NU-AZATHIOPRINE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AZATHIOPRINE

Disponibil de la:

NU-PHARM INC

Codul ATC:

L04AX01

INN (nume internaţional):

AZATHIOPRINE

Dozare:

50MG

Forma farmaceutică:

TABLET

Compoziție:

AZATHIOPRINE 50MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

IMMUNOSUPPRESSIVE AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED (UNRETURNED ANNUAL)

Data de autorizare:

2018-03-28

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
NU-AZATHIOPRINE
AZATHIOPRINE TABLETS USP
50 MG
IMMUNOSUPPRESSIVE AGENT
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET UNITS 1 & 2
January 12, 2004
RICHMOND HILL, ONTARIO
L4B 1E4
_Control #: 089003_
2
PRODUCT MONOGRAPH
NU-AZATHIOPRINE
Azathioprine Tablets USP
50 mg
THERAPEUTIC CLASSIFICATION
Immunosuppressive Agent
ACTIONS 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 (<1
:
g/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 Zyloprim® (allopurinol) is the basis for the
azathioprine dosage reduction
required in these 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
practised in