Allopurinol Sodium (Allopurinol Sodium)

Trade Name : Allopurinol sodium

West-Ward Pharmaceuticals Corp

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 500 mg/25mL

ALLOPURINOL SODIUM Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Allopurinol Sodium (Allopurinol Sodium) which is also known as Allopurinol sodium and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 500 mg/25mL per ml. Read more

Allopurinol Sodium (Allopurinol Sodium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Allopurinol sodium for injection is a xanthine oxidase inhibitor. It is available in vials as the sterile lyophilized sodium salt of allopurinol sodium equivalent to 500 mg of allopurinol. Allopurinol sodium for injection contains no preservatives.
The chemical name for allopurinol sodium is 1,5-dihydro-4-pyrazolo[3,4-]pyrimidin-4-one monosodium salt. It is a white amorphous mass with a molecular weight of 158.09 and molecular formula CHNNaO. The structural formula is
The pKa of allopurinol sodium is 9.31.

Allopurinol acts on purine catabolism without disrupting the biosynthesis of purines. It reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its formation. The degree of this decrease is dose dependent.
Allopurinol is a structural analogue of the natural purine base, hypoxanthine. It is an inhibitor of xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine and of xanthine to uric acid, the end product of purine metabolism in man. Allopurinol is metabolized to the corresponding xanthine analogue, oxypurinol (alloxanthine), which also is an inhibitor of xanthine oxidase.
Reutilization of both hypoxanthine and xanthine for nucleotide and nucleic acid synthesis is markedly enhanced when their oxidations are inhibited by allopurinol and oxypurinol. This reutilization does not disrupt normal nucleic acid anabolism, however, because feedback inhibition is an integral part of purine biosynthesis. As a result of xanthine oxidase inhibition, the serum concentration of hypoxanthine plus xanthine in patients receiving allopurinol for treatment of hyperuricemia is usually in the range of 0.3 to 0.4 mg/dL compared to a normal level of approximately 0.15 mg/dL. A maximum of 0.9 mg/dL of these oxypurines has been reported when the serum urate was lowered to less than 2 mg/dL by high doses of allopurinol. These values are far below the saturation levels, at which point their precipitation would be expected to occur (above 7 mg/dL).
The renal clearance of hypoxanthine and xanthine is at least 10 times greater than that of uric acid. The increased xanthine and hypoxanthine in the urine have not been accompanied by problems of nephrolithiasis. There are isolated case reports of xanthine crystalluria in patients who were treated with oral allopurinol.
The action of oral allopurinol differs from that of uricosuric agents, which lower the serum uric acid level by increasing urinary excretion of uric acid. Allopurinol reduces both the serum and urinary uric acid levels by inhibiting the formation of uric acid. The use of allopurinol to block the formation of urates avoids the hazard of increased renal excretion of uric acid posed by uricosuric drugs.

Following intravenous administration in six healthy male and female subjects, allopurinol was rapidly eliminated from the systemic circulation primarily via oxidative metabolism to oxypurinol, with no detectable plasma concentration of allopurinol after 5 hours post dosing. Approximately 12% of the allopurinol intravenous dose was excreted unchanged, 76% excreted as oxypurinol, and the remaining dose excreted as riboside conjugates in the urine. The rapid conversion of allopurinol to oxypurinol was not significantly different after repeated allopurinol dosing. Oxypurinol was present in systemic circulation in much higher concentrations and for a much longer period than allopurinol; thus, it is generally believed that the pharmacological action of allopurinol is mediated via oxypurinol. Oxypurinol was primarily eliminated unchanged in urine by glomerular filtration and tubular reabsorption, with a net renal clearance of about 30 mL/min.
To compare the pharmacokinetics of allopurinol and oxypurinol between intravenous (i.v.) and oral (p.o.) administration of allopurinol sodium for injection, a welI-controlled, four-way crossover study was conducted in 16 male healthy volunteers. Allopurinol sodium for injection was administered via an intravenous infusion over 30 minutes. Pharmacokinetic parameter estimates of allopurinol (mean u00b1 S.D.) following single i.v. and p.o. administration of allopurinol sodium for injection are summarized as follows:
Administration of Allopurinol Sodium for Injection
* n=7
u2020 Volume of Distribution (Steady-State)
u2020u2020Absolute Bioavailability
Oxypurinol was measurable in the plasma within 10 to 15 minutes following the administration of allopurinol sodium for injection. Pharmacokinetic parameter estimates of oxypurinol following i.v. and p.o. administration of allopurinol sodium for injection are shown below:n
Administration of Allopurinol Sodium for Injection
* Relative Bioavailability
In general, the ratio of the area under the plasma concentration vs time curve (AUC) between oxypurinol and allopurinol was in the magnitude of 30 to 40. The C and AUC, for both allopurinol and oxypurinol following i.v. administration of allopurinol sodium for injection were dose proportional in the dose range of 100 to 300 mg. The half-life of allopurinol and oxypurinol was not influenced by the route of allopurinol sodium for injection administration. Oral and intravenous administration of allopurinol sodium for injection at equal doses produced nearly superimposable oxypurinol plasma concentration vs time profiles, and the relative bioavailability of oxypurinol (F) was approximately 100%. Thus, the pharmacokinetics and plasma profiles of oxypurinol, the major pharmacological component derived from allopurinol, are similar after intravenous and oral administration of allopurinol sodium for injection.
A compassionate plea trial was conducted from 1977 through 1989 in which 718 evaluable patients with malignancies requiring treatment with cytotoxic chemotherapy, but who were unable to ingest or retain oral medication, received i.v. allopurinol sodium for injection in the U.S. Of these patients, 411 had established hyperuricemia and 307 had normal serum urate levels at the time that treatment was initiated. Normal serum uric acid levels were achieved in 68% (reduction of serum uric acid was documented in 93%) of the former, and were maintained throughout chemotherapy in 97% of the latter. Because of the study design, it was not possible to assess the impact of the treatment upon the clinical outcome of the patient groups.

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.

Patients who have developed a severe reaction to allopurinol should not be restarted on the drug.

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 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 - ).
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.

No data

In an uncontrolled, compassionate plea protocol, 125 of 1,378 patients reported a total of 301 adverse reactions while receiving 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 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 allopurinol sodium for injection. Two patients had serious adverse experiences (decreased renal function and generalized seizure) reported as being possibly attributable to allopurinol sodium for injection.
A listing of the adverse reactions regardless of causality reported from clinical trials follows:
The most frequent adverse reaction to oral allopurinol is skin rash. Skin reactions can be severe and sometimes fatal. Therefore, treatment with allopurinol sodium for injection should be discontinued immediately if a rash develops (see ). For further details on hypersensitivity reactions to treatment with oral allopurinol, refer to the package insert for allopurinol tablets.

Massive overdosing or acute poisoning by allopurinol sodium for injection has not been reported.
In mice, the minimal lethal dose is 45 mg/kg given intravenously or 500 mg/kg orally (about 1/3 or 4 times the usual human dose on a mg/m basis). Hypoactivity was observed with these doses. In rats, the minimum lethal dose is 100 mg/kg i.v., and 5000 mg/kg orally (about 1.5 and 75 times the usual human dose on a mg/m basis).
In the management of overdosage, there is no specific antidote for allopurinol sodium for injection. There has been no clinical experience in the management of a patient who has taken massive amounts of allopurinol.
Both allopurinol and oxypurinol are dialyzable; however, the usefulness of hemodialysis or peritoneal dialysis in the management of an overdose of allopurinol sodium for injection is unknown.

No data

STERILE SINGLE USE 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, ().
Store unreconstituted powder at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .
For Product Inquiry call 1-877-845-0689.
u00a0
Manufactured by:
HIKMA FARMACu00caUTICA (PORTUGAL), S.A.
Estrada do Rio da Mu00f3, 8, 8A e 8B u2013 Fervenu00e7a u2013 2705-906 Terrugem SNT, PORTUGAL
Distributed by:
West-Ward Pharmaceuticals
Eatontown, NJ 07724 USA
Revisedu00a0September 2015
PIN408-WES/1

NDC 0143-9533-01
Rx only
ALLOPURINOL SODIUM FOR INJECTION
500 mg/vial
FOR INTRAVENOUS INFUSION
STERILE SINGLE USE VIAL

NDC 0143-9533-01
Rx only
ALLOPURINOL SODIUM FOR INJECTION
500 mg/vial
FOR INTRAVENOUS INFUSION
STERILE SINGLE USE VIAL

No data

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Allopurinol Sodium (Allopurinol Sodium)

Trade Name : Allopurinol sodium

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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About GNH

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Allopurinol Sodium (Allopurinol Sodium)

Trade Name : Allopurinol sodium

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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