Allopurinol STELLA 300 mg

Rx

Indications:

• 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).
• 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.

Dosage:

Should the daily dosage exceed 300 mg and gastrointestinal intolerance be manifested, a divided doses regimen may be appropriate.

• Adults: 100 mg/day, increased only if the serum urate response is unsatisfactory. The following dosage schedules are suggested: 100 to 200 mg daily (mild conditions), 100 to 200 mg daily (moderately severe conditions), 700 to 900 mg daily (severe conditions); or 2 to 10 mg/kg bodyweight/day should be used if necessary.
• Children under 15 years in malignant conditions (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome: 10 to 20 mg/kg bodyweight/day up to a maximum of 400 mg daily
• Renal or hepatic impairment: dosage adjustment is required, severe renal insufficiency: < 100 mg/day or to use single doses of 100 mg at longer intervals than one, dialysis: an alternative schedule of 300 – 400 mg after each dialysis.
• Elderly: The lowest dosage which produces satisfactory urate reduction should be used.
• Treatment of high urate turnover conditions, e.g. neoplasia, Lesch-Nyhan syndrome: It is advisable to correct existing hyperuricaemia and/or hyperuricosuria with allopurinol before starting cytotoxic therapy. Dosage of allopurinol 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 in renal impairment should be followed.
• Use of suitable dosage forms is recommended when using doses of 100 mg, 200 mg and 700 mg.

Usage:

Allopurinol STELLA 300 mg may be taken orally once a day after a meal.

• Hypersensitive to allopurinol or to any of the components of the formulation.
• Patients with severe liver disease; severe renal disease (azotaemia).
• Idiopathic haemochromatosis (even if only in the familiar history).
• Allopurinol administration should not be initiated during an acute gouty attack.
• The drug is contraindicated in children except those with tumour diseases or enzyme disorder.

• The most common side-effect of allopurinol is skin rash (generally maculopapular or pruritic, sometimes purpuric, but more serious hypersensitivity reactions may occur and include exfoliative rashes, the Stevens-Johnson syndrome, and toxic epidermal necrolysis). Allopurinol must be withdrawn immediately if a rash occurs.
• Haematological effects include thrombocytopenia, aplastic anaemia, agranulocytosis, and haemolytic anaemia.

• Allopurinol should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs.
• Caution should be exercised when use for patients with hepatic or renal impairment, patients under treatment for hypertension or cardiac insufficiency.
• Asymptomatic hyperuricaemia per se is generally not considered an indication for use of allopurinol.
• In the early stages of treatment, 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. If acute attacks develop, treatment should continue at the same dosage while the acute attack is treated with a suitable anti-inflammatory agent.
• Allopurinol STELLA 300 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• 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 minimized by adequate hydration to achieve optimal urine dilution.
• Adequate therapy with allopurinol will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter.
• Allopurinol STELLA 300 mg contains sunset yellow lake which may cause allergic reactions.
• Use Allopurinol STELLA 300 mg in pregnancy only when there is no safer alternative.
• Patients should exercise caution before driving, using machinery or participating in dangerous activities.