Overview
Gout is a disease that occurs by the deposition of monosodium urate crystals (MSU) in body tissues, especially around joints . This disease has been well-documented in historical medical records and appears in the biographies of several prominent, historically recognized individuals . Allopurinol is a xanthine oxidase enzyme inhibitor that is considered to be one of the most effective drugs used to decrease urate levels and is frequently used in the treatment of chronic gout . It was initially approved by the FDA in 1966 and is now formulated by several manufacturers .
Indication
Allopurinol is indicated in : 1) the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). 2) the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present. 3) the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
Associated Conditions
- Hyperuricemia
- Primary Gout
- Recurrent calcium oxalate calculi
- Secondary gout
- Calcium oxalate calculi Renal Calculi
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/01/16 | Phase 2 | Completed | |||
2013/12/20 | Phase 3 | Completed | |||
2013/12/11 | Not Applicable | UNKNOWN | Istanbul Medeniyet University | ||
2013/11/20 | Phase 4 | Completed | |||
2013/11/19 | Phase 3 | Completed | Instituto de Investigacion Sanitaria La Fe | ||
2013/09/26 | Phase 4 | Completed | |||
2013/01/24 | Not Applicable | Withdrawn | |||
2012/11/29 | Phase 3 | Completed | |||
2012/11/09 | Phase 3 | Completed | Menarini Group | ||
2012/09/14 | Not Applicable | Terminated |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PD-Rx Pharmaceuticals, Inc. | 43063-975 | ORAL | 100 mg in 1 1 | 4/7/2023 | |
| Rebel Distributors Corp. | 21695-246 | ORAL | 300 mg in 1 1 | 6/1/2009 | |
| A-S Medication Solutions | 50090-5194 | ORAL | 300 mg in 1 1 | 11/18/2021 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8385 | ORAL | 100 mg in 1 1 | 3/8/2021 | |
| A-S Medication Solutions | 50090-6716 | ORAL | 100 mg in 1 1 | 12/14/2021 | |
| American Health Packaging | 60687-688 | ORAL | 300 mg in 1 1 | 2/28/2023 | |
| Quality Care Products, LLC | 55700-879 | ORAL | 100 mg in 1 1 | 8/26/2020 | |
| Aphena Pharma Solutions - Tennessee, LLC | 67544-736 | ORAL | 100 mg in 1 1 | 6/2/2016 | |
| Mylan Institutional Inc. | 51079-206 | ORAL | 300 mg in 1 1 | 12/27/2023 | |
| NorthStar RxLLC | 16714-577 | ORAL | 300 mg in 1 1 | 12/14/2021 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
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