Avinza

Product manufactured by Bryant Ranch Prepack

Application Nr Approved Date Route Status External Links
NDA021260 2008-12-18 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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. Avinza Is An Opioid Agonist Product 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. (1) Limitations Of Use Avinza Is Not For Use: –as An As-Needed (prn) Analgesic (1) –for Pain That Is Mild Or Not Expected To Persist For An Extended Period Of Time (1) –for Acute Pain (1) –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 (1) Avinza 90 Mg And 120 Mg Capsules Are Only For Patients In Whom Tolerance To An Opioid Of Comparable Potency Is Established. (1) 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.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Fumaric Acid FUMARIC ACID Molecular DS-Dietary supplement REG-Food additives for which a petition has been filed and a regulation issued.
2. Povidones POVIDONES Unresolved
3. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Morphine Sulfate MORPHINE SULFATE ZINC3812983

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