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Embeda (Morphine Sulfate / Naltrexone Hydrochloride) - Summary

 
 



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.

 

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


See all Embeda indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Embeda (Morphine / Naltrexone)

Brain Stimulation Effective for Phantom Limb Pain
Source: Medscape Anesthesiology Headlines [2016.08.25]
Patients with amputations from land mine explosions show analgesic improvement 15 days after treatments with repetitive transcranial magnetic stimulation, a new trial shows.
Medscape Medical News

Complex Regional Pain Syndrome in Children
Source: Medscape Anesthesiology Headlines [2016.08.25]
This article describes the incidence and clinical features of complex regional pain syndrome in children.
Archives of Disease in Childhood

Central Pain Processing in Those With Achilles Tendinopathy
Source: Medscape Anesthesiology Headlines [2016.08.25]
A new study compares the central pain processing mechanisms among people with and without Achilles tendinopathy.
British Journal of Sports Medicine

Medical Marijuana's Pain Relief May Work Better for Men
Source: MedicineNet Chronic Pain Specialty [2016.08.25]
Title: Medical Marijuana's Pain Relief May Work Better for Men
Category: Health News
Created: 8/24/2016 12:00:00 AM
Last Editorial Review: 8/25/2016 12:00:00 AM

Health Tip: Work Through Chronic Pain
Source: MedicineNet Chronic Pain Specialty [2016.08.25]
Title: Health Tip: Work Through Chronic Pain
Category: Health News
Created: 8/25/2016 12:00:00 AM
Last Editorial Review: 8/25/2016 12:00:00 AM

more 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.

more studies >>

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.

more trials >>

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 >>


Page last updated: 2016-08-25

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