Morphine and naltrexone

Morphine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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 MEDICINE 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.

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 your medicine. Morphine and naltrexone 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 morphine and naltrexone pills. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills down the toilet.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with morphine and naltrexone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Embeda

Available Dosage Forms:

• Capsule, Extended Release

Therapeutic Class: Analgesic Combination, Opioid Agonist/Antagonist

Pharmacologic Class: Naltrexone

Chemical Class: Morphine

• If you have an allergy to morphine, naltrexone, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Very bad asthma, trouble breathing, recent head injury, growths or tumors in the brain, raised pressure in the brain, or very bad bowel or stomach problems like bowel block.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking morphine and naltrexone within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with morphine and naltrexone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

• Headache.
• Feeling sleepy.
• Dizziness.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Dry mouth.
• Itching.
• Feeling tired or weak.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Morphine: Binds to opiate receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces generalized CNS depression.

Naltrexone: Pure opioid antagonist; reverses the subjective and analgesic effects of mu-opioid receptor agonists by competitively binding at mu-opioid receptors.

Applies to morphine / naltrexone: oral capsule extended release

Along with its needed effects, morphine / naltrexone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking morphine / naltrexone:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• chills
• confusion
• constipation
• drowsiness
• feeling of warmth
• irritability
• mental depression
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed and calm feeling
• restlessness
• sleepiness
• sudden sweating
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• unusual weight gain or loss

• Abnormal dreams
• being forgetful
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• clumsiness or unsteadiness
• confusion about identity, place, and time
• darkened urine
• decrease in frequency or volume of urination
• decreased awareness or responsiveness
• delusions
• dementia
• difficult or labored breathing
• difficult or painful urination
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast heartbeat
• feeling of warmth
• fever
• indigestion
• loss of appetite
• nausea
• nervousness
• pains in the stomach, side, or abdomen, possibly radiating to the back
• redness of the face, neck, arms, and occasionally, upper chest
• seeing, hearing, or feeling things that are not there
• severe nausea or vomiting
• severe sleepiness
• sweating
• tightness in the chest
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Some side effects of morphine / naltrexone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• anxiety
• belching
• decreased appetite
• diarrhea
• difficulty with moving
• excess air or gas in the stomach or intestines
• full feeling
• heartburn
• itching skin
• muscle pain or stiffness
• muscle spasm
• pain in the joints
• sleepiness or unusual drowsiness
• stomach discomfort or upset
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• weight loss

• Cold sweats
• dizziness
• dry mouth
• general feeling of discomfort or illness
• headache
• inability to have or keep an erection
• increased sweating
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• night sweats
• pressure in the stomach
• rash
• stomach tenderness
• swelling of the stomach area
• trouble sleeping
• upper abdominal or stomach pain

Use with caution.

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