PROGOUT VIATRIS

What it is

PROGOUT VIATRIS contains allopurinol, available as 100 mg and 300 mg tablets. Allopurinol inhibits xanthine oxidase, the enzyme which catalyses the conversion of hypoxanthine to xanthine, and of xanthine to urate/uric acid, thereby decreasing urate formation and reducing urate/uric acid concentrations in both body fluids and urine.

Approved indications

— Gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation in idiopathic gout. — Uric acid lithiasis and acute uric acid nephropathy. — Neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy. — Certain enzyme disorders which lead to overproduction of urate, including hypoxanthine guanine phosphoribosyltransferase (including Lesch-Nyhan syndrome), glucose-6-phosphatase (including glycogen storage disease), phosphoribosylpyrophosphate synthetase, and phosphoribosylpyrophosphate amidotransferase. — Management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyl transferase. — Management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

Dosing overview

PROGOUT VIATRIS may be taken orally once a day after a meal; if daily dosage exceeds 300 mg and gastrointestinal intolerance occurs, a divided dose regimen may be appropriate. For adults, dosing in mild conditions is 100 to 200 mg daily; in moderately severe conditions, 300 to 600 mg daily; in severe conditions, 700 to 900 mg daily. For children under 15 years, the dose is 10 to 20 mg/kg bodyweight/day or 100 to 400 mg daily, though use in children is rarely indicated except in malignant conditions and certain enzyme disorders such as Lesch-Nyhan syndrome. In elderly patients, the lowest dosage which produces satisfactory urate reduction should be used, with particular attention to dosage advice in renal disorders.

Key safety warnings

PROGOUT VIATRIS should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs. A skin rash may be followed by more severe hypersensitivity reactions such as exfoliative, urticarial, and purpuric lesions as well as Stevens-Johnson syndrome (SJS; erythema multiforme exudativum), drug rash with eosinophilia and systemic symptoms (DRESS), Lyell's syndrome, generalised vasculitis, irreversible hepatotoxicity, and on rare occasions death. The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol-related hypersensitivity syndrome and SJS/TEN, and screening for HLA-B*5801 should be considered before starting treatment in patient subgroups where the prevalence of this allele is known to be high. PROGOUT VIATRIS 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, acute gouty arthritis may be precipitated, so prophylaxis with a suitable anti-inflammatory agent or colchicine is advisable for at least one month. The occurrence of hypersensitivity reactions may be increased in patients with decreased renal function receiving thiazides and allopurinol concurrently, and such combinations should be administered with caution with close observation of patients.

Contraindications

PROGOUT VIATRIS should not be administered in individuals known to be hypersensitive to allopurinol or to any other ingredients of the product. PROGOUT VIATRIS should not be given concomitantly with iron salts to patients with idiopathic haemochromatosis, nor should it be given to the immediate relatives of such patients. <cite index index="1-40">PROGOUT VIATRIS is contraindicated in children with the exception of those with hyperuricemia secondary to malignancy or with Lesch-Nyhan syndrome.</cite>

PBS listing

No PBS listing information is available in the provided source documents.

Regulatory history

PROGOUT VIATRIS allopurinol 100 mg tablet and 300 mg tablet were first listed on the ARTG on 22 February 2017.