WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
AVINZA® contains pellets of morphine sulfate, an opioid agonist and 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 AVINZA. 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 AVINZA for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9) ].
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of AVINZA, 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 AVINZA 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 AVINZA or following a dose increase. Instruct patients to swallow AVINZA 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 ingestion of AVINZA, especially in children, can result in a fatal overdose of morphine [see Warnings and Precautions].
Interaction with Alcohol
The co-ingestion of alcohol with AVINZA 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 non-prescription products that contain alcohol while on AVINZA therapy.
AVINZA capsules are for oral use and contain pellets of morphine sulfate. Morphine sulfate is an agonist at the mu-opioid receptor.
AVINZA is 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.
Limitations of Use
AVINZA is not for use:
As an as-needed (prn) analgesic
For pain that is mild or not expected to persist for an extended period of time
For acute pain
For postoperative pain unless 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.
AVINZA 90 mg and 120 mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those taking at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
Media Articles Related to Avinza (Morphine Extended Release)
A Man With Fever and Leg Pain: Osmosis Question of the Week
Source: Medscape Emergency Medicine Headlines [2016.10.21]
A 67-year-old man presents to the urgent care clinic following several days of fever and dull pain in his left leg. Do you know the diagnosis?
Positive pivotal Phase 3 data announced demonstrating investigational Elagolix reduced endometriosis-associated pain
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.10.20]
AbbVie, a global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc.
'Fake Pills' May Help Ease Back Pain
Source: MedicineNet Chronic Pain Specialty [2016.10.20]
Title: 'Fake Pills' May Help Ease Back Pain
Category: Health News
Created: 10/19/2016 12:00:00 AM
Last Editorial Review: 10/20/2016 12:00:00 AM
Pregabalin may lessen pain from irritable bowel syndrome, Mayo Clinic study finds
Source: Irritable Bowel Syndrome News From Medical News Today [2016.10.19]
A pilot study by researchers at Mayo Clinic has found that patients suffering from pain related to irritable bowel syndrome (IBS) may benefit from taking pregabalin, a neuro-pain inhibitor commonly...
FDA Places Regeneron and Teva's Pain-Drug Study on Hold
Source: Medscape Orthopaedics Headlines [2016.10.18]
Regeneron Pharmaceuticals Inc and partner Teva Pharmaceutical Industries Ltd said the U.S. health regulator placed a clinical hold on a mid-stage study of their experimental drug for chronic lower back pain.
Reuters Health Information
Published Studies Related to Avinza (Morphine Extended Release)
Evaluation of a single-dose, extended-release epidural morphine formulation for
pain control after lumbar spine surgery. 
DepoDur, an extended-release epidural morphine, has been used effectively for
postoperative pain control following many orthopaedic and general surgery
procedures and has provided prolonged analgesia when compared with Duramorph. The
goal of this article was to compare the safety and analgesic efficacy of DepoDur
versus Duramorph after lumbar spine surgery...
Prior epidural lidocaine alters the pharmacokinetics and drug effects of extended-release epidural morphine (DepoDur(R)) after cesarean delivery. [2011.08]
BACKGROUND: A potential physicochemical interaction between epidural local anesthetics and extended-release epidural morphine (EREM) could negate the sustained release. In this study, we sought to determine the pharmacokinetic and drug effects of prior epidural lidocaine administration on EREM... CONCLUSION: A large dose of epidural lidocaine 1 hour before EREM administration alters the pharmacokinetics and drug effects of EREM. Clinicians must apply caution when EREM is administered even 1 hour after an epidural lidocaine "top-up" for cesarean delivery.
Impact of intravenous naltrexone on intravenous morphine-induced high, drug
liking, and euphoric effects in experienced, nondependent male opioid users. 
naltrexone in a clinical simulation of intravenous abuse of crushed MS-sNT... CONCLUSIONS: Results in this study population suggest that naltrexone added to
Food effects on the pharmacokinetics of morphine sulfate and naltrexone hydrochloride extended release capsules. [2010.11]
INTRODUCTION: Morphine sulfate and naltrexone hydrochloride extended release capsules, indicated for chronic moderate-to-severe pain, contain extended-release morphine pellets with a sequestered naltrexone core. If pellets are tampered by crushing, naltrexone is released to reduce morphine-induced effects that appeal to opioid abusers. The primary objective of this study was to assess single-dose relative bioavailability of morphine when morphine sulfate and naltrexone hydrochloride extended release capsules were taken under fed and fasting conditions and when pellets were sprinkled on apple sauce... CONCLUSION: Results indicated that morphine sulfate and naltrexone hydrochloride extended release capsules can be administered without regard to meals, and contents can be sprinkled over apple sauce and consumed without chewing by patients with difficulty swallowing.
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.
Clinical Trials Related to Avinza (Morphine Extended Release)
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.
Ketamine Associated With Morphine PCA After Total Hip Arthroplasty [Completed]
Ketamine (an analgesic drug often associated with morphine in the treatment of Opioid
Induced Hyperalgesia) is often mixed in Morphine PCA syringe. We make the hypothesis that
ketamine administrated separately via a continuous infusion, could induced a better
We will perform a randomised double blind study to determine the best infusion mode of
intravenous ketamine, associated with morphine in PCA syringe or alone in continuous
Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section [Recruiting]
The cesarean section is considered as a painful surgery during the post operative period.
Mothers may need to move immediately after the surgery to take care of their babies. This
may increase the risk of major pain and chronic pain. Thus, excellent postoperative
analgesia is required so that mothers do not experience pain in caring for their baby.
Currently, several techniques have been developed to manage postoperative pain related to
c-section scar such as intrathecal morphine during spinal anesthesia or continuous
pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never
been performed and it is still not know if the combination of intrathecal morphine plus
continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on
Reports of Suspected Avinza (Morphine Extended Release) Side Effects
Multiple Drug Overdose (13),
Drug Ineffective (10),
Substance Abuse (10),
Muscular Weakness (10),
Drug Dependence (10),
Confusional State (9), more >>
Page last updated: 2016-10-21