Allopurinol 100 mg N50 Tablet

ALLOPURINOL, tablets

Allopurinol composition

Active ingredient: 1 tablet contains 100 mg allopurinol (calculated on a dry substance basis). Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, hypromellose, magnesium stearate.

Indications:

 Adults - hyperuricemia (when the level of uric acid in blood serum is 500 µmol/L (8.5 mg/100 ml) or higher and is not controlled by diet); - diseases caused by an increase in the level of uric acid in the blood, especially gout, nephropathy associated with urates, and urolithiasis accompanied by the formation of urates; - secondary hyperuricemia of various etiologies, including in psoriasis; - primary and secondary hyperuricemia during various hemoblastoses (acute leukemia, chronic myelogenous leukemia, lymphosarcoma); - cytotoxic treatment of neoplastic and myeloproliferative diseases. Children - nephropathy associated with urates as a result of treatment of leukemia; - secondary hyperuricemia of various etiologies; - congenital enzyme deficiency, especially Lesch-Nyhan syndrome (partial or complete deficiency of the hypoxanthine-guanine phosphoribosyltransferase enzyme) and congenital deficiency of the adenine-phosphoribosyltransferase enzyme.

Contraindications:

 - hypersensitivity to allopurinol or to any other component of the product;

 - severe disorders of liver or kidney function (creatinine clearance below 2 ml/min);

 - acute gout attack.

Use during pregnancy and lactation:

There is insufficient information regarding the use of allopurinol during pregnancy. Considering that allopurinol affects purine metabolism and that the potential risk to humans is unknown, the use of allopurinol during pregnancy is contraindicated. Allopurinol passes into breast milk; therefore, the product must not be used during lactation. If it becomes necessary to use the product during lactation, breastfeeding must be discontinued.

How to use Allopurinol, dosage

 The product should be taken orally after meals, without chewing, with plenty of water. Adults and children over 10 years of age: depending on the level of uric acid in blood serum, the daily dose for adults and children over 10 years should be determined individually. Usually, the daily dose is 100–300 mg/day. To reduce the risk of additional reactions, treatment should be started by taking allopurinol 100 mg once daily. If necessary, the starting dose may be increased by 100 mg every 1–3 weeks until the maximum effect is achieved. The maintenance dose of the product is usually 200–600 mg/day. In individual cases, the dose may be increased up to 600–800 mg/day. When the daily dose of the product exceeds 300 mg, it should be divided into 2–4 equal intakes. When increasing the dose level, it is necessary to monitor the level of oxypurinol in blood serum, which should not exceed 15 µg/ml (100 µmol). The maximum single dose is 300 mg; the maximum daily dose is 800 mg. For children aged 3 to 6 years, the product should be prescribed at a daily dose of 5 mg/kg body weight. For children aged 6 to 10 years, the product should be prescribed at a daily dose of 10 mg/kg body weight. For children, the product should be prescribed 3 times per day; the maximum daily dose is 400 mg. Renal impairment: Treatment should be started with a daily dose of 100 mg, and the dose may be increased only if the product is not sufficiently effective. When selecting the dose, the creatinine clearance value must be taken into account: Creatinine clearance Allopurinol product daily dose Above 20 ml/min Standard dose 100–300 mg 10–20 ml/min 100–200 mg Below 10 ml/min The product should be taken with long intervals between each dose at doses of 100 mg or higher (depending on the patient’s condition and the functional capacity of the kidneys, 1–2 days or more). For patients receiving hemodialysis procedures, after each hemodialysis session (2–3 times per week), Allopurinol should be used at a dose of 300–400 mg. When performing cytostatic treatment of neoplastic and myeloproliferative diseases, Allopurinol should be prescribed at a dose of 400 mg/day for prophylaxis of hyperuricemia. Start taking the product 2–3 days before anti-blastoma treatment or simultaneously with that treatment, and continue using the product for several days after the specific treatment is completed. To support adequate diuresis, it is important to ensure adequate hydration and to alkalinize the urine to increase the solubility of urates in urine. The duration of treatment depends on the course of the underlying disease. Elderly patients: in the absence of specific data, use the minimum effective doses. Impaired liver function: when liver function is impaired, the dose should be reduced to the minimum effective level. Children: the product must not be used in children under 3 years of age.