Application Nr Approved Date Route Status External Links
NDA021217 2012-08-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Exalgo Is Indicated For The Management Of Moderate To Severe Pain In Opioid Tolerant Patients Requiring Continuous, Around-The-Clock Opioid Analgesia For An Extended Period Of Time. Patients Considered Opioid Tolerant Are Those Who Are Taking At Least 60 Mg Oral Morphine Per Day, 25 Mcg Transdermal Fentanyl/hour, 30 Mg Oral Oxycodone/day, 8 Mg Oral Hydromorphone/day, 25 Mg Oral Oxymorphone/day Or An Equianalgesic Dose Of Another Opioid, For A Week Or Longer. Limitations Of Use Exalgo 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. Exalgo Is An Opioid Agonist Indicated For The Management Of Moderate To Severe Pain In Opioid Tolerant Patients Requiring Continuous, Around-The-Clock Opioid Analgesia For An Extended Period Of Time (1). Limitations Of Use Exalgo 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) Exalgo Is Only For Patients In Whom Tolerance To An Opioid Of Comparable Potency Is Established. (1)

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Butylated Hydroxytoluene BUTYLATED HYDROXYTOLUENE Molecular
2. Cellulose Acetate CELLULOSE ACETATE Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Hypromelloses HYPROMELLOSES Unresolved
5. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. 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.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Povidones POVIDONES Unresolved
10. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.
11. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE ZINC402954

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