Aloprim
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Questions & Answers
Side Effects & Adverse Reactions
ALLOPURINOL SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR OTHER SIGNS WHICH MAY INDICATE AN ALLERGIC REACTION. In some instances with oral allopurinol, a skin rash may be followed by more severe hypersensitivity reactions such as exfoliative, urticarial, and purpuric lesions as well as Stevens-Johnson syndrome (erythema multiforme exudativum), and/or generalized vasculitis, irreversible hepatotoxicity and, on rare occasions, death.
In patients receiving mercaptopurine or azathioprine, the concomitant administration of 300 to 600 mg of ALOPRIM (allopurinol sodium) for Injection per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects (see PRECAUTIONS: Drug Interactions).
A few cases of reversible clinical hepatotoxicity have been noted in patients taking oral allopurinol, and in some patients asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed. If anorexia, weight loss, or pruritus develop in patients on allopurinol, evaluation of liver function should be part of their diagnostic workup. In patients with pre-existing liver disease, periodic liver function tests are recommended during the early stages of therapy.
Due to the occasional occurrence of drowsiness, patients should be alerted to the need for due precaution when engaging in activities where alertness is mandatory.
The occurrence of hypersensitivity reactions to allopurinol may be increased in patients with decreased renal function receiving thiazides and allopurinol concurrently. Thus, in patients with decreased renal function, such combinations should be administered with caution.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ALOPRIM (allopurinol sodium) for Injection is indicated for the management of 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.
History
There is currently no drug history available for this drug.
Other Information
ALOPRIM (allopurinol sodium) for Injection is the brand name for allopurinol, a xanthine oxidase inhibitor. ALOPRIM (allopurinol sodium) for Injection is a sterile solution for intravenous infusion only. It is available in vials as the sterile lyophilized sodium salt of allopurinol equivalent to 500 mg of allopurinol. ALOPRIM (allopurinol sodium) for Injection contains no preservatives.
The chemical name for allopurinol sodium is 1,5-dihydro-4H-pyrazolo[3,4-d]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula C5H3N4NaO. The structural formula is:
The pKa of allopurinol sodium is 9.31.
Sources
Aloprim Manufacturers
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Mylan Institutional Llc
![Aloprim (Allopurinol) Injection, Powder, Lyophilized, For Solution [Mylan Institutional Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Aloprim | Mylan Institutional Llc
Children and AdultsThe dosage of ALOPRIM (allopurinol sodium) for Injection to lower serum uric acid to normal or near-normal varies with the severity of the disease. The amount and frequency of dosage for maintaining the serum uric acid just within the normal range is best determined by using the serum uric acid level as an index. In adults, in one clinical trial, doses over 600 mg a day did not appear to be more effective. The recommended daily dose of ALOPRIM (allopurinol sodium) for Injection is as follows:
Recommended Daily DoseAdult:
200 to 400 mg/m2/day
Maximum 600 mg/dayChild:
Starting Dose 200 mg/m2/day
HydrationA fluid intake sufficient to yield a daily urinary output of at least two liters in adults and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable.
Impaired Renal FunctionThe dose of ALOPRIM (allopurinol sodium) for Injection should be reduced in patients with impaired renal function to avoid accumulation of allopurinol and its metabolites:
Creatinine Clearance Recommended Daily Dose10 to 20 mL/min
200 mg/day
3 to 10 mL/min
100 mg/day
<3 mL/min
100 mg/day at extended intervals
AdministrationIn both adults and children, the daily dose can be given as single infusion or in equally divided infusions at 6-, 8-, or 12- hour intervals at the recommended final concentration of not greater than 6 mg/mL (see Preparation of Solution). The rate of infusion depends on the volume of infusate. Whenever possible, therapy with ALOPRIM (allopurinol sodium) for Injection should be initiated 24 to 48 hours before the start of chemotherapy known to cause tumor cell lysis (including adrenocortical steroids).
ALOPRIM (allopurinol sodium) for Injection should not be mixed with or administered through the same intravenous port with agents which are incompatible in solution with ALOPRIM (allopurinol sodium) for Injection (see Preparation of Solution).
Preparation of SolutionALOPRIM (allopurinol sodium) for Injection must be reconstituted and diluted. The contents of each 30 mL vial should be dissolved with 25 mL of Sterile Water for Injection. Reconstitution yields a clear, almost colorless solution with no more than a slight opalescence. This concentrated solution has a pH of 11.1 to 11.8. It should be diluted to the desired concentration with 0.9% Sodium Chloride Injection or 5% Dextrose for Injection. Sodium bicarbonate-containing solutions should not be used. A final concentration of no greater than 6 mg/mL is recommended. The solution should be stored at 20° to 25°C (68° to 77°F) and administration should begin within 10 hours after reconstitution. Do not refrigerate the reconstituted and/or diluted product.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use this product if particulate matter or discoloration is present.
The following table lists drugs that are physically incompatible in solution with ALOPRIM (allopurinol sodium) for Injection.
Drugs That Are Physically Incompatible in Solution with ALOPRIM® (allopurinol sodium) for InjectionAmikacin 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
Netilmicin sulfate
Diphenhydramine HCl
Ondansetron HCl
Doxorubicin HCl
Prochlorperazine edisylate
Doxycycline hyclate
Promethazine HCl
Droperidol
Sodium bicarbonate
Floxuridine
Streptozocin
Gentamicin sulfate
Tobramycin sulfate
Haloperidol lactate
Vinorelbine tartrate
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