Name: Allopurinol Injection
- Allopurinol Injection injection
- Allopurinol Injection side effects
- Allopurinol Injection drug
- Allopurinol Injection uses
- Allopurinol Injection adverse effects
- Allopurinol Injection 100 mg
- Allopurinol Injection dosage
- Allopurinol Injection usual dose
- Allopurinol Injection oral dose
- Allopurinol Injection allopurinol injection dosage
- Allopurinol Injection 600 mg
- Allopurinol Injection mg
Uses of Allopurinol Injection
- It is used to prevent high uric acid levels during chemo.
- It may be given to you for other reasons. Talk with the doctor.
How is this medicine (Allopurinol Injection) best taken?
Use allopurinol injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as an infusion into a vein over a period of time.
- Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Pain when passing urine or blood in urine.
- Fever or chills.
- Sore throat.
- Eye irritation.
- Joint pain.
- Any unexplained bruising or bleeding.
- Feeling very tired or weak.
- Liver problems have happened with this medicine. Sometimes, liver problems have not gone back to normal after allopurinol injection was stopped. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
If OVERDOSE is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about allopurinol injection, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about allopurinol injection. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using allopurinol injection.
Review Date: October 4, 2017
A 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 to (1) avoid the theoretical possibility of formation of xanthine calculi under the influence of allopurinol therapy and (2) help prevent renal precipitation of urates in patients receiving concomitant uricosuric agents.
A few patients with pre-existing renal disease or poor urate clearance have shown a rise in BUN during allopurinol administration, although a decrease in BUN has also been observed. In patients with hyperuricemia due to malignancy, the vast majority of changes in renal function are attributable to the underlying malignancy rather than to therapy with allopurinol. Concurrent conditions such as multiple myeloma and congestive myocardial disease were present among those patients whose renal function deteriorated after allopurinol was begun. Renal failure is rarely associated with hypersensitivity reactions to allopurinol.
Patients with decreased renal function do require lower doses of allopurinol. Patients should be carefully observed during the early stages of allopurinol administration so that the dosage can be appropriately adjusted for renal function.
In patients with severely impaired renal function or decreased urate clearance, the half-life of oxypurinol in the plasma is greatly prolonged. Patients should be treated with the lowest effective dose, in order to minimize possible side effects. The appropriate dose of allopurinol sodium for injection for patients with a creatinine clearance ≤10 mL/min is 100 mg per day. For patients with a creatinine clearance between 10 and 20 mL/min, a dose of 200 mg per day is recommended. With extreme renal impairment (creatinine clearance less than 3 mL/min), the interval between doses may also need to be extended.
Bone marrow suppression has been reported in patients receiving allopurinol; however, most of these patients were receiving concomitant medications with the known potential to cause such an effect. The suppression has occurred from as early as 6 weeks to as long as 6 years after the initiation of allopurinol therapy.
The correct dosage and schedule for maintaining the serum uric acid within the normal range is best determined by using the serum uric acid as an index.
In patients with pre-existing liver disease, periodic liver function tests are recommended during the early stages of therapy (see WARNINGS).
Allopurinol and its primary active metabolite, oxypurinol, are eliminated by the kidneys; therefore, changes in renal function have a profound effect on dosage. In patients with decreased renal function, or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient’s allopurinol dosage reassessed.
The prothrombin time should be reassessed periodically in the patients receiving dicumarol who are given allopurinol.
The following drug interactions were observed in some patients undergoing treatment with oral allopurinol. Although the pattern of use for oral allopurinol includes longer term therapy, particularly for gout and renal calculi, the experience gained may be relevant.Mercaptopurine/Azathioprine
Allopurinol inhibits the enzymatic oxidation of mercaptopurine and azathioprine to 6-thiouric acid. This oxidation, which is catalyzed by xanthine oxidase, inactivates mercaptopurine. Therefore, the concomitant administration of 300 to 600 mg of oral allopurinol 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.Dicumarol
It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. Consequently, prothrombin time should be reassessed periodically in patients receiving both drugs. The clinical basis of this drug interaction has not been established.Uricosuric Agents
Since the excretion of oxypurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxypurinol. As a result, the concomitant administration of uricosuric agents decreases the inhibition of xanthine oxidase by oxypurinol and increases the urinary excretion of uric acid.Thiazide Diuretics
Reports that the concomitant administration of allopurinol and thiazide diuretics contributed to increased allopurinol toxicity were reviewed; a causal mechanism or cause-and-effect relationship was not found. Renal function should be monitored in patients on thiazide diuretics and allopurinol (see WARNINGS).Ampicillin/Amoxicillin
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of this reaction has not been established.Cytotoxic Agents
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.Chlorpropamide
The half-life of chlorpropamide in the plasma may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.Cyclosporine
Reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol sodium for injection. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.Drug/Laboratory Test Interactions
Allopurinol is not known to alter the accuracy of laboratory tests.
Carcinogenesis, Mutagenesis and Impairment of FertilityCarcinogenesis
Allopurinol was administered at doses up to 20 mg/kg/day to mice and rats for the majority of their life span. No evidence of carcinogenicity was seen in either mice or rats (at doses about 1/6 or 1/3 the recommended human dose on a mg/m2 basis, respectively).Mutagenesis
Allopurinol administered intravenously to rats (50 mg/kg) was not incorporated into rapidly replicating intestinal DNA. No evidence of clastogenicity was observed in an in vivo micronucleus test in rats, or in lymphocytes taken from patients treated with allopurinol (mean duration of treatment 40 months), or in an in vitro assay with human lymphocytes.Impairment of Fertility
Allopurinol oral doses of 20 mg/kg/day had no effect on male or female fertility in rats or rabbits (about 1/3 or 1/2 the human dose on a mg/m2 basis, respectively).
Teratogenic Effects: Pregnancy Category C.
There was no evidence of fetotoxicity or teratogenicity in rats or rabbits treated during the period of organogenesis with oral allopurinol at doses up to 200 mg/kg/day and up to 100 mg/kg/day, respectively (about three times the human dose on a mg/m2 basis). However, there is a published report in pregnant mice that single intraperitoneal doses of 50 or 100 mg/kg (about 1/3 or 3/4 the human dose on a mg/m2 basis) of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects (cleft palate, harelip, and digital defects). It is uncertain whether these findings represented a fetal effect or an effect secondary to maternal toxicity. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Experience with allopurinol during human pregnancy has been limited partly because women of reproductive age rarely require treatment with allopurinol. Two unpublished reports and one published paper describe women giving birth to normal offspring after receiving oral allopurinol during pregnancy. There have been no pregnancies reported in patients receiving allopurinol sodium for injection, but it is assumed that the same risks would apply.
Allopurinol and oxypurinol have been found in the milk of a mother who was receiving allopurinol. Since the effect of allopurinol on the nursing infant is unknown, caution should be exercised when allopurinol is administered to a nursing woman.
Clinical data are available on approximately 200 pediatric patients treated with allopurinol sodium for injection. The efficacy and safety profile observed in this patient population were similar to that observed in adults (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION).
Clinical studies of allopurinol sodium for injection did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Allopurinol Injection Dosage and Administration
Children and Adults
The dosage of 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 allopurinol sodium for injection is as follows:
Recommended Daily Dose
200 to 400 mg/m2/day
Starting Dose 200 mg/m2/day
A 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 Function
The dose of allopurinol sodium for injection should be reduced in patients with impaired renal function to avoid accumulation of allopurinol and its metabolites:
Recommended Daily Dose
10 to 20 mL/min
3 to 10 mL/min
100 mg/day at extended intervals
In 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 allopurinol sodium for injection should be initiated 24 to 48 hours before the start of chemotherapy known to cause tumor cell lysis (including adrenocorticosteroids).
Allopurinol sodium for injection should not be mixed with or administered through the same intravenous port with agents which are incompatible in solution with allopurinol sodium for injection (see Preparation of Solution).
Preparation of Solution
Allopurinol sodium for injection must be reconstituted and diluted. The contents of each 50 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 allopurinol sodium for injection.
Drugs That are Physically Incompatible in Solution with Allopurinol Sodium for Injection
Methylprednisolone sodium succinate
Allopurinol Sodium for Injection vial label
ALLOPURINOL SODIUM FOR INJECTION
FOR INTRAVENOUS INFUSION
STERILE SINGLE USE VIAL
|ALLOPURINOL SODIUM |
allopurinol sodium injection, powder, lyophilized, for solution
|Labeler - West-Ward Pharmaceuticals Corp (001230762)|