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Embeda

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Embeda

EMBEDA®
(morphine sulfate and naltrexone hydrochloride) Capsules

Embeda

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 [see WARNINGS AND PRECAUTIONS]. 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 [see Drug Abuse and Dependence].

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 [see WARNINGS AND PRECAUTIONS]. 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 [see WARNINGS AND PRECAUTIONS].

Interaction with Alcohol

The co-ingestion of alcohol with EMBEDA may result in an increase of plasma levels and potentially fatal overdose of morphine [see WARNINGS AND PRECAUTIONS]. Instruct patients not to consume alcoholic beverages or use prescription or non­prescription products that contain alcohol while on EMBEDA therapy.

DRUG DESCRIPTION

EMBEDA capsules are for oral use and contain pellets of morphine sulfate and naltrexone hydrochloride at a ratio of 100:4. Morphine sulfate is an agonist and naltrexone hydrochloride is an antagonist at the mu-opioid receptor.

Each EMBEDA capsule contains the following 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, FD&C yellow #10 (EMBEDA 20 mg/0.8 mg), FD&C red #3, FD&C blue #1 (EMBEDA 30 mg/1.2 mg), D&C red #28, FD&C red #40, FD&C blue #1 (EMBEDA 50 mg/2 mg), D&C red #28, FD&C red #40, FD&C blue #1 (EMBEDA 60 mg/2.4 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (EMBEDA 80 mg/3.2 mg), D&C yellow #10, FD&C blue #1 (EMBEDA 100 mg/4 mg).

Morphine Sulfate

The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2•H2SO4•5H2O and its molecular weight is 758.85.

Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:

Morphine sulfate - Structural Formula Illustration

Naltrexone Hydrochloride

The chemical name of naltrexone hydrochloride is (5α)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. The empirical formula is C20H23NO4•HCl and its molecular weight is 377.46. Naltrexone hydrochloride is a white to slightly off-white powder that is soluble in water. Its structural formula is:

Naltrexone Hydrochloride - Structural Formula Illustration

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; 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.

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Read All Potential Side Effects and See Pictures of Embeda »

What are the precautions when taking morphine sulfate and naltrexone hydrochloride (Embeda)?

Before taking morphine, tell your doctor or pharmacist if you are allergic to morphine; or to naltrexone; or to other narcotic pain medications (such as codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems/lung disease (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), chronic constipation/slow movement of the gut (such as paralytic ileus, blockage), kidney disease, liver disease, a certain spinal problem (kyphoscoliosis), heart problems (such as heart failure, low blood pressure, irregular heartbeat),...

Read All Potential Precautions of Embeda »

Last reviewed on RxList: 11/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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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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