drink alcohol while you are taking Embeda. Dangerous side effects or death can occur when alcohol is combined with Embeda. This medicine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Embeda side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Embeda: hives; fast or pounding heartbeats, chest pain, difficulty breathing; dizziness, extreme fear; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• mood changes, hallucinations (seeing or hearing things), confusion;

• slow heart rate, weak pulse, fainting, weak or shallow breathing (breathing may stop);

• seizure (convulsions); or

• severe constipation or stomach pain.

Less serious Embeda side effects may include:

• drowsiness, dizziness, anxiety, tired feeling;

• nausea, vomiting, constipation, diarrhea;

• blurred vision, headache; or

• sleep problems (insomnia).

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: Embeda side effects (in more detail)

What other drugs will affect Embeda?

Before taking Embeda, tell your doctor if you take other medications that can make you sleepy or slow your breathing. This includes cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety.

Also tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex).

Tell your doctor about all other medications you use, especially:

• a diuretic (water pill);

• quinidine (Quinaglute, Quinidex, Quin-Release);

• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

• a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva);

• ulcer or irritable bowel medication;

• bladder or urinary medications such as tolterodine (Detrol);

• an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

• an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);

• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), or verapamil (Calan, Covera, Isoptin, Verelan);

• HIV or AIDS medication such as indinavir (Crixivan) or ritonavir (Kaletra, Norvir); or

• medicines used to prevent organ transplant rejection.

This list is not complete and there may be other drugs that can interact with Embeda. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Embeda.