ZYLOPRIM (allopurinol) is a xanthine oxidase inhibitor. It has the following structural formula: ZYLOPRIM is known chemically as 1, 5-dihydro-4 H -pyrazolo [3, 4- d ]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white hexagon-shaped tablet contains 100 mg allopurinol and the inactive ingredients lactose monohydrate, magne...

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ZYLOPRIM is indicated for: The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 m...

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DOSAGE FORMS & STRENGTHS ZYLOPRIM tablets have functional scoring and are available in the following strengths: 100 mg: A flat-faced raised hexagon, beveled edge, white to off-white tablet, one side engraved “ZYLOPRIM 100” with a score bar and the other side plain. 200 mg: White to off-white, biconvex, round, scored tablets, imprinted “ZYLOPRIM” about the upper periphery, and 200 on the lower half, below the score and plain on the other side. 300 mg: A flat-faced raised hexagon, beveled edge, peac...

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Gout : Prior to initiating treatment assess serum uric acid level, complete blood count, chemistry panel, liver and kidney function tests. Prophylactic treatment for gout flares is recommended. Patients with normal kidney function: Initial dosage is 100 mg orally daily. Increase by 100 mg weekly increments until serum uric acid of 6 mg/dl or less is reached (maximum 800 mg daily). Patients with impaired kidney function: The initial dosage is 50 mg orally daily. Follow recommendations for titration in...

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Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue ZYLOPRIM at the first appearance of skin rash or other signs of hypersensitivity reaction. Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of ZYLOPRIM. He...

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The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. Capecitabine: Avoid concomitant use. Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information. Pegloticase: Discontinue and refrain from initiating treatment with ZYLOPRIM. See FPI for complete list of significant drug interactions. 7.1 Drugs Known to Affect the Occurrence of Skin Rash and Hypersen...

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Based on findings in animals, ZYLOPRIM may cause fetal harm when administered to a pregnant woman. Adverse developmental outcomes have been described in exposed animals ( see Data ). Allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol. Available limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse developmental outcomes. Among approximately 50 pre...

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