- Approval Id
- f8b977c4b654b71e
- Drug Name
- ZYLORIC TABLET 300MG
- Product Name
- ZYLORIC TABLET 300MG
- Approval Number
- SIN06061P
- Approval Date
- 1991-05-22
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>The dosage should be adjusted by monitoring serum urate concentrations and urinary urate/uric acid levels at appropriate intervals.</p>
<p><em>ZYLORIC</em> may be taken orally once a day after a meal. It is well tolerated, especially after food. Should the daily dosage exceed 300 mg and gastrointestinal intolerance be manifested, a divided dose regimen may be appropriate.</p>
<ul>
<li><p><strong>Adults</strong><br>
<em>ZYLORIC</em> should be introduced at low dosage e.g. 100 mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised if renal function is poor <em>(see Dosage and Administration - Renal impairment and Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>).</em></p>
<p>The following dosage schedules are suggested:</p>
<ul class="nobull">
<li>100 to 200 mg daily in mild conditions,</li>
<li>300 to 600 mg daily in moderately severe conditions,</li>
<li>700 to 900 mg daily in severe conditions.</li>
</ul>
<p>If dosage on a mg/kg bodyweight basis is required, 2 to 10 mg/kg bodyweight/day should be used.</p></li>
<li><p><strong>Children (under 15 years)</strong><br>
10 to 20 mg/kg bodyweight/day up to a maximum of 400 mg daily. Use in children is rarely indicated, except in malignant conditions (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.</p></li>
<li><p><strong>Elderly</strong><br>
In the absence of specific data, the lowest dosage which produces satisfactory urate reduction should be used. Particular attention should be paid to advice in <em>“Dosage and Administration — Renal impairment”</em> and <em>“Warnings and Precautions”</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>.</em></p></li>
<li><p><strong>Renal impairment</strong><br>
Since allopurinol and its metabolites are excreted by the kidney, impaired renal function may lead to retention of the drug and/or its metabolites with consequent prolongation of plasma half-lives. In severe renal insufficiency, it may be advisable to use less than 100 mg per day or to use single doses of 100 mg at longer intervals than one day.</p>
<p>If facilities are available to monitor plasma oxipurinol concentrations, the dose should be adjusted to maintain plasma oxipurinol levels below 100 micromol/litre (15.2 mg/litre).</p>
<p>Allopurinol and its metabolites are removed by renal dialysis. If dialysis is required two to three times a week consideration should be given to an alternative dosage schedule of 300 to 400 mg allopurinol immediately after each dialysis with none in the interim.</p></li>
<li><p><strong>Hepatic impairment</strong><br>
Reduced doses should be used in patients with hepatic impairment.</p>
<p>Periodic liver function tests are recommended during the early stages of therapy.</p></li>
<li><p><strong>Treatment of High Urate Turnover Conditions e.g. Neoplasia, Lesch-Nyhan Syndrome</strong><br>
It is advisable to correct existing hyperuricaemia and/or hyperuricosuria with <em>ZYLORIC</em> before starting cytotoxic therapy. Adequate hydration is important to maintain optimum diuresis and alkalinisation of the urine is advisable to increase solubility of urinary urate/uric acid. Dosage of <em>ZYLORIC</em> should be at the lower end of the recommended dosage schedule.</p>
<p>If urate nephropathy or other pathology has compromised renal function, the advice given in <em>“Dosage and Administration — Renal impairment”</em> should be followed. These steps may reduce the risk of xanthine and/or oxipurinol deposition complicating the clinical situation <em>(see Interactions and Adverse Reactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>).</em></p></li>
</ul>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>ZYLORIC</em> is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical risk (e.g. treatment of malignancy potentially leading to acute uric acid nephropathy).</p>
<p>The main clinical conditions where urate/uric acid deposition may occur are:</p>
<ul>
<li>idiopathic gout;</li>
<li>uric acid lithiasis;</li>
<li>acute uric acid nephropathy;</li>
<li>neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously, or after cytotoxic therapy;</li>
<li>certain enzyme disorders which lead to overproduction of urate, for example;
<ul class="dash">
<li>hypoxanthine-guanine phosphoribosyltransferase, including Lesch-Nyhan syndrome;</li>
<li>glucose-6-phosphatase including glycogen storage disease;</li>
<li>phosphoribosylpyrophosphate synthetase;</li>
<li>phosphoribosylpyrophosphate amidotransferase;</li>
<li>adenine phosphoribosyltransferase.</li>
</ul>
</li>
</ul>
<p><em>ZYLORIC</em> is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltranferase.</p>
<p><em>ZYLORIC</em> is indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><em>ZYLORIC</em> tablets should not be administered to individuals known to be hypersensitive to allopurinol or to any of the components of the formulation.</p>
- Atc Code
- Pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- DCH AURIGA SINGAPORE
