Allopurinol 300 mg Tablets — Generic For Zyloprim — Unichem

These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS.

ALLOPURINOL tablets, for oral use.

Initial U.S. Approval:1966

Indications And Usage

Allopurinol is a xanthine oxidase inhibitor indicated for the management of:

Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) (1)

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 (1)

Adult 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, despite lifestyle changes (1)

Limitations of Use

Allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia. (1)

Dosage And Administration

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. (2.1,2.2)

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). (2.3)

Patients with impaired kidney function: The initial dosage is 50 mg orally daily. Follow recommendations for titration in patients with renal impairment until target serum uric acid level is reached. (2.6)

See complete information in the Full Prescribing Information (FPI).

Hyperuricemia Associated with Cancer Therapy: The recommended dosage is:

Adults: 300 mg to 800 mg orally daily.

Pediatric patients: 100 mg/m2orally every 8 hours to 12 hours (10 mg/kg/day, maximum 800 mg/day)

See complete information in the FPI. (2.4, 2.6)

Recurrent Calcium Oxalate Calculi: The recommended initial dosage in patients with normal kidney function is 200 mg to 300 mg orally daily. (2.5)

Dosage in Patients with Renal Impairment: See FPI for dosage modifications in patients with renal impairment. (2.6)

Dosage Forms And Strengths

Tablets: 100 mg, and 300 mg, functionally scored (3)

Contraindications

Known hypersensitivity to allopurinol or to any of the ingredients of allopurinol tablets. (4)

Warnings And Precautions

• Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue allopurinol at the first appearance of skin rash or other signs of hypersensitivity reaction. (5.1)
• Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. (5.2)
• Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of allopurinol. (5.3)
• Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. (5.4)
• Myelosuppression: Bone marrow suppression has been reported with allopurinol. (5.5)
• Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol. (5.6)

• Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue allopurinol at the first appearance of skin rash or other signs of hypersensitivity reaction. (5.1)
• Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. (5.2)
• Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of allopurinol. (5.3)
• Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. (5.4)
• Myelosuppression: Bone marrow suppression has been reported with allopurinol. (5.5)
• Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol. (5.6)

Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue allopurinol at the first appearance of skin rash or other signs of hypersensitivity reaction. (5.1)

Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. (5.2)

Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of allopurinol. (5.3)

Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. (5.4)

Myelosuppression: Bone marrow suppression has been reported with allopurinol. (5.5)

Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol. (5.6)

Adverse Reactions

Most common adverse reactions (incidence > 1%) are nausea, diarrhea, and increase in liver function tests. (6)

To report SUSPECTED ADVERSE REACTIONS, Unichem Pharmaceuticals (USA), Inc., at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. (7.1)

Capecitabine: Avoid concomitant use. (7.2)

Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information. (7.2)

Pegloticase: Discontinue and refrain from initiating treatment with allopurinol. (7.2)

See FPI for complete list of significant drug interactions. (7.2)

Use In Specific Populations

Pregnancy: May cause fetal harm. (8.1)

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2024