ALLOPURINOL- allopurinol tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Cardinal Health

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces 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 is indicated in: Patients who have developed a severe reaction to allopurinol should not be restarted on the drug.

Rezumat produs:

Allopurinol Tablets USP, 100 mg are scored, round, white tablets imprinted “DAN DAN ” and “5543 ” supplied overbagged with 10 tablets per bag, NDC 55154-4750-0. Allopurinol Tablets USP, 300 mg are scored, round, orange tablets imprinted “DAN DAN ” and “5544 ”  supplied overbagged with 10 tablets per bag, NDC 55154-2056-0. Store at 20° to 25°C (68°-77°F). [See USP controlled room temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

ALLOPURINOL- ALLOPURINOL TABLET
CARDINAL HEALTH
----------
ALLOPURINOL TABLETS USP
8000988/0915
RX ONLY
DESCRIPTION
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. Its solubility in
water at 37°C is 80 mg/dL and is greater
in an alkaline solution. The structural formula is represented below:
C H N O M.W. 136.11
Allopurinol Tablets USP, 100 mg and 300 mg contain the following
inactive ingredients:
croscarmellose sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch and sodium lauryl sulfate.
Allopurinol Tablets USP, 300 mg also contain FD&C Yellow No. 6.
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.
5
4
4
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 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 low