ZYLOPRIM SUMMARY
PRODUCT INFORMATION
ZYLOPRIM® (allopurinol)
100-mg Scored Tablets and
300-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:
- the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
- 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.
- 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.
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NEWS HIGHLIGHTSMedia Articles Related to Zyloprim (Allopurinol)
ACR: Pump Up the Allopurinol to Prevent Gout (CME/CE)
Source: MedPage Today Rheumatology [2009.10.23]
PHILADELPHIA (MedPage Today) -- Going beyond the recommended dosing of allopurinol (Zyloprim) to treat patients with gout may help prevent recurrence safely, researchers contended here.
ACR: Allopurinol Sensitivity More Likely in Patients with Renal Problems (CME/CE)
Source: MedPage Today Rheumatology [2009.10.28]
PHILADELPHIA (MedPage Today) -- Hypersensitivity to the anti-uricemic drug allopurinol, often leading to acute kidney failure, is up to three times as common in patients who already suffer renal impairment, according to research presented here.
ASN: Febuxostat Works in Gout Patients with Renal Impairment (CME/CE)
Source: MedPage Today Rheumatology [2009.11.02]
SAN DIEGO (MedPage Today) -- In patients with gout and preexisting mild to moderate renal impairment, febuxostat (Uloric) is more effective and as safe as allopurinol, the gold standard gout treatment, researchers found.
ACR: Gout and Metabolic Disease Go Hand in Hand (CME/CE)
Source: MedPage Today Rheumatology [2009.10.27]
PHILADELPHIA (MedPage Today) -- Gout and hyperuricemia may represent another facet of metabolic syndrome, so closely tied are they to obesity, high cholesterol, and type 2 diabetes, suggested several studies presented here.
Low-Dose Colchicine (Colcrys) Is Rapid, Effective Treatment For Acute Gout Flares
Source: Gout News From Medical News Today [2009.10.26]
PHILADELPHIA - New data show that low-dose colchicine (ColcrysTM) rapidly controls acute gout flares. The results, which were presented at the 2009 Annual Scientific Meeting of the American College of Rheumatology, are drawn from a secondary analysis of the phase III Acute Gout Flare Receiving Colchicine Evaluation (AGREE) trial.
Published Studies Related to Zyloprim (Allopurinol)
Allopurinol mouth rinse for prophylaxis of fluorouracil-induced mucositis. [2009.07.29]
Allopurinol mouth rinse for prophylaxis of fluorouracil-induced mucositisTo prepare and evaluate an allopurinol mouth rinse for prophylaxis of fluorouracil-induced mucositis, 33 patients with malignant disorders, who were going to receive 5-fluorouracil containing chemotherapy, were enrolled in a placebo-controlled double-blinded randomized clinical trial...
Maternal allopurinol during fetal hypoxia lowers cord blood levels of the brain injury marker S-100B. [2009.07]
BACKGROUND: Fetal hypoxia is an important determinant of neonatal encephalopathy caused by birth asphyxia, in which hypoxia-induced free radical formation plays an important role. HYPOTHESIS: Maternal treatment with allopurinol, will cross the placenta during fetal hypoxia (primary outcome) and reduce S-100B and free radical formation (secondary outcome)... CONCLUSIONS: Maternal allopurinol/oxypurinol crosses the placenta during fetal hypoxia. In fetuses/newborns with therapeutic allopurinol/oxypurinol concentrations in cord blood, lower plasma levels of the brain injury marker protein S-100B were detected. A larger allopurinol trial in compromised fetuses at term seems warranted. The allopurinol dosage must be adjusted to achieve therapeutic fetal allopurinol/oxypurinol concentrations.
A randomised controlled trial on the efficacy and tolerability with dose escalation of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in patients with gout. [2009.06]
OBJECTIVES: To compare the efficacy and tolerability of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day used to attain a target serum urate concentration (sUr) < or =0.30 mmol/l (5 mg/dl)... CONCLUSIONS: Increasing the allopurinol dose from 300 to 600 mg/day and the benzbromarone dose from 100 to 200 mg/day according to the target sUr produced significantly higher success rates (both 78% successful in attaining sUr < or =0.30 mmol/l). No significant differences in treatment success between benzbromarone and allopurinol were found after dose escalation. Trial registration number: ISRCTN49563848).
Oral allopurinol to prevent hyperamylasemia and acute pancreatitis after endoscopic retrograde cholangiopancreatography. [2009.04.07]
AIM: To assess the efficacy of allopurinol to prevent hyperamylasemia and pancreatitis after endoscopic retrograde cholangiopancreatography (PEP)... CONCLUSION: Oral allopurinol before ERCP decreased the incidences of hyperamylasemia and pancreatitis in patients submitted to high-risk procedures.
A double-blind trial of adjunctive allopurinol for schizophrenia. [2009.04]
CONCLUSIONS: Allopurinol may be an effective adjunctive medication for some patients with persistent schizophrenia.
Clinical Trials Related to Zyloprim (Allopurinol)
Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as Add-on Antipsychotics in Patients With Schizophrenia [Not yet recruiting]
The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo,
as add-on to anti-psychotics in the treatment of patients with schizophrenia.
APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X [Recruiting]
Morbidity of patients with cardiac syndrome X (typical anginal-like chest pain and normal
coronary arteriograms) is high with continuing episodes of chest pain and frequent hospital
readmissions. Management of this syndrome represents a major challenge to the treating
physician. Evidence for the important role of endothelial dysfunction and oxidative stress
in the pathogenesis of cardiac syndrome X has been recently strengthened by the finding that
basal superoxide production predicts future cardiovascular events in this patient group. The
investigators have recently shown that high-dose allopurinol abolishes vascular oxidative
stress and improves endothelial function in patients with chronic heart failure, which makes
allopurinol a prime candidate to reduce oxidative stress in syndrome X. The hypothesis to be
tested in this study is whether allopurinol offers dual benefits of improving vascular
function and reducing myocardial ischaemia in patients with cardiac syndrome X. This study
may discover a novel way to improve endothelial function and anginal symptoms which are
often debilitating in these patients.
Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients [Recruiting]
Antenatal Allopurinol During Fetal Hypoxia [Recruiting]
A former study (submitted) in 32 severely asphyxiated infants participating in a randomized
double blind study, in which early postnatal allopurinol or a placebo (within 4 hours after
birth) was administered to reduce free radical formation and consequently
reperfusion/reoxygenation injury to the newborn brain, showed an unaltered high mortality
and no clinically relevant improvement in morbidity in infants treated with allopurinol. It
was hypothesized that postnatal allopurinol treatment started too late to reduce
reperfusion-induced free radical surge and that initiating allopurinol treatment of the
fetus with (imminent) hypoxia already via the mother during labor will be more effective to
reduce free radical-induced post-asphyxial brain damage.
Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol [Recruiting]
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries,
that has shown an increasing incidence over the last many decades. For the last 60 years
antimony compounds are considered the treatment of choice. Though their use is expensive,
cumbersome, has many adverse effects and not effective in all patients, the search for a
better alternative is still going on. Low dose antimony compounds in combination with
several agents have shown promise of reducing adverse effects of antimony compounds without
compromising efficacy. Allopurinol is one such agent which though promising lacks
randomized, controlled trials to prove efficacy. The main objective of this study is to
evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it
with high dose sodium stibogluconate in terms of efficacy and adverse effects.
Methods and design: A multi-center randomized, controlled trial including 620 patients from
endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research
question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study.
After evaluating the inclusion/exclusion criteria patients will be randomized to receive
either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a
maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and
allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During
treatment patients will be admitted to hospital and monitored daily for the presence of
adverse effects. Follow up period will last six months during which patients will visits the
research centers for assessment of healing process at monthly intervals.
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