COMPOSITIONS :
Benoxuric® Tablet 300 mg, each tablet contains : Allopurinol 300 mg.
DESCRIPTIONS :
Benoxuric® with active ingredient Allopurinol available as tablet 100 mg and 300 mg.
INDICATIONS :
- Primary hyperuricemia : Gout.
- Secondary hyperuricemia : Prevents the sedimentation of uric acid and calcium oxalate, uric acid overproduction, such as, in malignancy, polycythemia vera, cytostatic therapy.
DOSAGE AND ADMINISTRATIONS :
Adults :
Initial dose : 100 – 300 mg daily.
Maintenance dose : 200 – 600 mg daily.
The maximum single doses is 300 mg. If required it may be given at higher doses, maximum 900 mg a day. The dose should be adjusted by monitoring the levels of uric acid in serum/urine with appropriate intervals time until the desired effect is achieved for ± 1 – 3 weeks or :
- Mild condition : 2 – 10 mg/kg of body weight daily or 100 – 200 mg daily.
- Moderate condition : 300 – 600 mg daily.
- Severe condition : 700 – 900 mg daily.
Children :
10 – 20 mg/kg of body weight daily or 100 – 400 mg daily.
Use in children particularly in malignant condicition especially leukemia and abnormalities of certain enzymes, such as Lesch-Nyhan syndrome.
Patients with renal impairment :
The number and interval of administration should be reduced adjusted to the results of monitoring serum uric acid levels.
For adult patients, use following doses :
| Creatinine clearence | Dose |
| 2 – 10 ml/minute | 100 mg daily or with a longer interval |
| 10 – 20 ml/minute | 100 – 200 mg daily |
| > 20 ml/minute | Normal dose |
The recommended dose in patients with dialysis :
Allopurinol and its metabolites are removed by renal dialysis. If necessary to do dialysis more frequent, can be considered and alternative dose administration of Allopurinol 300 – 400 mg immediately after dialysis without giving more among intervals of time.
OVERDOSAGE :
Use up to 5 gram and 20 gram of Allopurinol have been reported. Signs and symptoms of poisoning are dizziness, nausea and vomiting. It is advisable to drink a lot to facilitate diuresis of Allopurinol and its metabolites. If deemed necessary, dialysis can be done.
CONTRAINDICATIONS :
- Patients who hypersensitive to Allopurinol.
- The condition of acute attacks of gout.
WARNINGS AND PRECAUTIONS :
- The effects of Allopurinol can be reduced by salicylate group and uricosuric, such as Probenecid.
- If symptoms of redness on the skin or allergic symptoms occurs, discontinu the treatment.
- Avoid use in patients with renal dysfunction or patients with asymptomatic hyperuricemia.
- In patients with liver damage, it is advisable to perform liver function tests periodically during the early stages of treatment.
- Risks and benefits of the use of Allopurinol during pregnancy and breastfeeding should be weighed against the fetus, infant or mother.
- Allopurinol may cause drowsiness. Use with caution in patients who have to work with full concentration, including driving and running the engine.
- Allopurinol should be taken after meals to reduce gastric irritation.
- It is recommended to improve the administration of fluids during the use of Allopurinol to prevent kidney stones.
- It there is itching, anorexia and weight loss, liver function tests should be performed.
DRUG INTERACTIONS :
- Allopurinol may increase the toxicity of Cyclophosphamide and other cytotoxic.
- Allopurinol may inhibits drug metabolism in the liver, such as Warfarin.
- Allopurinol may enhance the effect of Azathioprine and Mercaptopurine, so that daily doses of these drugs should be reduced prior to treatment with Allopurinol.
- Allopurinol can prolong the half-life of Chlorpropamide and increase the risk of hypoglycemia, particularly in patients with impaired renal function.
- The effects of Allopurinol can be reduced by salicylate groups and uricosuric, such as Probenecid.
ADVERSE REACTIONS :
- Symptoms of hypersensitivity such as exfoliative, fever, lymphadenopathy, arthralgia, eosinophilia.
- Skin reactions : Pruritus, maculopapular.
- Gastrointestinal disorders : Nausea, diarrhea.
- Headache, vertigo, drowsiness, eye and taste disorders.
- Blood disorders : Leukopenia, thrombocytopenia, hemolytic anemia, aplastic anemia.
PRESENTATIONS :
Benoxuric® Tablet 300 mg Box, 10 strips @ 10 tablets Reg. No. DKL9202316410B1
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
