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Avinza (Morphine Sulfate Extended Release) - Summary

 

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WARNING:

AVINZA capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. AVINZA CAPSULES ARE TO BE SWALLOWED WHOLE OR THE CONTENTS OF THE CAPSULES SPRINKLED ON APPLESAUCE. THE CAPSULE BEADS ARE NOT TO BE CHEWED, CRUSHED, OR DISSOLVED DUE TO THE RISK OF RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE. PATIENTS MUST NOT CONSUME ALCOHOLIC BEVERAGES WHILE ON AVINZA THERAPY. ADDITIONALLY, PATIENTS MUST NOT USE PRESCRIPTION OR NON-PRESCRIPTION MEDICATIONS CONTAINING ALCOHOL WHILE ON AVINZA THERAPY. CONSUMPTION OF ALCOHOL WHILE TAKING AVINZA MAY RESULT IN THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.

 

AVINZA SUMMARY

AVINZA® C II
(morphine sulfate extended-release capsules)
30 mg, 60 mg, 90 mg, 120 mg

Rx Only

AVINZA (morphine sulfate extended-release capsules) 30, 60, 90, and 120 mg contain both immediate release and extended release beads of morphine sulfate for once daily oral administration.

AVINZA capsules are a modified-release formulation of morphine sulfate intended for once daily administration indicated for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time.

AVINZA is NOT intended for use as a prn analgesic.

The safety and efficacy of using AVINZA in the postoperative setting has not been evaluated. AVINZA is not indicated for postoperative use. If the patient has been receiving the drug prior to surgery, resumption of the pre-surgical dose may be appropriate once the patient is able to take the drug by mouth. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (see American Pain Society guidelines)

AVINZA is a mu-agonist opioid and is a Schedule II controlled substance. Morphine, like other opioids used in analgesia, can be abused and is subject to criminal diversion.

AVINZA is intended for oral use only. Abuse of the crushed capsule poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. With parenteral abuse, the capsule excipients, especially talc, can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

AVINZA NEWS HIGHLIGHTS

Media Articles Related to Avinza (Morphine Extended Release)

Exercise Helps Reduce Pain, Disability After Lower Back Surgery
Source: Bones / Orthopaedics News From Medical News Today [2008.10.09]

Cell Protein Suppresses Pain Eight Times More Effectively Than Morphine
Source: Pain / Anesthetics News From Medical News Today [2008.10.09]

New Survey: Painful Economy Puts Health Care Pinch On Young Adults
Source: Public Health News From Medical News Today [2008.10.09]

Super-Potent Painkiller Demonstrated in Mice
Source: MedPageToday.com - medical news plus CME for physicians [2008.10.09]

Cell Protein Suppresses Pain Better Than Morphine
Source: MedicineNet Chronic Pain Specialty [2008.10.09]

more>>

Published Studies Related to Avinza (Morphine Extended Release)

Single-dose, extended-release epidural morphine (DepoDur) compared to conventional epidural morphine for post-cesarean pain. [2007.07]

A randomized, open-label, multicenter trial comparing once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for the treatment of chronic, moderate to severe low back pain: improved physical functioning in the ACTION trial. [2007.01]

A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: the extension phase of the ACTION trial. [2006.11]

Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain. [2006.08]

Single-dose extended-release epidural morphine for pain after hip arthroplasty. [2006.07]

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Clinical Trials Related to Avinza (Morphine Extended Release)

Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction [Completed]

Intrathecal Morphine in Knee Arthroplasty [Completed]

Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery [Completed]

A Study of Kadian NT in Subjects With Pain Due to Osteoarthritis of the Hip or Knee [Completed]

INFUSE Morphine Study [Completed]

more>>

Page last updated: 2008-10-09

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