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COSURIC/ALLOPURINOL is a brand name for Allopurinol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cosuric 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…
Verbatim from this product's MHRA label. Tap a section to expand.
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. g. 100 mg daily 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 ‘Patients with renal impairment’). The following dosage schedules are suggested; • in mild conditions; 100-200 mg daily • in moderately severe conditions; 300-600 mg daily • in severe conditions; 700-900 mg daily If dosage on a mg/kg bodyweight basis is required, 2 to 10 mg/kg bodyweight/day should be used.
Paediatric population Children under 15 years:
The daily dose is 10-20 mg per kilogram bodyweight. The maximum dose is 400 mg daily. Use in children is rarely indicated, except in malignant conditions (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.
Older people The dose should be maintained at the lowest necessary to maintain satisfactory serum and urinary urate levels. Particular attention should be paid to advice in ‘Patients with renal impairment’ and section
8. Monitoring Advice The dosage should be adjusted by monitoring serum urate concentrations and urinary urate/uric acid levels at appropriate intervals.
Method of administration:
Cosuric 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. 3 Contraindications This product is contra-indicated as a treatment for the acute phase of gout.
Prophylactic therapy may be instituted when the acute gouty attack has completely subsided provided also that anti-inflammatory agents are also taken. 1. 5). Hypersensitivity syndrome, SJS and TEN Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS, Drug Rash with Eosinophilia and Systemic Symptoms) and SJS/TEN (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis).
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 and permanently. 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 (and possibly other serious hypersensitivity reactions) in retrospective, case-control, pharmacogenetic studies in patients of Han Chinese, Thai, Korean, Japanese and European descent.
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*58:01 should be considered before starting treatment with allopurinol in patient subgroups where the prevalence of this allele is known to be high.
4.
Commencing therapy:
When commencing treatment with COSURIC, as with all uricosuric agents, an acute attack of gout may be precipitated. It is recommended that a prophylactic dose of an anti-inflammatory agent or colchicine is given for at least one month after hyperuricaemia is corrected.
Aspirin and salicylates are not recommended for prophylactic use.
Use with uricosurics:
COSURIC may be given concurrently with uricoguric agents. However, when changing to COSURIC from uricosuric therapy it is advisable to overlap treatment for one to three weeks thus ensuring a continuous hypouricaemic effect. In neoplastic conditions to avoid acute uric acid nephropathy COSURIC should precede any treatment with cytotoxic drugs.
Patients with renal impairment Since allopurinol and its metabolites are excreted via the kidney, impaired renal function may lead to retention of the drug and/or its metabolites will occur with consequent prolongation of plasma half-lives.
Prolongation of action of COSURIC may require reduction as indicated by regular monitoring of serum uric acid levels. For guidance, the following scheme provided relates to adults: • if renal creatinine is greater than 20 ml/per minute use a standard dose.
• in severe renal insufficiency, when creatinine clearance is less than 10 ml/per minute use less than l00 mg daily or to use single doses of 100 mg at regular intervals longer than one day. 2 mg/litre).
In renal dialysis:
Renal dialysis removes allopurinol and its metabolites. When dialysis is required two to three times a week then consideration should be given to an alternative dosage schedule of 300 mg – 400 mg COSURIC immediately after each dialysis without any dosage in between.
This product is contra-indicated as a treatment for the acute phase of gout. Prophylactic therapy may be instituted when the acute gouty attack has completely subsided provided also that anti-inflammatory agents are also taken. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 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 of use are thought to exceed the potential associated risks.
Patients who are found to be negative for HLA- B*58:01 still have a low risk of SJS/TEN irrespective of their ethnic origin. 8). 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). 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 Cosuric.
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 Cosuric, 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 Cosuric 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. 5 […]
Patients with 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 Cosuric 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 Cosuric 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 ‘Patients with 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 concentrations and urinary urate/uric acid levels at appropriate intervals.
Method of administration:
Cosuric 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. 3 Contraindications This product is contra-indicated as a treatment for the acute phase of gout.
Prophylactic therapy may be instituted when the acute gouty attack has completely subsided provided also that anti-inflammatory agents are also taken. 1. 5). Hypersensitivity syndrome, SJS and TEN Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS, Drug Rash with Eosinophilia and Systemic Symptoms) and SJS/TEN (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis).
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 and permanently. 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 (and possibly other serious hypersensitivity reactions) in retrospective, case-control, pharmacogenetic studies in patients of Han Chinese, Thai, Korean, Japanese and European descent.
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*58:01 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 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 of use are thought to exceed the potential associated risks.
Patients who are found to be negative for HLA- B*58:01 still have a low risk of […]