ZYLOPRIM 100 MG TABLET
Indications / Uses :
For reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (eg, gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical risk (eg, 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 eg, hypoxanthine-guanine phosphoribosyltransferase including Lesch-Nyhan syndrome; glucose-6-phosphatase including glycogen storage disease; phosphoribosylpyrophosphate synthetase; phosphoribosylpyrophosphate amidotransferase; and adenine phosphoribosyltransferase.
Management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltransferase.
Management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria when fluid, dietary and similar measures have failed.
Should be taken with food.
Hypersensitivity to allopurinol or to any of the excipients of Zyloprim.
Special Precautions :
Zyloprim should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs as this could result in more serious hypersensitivity reactions including Stevens-Johnson syndrome and toxic epidermal necrosis (see Immune System Disorders and Skin and Subcutaneous Tissue Disorders under Adverse Reactions).
Reduced doses should be used in patients with hepatic or renal impairment. Patients under treatment for hypertension or cardiac insufficiency eg, with diuretics or ACE inhibitors, may have some concomitant impairment of renal function and Zyloprim should be used with care in this group.
Asymptomatic hyperuricemia per se is generally not considered an indication for use of Zyloprim. Fluid and dietary modification with management of the underlying cause may correct the condition.
Acute Gouty Attacks: Zyloprim treatment should not be started until an acute attack of gout has completely subsided, as further attacks may be precipitated.
In the early stages of treatment with Zyloprim, as with uricosuric agents, an acute attack of gouty arthritis may be precipitated. Therefore, it is advisable to give prophylaxis with a suitable anti-inflammatory agent or colchicine for a few months.
If acute attacks develop in patients receiving Zyloprim, treatment should continue at the same dosage while the acute attack is treated with a suitable anti-inflammatory agent.
Xanthine Deposition: In conditions where the rate of urate formation is greatly increased (eg, malignant disease and its treatment, Lesch-Nyhan syndrome), the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract. This risk may be minimized by adequate hydration to achieve optimal urine dilution.
Impaction of Uric Acid Renal Stones: Adequate therapy with Zyloprim will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter.
Effects on the Ability to Drive or Operate Machinery: Since adverse reactions eg, somnolence, vertigo and ataxia have been reported in patients receiving Zyloprim, patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that Zyloprim does not adversely affect performance.
Use in pregnancy: There is inadequate evidence of safety of Zyloprim in human pregnancy, although it has been in wide use for many years without apparent ill consequence.
Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or unborn child (see also Teratogenicity under Actions).
Use in lactation: Reports indicate that allopurinol and oxipurinol are excreted in human breast milk. Concentrations of allopurinol 1.4 mg/L and oxipurinol 53.7 mg/L have been demonstrated in breast milk from a woman taking Zyloprim 300 mg/day. However, there are no data concerning the effects of allopurinol or its metabolites on the breastfed baby.