国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ALLOPURINOL SODIUM (UNII: 428673RC2Z) (ALLOPURINOL - UNII:63CZ7GJN5I)
Hikma Pharmaceuticals USA Inc.
ALLOPURINOL SODIUM
ALLOPURINOL 500 mg in 25 mL
INTRAVENOUS
PRESCRIPTION DRUG
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. Allopurinol Sodium for Injection is contraindicated in patients with a history of severe reaction to any formulation of allopurinol. Based on findings in animals, Allopurinol Sodium for Injection may cause fetal harm when administered to a pregnant woman. Adverse developmental outcomes have been described in exposed animals (see Data) . Allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol. Available limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse developmental outcomes. Among approximately 50 pregnancies described in published literature, 2 infants with major congenital malf
STERILE SINGLE DOSE VIAL FOR INTRAVENOUS INFUSION. Allopurinol Sodium for Injection, 50 mL flint glass vials with rubber stoppers each containing allopurinol sodium equivalent to 500 mg of allopurinol (white lyophilized powder), individually boxed, (NDC 0143-9533-01 ). Store unreconstituted powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
ALLOPURINOL SODIUM- ALLOPURINOL SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALLOPURINOL SODIUM FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALLOPURINOL SODIUM FOR INJECTION. ALLOPURINOL SODIUM FOR INJECTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1966 INDICATIONS AND USAGE Allopurinol Sodium for Injection is a xanthine oxidase inhibitor 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. (1) DOSAGE AND ADMINISTRATION Recommended Dosage (2.2) ADULT PATIENTS 200 mg/m /day to 400 mg/m /day Maximum 600 mg/day PEDIATRIC PATIENTS Starting Dose 200 mg/m /day Maximum 400 mg/day Recommended Dosage in Adult Patients with Renal Impairment (2.2, 5.2, 8.6) 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 DOSAGE FORMS AND STRENGTHS For injection: 500 mg as a white lyophilized powder or cake in a single-dose vial for reconstitution (3) CONTRAINDICATIONS Known hypersensitivity to allopurinol. (4) WARNINGS AND PRECAUTIONS 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. (5.3) Myelosuppression: Bone marrow suppression has been reported with allopurinol. (5.4) Drowsiness: Drowsiness has been reported in patients 阅读完整的文件