Alurol 100mg tablet
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- Brand: Incepta Pharmaceuticals
- Product ID: Allopurinol
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Indications
• In the management of primary gout or secondary hyperuricaemia associated with chronic gout.
In severe cases of chronic gout, Allopurinol can be used together with a uricosuric agent unless the latter is contra-indicated.
• Uric acid nephropathy
• Recurrent uric acid stone formation
• Certain enzyme disorders or blood disorders which lead to overproduction of urate (e.g., Lesch-Nyhan syndrome, hemolytic anaemia)
• Hyperuricaemia associated with malignancy and cytotoxic therapy which results in a high cell turnover rate
• The prevention and treatment of calcium oxalate/phosphate renal stonesin the presence of high uric acid levels of the blood and/or urine.
In severe cases of chronic gout, Allopurinol can be used together with a uricosuric agent unless the latter is contra-indicated.
• Uric acid nephropathy
• Recurrent uric acid stone formation
• Certain enzyme disorders or blood disorders which lead to overproduction of urate (e.g., Lesch-Nyhan syndrome, hemolytic anaemia)
• Hyperuricaemia associated with malignancy and cytotoxic therapy which results in a high cell turnover rate
• The prevention and treatment of calcium oxalate/phosphate renal stonesin the presence of high uric acid levels of the blood and/or urine.
Descriptions
Alurolis used to decrease uric acid concentrations in plasma and/or urine when hyperuricaemia is clinically significant. Alurol and its active metabolite oxypurinol inhibit xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine to uric acid. Inhibition of this enzyme accounts for the major pharmacological effects of Alurol.In contrast with the uricosuric agents that increase the renal excretion of urate, Alurol inhibits the terminal steps in uric acid biosynthesis.
90% of the Alurol from tablets is absorbed in the gastro-intestinal tract. The Alurol is rapidly metabolized to the active metabolite oxypurinol (alloxanthine). After administration, peak plasma levels occur generally at 1.5 hrs for Alurol. It has a plasma half-life of approximately 1 hour.
Allopurinolmay be taken once daily after a meal. It is normally well tolerated especially after food. Should the total daily dose exceed 300 mg and/or gastro-intestinal intolerance be manifested, a divided doses regimen maybe appropriate. The dosage should be adjusted by monitoring serum urateconcentrations and urinary urate/uric acid levels at appropriate intervals.
Adults
The average daily dose is 2-10 mg/kg body weight or 100 mg to 200 mg formild conditions, 300 mg to 600 mg daily for moderate severe conditions and 700 to 900 mg for severe conditions.
Initial therapy:
Allopurinol may increase the frequency of acute attacks during the firstfew months of therapy; it is therefore recommended that low doses be given initially and slowly increased, and that anti-inflammatory agents or colchicines should be given concomitantly during this period as prophylactic cover. In patients with renal function, doses of 100 mg should be given and increased by 50 mg to 100 mg at weekly intervals until serum levels of 0.6 mg per ml are achieved.
Hyperuricaemia of malignancy or cancer therapy:
Therapy should be initiated 2 to 3 days prior to cytotoxic therapy afterwhich maintenance doses are given according to response. Adequate hydration is essential throughout.
Children
Hyperuricaemia associated with malignancy:
6-10 years: 300 mg daily
Under 6 years: 150 mg daily
Impaired renal function:
100-200 mg daily
90% of the Alurol from tablets is absorbed in the gastro-intestinal tract. The Alurol is rapidly metabolized to the active metabolite oxypurinol (alloxanthine). After administration, peak plasma levels occur generally at 1.5 hrs for Alurol. It has a plasma half-life of approximately 1 hour.
Dosage & Administration
Adults
The average daily dose is 2-10 mg/kg body weight or 100 mg to 200 mg formild conditions, 300 mg to 600 mg daily for moderate severe conditions and 700 to 900 mg for severe conditions.
Initial therapy:
Allopurinol may increase the frequency of acute attacks during the firstfew months of therapy; it is therefore recommended that low doses be given initially and slowly increased, and that anti-inflammatory agents or colchicines should be given concomitantly during this period as prophylactic cover. In patients with renal function, doses of 100 mg should be given and increased by 50 mg to 100 mg at weekly intervals until serum levels of 0.6 mg per ml are achieved.
Hyperuricaemia of malignancy or cancer therapy:
Therapy should be initiated 2 to 3 days prior to cytotoxic therapy afterwhich maintenance doses are given according to response. Adequate hydration is essential throughout.
Children
Hyperuricaemia associated with malignancy:
6-10 years: 300 mg daily
Under 6 years: 150 mg daily
Impaired renal function:
100-200 mg daily
Side Effects
Themost common side effect is skin rash. Fever, chills, leucopenia, eosinophilia, arthalgia, nausea, vomiting, abdominal pain, diarrhea, alopecia, headache, drowsiness and peripheral neuritis are other side effects.
Precautions
Allopurinolshould be discontinued at the first sign of a rash or other sign of immediate allergic reactions. It is not recommended for the treatment ofmild asymptomatic hyperuricaemia.It should generally only be consideredif serum urate concentrations exceed 0.8 to 0.9 mg/ml with an aim of reducing levels to 0.6 mg/ml.
Contraindications
Acute gout and allergy to Allopurinol.
Use in Pregnancy & Lactation
CategoryB2. Although animal studies have not indicated any incidence of teratogenicity, the effect of Allopurinol on the human fetus is unknown and it should be used in pregnancy only if clearly needed.
Allopurinol is distributed into breast milk. It should be used with caution in view of the potential for hypersensitivity reactions.
Allopurinol is distributed into breast milk. It should be used with caution in view of the potential for hypersensitivity reactions.
Drug Interaction
Allopurinolmay increase the incidence of skin rash in patients taking Ampicillin. Aluminium hydroxide, as the antacid can reduce the absorption of Allopurinol.
Overdose
Nausea,vomiting, diarrhea and dizziness have been reported who ingested 20 gm Allopurinol. The patient should be monitored and receive normal supportive measures and should be adequately hydrated to maintain urinary excretion of allopurinol and its metabolites.
Commercial Packaging
Alurol 100 mg tablet: Each box contains 10 blister strips of 10 tablets
