Allopurinol STELLA 100 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.

Usage:

Allopurinol STELLA 100 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 Allopurinol must be withdrawn immediately if a rash occurs.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• Allopurinol should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs.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 100 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Allopurinol STELLA 100 mg contains sunset yellow lake which may cause allergic reactions.
• Patients should exercise caution before driving, using machinery or participating in dangerous activities.