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Aloprim

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Aloprim

Aloprim

Aloprim Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aloprim (allopurinol sodium) for Injection is a xanthine oxidase inhibitor used to manage 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. This medication is available in generic form. Common side effects include injection site reactions, rash, diarrhea, nausea, vomiting, or kidney problems.

The recommended adult dose of Aloprim is 200 to 400 mg/m2/day, with a maximum dose of 600 mg/day. The recommended pediatric starting dose of Aloprim is 200 mg/m2/day. Aloprim may interact with mercaptopurine, azathioprine, dicumarol, uricosuric agents, diuretics, cyclophosphamide and other cytotoxic agents, chlorpropamide, and cyclosporine. Tell your doctor all medications and supplements you use. During pregnancy, Aloprim should be used only if prescribed. Aloprim passes into breast milk. The effect of Aloprim on the nursing infant is unknown. Nursing mothers should exercise caution. Consult your doctor before breastfeeding.

Our Aloprim (allopurinol sodium) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aloprim FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In an uncontrolled, compassionate plea protocol, 125 of 1,378 patients reported a total of 301 adverse reactions while receiving ALOPRIM (allopurinol sodium) for Injection. Most of the patients had advanced malignancies or serious underlying diseases and were taking multiple concomitant medications. Side effects directly attributable to ALOPRIM (allopurinol sodium) for Injection were reported in 19 patients. Fifteen of these adverse experiences were allergic in nature (rash, eosinophilia, local injection site reaction). One adverse experience of severe diarrhea and one incidence of nausea were also reported as being possibly attributable to ALOPRIM (allopurinol sodium) for Injection. Two patients had serious adverse experiences (decreased renal function and generalized seizure) reported as being possibly attributable to ALOPRIM (allopurinol sodium) for Injection.

A listing of the adverse reactions regardless of causality reported from clinical trials follows:

Incidence Greater Than 1%

Cutaneous/Dermatologic: rash (1.5%)

Genitourinary: renal failure/insufficiency (1.2%)

Gastrointestinal: nausea (1.3%), vomiting (1.2%)

Incidence Less Than 1%

Body as Whole: fever, pain, chills, alopecia, infection, sepsis, enlarged abdomen, mucositis/pharyngitis, blast crisis, cellulitis, hypervolemia
Cardiovascular: heart failure, cardiorespiratory arrest, hypertension, pulmonary embolus, hypotension, decreased venous pressure, flushing, headache, stroke, septic shock, cardiovascular disorder, ECGabnormality, hemorrhage, bradycardia, thrombophlebitis, ventricular fibrillation
Cutaneous/Dermatologic: urticaria, pruritus, local injection site reaction
Gastrointestinal: diarrhea, gastrointestinal bleeding, hyperbilirubinemia, splenomegaly, hepatomegaly, intestinal obstruction, jaundice, flatulence, constipation, liver failure, proctitis
Genitourinary: hematuria, increased creatinine, oliguria, kidney function abnormality, urinary tract infection
Hematologic: leukopenia, marrow aplasia, thrombocytopenia, eosinophilia, neutropenia, anemia, pancytopenia, ecchymosis, bone marrow suppression, disseminated intravascular coagulation
Metabolic: hypocalcemia, hyperphosphatemia, hypokalemia, hyperuricemia, electrolyte abnormality, hypercalcemia, hyperglycemia, hypernatremia, hyponatremia, metabolic acidosis, edema, glycosuria, hyperkalemia, lactic acidosis, water intoxication, hypomagnesemia
Neurologic: seizure, status epilepticus, myoclonus, twitching, agitation, mental status changes, cerebral infarction, coma, dystonia, paralysis, tremor
Pulmonary: respiratory failure/insufficiency, ARDS, increased respiration rate, apnea
Musculoskeletal: arthralgia
Other: hypotonia, diaphoresis, tumor lysis syndrome

The most frequent adverse reaction to oral allopurinol is skin rash. Skin reactions can be severe and sometimes fatal. Therefore, treatment with ALOPRIM (allopurinol sodium for injection) (allopurinol sodium) for Injection should be discontinued immediately if a rash develops (see WARNINGS). For further details on hypersensitivity reactions to treatment with oral allopurinol, refer to the package insert for allopurinol tablets.

Read the entire FDA prescribing information for Aloprim (Allopurinol Sodium for Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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