ZYLOPRIM allopurinol tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ALLOPURINOL (UNII: 63CZ7GJN5I) (ALLOPURINOL - UNII:63CZ7GJN5I)

Διαθέσιμο από:

REMEDYREPACK INC.

INN (Διεθνής Όνομα):

ALLOPURINOL

Σύνθεση:

ALLOPURINOL 300 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

ZYLOPRIM- ALLOPURINOL TABLET
REMEDYREPACK INC.
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PRODUCT INFORMATION
ZYLOPRIM (ALLOPURINOL)
100-MG SCORED TABLETS AND
300-MG SCORED TABLETS
Rx Only
DESCRIPTION
ZYLOPRIM (allopurinol) has the following structural formula:
ZYLOPRIM is known chemically as 1,5-dihydro-4 _H_-pyrazolo [3,4-
_d_]pyrimidin-4-one. It is a xanthine
oxidase inhibitor which is administered orally. Each scored white
tablet contains 100 mg allopurinol
and the inactive ingredients lactose, magnesium stearate, potato
starch, and povidone. Each scored peach
tablet contains 300 mg allopurinol and the inactive ingredients corn
starch, FD&C Yellow No. 6 Lake,
lactose, magnesium stearate, and povidone. Its solubility in water at
37°C is 80.0 mg/dL and is greater in
an alkaline solution.
CLINICAL PHARMACOLOGY
ZYLOPRIM acts on purine catabolism, without disrupting the
biosynthesis of purines. It reduces the
production of uric acid by inhibiting the biochemical reactions
immediately preceding its formation.
ZYLOPRIM is a structural analogue of the natural purine base,
hypoxanthine. It is an inhiboitor of
xanthine oxidase, the enzyme responsible for the conversion of
hypoxanthine to xanthine and of xanthine
to uric acid, the end product of purine metabolism in man. ZYLOPRIM is
metabolized to the
corresponding xanthine analogue, oxipurinol (alloxanthine), which also
is an inhibitor of xanthine
oxidase.
®
It has been shown that reutilization of both hypoxanthine and xanthine
for nucleotide and nucleic acid
synthesis is markedly enhanced when their oxidations are inhibited by
ZYLOPRIM and oxipurinol. This
reutilization does not disrupt normal nucleic acid anabolism, however,
because feedback inhibition is an
integral part of purine biosynthesis. As a result of xanthine oxidase
inhibition, the serum concentration
of hypoxanthine plus xanthine in patients receiving ZYLOPRIM for
treatment of hyperuricemia is
usually in the range of 0.3 to 0.4 mg/dL compared to a normal level of
approximately 0.15 mg/dL. A
maximum of 0.9 mg/dL of these oxypurines has