ALLOPURINOL tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Cardinal Health 107, LLC

INN (Διεθνής Όνομα):

ALLOPURINOL

Σύνθεση:

ALLOPURINOL 100 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS). Allopurinol tablets are indicated in: Patients who have developed a severe reaction to allopurinol tablets should not be restarted on the drug.

Περίληψη προϊόντος:

Allopurinol Tablets, USP are available containing 100 mg or 300 mg of allopurinol, USP. The 100 mg tablets are white, round, scored tablets debossed with M to the left of the score and 31 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5534-0 The 300 mg tablets are white, round, scored tablets debossed with M to the left of the score and 71 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-5454-0 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from moisture. The brands listed are trademarks of their respective owners. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505   U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Distributed By: Cardinal Health Dublin, OH 43017 L32341190124 L32341010224 S-12765 R1 7/23

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ALLOPURINOL- ALLOPURINOL TABLET
CARDINAL HEALTH 107, LLC
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DESCRIPTION
Allopurinol has the following structural formula:
Allopurinol 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 or 300 mg allopurinol, USP and the inactive
ingredients colloidal silicon
dioxide, magnesium stearate, microcrystalline cellulose,
pregelatinized starch (corn),
sodium lauryl sulfate and sodium starch glycolate (potato). Its
solubility in water at 37ºC
is 80.0 mg/dL and is greater in an alkaline solution.
CLINICAL PHARMACOLOGY
Allopurinol 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.
Allopurinol is a structural analogue of the natural purine base,
hypoxanthine. It is an
inhibitor 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. Allopurinol 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
allopurinol 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 allopurinol tablets
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 been
reported when the serum urate was lowered to less than 2 mg/dL by high
doses of
allopurinol tablets. These values