"Medscape Medical News
August 22, 2016
The US Food and Drug Administration (FDA) has approved an oral, abuse-deterrent, extended-release (ER) formulation of oxycodone hydrochloride and naltrexone hydrochloride"...
Embeda Patient Information Including Side Effects
Brand Names: Embeda
Generic Name: morphine and naltrexone (Pronunciation: MOR feen and nal TREX one)
- What is morphine and naltrexone (Embeda)?
- What are the possible side effects of morphine and naltrexone (Embeda)?
- What is the most important information I should know about morphine and naltrexone (Embeda)?
- What should I discuss with my healthcare provider before taking morphine and naltrexone (Embeda)?
- How should I use morphine and naltrexone (Embeda)?
- What happens if I miss a dose (Embeda)?
- What happens if I overdose (Embeda)?
- What should I avoid while using morphine and naltrexone (Embeda)?
- What other drugs will affect morphine and naltrexone (Embeda)?
- Where can I get more information?
What is morphine and naltrexone (Embeda)?
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.
The combination of morphine and naltrexone is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long time period.
Morphine and naltrexone may also be used for purposes not listed in this medication guide.
What are the possible side effects of morphine and naltrexone (Embeda)?
Get emergency medical help if you have any of these signs of an allergic reaction: 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 a serious side effect such as:
- mood changes, hallucinations, confusion, unusual thoughts or behavior;
- weak or shallow breathing, feeling like you might pass out;
- cold and clammy skin, blue lips or skin;
- painful or difficult urination;
- severe constipation or stomach pain; or
- slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).
Less serious side effects may include:
- drowsiness, dizziness, anxiety, feeling tired;
- dry mouth, nausea, vomiting, mild constipation, diarrhea;
- blurred vision, headache;
- sleep problems (insomnia); or
- itching, sweating, or flushing (warmth, redness, or tingly 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.
Read the Embeda (morphine sulfate and naltrexone hydrochloride) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about morphine and naltrexone (Embeda)?
You should not use morphine and naltrexone 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.
Do not use morphine and naltrexone if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Before taking morphine and naltrexone, tell your doctor if you have a breathing disorder, liver or kidney disease, low blood pressure, a thyroid disorder, curvature of the spine, 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, a history of head injury or brain tumor, or a history of alcoholism or drug addiction.
Morphine and naltrexone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using morphine and naltrexone.
You should not breast-feed while you are using morphine and naltrexone.
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how morphine and naltrexone will affect you. Do not take morphine and naltrexone with other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.
Do not drink alcohol while you are using this medication. Dangerous side effects or death can occur when alcohol is combined with morphine and naltrexone. Check your food and medicine labels to be sure these products do not contain alcohol.
Do not crush, chew, or dissolve the medicine pellets inside an 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.
Never take morphine and naltrexone in larger amounts, or for longer than recommended by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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