"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
(morphine sulfate and naltrexone hydrochloride) Extended-release Capsules
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL
Addiction, Abuse, and Misuse
EMBEDA® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing EMBEDA, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of EMBEDA. 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, chewing, or dissolving EMBEDA can cause rapid release and absorption of a potentially fatal dose of morphine [see WARNINGS AND PRECAUTIONS].
Accidental ingestion of even one dose of EMBEDA, especially by children, can result in a fatal overdose of morphine [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of EMBEDA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS].
Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking EMBEDA. The co-ingestion of alcohol with EMBEDA may result in increased plasma level and a potentially fatal overdose of morphine [see WARNINGS AND PRECAUTIONS].
EMBEDA extended-release 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 extended-release 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).
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:
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:
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;...
What are the precautions when taking morphine sulfate and naltrexone hydrochloride (Embeda)?
Last reviewed on RxList: 10/31/2014
This monograph has been modified to include the generic and brand name in many instances.
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