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ALLOPURINOL is a brand name for Allopurinol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Gout. Primary hyperuricaemia. Secondary hyperuricaemia. Prophylaxis of uric acid and calcium oxalate stones.
Verbatim from this product's MHRA label. Tap a section to expand.
g. 100mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. 2 Renal impairment). 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 10mg/kg bodyweight/day should be used.
Paediatric population:
Children under 15 years: 10 to 20mg/kg body weight/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 patients:
In the absence of specific data, the lowest dosage which produces satisfactory urate reduction should be used. 2 Renal impairment and section
8.
Monitoring advice:
The dosage should be adjusted by monitoring serum urate concentration and urinary urate/uric acid levels at appropriate intervals.
Method of administration:
Allopurinol 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 doses regimen may be appropriate. 1.
4 Special warnings and precautions for use Hypersensitivity syndrome, SJS and TEN Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS) and SJS/TEN.
These reactions are clinical diagnoses, and their clinical presentations remain the basis for decision making. If such reactions occur at any time during treatment, allopurinol should be withdrawn immediately. Rechallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN.
Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions. 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 between ethnic populations: up to 20% in Han Chinese population, 8-15% in the Thai, about 12% in the Korean population and 1-2% in individuals of Japanese or European origin. Screening for HLA-B*5801 should be considered before starting treatment with allopurinol in patient subgroups where the prevalence of this allele is known to be high.
Chronic kidney disease may increase the risk in these patients additionally. In case that no HLA-B*5801 genotyping is available for patients with Han Chinese, Thai or Korean descent, the benefits should be thoroughly assessed and considered to outweigh the possible higher risks before starting therapy.
4.
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.
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 300-400 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. g. neoplasia, Lesch-Nyhan syndrome: It is advisable to correct existing hyperuricaemia and/or hyperuricosuria with allopurinol before starting cytotoxic therapy.
It is important to ensure adequate hydration to maintain optimum diuresis and to attempt alkalinisation of urine to increase solubility of urinary urate/uric acid. Dosage of allopurinol should be at the lower end of the recommended dosage schedule.
2 Renal impairment should be followed. These steps may reduce the risk of xanthine and/or oxipurinol deposition complicating the clinical situation. 8.
Monitoring advice:
The dosage should be adjusted by monitoring serum urate concentration and urinary urate/uric acid levels at appropriate intervals.
Method of administration:
Allopurinol 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 doses regimen may be appropriate. 1.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The use of genotyping has not been established in other patient populations. If the patient is a known carrier of HLA-B*5801 (especially in those who are from Han Chinese, Thai or Korean descent), allopurinol should not be started unless there are no other reasonable therapeutic options and the benefits are thought to exceed the risks.
Extra vigilance for signs of hypersensitivity syndrome or SJS/TEN is required and the patient should be informed 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.
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. 8).
5). 2). Patients under treatment for hypertension or cardiac insufficiency, for example with diuretics or ACE inhibitors, may have some concomitant impairment of renal function and allopurinol should be used with care in this group. Asymptomatic hyperuricaemia Asymptomatic hyperuricaemia per se is generally not considered an indication for use of allopurinol.
Fluid and dietary modification with management of the underlying cause may correct the condition. Acute gouty attacks Allopurinol 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 allopurinol, 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 at least one month.
The literature should be consulted for details of appropriate dosage and precautions and warnings. If acute 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.
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. 8%) in a long term open label extension study.
Caution is required when allopurinol is used in patients with alteration of thyroid function. Lactose Allopurinol tablets contain lactose and therefore patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
5 Interaction with other medicinal products and other forms of interaction 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 […]
4 Special warnings and precautions for use Hypersensitivity syndrome, SJS and TEN Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS) and SJS/TEN.
These reactions are clinical diagnoses, and their clinical presentations remain the basis for decision making. If such reactions occur at any time during treatment, allopurinol should be withdrawn immediately. Rechallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN.
Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions. 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 between ethnic populations: up to 20% in Han Chinese population, 8-15% in the Thai, about 12% in the Korean population and 1-2% in individuals of Japanese or European origin. Screening for HLA-B*5801 should be considered before starting treatment with allopurinol in patient subgroups where the prevalence of this allele is known to be high.
Chronic kidney disease may increase the risk in these patients additionally. In case that no HLA-B*5801 genotyping is available for patients with Han Chinese, Thai or Korean descent, the benefits should be thoroughly assessed and considered to outweigh the possible higher risks before starting therapy.
The use of genotyping has not been established in other patient populations. If the patient is a known carrier of HLA-B*5801 (especially in those who are from Han Chinese, Thai or Korean descent), allopurinol should not be started unless there are no other reasonable therapeutic options and the benefits are thought to exceed the risks.
Extra vigilance for signs of hypersensitivity syndrome or SJS/TEN is required and the patient should be informed 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.
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. 8).
5). 2). Patients under treatment for hypertension or cardiac insufficiency, for example with diuretics or ACE inhibitors, may have some concomitant impairment of renal function and allopurinol should be used with care in this group. Asymptomatic hyperuricaemia Asymptomatic hyperuricaemia per se is generally not considered an indication for use of allopurinol.
Fluid and dietary modification with management of the underlying cause may correct the condition. Acute gouty attacks Allopurinol 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 allopurinol, 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 at least one month.
The […]