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Zyloprim (Allopurinol) - Summary

 
 



ZYLOPRIM SUMMARY

PRODUCT INFORMATION
ZYLOPRIM® (allopurinol)
-mg Scored Tablets and
-mg Scored Tablets

ZYLOPRIM is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allopurinol and each scored peach tablet contains 300 mg allopurinol.

THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.

ZYLOPRIM reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).

ZYLOPRIM is indicated in:

  1. the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
  2. the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with ZYLOPRIM should be discontinued when the potential for overproduction of uric acid is no longer present.
  3. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.

See all Zyloprim indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zyloprim (Allopurinol)

Gout: data from Phase III studies of lesinurad in combination with allopurinol
Source: Gout News From Medical News Today [2014.11.19]
AstraZeneca has presented top-line results of two pivotal Phase III trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), when used in combination...

Less than half of gout patients reach recommended treatment goal following treatment with allopurinol
Source: Gout News From Medical News Today [2013.10.31]
AstraZeneca and Ardea Biosciences presented results from a large study of allopurinol, a treatment commonly used to lower uric acid in patients with gout.

Gout drug may reduce risk of death
Source: Gout News From Medical News Today [2014.03.26]
In a recently to be published study in Annals of the Rheumatic Diseases, researchers have found the use of the drug allopurinol was associated with a reduced risk of death in hyperuricemic (gout)...

Can Tomatoes Trigger Gout? (CME/CE)
Source: MedPage Today Rheumatology [2015.08.27]
(MedPage Today) -- Some support for patient claims seen in new study

New research backs belief that tomatoes can be a gout trigger
Source: Gout News From Medical News Today [2015.08.20]
People who maintain that eating tomatoes can cause their gout to flare up are likely to welcome new research from New Zealand's University of Otago that has, for the first time, found a biological...

more news >>

Published Studies Related to Zyloprim (Allopurinol)

In a double-blind, randomized and placebo-controlled trial, adjuvant allopurinol improved symptoms of mania in in-patients suffering from bipolar disorder. [2014]
Allopurinol is a drug used primarily to treat hyperuricemia. In patients suffering from acute mania, increased levels of uric acid are observed, and symptom improvements are associated with decreased levels of uric acid...

Allopurinol for mania: a randomized trial of allopurinol versus placebo as add-on treatment to mood stabilizers and/or antipsychotic agents in manic patients with bipolar disorder. [2014]
bipolar disorder... CONCLUSIONS: The findings of this large, well-powered study do not support add-on

Allopurinol reduces left ventricular mass in patients with type 2 diabetes and left ventricular hypertrophy. [2013]
regression of LVH in patients with T2DM... CONCLUSIONS: Allopurinol causes regression of LVM in patients with T2DM and LVH.

High-dose allopurinol reduces left ventricular mass in patients with ischemic heart disease. [2013]
to reduce LV afterload in IHD and may therefore also regress LVH... CONCLUSIONS: High-dose allopurinol regresses LVH, reduces LV end-systolic volume,

Mechanistic insights into the therapeutic use of high-dose allopurinol in angina pectoris. [2011.08.16]
OBJECTIVES: The aim of this study was to evaluate the effect of high-dose allopurinol on vascular oxidative stress (OS) and endothelial function in subjects with stable coronary artery disease (CAD). BACKGROUND: Allopurinol, a xanthine oxidase inhibitor, prolongs the time to chest pain during exercise in angina. We sought to ascertain whether allopurinol also improves endothelial dysfunction in optimally treated CAD patients, because such an effect might be of value to reduce future cardiovascular mortality. The mechanism of the anti-ischemic effect of allopurinol could be related to its reducing xanthine oxidase-induced OS, and our second aim was to see whether allopurinol really does reduce vascular tissue OS in CAD patients... CONCLUSIONS: Our study demonstrates that, in optimally treated CAD patients, high-dose allopurinol profoundly reduces vascular tissue OS and improves 3 different measures of vascular/endothelial dysfunction. The former effect on OS might underpin the anti-ischemic effect of allopurinol in CAD. Both effects (on OS and endothelial dysfunction) increase the likelihood that high-dose allopurinol might reduce future cardiovascular mortality in CAD, over and above existing optimum therapy. (Exploring the therapeutic potential of xanthine oxidase inhibitor allopurinol in angina; ISRCTN15253766). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Zyloprim (Allopurinol)

A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL [Recruiting]
This research is being done to determine if allopurinol can change the metabolism of the oral chemotherapeutic medication 6-mercaptopurine (6-MP) in children with acute lymphoblastic leukemia (ALL). 6-MP is originally started at a standard dose in children with ALL, but the dose is adjusted according to the absolute neutrophil count (ANC). Occasionally, 6-MP doses need to be increased in order to get the ANC into a specific target range. Also, increasing the 6-MP dose can lead to unwanted side effects, such as inflammation of the liver as shown by increases in laboratory values (ALT, aspartate aminotransferase (AST), bilirubin), nausea, and abdominal discomfort. Previous studies in children with inflammatory bowel disease has shown that combining allopurinol with 6-MP can decrease side effects associated with high doses of 6-MP and also increase the efficacy of 6-MP. Allopurinol is approved by the Food and Drug Administration for the treatment of tumor lysis syndrome in ALL. Through this research study, we hope to show that the combination of allopurinol and 6-MP will be safe, tolerable, and effective in children with ALL.

Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study [Active, not recruiting]
Kidney patients on dialysis commonly die because of heart disease. One of the biggest problems in their hearts is that the muscle wall of the heart thickens. This makes it less efficient. We found in patients with mild kidney disease that a drug normally used to treat gout (allopurinol) had the remarkable side effect of being able to reduce this thickening of their heart wall. In this new study we aim to find out if this benefit of allopurinol also occurs in severe kidney patients i. e. those on regular dialysis. We also are trying to figure out the best dose of allopurinol to use. To do this we are planning a study where we will recruit patients with kidney disease who are on dialysis. The 1st phase of the trial will be to determine the best dose of allopurinol to use and the second phase will be to do a clinical trial where patients will be randomly allocated to either this optimum dose of allopurinol or a dummy medication (placebo) and will receive one year of treatment. They will have a special scan of the heart using an MRI machine to measure the extent of thickening of their heart muscle before they start on treatment and will have a further MRI scan when their one year treatment finishes. Phase 1- the dose finding study, will involve 10 patients who will have between 3 and 7 visits to the hospital scheduled around 4 to 17 dialysis sessions. The later study will involve up to 76 patients who will be asked to attend the hospital up to 8 times over a 13 month period.

Does Allopurinol Reduce Thickening of the Left Ventricle of the Heart in Patient With Treated Hypertension? [Recruiting]
Does Allopurinol regress Left Ventricular Hypertrophy in Patients with Treated Essential Hypertension? People with high blood pressure are at increased risk of heart complications. One of the biggest problems is that the muscle wall of the heart thickens. The medical term for this is Left Ventricular Hypertrophy (LVH). LVH makes the heart less efficient and patients with LVH are at a 10 times greater risk of heart complications than those without it. A goal of treating high blood pressure is to reduce the strain on the heart and to try to decrease this thickening of the heart wall. However, even when blood pressure is treated and is under control, LVH can persist, and as there are no symptoms to LVH it can go undetected. Currently the only way to reduce LVH would be to lower blood pressure (BP) even further. This can cause side-effects from low BP such as dizziness and nausea. It has previously been shown that a drug allopurinol, which is usually used to treat gout had the remarkable side effect of being able to reduce this thickening of the heart wall in patients who had kidney disease or diabetes. The aim now is to see if patients with high blood pressure and LVH may also benefit from treatment with allopurinol. If LVH can be reduced using allopurinol, this might be a new way to reduce cardiac risk in these patients without needing to lower BP even further. In this study the aim is to recruit 66 patients who have treated and well controlled blood pressure but may still have LVH. They will be screened for LVH by doing an ultrasound scan of the heart and then that will be confirmed with a Magnetic Resonance Imaging (MRI) scan, which is a special scan of the heart using an MRI machine to measure the extent of thickening of the heart muscle before they start on treatment of allopurinol or placebo. As this is a clinical trial the participants will be randomly allocated to either allopurinol or a dummy medication (placebo) and will receive one year of treatment so that the investigators can compare if there is a difference between normal treatment and addition of allopurinol. All the patients currently prescribed medication for their high blood pressure will continue as normal on that. They will have a further MRI scan when their one year treatment with allopurinol or placebo finishes.

Benefits - You will be monitored closely during the study and will be seen by a doctor with

a special interest in cardiology at each of your study visits and your medication will be reviewed on a regular basis. The tests will give us information about the function of your heart, kidneys and blood circulation. If any of these investigations, including information from the MRI scan of your heart reveal any new abnormality we will either discuss this with your hospital consultant or refer you to a specialist clinic (whichever seems most appropriate). The study will not immediately benefit you, but if the results of the study are positive it may change the practice of managing patients with treated high blood pressure but may still have LVH, like you and potentially will have a great impact on other such patients in the future. If so, you may gain eventually from our discovering a new treatment for your condition.

Risks - The side effects of the allopurinol are very rare (less than 1 in 10,000 people) and

include headache, stomach upset, drowsiness and anaemia. Having blood tests taken can cause some mild bruising. The flow mediated dilatation may cause temporary numbness. MRI scanning is very safe and does not use radiation but some may feel a bit closed in. The scanner is a bit noisy but you will be given ear protection which also plays music. Your kidney function will be assessed before the scan to ensure it is safe to give you the contrast agent described above.

Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition [Completed]
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, human male subjects.

Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia [Completed]
This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum uric acid levels.

more trials >>


Page last updated: 2015-08-27

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