Allopurinol 100mg Tablets

… hallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN. Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions. Chronic renal impairment Patients with chronic renal impairment and concomitant diuretic use, in particular thiazides, may be at increased risk of developing hypersensitivity reactions including SJS/TEN associated with allopurinol. Extra vigilance for the signs of hypersensitivity syndrome or SJS/TEN is required and the patient should be informed of the need to stop treatment immediately and permanently at the first appearance of symptoms (see section 4.8) HLA-B*5801 allele The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol related hypersensitivity syndrome and SJS/TEN. The frequency of the HLA- B*5801 all …

… cid renal stones Adequate therapy with Allopurinol will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter. Lactose intolerance Allopurinol tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Thyroid disorders Increased TSH values (>5.5 μIU/mL) were observed in patients on long-term treatment with allopurinol (5.8%) in a long term open label extension study. Caution is required when a …

… . Impaction of uric acid renal stones Adequate therapy with Allopurinol will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter. Lactose intolerance Allopurinol tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose ma …

… of the need to stop treatment immediately at the first appearance of symptoms. SJS/TEN can still occur in patients who are found to be negative for HLA-B*5801 irrespective of their ethnic origin. Hepatic or renal impairment Reduced doses should be used in patients with hepatic or renal impairment. (See Section 4.2) Patients under treatment for hypertension or cardiac insufficiency, for example with diuretics or ACE in …

… . Impaction of uric acid renal stones Adequate therapy with Allopurinol will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter. Lactose intolerance Allopurinol tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose ma …

… cute attacks develop in patients receiving allopurinol, 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 (e.g. 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 minimised by adequate hydration to achieve optimal urine dilution. Impaction of uric acid renal stones Adequate therapy with Allopurinol will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter. L …

… withdrawn immediately. Rechallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN. Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions. Chronic renal impairment Patients with chronic renal impairment and concomitant diuretic use, in particular thiazides, may be at increased risk of developing hypersensitivity reactions including SJS/TEN associated with all …

… tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Thyroid disorders Increased TSH values (>5.5 μIU/mL) were observed in patients on long-term treatment with allopurinol (5.8%) in a long term open label extension study. Caution is required when allopurinol is used i …

… f hypersensitivity syndrome or SJS/TEN is required and the patient should be informed of the need to stop treatment immediately and permanently at the first appearance of symptoms (see section 4.8) HLA-B*5801 allele The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol related hypersensitivity syndrome and SJS/TEN. The frequency of the HLA- B*5801 allele varies widely be …

… ne is clinically needed, dosing should be reduced to one quarter (25%) of the usual dose of 6-mercaptopurine or azathioprine and frequent haematologic monitoring should be ensured (see section 4.4). Patients should be advised to report any signs or symptoms of bone marrow suppression (unexplained bruising or bleeding, sore throat, fever). Vidarabine (Adenine Arabinoside): Evidence suggests that the plasma half-life of vidarabine is increased in the presence of allopurinol. When the two products are used concomitantly extra vigilance …

6-mercaptopurine and azathioprine: Azathioprine is metabolised to 6-mercaptopurine which is inactivated by the action of xanthine oxidase. When 6-mercaptopurine or azathioprine is given concurrently with Allopurinol, a xanthine oxidase inhibitor, inhibition of xanthine oxidase will prolong their activity. Serum concentrations of 6-mercaptopurine or azathioprine may reach toxic levels with consequent life-threatening pancytopenia and myelosuppression when these medicinal products are given concurrently with allopurinol. Therefore, concomitant use of allopurinol with 6-mercaptopurine or azathioprine should be avoided. If it is determined that co-administration with 6-mercaptopurine or azathioprine is clinically needed, dosing should be reduced to one quarter (25%) of the usual dose of 6-mercaptopurine or azathioprine and frequent haematologic monitoring should be ensured (see section 4.4). Patients should be advised to report any signs or symptoms of bone marrow suppression (unexplained bruising or bleeding, sore throat, fever). Vidarabine (Adenine Arabinoside): Evidence suggests th …

… or many years without apparent ill consequence (see section 5.3). Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or unborn child. Breastfeeding Allopurinol and its metabolite oxipurinol is excreted in the human breast milk. Concentrations of 1.4 mg/litre allopurinol and 53.7 mg/litre oxipurinol have been demonstrated in breast milk from a …

Pregnancy There is inadequate evidence of safety of Allopurinol in human pregnancy, although it has been in wide use for many years without apparent ill consequence (see section 5.3). Use in pregnancy only …

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Not found in the sections read for this label. Not the same as the label being silent.