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WARNING
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)
The Opioid Crisis and Need for Compassion in Pain Management
Source: Medscape Anesthesiology Headlines [2017.09.28]
In this commentary, the author expresses concern that the response to the public health crisis of opioid addiction is creating a growing crisis of inadequate pain management.
American Journal of Public Health
CVS to Restrict Opioid Painkiller Prescription Amounts
Source: MedicineNet Drug Abuse Specialty [2017.09.25]
Title: CVS to Restrict Opioid Painkiller Prescription Amounts
Category: Health News
Created: 9/22/2017 12:00:00 AM
Last Editorial Review: 9/25/2017 12:00:00 AM
Stomach Pain Quiz: Nausea & Other Causes
Source: MedicineNet Anal Fissure Specialty [2017.09.19]
Title: Stomach Pain Quiz: Nausea & Other Causes
Category: MedicineNet Quiz
Created: 1/20/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 5:59:56 PM
Back Pain Quiz: Test Your Back Pain IQ
Source: MedicineNet Ankylosing Spondylitis Specialty [2017.09.19]
Title: Back Pain Quiz: Test Your Back Pain IQ
Category: MedicineNet Quiz
Created: 6/16/2011 3:41:00 PM
Last Editorial Review: 9/19/2017 6:39:04 PM
Pain Quiz: Test Your IQ of Pain
Source: MedicineNet Constipation Specialty [2017.09.19]
Title: Pain Quiz: Test Your IQ of Pain
Category: MedicineNet Quiz
Created: 7/14/2011 3:53:00 PM
Last Editorial Review: 9/19/2017 6:41:41 PM
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 [Terminated]
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.
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo [Completed]
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study
designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine
sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational
opioid users. An appropriate dose of morphine sulfate CR (i. e., 30 mg, 60 or 90 mg) was to
be selected during Part A of the study (Dose Selection Phase). Each subject participated in
the study for up to (approximately) 16 weeks and was confined in the clinic for a total of
up to 12 nights.
Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens [Completed]
Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery
for morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia
has been studied, but up to date no data are available concerning the use of thoracic
epidural patient-controlled analgesia regarding the use of levobupivacaine combined with
morphine in morbidly obese patients. The investigators' aim in this prospective,
randomized, double-blinded study was to compare the analgesic effectiveness, the dose
requirements and side effects of thoracic epidural patient controlled analgesia 0. 1% and
0. 2% levobupivacaine combined with a continuous epidural administration of morphine, with or
without a loading dose, after open gastric bypass for morbid obesity.
The Median Effective Dose (ED50) of Paracetamol and Morphine : A Study of Interaction Study [Completed]
The aim of our study is to define the median effective analgesic doses (ED50) of
paracetamol, morphine, and their combination and determination the nature of their
interaction administered IV for postoperative pain after moderate painful surgery using
up-and-down and isobolographic methods.
A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain [Recruiting]
The purpose of this study is to determine whether dexmedetomidine added to morphine is
effective in the treatment of chronic cancer pain.
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: 2017-09-28
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