Product manufactured by Unit Dose Services

Application Nr Approved Date Route Status External Links
ANDA071450 1987-01-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage This Is Not An Innocuous Drug. It Is Not Recommended For The Treatment Of Asymptomatic Hyperuricemia. Allopurinol Reduces Serum And Urinary Uric Acid Concentrations. Its Use Should Be Individualized For Each Patient And Requires An Understanding Of Its Mode Of Action And Pharmacokinetics (see Clinical Pharmacology, Contraindications, Warnings, And Precautions). 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.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM 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. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Allopurinol ALLOPURINOL ZINC13298313