PMS-PYRAZINAMIDE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PYRAZINAMIDE

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

J04AK01

INN (nume internaţional):

PYRAZINAMIDE

Dozare:

500MG

Forma farmaceutică:

TABLET

Compoziție:

PYRAZINAMIDE 500MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTITUBERCULOSIS AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0107627001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-09-21

Caracteristicilor produsului

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-PYRAZINAMIDE
PYRAZINAMIDE TABLETS, USP
500 MG
ANTITUBERCULOSIS AGENT
PHARMASCIENCE INC.
6111, Royalmount Ave, Suite

100
Montréal, Canada H4P 2T4
WWW.PHARMASCIENCE.COM
CONTROL NO: 256065
DATE OF
PREPARATION:
September
21, 2021
_pms-PYRAZINAMIDE _
_–_
_ Prescribing Information _
_ Page 2 of 11 _
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PRESCRIBING INFORMATION
PR
PMS-PYRAZINAMIDE
Pyrazinamide Tablets, USP
500 mg
MECHANISM OF ACTION
Pyrazinamide may be bacteriostatic or bacteriocidal in action,
depending on the concentration of the
drug attained at the site of the infection and the susceptibility of
the infecting organism. _In vitro _and _in _
_vivo_, the drug is active only at a slightly acidic pH. The exact
mechanism of action of pyrazinamide
has not been fully elucidated. The antimycobacterial activity of
pyrazinamide appears to partly
depend on conversion of the drug to pyrazinoic acid (POA). Susceptible
strains of _Mycobacterium _
_tuberculosis _produce pyrazinamidase, an enzyme that deaminates
pyrazinamide to POA, and the _in _
_vitro _susceptibility of a given strain of the organism appears to
correspond to its pyrazinamidase
activity. _In vitro _studies indicate that POA has specific
antimycobacterial activity against
_Mycobacterium tuberculosis_. In addition, the fact that POA lowers
the pH of the environment below
that which is necessary for growth of _M. tuberculosis _appears to
contribute to the drug's
antimycobacterial activity _in vitro. _
_ _
PHARMACOLOGY
Pyrazinamide is a highly specific agent and is active only against _M.
tuberculosis_. Results of _in vitro _
susceptibility testing with pyrazinamide are affected by the test
media, inoculum size, and pH. _In _
_vitro_, in media with a pH of 5.5, the minimum inhibitory
concentration (MIC) of pyrazinamide for
_M. tuberculosis _is generally less than 20 mcg/mL. In one _in vitro
_study in 7H12 liquid media, MICs
of the drug reported for _M. tuberculosis _were 50 mcg/mL at pH 5.5
and 400 mcg/mL at pH 5.95.
RESISTA