ALLOPURINOL tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

American Health Packaging

INN (International Adı):

ALLOPURINOL

Kompozisyon:

ALLOPURINOL 100 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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: - the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). - the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present. - the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female

Ürün özeti:

Allopurinol Tablets USP, 100 mg are scored, round, white tablets imprinted “ DAN DAN ” and “ 5543 ” supplied in unit dose packages of 100 (10x10) NDC 62584-988-01. Allopurinol Tablets USP, 300 mg are scored, round, orange tablets imprinted “ DAN DAN ” and “ 5544 ” supplied in unit dose packages of 100 (10x10) NDC 62584-713-01. 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.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

ALLOPURINOL- ALLOPURINOL TABLET
AMERICAN HEALTH PACKAGING
----------
ALLOPURINOL TABLETS, USP
8000988/0719
RX ONLY
DESCRIPTION
Allopurinol, USP 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 corn 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