Information about UNILORIC
Chemical Composition:
Each tablet contains: Allopurinol 100 mg or 300 mg
Pharmacological Classification:
Drugs used to treat gout.
Mechanism of Action:
Allopurinol is a xanthine-oxidase inhibitor. Allopurinol and its main metabolite oxipurinol
lower the level of uric acid in plasma and urine by inhibition of xanthine oxidase, the enzyme catalyzing the oxidation of hypoxanthine to xanthine and xanthine to uric acid. In addition to the inhibition of purine catabolism in some patients.
Indications:
Uniloric tablets is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis). idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease, myeloproliferative disease and certain enzyme disorders which lead to overproduction of urate. The drug is indicated for the management of renal stones related to deficient activity of adenine phosphoribosyl transferase. The drug is also indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria.
Contraindications:
The drug should not be administered to individuals known to be hypersensitive to allopurinol or to any of its components.
Warnings and Precautions:
• Allopurinol should be withdrawn immediately when a skin rash or other evidence of
sensitivity occurs as this could result in more serious hypersensitivity reactions, (including Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN)).
• Screening for HLA-B*58:01(The HLA-B*58:01 allele has been identified as a genetic risk factor for allopurinol associated SJS/TEN) should be considered before starting treatment with allopurinol.
• Patients with chronic renal impairment and concomitant diuretic use, in particular
thiazides, may be at increased risk of developing hypersensitivity reactions.
• Reduced doses should be used in patients with hepatic or renal impairment or patients
under treatment for hypertension or cardiac insufficiency.
• Allopurinol treatment should not be started until an acute attack of gout has completely
subsided. If acute attacks develop in patients receiving allopurinol, treatment should
continue at the same dosage while the acute attack is treated with a suitable anti-inflammatory agent.
• In conditions where the rate of urate formation is greatly increased, the concentration of
xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.
This risk may be minimized by adequate hydration to achieve optimal urine dilution.
• Adequate therapy with this drug will lead to dissolution of large uric acid renal pelvic
stones, with the remote possibility of impaction in the ureter.
• These tablets contain lactose and therefore should not be administered to patients with
rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Pregnancy:
Only use during pregnancy if there is no safer substitute and if the illness itself has a high risk on the mother or the fetus.
Breastfeeding:
There are no sufficient studies about Allopurinol or its receptors use on breastfeeding child or the presence of milk in the breast of the mother.
Dosage and Administration:
*Adults: 100 to 200 mg daily in mild conditions, 300 to 600 mg daily in moderately severe
conditions,700 to 900 mg daily in severe conditions.
*Children under 15 years: 10 to 20 mg/kg body weight/day up to a maximum of 400 mg daily.
*Older people: the lowest dosage which produces satisfactory urate reduction should be
used.
*Patients with renal impairment: In severe renal insufficiency, it may be advisable to use less than 100 mg per day or to use single doses of 100 mg at longer intervals than one day.
*Patients with hepatic impairment: Reduced doses should be used in patients with hepatic impairment. Dosage should be at the lower end of the recommended dosage schedule.
Overdose:
Symptoms: nausea, vomiting, diarrhoea and dizziness in a patient who ingested 20 g
allopurinol.
Treatment: Adequate hydration to maintain optimum diuresis facilitates excretion of
allopurinol and its metabolites also, haemodialysis may be used.
Package:
For Strength 100 mg: Carton Pack of 30 tablets.
For Strength 300 mg: Carton Pack of 24 tablets.
Storage:
Don’t Store above 30°C