SYNERCID POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

QUINUPRISTIN; DALFOPRISTIN

Disponible depuis:

MONARCH PHARMACEUTICALS IRELAND LIMITED

Code ATC:

J01FG02

DCI (Dénomination commune internationale):

QUINOPRISTIN AND DALFOPRISTIN

Dosage:

150MG; 350MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

QUINUPRISTIN 150MG; DALFOPRISTIN 350MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

1/10VIALS

Type d'ordonnance:

Prescription

Domaine thérapeutique:

STREPTOGRAMINS

Descriptif du produit:

Active ingredient group (AIG) number: 0239201001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2008-05-28

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
Pr
SYNERCID
TM
(quinupristin 150 mg)
(dalfopristin 350 mg)
Powder for Intravenous Injection
Antibacterial Agent
Monarch Pharmaceuticals Ireland Limited
Date of preparation:
(Subsidiary of King Pharmaceuticals, Inc.,
October 21, 2005
Bristol, Tennesee)
Alexandra House, The Sweepstakes, Ballsbridge
Dublin 4
Ireland
Control#: 101819
_Synercid_
_®_
_Quinupristin, 150 mg _
_Dalfopristin, 350 mg _
_ _
Powder for injection
For intravenous infusion only
_ _
THERAPEUTIC CLASSIFICATION
Antibacterial agent
ACTION and CLINICAL PHARMACOLOGY
Action
SYNERCID (quinupristin and dalfopristin in the ratio of 30:70) is a
streptogramin antibacterial
agent for intravenous administration. The streptogramin components of
SYNERCID,
quinupristin and dalfopristin, individually possess bacteriostatic
activity against Gram-positive
bacteria, as do the principal components, PI and PIIA, of the
naturally occurring streptogramin,
pristinamycin. The main target of quinupristin and dalfopristin is the
bacterial ribosome. When
combined, quinupristin and dalfopristin, as SYNERCID, exert
bactericidal activity by inhibiting
early and late phases of bacterial protein synthesis and interact
synergistically at the ribosomal
site so that SYNERCID's activity is much greater than that of the
components individually. The
mode of action of streptogramins, _e.g., _SYNERCID, differs somewhat
from that of the
macrolides and lincosamides. SYNERCID differs in chemical structure
and mode of action from
other classes of antimicrobial agents such β-lactams, glycopeptides
and quinolone antibiotics.
Therefore, microorganisms resistant to these latter classes of
antimicrobial agents may be
susceptible to SYNERCID. SYNERCID is bacteriostatic against
_Enterococcus faecium _and
bactericidal against strains of methicillin susceptible
_staphylococci. _
A prolonged post-antibiotic effect (PAE) of SYNERCID was observed with
_Staphylococcus _
_aureus _(10 hours) and _Streptococcus pneumoniae _(9.1 hours) in the
neutropenic mouse thigh
abscess model, support