Application Nr Approved Date Route Status External Links
NDA022272 2010-04-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Oxycontin Tablets Are A Controlled-Release Oral Formulation Of Oxycodone 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. Oxycontin Is Not Intended For Use On An As Needed Basis. Physicians Should Individualize Treatment In Every Case, Initiating Therapy At The Appropriate Point Along A Progression From Non-Opioid Analgesics, Such As Non-Steroidal Anti-Inflammatory Drugs And Acetaminophen To Opioids In A Plan Of Pain Management Such As Outlined By The World Health Organization, The Agency For Healthcare Research And Quality (formerly Known As The Agency For Healthcare Policy And Research), The Federation Of State Medical Boards Model Guidelines, Or The American Pain Society. Oxycontin Is Not Indicated For Pain In The Immediate Postoperative Period (the First 12-24 Hours Following Surgery), Or If The Pain Is Mild, Or Not Expected To Persist For An Extended Period Of Time. Oxycontin Is Only Indicated For Postoperative Use If The Patient Is Already Receiving The Drug 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 American Pain Society Guidelines.)

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Ammonio Methacrylate Copolymer AMMONIO METHACRYLATE COPOLYMER Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
6. Povidones POVIDONES Unresolved
7. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Sorbic Acid SORBIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
9. Stearyl Alcohol STEARYL ALCOHOL Molecular
10. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
11. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE ZINC403533

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