Allopurinol Sodium

ALLOPURINOL SODIUM- allopurinol sodium injection, powder, lyophilized, for solution
Hikma Pharmaceuticals USA Inc.

1 INDICATIONS AND USAGE

Allopurinol Sodium for Injection is indicated for 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 and who cannot tolerate oral therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Initiate therapy with Allopurinol Sodium for Injection 24 to 48 hours before the start of chemotherapy known to cause tumor cell lysis. Additionally, administer fluids sufficient to yield a daily urinary output of at least two liters in adults with a neutral or, preferably, slightly alkaline urine.

The recommended daily dose of Allopurinol Sodium for Injection is shown in Table 1. Administer the daily dose as single infusion or in equally divided infusions at 6-, 8-, or 12-hour intervals at a rate appropriate for the volume of infusate.

Table 1: Recommended Daily Dose of Allopurinol Sodium for Injection

Adult Patients

200 mg/m2 /day to 400 mg/m2 /day intravenously
Maximum 600 mg/day

Pediatric Patients

Starting Dose 200 mg/m2 /day intravenously

Maximum 400 mg/day

The dosage of Allopurinol Sodium for Injection to lower serum uric acid to normal or near-normal varies with the severity of the disease. Monitor serum uric acid levels at least daily and administer Allopurinol Sodium for Injection at a dose and frequency to maintain the serum uric acid within the normal range. Discontinue Allopurinol Sodium for Injection when the patient is able to take oral therapy or when the risk of tumor lysis has abated.

2.2 Dosage Modifications in Patients with Renal Impairment

Reduce the dose of Allopurinol Sodium for Injection in patients with impaired renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. The recommended dosage reductions of Allopurinol Sodium for Injection in adult patients with renal impairment are shown in Table 2.

Table 2: Recommended Daily Dose of Allopurinol Sodium for Injection in Adult Patients with Renal Impairment
Creatinine Clearance Recommended Daily Dose

10 to 20 mL/min

200 mg/day

Less than 10 mL/min

100 mg/day

On dialysis

50 mg every 12 hours, or

100 mg every 24 hours

Treatment with Allopurinol Sodium for Injection has not been studied in pediatric patients with severe renal impairment or on dialysis. For pediatric patients with severe renal impairment or on dialysis, consider the risks and potential benefits before initiating treatment with Allopurinol Sodium for Injection [see Warnings and Precautions (5.2) and Use In Specific Populations (8.6)].

2.3 Preparation Instructions

Reconstitute and further dilute Allopurinol Sodium for Injection prior to intravenous infusion.

Reconstitution

  • Reconstitute each vial of Allopurinol Sodium for Injection with 25 mL of Sterile Water for Injection, USP to obtain a concentration of 20 mg/mL of allopurinol.
  • Inspect the reconstituted solution for discoloration and particulate matter. The reconstituted solution should appear as a clear, almost colorless solution with no more than a slight opalescence. Do not use if the reconstituted solution contains particulate matter or discoloration is present.

Dilution

  • Dilute with 0.9% Sodium Chloride Injection, USP or 5% Dextrose for Injection, USP to obtain a final concentration of less than 6 mg/mL.
  • Inspect the diluted solution for particulate matter or discoloration and discard if present.
  • If not used immediately, the diluted Allopurinol Sodium for Injection solution can be stored at 20° to 25°C (68° to 77°F) for up to 10 hours after initial reconstitution. The storage includes time for infusion. Do not refrigerate the reconstituted and/or diluted product.
  • If stored, the administration should be completed within 10 hours after reconstitution.
  • Discard unused portion.

2.4 Administration Instructions

Do not mix Allopurinol Sodium for Injection with or administer it through the same intravenous port as agents which are incompatible in solution with Allopurinol Sodium for Injection. The following table lists drugs that are known to be physically incompatible in solution with Allopurinol Sodium for Injection.

Table 3: Drugs That Are Physically Incompatible in Solution with Allopurinol Sodium for Injection

Amikacin sulfate

Hydroxyzine HCl

Amphotericin 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

Ondansetron HCl

Diphenhydramine HCl

Prochlorperazine edisylate

Doxorubicin HCl

Promethazine HCl

Doxycycline hyclate

Sodium bicarbonate

Droperidol

Streptozocin

Floxuridine

Tobramycin sulfate

Gentamicin sulfate

Vinorelbine tartrate

Haloperidol lactate

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