Morphine sulfate; naltrexone hydrochloride

What is Morphine sulfate; naltrexone hydrochloride?

• Morphine sulfate; naltrexone hydrochloride (EMBEDA) is a combination opioid agonist/opioid antagonist product used for the management of pain.

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Morphine numbered

Naltrexone skeletal

What are the uses of this medicine?

• Morphine sulfate; naltrexone hydrochloride (EMBEDA) is a prescription medicine that contains morphine sulfate, an opioid receptor agonist (narcotic pain medicine) and naltrexone hydrochloride, an opioid receptor antagonist.
• Naltrexone hydrochloride is in the middle of each pellet and has a special coating to protect it from being released. If you crush or chew EMBEDA, the naltrexone will be released all at one time.
• EMBEDA is used to manage moderate to severe pain that continues around-the-clock and is expected to last for a long period of time.

How does this medicine work?

Mechanism of Action of Morphine:

• Morphine is a natural alkaloid that is derived from resin extracts from the seeds of the opium poppy, Papaver somniferum.
• Morphine has potent and profound analgesic effects and has been used in clinical medicine for almost two hundred years.
• Morphine acts by engagement in cell surface opiate receptors (predominant µ type receptors) that are found in the central nervous system, but also heart, lung, vascular and intestinal cells.
• Current indications are for severe pain, pre- and postoperative analgesia, control of pain from angina pectoris or acute myocardial infarction and therapy of pulmonary edema.

Mechanism of Action of Naltrexone:

• Naltrexone is a pure, centrally acting mu-opioid antagonist that reverses the subjective and analgesic effects of mu-opioid receptor agonists by competitively binding at mu-opioid receptors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
• have a bowel blockage called paralytic ileus.
• are allergic to morphine, morphine salts, naltrexone, or any of the ingredients in EMBEDA.

What drug interactions can this medicine cause?

Some medicines may cause serious problems when taken with EMBEDA. Sometimes, the doses of certain medicines and EMBEDA may need to be changed if used together. Be especially careful about taking other medicines that make you sleepy such as:

• other pain medicines
• anti-depressant medicines
• sleeping pills
• anti-anxiety medicines
• muscle relaxants
• antihistamines
• anti-nausea medicines
• tranquilizers

Also tell your healthcare provider if you take:

• cimetidine (Tagamet)
• a water pill (diuretic)
• an anticholinergic medicine

• Do not take EMBEDA if you already take a monoamine oxidase inhibitor medicine (MAOI) or within 14 days after you stop taking an MAOI medicine.
• Do not take any new medicine while using EMBEDA until you have talked to your healthcare provider or pharmacist. They will tell you if it is safe to take other medicines with EMBEDA.

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage:

• EMBEDA 100 mg/4 mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established.
• Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.
• For opioid-naïve and opioid non-tolerant patients, initiate with 20 mg/0.8 mg capsules (morphine sulfate/naltrexone hydrochloride) orally every 24 hours.
• Do not abruptly discontinue EMBEDA in a physically-dependent patient.

Administration:

• You can take EMBEDA with or without food.
• Swallow EMBEDA capsule whole. Do not crush, dissolve, or chew EMBEDA or the pellets in the capsules before swallowing.
• If you cannot swallow 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.
• If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
• If you take too much EMBEDA or overdose, call 911 or poison control center right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release capsules (morphine sulfate/naltrexone hydrochloride): 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg

This medicine is available in fallowing brand namesː

• EMBEDA

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• nausea
• sleepiness
• vomiting
• dizziness
• itching
• headache

EMBEDA can cause serious side effects, including:

• Serious breathing problems
• blood pressure to drop
• physical dependence
• abuse or addiction with EMBEDA
• Serious allergic reactions

What special precautions should I follow?

• Do not drive, operate heavy machinery, or do other dangerous activities, especially when you start taking EMBEDA and when your dose is changed, until you know how you react to this medicine. EMBEDA can make you sleepy, and also cause you to feel dizzy and lightheaded. Ask your healthcare provider to tell you when it is okay to do these activities.
• EMBEDA is to be swallowed whole or the contents of the capsules sprinkled on apple sauce. The pellets in the capsules are not to be crushed, dissolved, or chewed.
• Opioid agonists have the potential for being abused and are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
• EMBEDA may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, hypotension, and profound sedation or coma may result. Patients should not consume alcoholic beverages, prescription or non-prescription medications containing alcohol while on EMBEDA therapy.
• Respiratory depression is the chief hazard of all morphine preparations such as EMBEDA. EMBEDA should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve.
• EMBEDA can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in pressure in patients with head injuries. EMBEDA should only be administered under such circumstances when considered essential and then with extreme care.
• EMBEDA may cause severe hypotension. EMBEDA may produce orthostatic hypotension and syncope in ambulatory patients. EMBEDA should be administered with caution to patients in circulatory shock, as vasodilation produced by the drug may further reduce cardiac output and blood pressure.
• EMBEDA should be used with caution and in reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma may result.
• EMBEDA should not be given to patients with gastrointestinal obstruction, particularly paralytic ileus. EMBEDA may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
• Physical dependence and tolerance are common during chronic opioid therapy.
• Caution should also be exercised in the administration of EMBEDA to patients with CNS depression, toxic psychosis, acute alcoholism, and delirium tremens.
• Although extremely rare, cases of anaphylaxis have been reported with the use of a similar extended release morphine formulation.
• Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with EMBEDA.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• respiratory depression
• somnolence progressing to stupor or coma
• skeletal muscle flaccidity
• cold and clammy skin
• constricted pupils
• pulmonary edema
• bradycardia
• hypotension
• death
• severe hypoxia

Management of overdosage:

• Primary attention should be given to the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Other supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
• The pure opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression which results from opioid overdose.
• EMBEDA will continue to release and add to the morphine load for up to 24 hours after administration and the management of an overdose should be monitored accordingly

Can this medicine be used in pregnancy?

• EMBEDA may harm your unborn baby.
• There are no adequate and well-controlled studies in pregnant women. EMBEDA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and efficacy of EMBEDA in patients less than 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredients: pellets of morphine sulfate and naltrexone hydrochloride

• Inactive Ingredients common to all strengths: talc, ammonio methacrylate copolymer, sugar spheres, ethylcellulose, sodium chloride, polyethylene glycol, hydroxypropyl cellulose, dibutyl sebacate, methacrylic acid copolymer, diethyl phthalate, magnesium stearate, sodium lauryl sulfate, and ascorbic acid. The capsule shells contain gelatin, titanium dioxide, and grey ink, D and C yellow #10 (EMBEDA 20 mg/0.8 mg), FD and C red #3, FD and C blue #1 (EMBEDA 30 mg/1.2 mg), D and C red #28, FD and C red #40, FD and C blue #1 (EMBEDA 50 mg/2 mg), D and C red #28, FD and C red #40, FD and C blue #1 (EMBEDA 60 mg/2.4 mg), FD and C blue #1, FD and C red #40, FD and C yellow #6 (EMBEDA 80 mg/3.2 mg), D and C yellow #10, FD and C blue #1 (EMBEDA 100 mg/4 mg).

Who manufactures and distributes this medicine?

• Manufactured for: King Pharmaceuticals, Inc., 501 Fifth Street, Bristol, TN
• Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207 USA

• EMBEDA is a trademark of Alpharma Pharmaceuticals LLC, a wholly owned subsidiary of King Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Keep EMBEDA out of the reach of children.
• Keep EMBEDA in the container it comes in.
• Keep EMBEDA at room temperature between 59° to 86°F (15° to 30°C).
• After you stop taking EMBEDA, flush the unused capsules down the toilet.

• Dailymed label info on Morphine sulfate; naltrexone hydrochloride
• FDA Morphine sulfate; naltrexone hydrochloride

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