ALLOPURINOL SODIUM injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALLOPURINOL SODIUM (UNII: 428673RC2Z) (ALLOPURINOL - UNII:63CZ7GJN5I)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

ALLOPURINOL SODIUM

Composition:

ALLOPURINOL 500 mg in 25 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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