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IPG-ALLOPURINOL 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: IPG-ALLOPURINOL (allopurinol) 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 tissue…
Verbatim from this product's HC label. Tap a section to expand.
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 IPG-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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IPG-Allopurinol PM Page 6 of 26 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.
IPG-ALLOPURINOL (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 IPG-ALLOPURINOL (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 IPG-ALLOPURINOL (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):
IPG-ALLOPURINOL (allopurinol) is contraindicated in children except for the treatment of secondary hyperuricemia associated with malignancies and in the Lesch-Nyhan syndrome. IPG-ALLOPURINOL (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.
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.
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, IPG-Allopurinol PM Page 7 of 26 which should have no untoward effects unless affecting concomitant medication, especially with mercaptopurine and/or azathioprine.
No treatment is normally required provided the drug is withdrawn and adequate hydration is maintained to facilitate excretion of the drug. If considered necessary hemodialysis may be used. If, however, other forms of acute distress are observed, gastric lavage should be considered, otherwise the treatment is symptomatic.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form/Strength/Composition Non-medicinal Ingredients oral tablet 100 mg, 200 mg, 300 mg of allopurinol Corn starch, lactose monohydrate, sodium starch glycolate, povidone and stearic acid 200 and 300 mg tablets also contain the dye Sunset Yellow Aluminium Lake.
IPG-ALLOPURINOL 100 mg:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Allopurinol in Canada.
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See 2 CONTRAINDICATIONS Geriatrics (>65 years of age):
In the absence of specific data, the lowest dosage of IPG-ALLOPURINOL (allopurinol) which produces satisfactory urate reduction should be used.
Renal Impairment:
Since IPG-ALLOPURINOL (allopurinol) and its metabolites are excreted only by the kidney, accumulation of the drug can occur in renal failure and the dose of IPG-ALLOPURINOL (allopurinol) should consequently be reduced. Witha creatinine clearance of 20 to 10 mL/min, a daily dosage of 200 mg of IPG-ALLOPURINOL (allopurinol) is suitable.
When thecreatinine 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.
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, IPG-Allopurinol PM Page 7 of 26 which should have no untoward effects unless affecting concomitant medication, especially with mercaptopurine and/or azathioprine.
No treatment is normally required provided the drug is withdrawn and adequate hydration is maintained to facilitate excretion of the drug. If considered necessary hemodialysis may be used. If, however, other forms of acute distress are observed, gastric lavage should be considered, otherwise the treatment is symptomatic.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form/Strength/Composition Non-medicinal Ingredients oral tablet 100 mg, 200 mg, 300 mg of allopurinol Corn starch, lactose monohydrate, sodium starch glycolate, povidone and stearic acid 200 and 300 mg tablets also contain the dye Sunset Yellow Aluminium Lake.
IPG-ALLOPURINOL 100 mg:
White to off white, colored, round, biconvex uncoated tablets with “AL” and “100” separated by breakline on one side and plain on the other side. Available in bottles of 100’s and 1000’s tablets.
IPG-ALLOPURINOL 200 mg:
Peach colored, round, biconvex uncoated tablets with “AL” and “200” separated by breakline on one side and plain on the other side. Available in bottles of 100’s and 500’s tablets.
IPG-ALLOPURINOL 300 mg:
Peach colored, round, biconvex uncoated tablets with “AL” and “300” separated by breakline on one side and plain on the other side. Available in bottles of 100’s and 500’s tablets. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Asymptomatic hyperuricemia per se is generally not considered an indication for use of allopurinol. Fluid and dietary modification with management of the underlying cause may correct the condition.
Driving and Operating Machinery Occupational hazards:
Due to occasional occurrence of drowsiness, patients should be alerted to the need for precautions when engaging in activities where alertness is mandatory. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
8%) in a long-term open label extension study. Caution is required when For management of a suspected drug overdose, contact your regional poison control centre. IPG-Allopurinol PM Page 8 of 26 allopurinol is used in patients with alteration of thyroid function and increased monitoring of thyroid parameters is recommended […]
White to off white, colored, round, biconvex uncoated tablets with “AL” and “100” separated by breakline on one side and plain on the other side. Available in bottles of 100’s and 1000’s tablets.
IPG-ALLOPURINOL 200 mg:
Peach colored, round, biconvex uncoated tablets with “AL” and “200” separated by breakline on one side and plain on the other side. Available in bottles of 100’s and 500’s tablets.
IPG-ALLOPURINOL 300 mg:
Peach colored, round, biconvex uncoated tablets with “AL” and “300” separated by breakline on one side and plain on the other side. Available in bottles of 100’s and 500’s tablets. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Asymptomatic hyperuricemia per se is generally not considered an indication for use of allopurinol. Fluid and dietary modification with management of the underlying cause may correct the condition.
Driving and Operating Machinery Occupational hazards:
Due to occasional occurrence of drowsiness, patients should be alerted to the need for precautions when engaging in activities where alertness is mandatory. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
8%) in a long-term open label extension study. Caution is required when For management of a suspected drug overdose, contact your regional poison control centre. IPG-Allopurinol PM Page 8 of 26 allopurinol is used in patients with alteration of thyroid function and increased monitoring of thyroid parameters is recommended during treatment with allopurinol.
Hepatic/Biliary/Pancreatic Reduced doses should be administered to patients with hepatic impairment. The drug should be withdrawn if increased abnormalities in hepatic functions appear. The incidence of adverse reactions in association with allopurinol is higher in the presence of hepatic disorder.
See 4 DOSAGE AND ADMINISTRATION Monitoring and Laboratory Tests Urate/uric acid levels: The dose of IPG-ALLOPURINOL (allopurinol) should be adjusted by monitoring serum urate concentrations and urinary urate/uric acid levels at appropriate intervals.
See 4 DOSAGE AND ADMINISTRATION Hepatic function:
Periodic liver function tests should be performed in all patients on IPG- ALLOPURINOL (allopurinol) therapy. 2 mg/litre). In patients with decreased renal function or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient's dosage of IPG-ALLOPURINOL (allopurinol) reassessed.
Musculoskeletal IPG-ALLOPURINOL (allopurinol) treatment should not be started until an acute attack of gout has completely subsided, as further attacks may be precipitated. Acute gout attacks may be precipitated at the start of treatment with allopurinol in new patients, and these may continue even after serum uric acid levels begin to fall.
Prophylactic administration of colchicine is advisable, particularly in new patients and in those where the previous attack rate has been high. In addition, it is recommended that the patient start with a low dose of allopurinol (100 and 200 mg daily) and the dose be built up slowly until a serum uric acid level of 6 mg/100 mL or less is attained.
See 4 DOSAGE AND ADMINISTRATION If acute gouty 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. , malignant disease and its treatment; Lesch-Nyhan syndrome), the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition […]