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EMBEDA™ capsules contain morphine, an opioid
agonist and a Schedule II controlled substance with an abuse liability similar
to other opioid agonists. EMBEDA can be abused in a manner similar to other
opioid agonists, legal or illicit. This should be considered when prescribing or
dispensing EMBEDA in situations where the physician or pharmacist is concerned
about an increased risk of misuse, abuse, or diversion.
EMBEDA contains pellets of an extended-release oral
formulation of morphine sulfate, an opioid receptor agonist, surrounding an
inner core of naltrexone hydrochloride, an opioid receptor antagonist indicated
for the management of moderate to severe pain when a continuous,
around-the-clock opioid analgesic is needed for an extended period of
time.
EMBEDA is NOT intended for use as a prn analgesic.
EMBEDA 100 mg/4 mg IS FOR USE IN OPIOID-TOLERANT PATIENTS
ONLY. Ingestion of these capsules or the pellets within the capsules may cause
fatal respiratory depression when administered to patients not already tolerant
to high doses of opioids.
Patients should not consume alcoholic beverages while on
EMBEDA therapy. Additionally, patients must not use prescription or
non-prescription medications containing alcohol while on EMBEDA therapy. The
co-ingestion of alcohol with EMBEDA may result in an increase of plasma levels
and potentially fatal overdose of morphine. 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 due to the risk of rapid
release and absorption of a potentially fatal dose of morphine.
Crushing, chewing, or dissolving EMBEDA will also result in
the release of naltrexone which may precipitate withdrawal in opioid-tolerant
individuals.
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EMBEDA SUMMARY
EMBEDA capsules 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.
EMBEDA is an extended-release oral formulation of morphine sulfate and naltrexone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
EMBEDA is NOT intended for use as a prn analgesic.
EMBEDA is not indicated for acute/postoperative pain or if the pain is mild or not expected to persist for an extended period of time. EMBEDA is only indicated for postoperative use if the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate
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NEWS HIGHLIGHTSMedia Articles Related to Embeda (Morphine / Naltrexone)
Erectile Dysfunction Tied To Long Term Painkiller Use
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.16]
A new study suggests that long term use of opioid prescription painkillers for back pain is tied to a higher risk of erectile dysfunction (ED). The findings are published in the 15 May online issue of the journal Spine. Lead author Richard A...
Painkillers Increase Risk of Erectile Dysfunction
Source: Erectile Dysfunction / Premature Ejaculation News From Medical News Today [2013.05.15]
Regularly taking prescription painkillers, commonly called opioids, is linked to a greater risk of erectile dysfunction (ED) in men, according to a new study published in Spine. Over 11,000 men suffering from back pain were involved in the research...
Retooling Pain Assessment for Older Adults
Source: Medscape Emergency Medicine Headlines [2013.05.14]
Current pain assessment tools for older adults are inadequate, and education for healthcare professionals falls short in meeting the unique challenges posed by pain management for elderly patients.
Medscape Medical News
Tanezumab Makes Good in Chronic Back Pain (CME/CE)
Source: MedPage Today Neurology [2013.05.14]
NEW ORLEANS (MedPage Today) -- The controversial agent tanezumab, which was once put on an FDA regulatory hold, offered durable reduction of chronic low back pain, a long-term safety and efficacy study showed.
Persistent Pain After Sexual Assault Often Untreated
Source: Medscape Nurses Headlines [2013.05.13]
Although pain is common after sexual assault, more than 50% of women don't seek appropriate medical care 6 weeks after presenting to the ED.
Medscape Medical News
Published Studies Related to Embeda (Morphine / Naltrexone)
Impact of intravenous naltrexone on intravenous morphine-induced high, drug
liking, and euphoric effects in experienced, nondependent male opioid users. [2011]
naltrexone in a clinical simulation of intravenous abuse of crushed MS-sNT... CONCLUSIONS: Results in this study population suggest that naltrexone added to
Morphine sulfate and naltrexone hydrochloride extended release capsules in patients with chronic osteoarthritis pain. [2010.07]
OBJECTIVE: To assess the efficacy and safety of morphine sulfate and naltrexone hydrochloride extended release capsules (EMBEDA; MS-sNT), which contain morphine sulfate pellets with a sequestered naltrexone core, in treating patients with chronic, moderate-to-severe osteoarthritis (hip or knee) pain... CONCLUSION: MS-sNT provided effective analgesia in patients with chronic, moderate-to-severe osteoarthritis pain, with a safety profile typical of morphine-containing products. Naltrexone sequestered in MS-sNT had no clinically relevant effect when MS-sNT was taken as directed.
ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: pharmacokinetics, efficacy, and safety. [2010.04]
ALO-01 (EMBEDA [morphine sulfate and naltrexone hydrochloride] extended-release capsules [King Pharmaceuticals, Inc, Bridgewater, NJ]), indicated for chronic moderate-to-severe pain, is designed to release naltrexone upon tampering (eg, by crushing), reducing morphine-induced subjective effects.
Morphine sulfate and naltrexone hydrochloride extended release capsules in
patients with chronic osteoarthritis pain. [2010]
chronic, moderate-to-severe osteoarthritis (hip or knee) pain... CONCLUSION: MS-sNT provided effective analgesia in patients with chronic,
ALO-01 (morphine sulfate and naltrexone hydrochloride) extended-release capsules
in the treatment of chronic pain of osteoarthritis of the hip or knee:
pharmacokinetics, efficacy, and safety. [2010]
ALO-01 (EMBEDA [morphine sulfate and naltrexone hydrochloride] extended-release
capsules [King Pharmaceuticals, Inc, Bridgewater, NJ]), indicated for chronic
moderate-to-severe pain, is designed to release naltrexone upon tampering (eg, by
crushing), reducing morphine-induced subjective effects.Results highlight the potential for
morphine in ALO-01 to manage moderate-to-severe osteoarthritis pain, while the
sequestered naltrexone does not interfere with efficacy.
Clinical Trials Related to Embeda (Morphine / Naltrexone)
Conversion to Embeda With Rescue Trial [Recruiting]
The purpose of the research study is to find out if opioid dependent chronic pain patients
who are judged by their physician to be eligible to change their current opioid medicine and
to participate in this study can be successfully adjusted to a stable dose of EMBEDA®
(morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's
risk for prescription opioid abuse, misuse and diversion.
Self Medication With Oral Morphine After Total Knee Arthroplasty. [Recruiting]
The study aims to compare two post operative pain management strategy's, traditional nurse
dispensed pain control versus patient self medication. The investigators aim to establish if
patients who self medicate have differing pain levels than those who take nurse dispensed
oral morphine.
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia [Recruiting]
Extended-release Epidural Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children [Recruiting]
The purpose of this proposal is to improve the investigators' current Selective Dorsal
Rhizotomy (SDR) analgesia protocol by eliminating or minimizing the use of fentanyl in the
post-operative period.
Children undergoing SDR for spastic cerebral palsy have significant post-operative pain.
The procedure requires dissection of the lumbar back musculature and removal of the L1
lamina (the bony posterior part of the vertebra). The majority of the operation is
intradural, and a water-tight dural closure at the termination of the operation is critical
in order to prevent leakage of cerebrospinal fluid (CSF) from the wound. In fact, these
children must remain flat on their back for 48 hours to allow the dural incision to heal
prior to mobilization. Thus, adequate pain control is essential not only for patient
comfort, but also to prevent agitation and additional stress on the dural closure.
Currently, the investigators' patients undergoing SDR are treated for 48 hours with
scheduled intravenous (IV) narcotic (continuous fentanyl infusion at 0. 5-2. 0 μg/kg/hour) in
addition to the sedative/muscle relaxant Valium (0. 2 mg/kg IV every 4 hours for 24 hours,
then every 6 hours for 24 hours). The IV fentanyl, and to a lesser degree Valium, carries a
real risk of hypotension and respiratory depression and requires frequent dose adjustments
to achieve adequate analgesia.
By improving the current SDR analgesia protocol, the investigators hope to maximize patient
safety and comfort while maintaining the effectiveness of the operation by minimizing the
risk of CSF leak.
Pharmacokinetic, Pharmacodynamic and Pharmacogenetic of Morphine After Surgery [Recruiting]
The main objective of this study is to improve our knowledge on the pharmacodynamic,
pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe
postoperative pain. The analysis will encompass the efficacy (acute during titration and
subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to
better characterize the age- and sex-related differences which probably markedly differ
between the two periods (acute vs sub acute).
Reports of Suspected Embeda (Morphine / Naltrexone) Side Effects
Intentional Overdose (4),
Migraine (4),
Drug Ineffective (3),
Pain (3),
Convulsion (3),
Pruritus (2),
Lymphoma Operation (2),
Speech Disorder (2),
Completed Suicide (2),
Posterior Reversible Encephalopathy Syndrome (2), more >>
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Page last updated: 2013-05-16
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