ALLOPURINOL SODIUM

Following single 100 mg and 300 mg intravenous and oral administration of Allopurinol Sodium for Injection, the relative intravenous Cmax was approximately 3-fold and 3.8-fold and AUC 0-inf was approximately 1.9-fold higher for allopurinol at both dosages, respectively. The relative intravenous oxypurinol C max and AUC 0-inf was approximately 1 compared to oral administration at both dosages. The C max and AUC 0- inf for both allopurinol and oxypurinol following intravenous administration of All...

A compassionate use trial of Allopurinol Sodium for Injection conducted in the United States from 1977 through 1989 included 718 evaluable patients with malignancies requiring treatment with cytotoxic chemotherapy who were unable to ingest or retain oral medication. Of these patients, 411 had established hyperuricemia and 307 had normal serum urate levels at the time that treatment was initiated. Normal serum uric acid levels were achieved in 68% of the former (reduction of serum uric acid was documented in 93%), and were maintained throughout chemotherapy in 97% of the latter. Because of the ...

The following clinically significant adverse reactions are described elsewhere in the labeling: Skin Rash and Hypersensitivity [see Warnings and Precautions (5.1) ] Renal Function Impairment [see Warnings and Precautions (5.2) ] Hepatoxicity [see Warnings and Precautions (5.3) ] Myelosuppression [see Warnings and Precautions (5.4) ] Drowsiness [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence > 1%) are skin rash, nausea, vomiting, and renal failure/insufficiency. ( 6...

Allopurinol Sodium for Injection is contraindicated in patients with a history of severe reaction to any formulation of allopurinol. Known hypersensitivity to allopurinol. ( 4 )

Skin Rash and Hypersensitivity: Discontinue Allopurinol Sodium for Injection at the first appearance of skin rash or other signs which may indicate a hypersensitivity reaction. Allopurinol has been associated with serious and sometimes fatal dermatologic reactions. ( 5.1 ) Renal Function Impairment: Patients with decreased renal function require lower doses of allopurinol. ( 5.2 ) Hepatotoxicity: If signs and symptoms of hepatotoxicity develop, liver function evaluation should be performed. ( 5....

7 DRUG INTERACTIONS Clinically important interactions with the drugs listed below were observed in patients undergoing treatment with an oral allopurinol formulation. Capecitabine: Avoid the concomitant use of allopurinol ( 7.2 ). Pegloticase: Discontinue and do not institute allopurinol therapy during treatment with pegloticase ( 7.2 ). Mercaptopurine or Azathioprine: Reduce mercaptopurine or aza...