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ALLOPURINOL-300 is a brand name for Allopurinol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ALLOPURINOL (Allopurinol tablets) is indicated for: • Treatment of gout, either primary, or secondary to hyperuricemia which occurs in blood dyscrasias and their therapy. • Treatment of primary or secondary uric acid nephropathy, with or without accompanying signs or symptoms of gout. • Prophylactically, to prevent…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 4 Geriatrics. 2 CONTRAINDICATIONS ALLOPURINOL (allopurinol) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
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2 Recommended Dose and Dosage Adjustment Adults: ALLOPURINOL is administered orally. The total daily requirement should be divided into 1 to 3 doses. Daily doses up to and including 300 mg of ALLOPURINOL may be taken once a-day after a meal.
Larger doses should be administered as divided doses of not more than 300 mg. It should be noted that ALLOPURINOL is generally better tolerated if taken following meals.
Treatment of Gout:
The dose of ALLOPURINOL varies with the severity of the disease. The minimum effective dose is 100 to 200 mg. The average is 200 to 300 mg/day for patients with mild gout, 400 to 600 mg/day for patients with moderately severe tophaceous gout, and 700 to 800 mg in severe conditions.
The maximal recommended dose is 800 mg/day in patients with normal renal function. As no simple method of measuring the blood concentrations of ALLOPURINOL is available, the correct size and frequency of dosage for maintaining the serum uric acid just within the normal range is best determined by using the serum uric acid level as an index.
Once the daily dose of ALLOPURINOL necessary to produce the desired serum uric acid level has been determined, this dose should be continued until the serum uric acid level indicates a need for dosage adjustment. Normal serum urate levels are achieved in 1 to 3 weeks.
The upper limit of normal is about 6 mg/dLfor men and postmenopausal women and 5 mg/dL for premenopausal women. By the selection of the appropriate dose, together with the use of uricosurics agents in certain patients, it is possible to reduce the serum uric level to normal and, if desired, to hold it as low as 2 to 3 mg/dL.
Combined therapy of ALLOPURINOL and uricosurics will often result in a reduction in dosage of both agents. To reduce the possibility of an increase in acute attacks of gout during the early stages of ALLOPURINOL administration, it is recommended that the patient start with a low dose of ALLOPURINOL (100 to 200 mg daily) and increase at weekly intervals by 100 mg until a serum uric acid level of about 6 mg/dL or less is attained.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Also, a maintenance dose of colchicine should be given prophylactically when allopurinol is begun, and a high fluid intake is advisable. In patients who are being treated with uricosuric agents, colchicine and/or anti-inflammatory agents, it is wise to continue this therapy while adjusting the dosage of allopurinol until a normal serum uric acid ALLOPURINOL (Allopurinol) Tablets – Product Monograph Page 6 of 26 level and freedom from acute attacks have been maintained for several months.
If desired, the patient may then be transferred to allopurinol therapy exclusively. For the Prevention of Uric Acid Nephropathy During the Vigorous Therapy of Neoplastic Disease: Treatment with 600 to 800 mg daily for 2 or 3 days prior to chemotherapy of X-irradiation is advisable.
Treatment should be continued at a dosage adjusted to the serum uric acid level until there is no longer a threat of hyperuricemia and hyperuricosuria. ALLOPURINOL treatment can be maintained during the antimitotic therapy for prophylaxis of the hyperuricemia which may arise during the natural crises of the disease.
In prolonged treatment, 300 to 400 mg of ALLOPURINOL daily is usually enough to control the serum uric acid level. It is essential that a daily urinary output of 2 L or more be maintained during allopurinol therapy, and neutral or alkaline urine is desirable.
Prophylaxis of Renal Calcium Lithiasis:
The recommended starting dose of ALLOPURINOL for the prevention of recurrent calcium stones is 200 to 300 mg daily as one dose or individual doses. Therapy should be continued indefinitely. Some patients have received maintenance dosages of 200 to 300 mg daily for more than 7 years.
In some patients, the maintenance dosage may be reduced to 100 to 200 mg daily.
Pediatrics (<18 years of age):
ALLOPURINOL is contraindicated in children except for the treatment of secondary hyperuricemia associated with malignancies and in the Lesch-Nyhan syndrome. ALLOPURINOL should be given in doses of 10 mg/kg/day. The response should be evaluated after approximately 48 hours by monitoring serum uric acid and/or urinary uric acid levels and adjusting the dose if necessary.
See 2 CONTRAINDICATIONS.
Geriatrics (>65 years of age):
In the absence of specific data, the lowest dosage of ALLOPURINOL which produces satisfactory urate reduction should be used.
Renal Impairment:
Since ALLOPURINOL and its metabolites are excreted only by the kidney, accumulation of the drug can occur in renal failure and the dose of ALLOPURINOL should consequently be reduced. With a creatinine clearance of 20 to 10 mL/min, a daily dosage of 200 mg of ALLOPURINOL is suitable.
When the creatinine clearance is less than 10 mL/min, the daily dosage should not exceed 100 mg. With extreme renal impairment (creatinine clearance less than 3 mL/min), the interval between doses may also need to be lengthened. See 7 WARNINGS AND PRECAUTIONS.
Hepatic Impairment:
Reduced doses should be administered to patients with hepatic impairment. Periodic liver function tests are recommended during the early stages of therapy. The drug should be withdrawn if increased abnormalities in hepatic functions appear.
See 7 WARNINGS AND PRECAUTIONS. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.
5 g allopurinol without adverse effect has been reported. Symptoms and signs including nausea, vomiting, diarrhea, and dizziness have been reported in a patient who ingested 20 g allopurinol. Recovery followed general supportive measures.
Massive absorption of allopurinol may lead to considerable inhibition of xanthine oxidase activity, which […]