Allopurinol Sandoz
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
19-09-2013
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Active ingredient:
Allopurinol 100mg;
Available from:
Sandoz New Zealand Limited
INN (International Name):
Allopurinol 100 mg
Dosage:
100 mg
Pharmaceutical form:
Tablet
Composition:
Active: Allopurinol 100mg Excipient: Crospovidone Macrogol 4000 Magnesium stearate Microcrystalline cellulose Povidone Powdered cellulose Purified talc
Units in package:
Bottle, plastic, HDPE, 200 tablets, 200 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Sicor (Societa Italiana Corticosteroidi) Srl
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with child resistant closure - 200 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE bottle with child resistant closure - 250 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization date:
1998-10-28
Summary of Product characteristics
NEW ZEALAND DATA SHEET
ALLOPURINOL SANDOZ
®
_ALLOPURINOL PH EUR, TABLETS, 100 MG AND 300 MG _
PRESENTATION
100 MG
White, round, plain, uncoated tablets, scored on one side. Each
tablet contains allopurinol 100 mg.
300 MG
White to off-white, 17
mm x 7 mm oblong, biconvex plain, uncoated tablets with a breaking notch
on
both sides. Each tablet contains allopurinol 300 mg.
USES
_ACTIONS _
Allopurinol is used to decrease uric acid concentrations in
plasma and/or urine when hyperuricaemia
is clinically significant.
PHARMACOTHERAPEUTIC GROUP
M04AA01 - Preparations inhibiting uric acid production,
allopurinol.
MECHANISM OF ACTION
Allopurinol inhibits xanthine oxidase, the enzyme which
catalyses the oxidation of hypoxanthine to
xanthine, and of xanthine to urate/uric acid.
PHARMACODYNAMIC EFFECTS
Allopurinol and its main metabolite oxypurinol lower the
level of uric acid in plasma and urine in two
ways: the inhibition of xanthine oxidase reduces the
amount of hypoxanthine and xanthine converted
to urate/uric acid; this action, in some
but not all hyperuricaemic patients, makes more hypoxanthine
and xanthine available for reutilisation in the purine
metabolic cycle, which in turn, depresses overall
_de novo_ purine biosynthesis via feedback inhibition of hypoxanthine-guanine
phosphorbosyltransferase.
With the lowered urate/uric acid levels in
serum and urine produced by allopurinol there are also
increased levels of the substrates hypoxanthine and xanthine.
Plasma concentrations of these
oxypurines are only slightly increased and the
rate and extent of their renal clearance is greater than
that of uric acid. In the absence of allopurinol,
normal urinary output of oxypurines is almost solely in
the form of uric acid. After administration of allopurinol,
it is composed of hypoxanthine, xanthine a
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