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Avinza (Morphine Sulfate Extended Release) - Summary

 
 



WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL

Abuse Potential

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 Exposure

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 SUMMARY

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.


See all Avinza indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Avinza (Morphine Extended Release)

DPP-4 Inhibitors Can Cause Severe Joint Pain, FDA Says
Source: Medscape Diabetes & Endocrinology Headlines [2015.08.28]
However, the pain associated with dipeptidyl peptidase-4 inhibitors for type 2 diabetes goes away once patients stop taking the medicine, according to the agency.
News Alerts

Group Offers Guidelines to Lessen Vaccination Pain
Source: Medscape Pediatrics Headlines [2015.08.28]
Clinicians can shuffle the order of vaccine injections, leverage the calming influence of parents and breast-feeding, and routinely apply topical anesthetic to ease vaccination pain for patients.
Medscape Medical News

DPP-4 Inhibitors Linked to Severe Joint Pain, FDA Warns
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.28]
(MedPage Today) -- The agency has identified 33 cases since 2006

Low Back Pain and GI Symptoms on the Swiss Alps
Source: Medscape Gastroenterology Headlines [2015.08.26]
Dr Paget discusses a recent patient of his who presented with a 5-year history of recurrent severe low back pain and gastrointestinal symptoms.
Medscape Rheumatology

Is There Sex After Low Back Pain?
Source: Medscape Orthopaedics Headlines [2015.08.26]
For many people with low back pain, sex is excruciating. But the recommended position for the past 25 years--'side-lying' (ie, 'spooning')--is contraindicated by two new biomechanical studies.
Medscape Orthopedics

more news >>

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. [2014]
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. [2011]
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.

more studies >>

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 analgesic effect. 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 infusion.

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 pain relief.

more trials >>

Reports of Suspected Avinza (Morphine Extended Release) Side Effects

Pain (18)Multiple Drug Overdose (13)Vomiting (12)Anxiety (11)Drug Ineffective (10)Substance Abuse (10)Muscular Weakness (10)Insomnia (10)Drug Dependence (10)Confusional State (9)more >>


Page last updated: 2015-08-28

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