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APO-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: APO-ALLOPURINOL TABLETS (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…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 09/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 2 Recommended Dose and Dosage Adjustment .........................................................
5 Missed Dose .............................................................................................................. 7 5 OVERDOSAGE.............................................................................................................
7
2 Recommended Dose and Dosage Adjustment Adults: APO-ALLOPURINOL TABLETS are administered orally. The total daily requirement should be divided into 1 to 3 doses. Daily doses up to and including 300 mg of APO- ALLOPURINOL TABLETS 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 APO- ALLOPURINOL TABLETS is generally better tolerated if taken following meals.
Treatment of Gout:
The dose of APO-ALLOPURINOL TABLETS 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 APO-ALLOPURINOL TABLETS 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 APO-ALLOPURINOL TABLETS 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/dL for 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 tablets 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 tablets administration, it is recommended that the patient start with a low dose of APO-ALLOPURINOL TABLETS (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.
4 Geriatrics 09/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 2 Recommended Dose and Dosage Adjustment .........................................................
5 Missed Dose .............................................................................................................. 7 5 OVERDOSAGE.............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations .................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Also, a maintenance dose of PrAPO-ALLOPURINOL TABLETS (Allopurinol Tablets) Page 6 of 30 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 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. APO-ALLOPURINOL TABLETS 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 APO-ALLOPURINOL TABLETS 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 APO-ALLOPURINOL TABLETS 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):
APO-ALLOPURINOL TABLETS is contraindicated in children except for the treatment of secondary hyperuricemia associated with malignancies and in the Lesch- Nyhan syndrome. APO-ALLOPURINOL TABLETS 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 tablets which produces satisfactory urate reduction should be used.
Renal Impairment:
Since APO-ALLOPURINOL TABLETS and its metabolites are excreted only by the kidney, accumulation of the drug can occur in renal failure and the dose of APO- ALLOPURINOL TABLETS should consequently be reduced. With a creatinine clearance of 20 to 10 mL/min, a daily dosage of 200 mg of APO-ALLOPURINOL TABLETS 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 PrAPO-ALLOPURINOL TABLETS (Allopurinol Tablets) Page 7 of 30 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 […]
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics...........................................................................................................
4 Geriatrics ........................................................................................................... 11 8 ADVERSE REACTIONS................................................................................................
1 Adverse Reaction Overview .................................................................................... 11 9 DRUG INTERACTIONS ............................................................................................... 2 Drug Interactions Overview ....................................................................................
4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions.......................................................................... 16 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics ..............................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 19 PART II: SCIENTIFIC INFORMATION ......................................................................................
20 13 PHARMACEUTICAL INFORMATION ........................................................................... 20 14 CLINICAL TRIALS .......................................................................................................
20 15 MICROBIOLOGY ....................................................................................................... 20 16 NON-CLINICAL TOXICOLOGY .....................................................................................
21 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 22 PATIENT MEDICATION INFORMATION ................................................................................. 23 PrAPO-ALLOPURINOL TABLETS (Allopurinol Tablets) Page 4 of 30 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-ALLOPURINOL TABLETS (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 urate deposition or renal calculi in patients with leukemias, lymphomas or other malignancies, receiving antineoplastic treatment (radiation or cytotoxic drugs) which might induce increased uricemia levels.
Also in the therapy and prophylaxis of acute urate nephropathy and resultant renal failure in patients with neoplastic disease who are particularly susceptible to hyperuricemia and uric acid stone formation (especially after radiation therapy or use of antineoplastic drugs).
• Prevention of the occurrence and recurrence of uric acid stones or gravel and renal calcium lithiasis in […]