ZYLORIC TABLET 300MG [SIN06061P]

Product Info

ZYLORIC TABLET 300MG

[SIN06061P]

Indications

ZYLORIC 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).

The main clinical conditions where urate/uric acid deposition may occur are:

• idiopathic gout;

• uric acid lithiasis;

• acute uric acid nephropathy;

• neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously, or after cytotoxic therapy;

• certain enzyme disorders which lead to overproduction of urate, for example;

  • hypoxanthine-guanine phosphoribosyltransferase, including Lesch-Nyhan syndrome;

  • glucose-6-phosphatase including glycogen storage disease;

  • phosphoribosylpyrophosphate synthetase;

  • phosphoribosylpyrophosphate amidotransferase;

  • adenine phosphoribosyltransferase.

ZYLORIC is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltranferase.

ZYLORIC 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.

Dosage and Administration

The dosage should be adjusted by monitoring serum urate concentrations and urinary urate/uric acid levels at appropriate intervals.

ZYLORIC 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.

• Adults
  ZYLORIC 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 (see Dosage and Administration - Renal impairment and Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  The following dosage schedules are suggested:

  • 100 to 200 mg daily in mild conditions,

  • 300 to 600 mg daily in moderately severe conditions,

  • 700 to 900 mg daily in severe conditions.

  If dosage on a mg/kg bodyweight basis is required, 2 to 10 mg/kg bodyweight/day should be used.

• Children (under 15 years)
  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.

• Elderly
  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 “Dosage and Administration — Renal impairment” and “Warnings and Precautions” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Renal impairment
  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.

  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).

  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.

• Hepatic impairment
  Reduced doses should be used in patients with hepatic impairment.

  Periodic liver function tests are recommended during the early stages of therapy.

• Treatment of High Urate Turnover Conditions e.g. Neoplasia, Lesch-Nyhan Syndrome
  It is advisable to correct existing hyperuricaemia and/or hyperuricosuria with ZYLORIC 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 ZYLORIC should be at the lower end of the recommended dosage schedule.

  If urate nephropathy or other pathology has compromised renal function, the advice given in “Dosage and Administration — Renal impairment” should be followed. These steps may reduce the risk of xanthine and/or oxipurinol deposition complicating the clinical situation (see Interactions and Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

ZYLORIC tablets should not be administered to individuals known to be hypersensitive to allopurinol or to any of the components of the formulation.