NTP-AZATHIOPRINE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

AZATHIOPRINE

Доступна з:

TEVA CANADA LIMITED

Код атс:

L04AX01

ІПН (Міжнародна Ім'я):

AZATHIOPRINE

Дозування:

50MG

Фармацевтична форма:

TABLET

Склад:

AZATHIOPRINE 50MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100/250/500/1000

Тип рецепту:

Prescription

Терапевтична области:

IMMUNOSUPPRESSIVE AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0101830001; AHFS:

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2015-08-06

Характеристики продукта

PRODUCT MONOGRAPH
Pr
NTP-AZATHIOPRINE
(azathioprine)
50 mg Tablets
USP
Immunosuppressive Agent
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165860
Date of Preparation:
July 5, 2013
PRODUCT MONOGRAPH
Pr
NTP-AZATHIOPRINE
(azathioprine)
50mg Tablets
USP
THERAPEUTIC CLASSIFICATION
Immunosuppressive Agent
ACTION AND CLINICAL PHARMACOLOGY
Metabolism:
Azathioprine is well absorbed following oral administration. Maximum
serum radioactivity
occurs at one to two hours after oral
35
S-azathioprine and decays with a half-life of five hours.
This is not an estimate of the half-life of azathioprine itself but is
the decay rate for all
35
S-
containing metabolites of the drug. Because of extensive metabolism,
only a fraction of the
radioactivity is present as azathioprine. Usual doses produce blood
levels of azathioprine, and of
mercaptopurine derived from it, which are low (< 1µg/mL). Blood
levels are of little predictive
value for therapy since the magnitude and duration of clinical effects
correlate with thiopurine
nucleotide levels in tissues rather than with plasma drug levels.
Azathioprine and
mercaptopurine are moderately bound to serum proteins (30%) and are
partially dialyzable.
Azathioprine is cleaved _in vivo_ to mercaptopurine. Both compounds
are rapidly eliminated from
blood and are oxidized or methylated in erythrocytes and liver; no
azathioprine or
mercaptopurine is detectable in urine after eight hours. Conversion to
inactive 6-thiouric acid by
xanthine oxidase is an important degradative pathway, and the
inhibition of this pathway in
patients receiving allopurinol is the basis for the azathioprine
dosage reduction required in these
2
patients (see Drug Interactions under PRECAUTIONS). Proportions of
metabolites are different
in individual patients, and this presumably accounts for variable
magnitude and duration of drug
effects. Renal clearance is probably not important in predicting
biological effectiveness or
toxicities, although dose reduction is practiced in p