ALLOPURINOL Tablets 100 mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
ALLOPURINOL
Available from:
Roussel Laboratories Limited
Dosage:
100 mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
1988-07-25
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Allopurinol Tablets 100mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg of Allopurinol
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablets
White biconvex tablets about 9.5mm in
diameter. One face is marked
with ‘AP’, a breakline and ‘100’, the reverse
carries the Roussel logo.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
In the management of conditions of excess body urate, including
gout, neoplastic disease and associated treatment,
enzyme disorders such as the Lesch – Nyhan Syndrome,
renal calculi, renal failure, diuretic therapy and psoriasis.
2.
In the prophylaxis and treatment of calcium renal lithiasis in
patients with raised serum or urinary uric acid.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
DOSAGE:
Adults:
The usual daily dose is 300mg as a single dose with
increments, as indicated by monitoring of serum and/or urinary
uric acid, to the level necessary for optimum control, seldom in
excess of 900mg. Dosage higher than 300mg should be
given in divided doses not exceeding 300mg at any one time.
Children:
The usual daily dose is 10 to 20 mg/kg b.w.
To avoid an acute attack of gouty arthritis in
the initial stages of treatment,
colchicine or other appropriate agents
should be given for at least a month. When used in
neoplasia allopurinol therapy should be commenced before
cytotoxics.
In renal insufficiency, dosage requirements must be reduced
if creatinine clearance is less than 20ml/minute.
CREATININE CLEARANCE
DOSAGE
10-20 ml/min
100 to 200mg daily
<10ml/min
100mg daily or at longer intervals
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 25/08/2005_
_CRN 2014137_
_page number: 1_
If frequent renal dialysis is require
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