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MAR-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: MAR-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.
4 Geriatrics 2 CONTRAINDICATIONS MAR-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.
For a complete listing, see
1 Adverse Reaction Overview Adverse reactions in association with allopurinol are rare in the overall treated population. The incidence is higher in the presence of renal and/or hepatic disorder.
See 7 WARNINGS AND PRECAUTIONS Blood and Lymphatic System:
There have been occasional reports of reduction in the number of circulating formed elements of the blood, including agranulocytosis, thrombocytopenia and aplastic anemia, usually in association with renal and/or hepatic disorders or when concomitant drugs have been administered which have a potential for causing these reactions.
Body as a Whole:
General malaise, asthenia, vertigo, rise in Blood Urea Nitrogen (BUN), hyperlipemia, edema, and angioedema. Fever has been reported to occur with and without signs/symptoms of a more generalized hypersensitivity reaction.
Cardiac Disorders:
Angina, bradycardia Ear and Labyrinth Disorders: Vertigo Eye Disorders: Cataract, visual disorder, macular changes Gastrointestinal Disorders: Stomatitis, changed bowel habit. Diarrhea, intermittent abdominal pain, nausea and vomiting were reported.
Gastrointestinal disorders diminish if allopurinol is taken after meals. Recurrent hematemesis has been reported as an extremely rare event, as has steatorrhoea.
Hepatic Function:
Rare reports of hepatic dysfunction ranging from asymptomatic rises in liver function tests to hepatitis (including hepatic necrosis and granulomatous hepatitis) have been reported without overt incidence of more generalized hypersensitivity.
Immune System Disorders:
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, MAR-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 mgof 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.
MAR-ALLOPURINOL 100 mg:
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. See
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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Hypersensitivity reactions. See 7 WARNINGS AND PRECAUTIONS Angioimmunoblastic lymphadenopathy has been described rarely following biopsy of a generalized lymphadenopathy. It appears to be reversible on withdrawal of allopurinol.
Infections and Infestations:
Furunculosis Metabolism and Nutrition Disorders: Diabetes mellitus, hyperlipidaemia Psychiatric Disorders: Depression MAR-Allopurinol PM Page 11 of 26 Nervous System Disorders: Coma, paralysis, ataxia, neuropathy, paraesthesia, somnolence, headache, taste perversion, drowsiness, peripheral neuritis Renal and Urinary Disorders: Haematuria, uraemia Reproductive System and Breast Disorders: Infertility, impotence, gynaecomastia Skin: Skin Reactions (rash) are the most common reactions and may occur at any time during treatment.
They may be pruritic, maculopapular, sometimes scaly, sometimes purpuric and rarely exfoliative. Allopurinol should be withdrawn immediately should such reactions occur. , 50 mg/day) and gradually increased. If the rash recurs, allopurinol should be permanently withdrawn.
Skin reactions associated with exfoliation, fever, chills, nausea and vomiting, lymphadenopathy, arthralgia and/or eosinophilia including Stevens-Johnson Syndrome, DRESS, and Toxic Epidermal Necrolysis have occurred. Associated vasculitis and tissue response may be manifested in various ways including hepatitis, interstitial nephritis and very rarely, epilepsy.
If they do occur, it may be at any time during treatment. Allopurinol should be discontinued immediately and permanently. Rechallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN. Extra vigilance for signs of hypersensitivity syndrome or SJS/TEN/DRESS is required and the patient should be informed of the need to stop treatment immediately at the first appearance of symptoms.
Corticosteroids may be beneficial in overcoming such reactions. When generalized hypersensitivity reactions have occurred, renal and/or hepatic disorders have usually been present particularly when the outcome has been fatal. Angioedema has been reported to occur with and without signs and symptoms of a more generalized allopurinol hypersensitivity reaction.
Very rarely acute anaphylactic shock, fixed drug eruptions, alopecia and discolored hair have been reported.
Thyroid Disorders:
The occurrence of increased thyroid stimulating hormone (TSH) was reported.
Vascular Disorders:
Hypertension
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.
MAR-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.
MAR-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. MAR-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 MAR-ALLOPURINOL (allopurinol) should be adjusted by monitoring serum urate concentrations and urinary urate/uric acid levels at appropriate intervals.
See 4 DOSAGE ANDADMINISTRATION Hepatic function:
Periodic liver function tests should be performed in all patients on MAR- 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 MAR-ALLOPURINOL (allopurinol) reassessed.
Musculoskeletal MAR-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 […]