ALOPRIM (allopurinol sodium) for Injection is indicated for the management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.

Children and Adults:   The dosage of ALOPRIM (allopurinol sodium) for Injection to lower serum uric acid to normal or near-normal varies with the severity of the disease. The amount and frequency of dosage for maintaining the serum uric acid just within the normal range is best determined by using the serum uric acid level as an index. In adults, in one clinical trial, doses over 600 mg a day did not appear to be more effective. The recommended daily dose of ALOPRIM (allopurinol sodium) for Injection is as follows:

Hydration:   A fluid intake sufficient to yield a daily urinary output of at least two liters in adults and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable.

Impaired Renal Function:   The dose of ALOPRIM (allopurinol sodium) for Injection should be reduced in patients with impaired renal function to avoid accumulation of allopurinol and its metabolites:

Administration:   In both adults and children, the daily dose can be given as single infusion or in equally divided infusions at 6-, 8-, or 12-hour intervals at the recommended final concentration of not greater than 6 mg/mL (see Preparation of Solution ). The rate of infusion depends on the volume of infusate. Whenever possible, therapy with ALOPRIM (allopurinol sodium) for Injection should be initiated 24 to 48 hours before the start of chemotherapy known to cause tumor cell lysis (including adrenocortico steroids).

ALOPRIM (allopurinol sodium) for Injection should not be mixed with or administered through the same intravenous port with agents which are incompatible in solution with ALOPRIM (allopurinol sodium) for Injection (see Preparation of Solution ).

Preparation of Solution:   ALOPRIM (allopurinol sodium) for Injection must be reconstituted and diluted. The contents of each 30 mL vial should be dissolved with 25 mL of Sterile Water for Injection. Reconstitution yields a clear, almost colorless solution with no more than a slight opalescence. This concentrated solution has a pH of 11.1 to 11.8. It should be diluted to the desired concentration with 0.9% Sodium Chloride Injection of 5% Dextrose for Injection. Sodium bicarbonate-containing solutions should not be used. A final concentration of no greater than 6 mg/mL is recommended. The solution should be stored at 20° to 25°C (68° to 77°F) and administration should begin within 10 hours after reconstitution. Do not refrigerate the reconstituted and/or diluted product.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use this product if particulate matter or discoloration is present.

The following table lists drugs that are physically incompatible in solution with ALOPRIM (allopurinol sodium) for Injection.

STERILE SINGLE USE VIAL FOR INTRAVENOUS INFUSION.

ALOPRIM (allopurinol sodium) for Injection, 30 mL flint glass vials with rubber stoppers each containing allopurinol sodium equivalent to 500 mg of allopurinol (white lyophilized powder), box of 1 (NDC 59730-5601-1). Store unreconstituted powder at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature].

Distributed by:

Nabi®

Boca Raton, FL 33487

Manufactured by:

Catalytica Pharmaceuticals, Inc.

Greenville, NC 27834

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