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Aloprim

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Aloprim

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

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:

Recommended Daily Dose

Adult: 200 to 400 mg/m2/day Maximum 600 mg/day
Child: Starting Dose 200 mg/m2/day

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:

Creatinine Clearance Recommended Daily Dose
10 to 20 mL/min 200 mg/day
3 to 10 mL/min 100 mg/day
< 3 mL/min 100 mg/day at extended intervals

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 or 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.

Drugs That are Physically Incompatible in Solution with ALOPRIM™ (allopurinol sodium for injection) (allopurinol sodium) for Injection

Amikacin sulfate Hydroxyzine HCl
Amphoterecin B Idarubicin HCl
Carmustine Imipenem-cilastatin sodium
Cefotaxime sodium Mechlorethamine HCl
Chlorpromazine HCl Meperidine HCl
Cimetidine HCl Metoclopramide HCl
Clindamycin phosphate Methylprednisolone sodium succinate
Cytarabine Minocycline HCl
Dacarbazine Nalbuphine HCl
Daunorubicin HCl Netilmicin sulfate
Diphenhydramine HCl Ondansetron HCl
Doxorubicin HCl Prochlorperazine edisylate
Doxycycline hyclate Promethazine HCl
Droperidol Sodium bicarbonate
Floxuridine Streptozocin
Gentamicin sulfate Tobramycin sulfate
Haloperidol lactate Vinorelbine tartrate

HOW SUPPLIED

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: DSM Pharmaceuticals, Inc. Greenville, NC 27834. February 2003

Last reviewed on RxList: 5/28/2009
This monograph has been modified to include the generic and brand name in many instances.

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