SYNERCID- quinupristin and dalfopristin injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUINUPRISTIN (UNII: 23OW28RS7P) (QUINUPRISTIN - UNII:23OW28RS7P), DALFOPRISTIN (UNII: R9M4FJE48E) (DALFOPRISTIN - UNII:R9M4FJE48E)

Available from:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

QUINUPRISTIN

Composition:

QUINUPRISTIN 150 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Synercid and other antibacterial drugs, Synercid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Synercid is indicated in adults for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Complicated skin and skin structure infections caused by Staphylococcus aureus (methicillin susceptible ) or Streptococcus pyogenes . (See CLINICAL STUDIES. ) Synercid is contraindicated in patients with known hypersensitivity to Synercid , or with prior hypersensitivity to other streptogramins (e.g. , pristinamycin or virginiamycin).

Product summary:

Synercid is supplied as a sterile lyophilized pyrogen-free preparation in single-dose 10 mL type I glass vials with gray elastomeric closure, and aluminum seal with a dark blue flip-off cap for the 500 mg vial.

Authorization status:

New Drug Application

Summary of Product characteristics

SYNERCID- QUINUPRISTIN AND DALFOPRISTIN INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
----------
SYNERCID I.V.
(QUINUPRISTIN AND DALFOPRISTIN FOR INJECTION)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
SYNERCID and other antibacterial drugs, SYNERCID should be used only
to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
SYNERCID (quinupristin and dalfopristin powder for injection) I.V., a
streptogramin
antibacterial agent for intravenous administration, is a sterile
lyophilized formulation of
two semisynthetic pristinamycin derivatives, quinupristin (derived
from pristinamycin I)
and dalfopristin (derived from pristinamycin IIA) in the ratio of
30:70 (w/w).
Quinupristin is a white to very slightly yellow, hygroscopic powder.
It is a combination of
three peptide macrolactones. The main component of quinupristin (>
88.0%) has the
following chemical name:
N-[(6_R_,9_S_,10_R_,13_S_,15_aS_,18_R_,22_S_,24_aS_ )-22-[_p_-
(dimethylamino)benzyl]-6-ethyldocosahydro-10,23-dimethyl-5,8,12,15,17,21,24-
heptaoxo-13-phenyl-18-[[(3_S_ )-3-quinuclidinylthio]
methyl]-12_H_-pyrido[2,1-_f_ ]pyrrolo-
[2,1-_l_ ][1,4,7,10,13,16]
oxapentaazacyclononadecin-9-yl]-3-hydroxypicolinamide.
The main component of quinupristin has an empirical formula of C
H
N O
S, a
molecular weight of 1022.24 and the following structural formula:
Dalfopristin is a slightly yellow to yellow, hygroscopic, powder. The
chemical name for
dalfopristin is: (3_R_,4_R_,5_E_,10_E_,12_E_,14_S_,26_R_,26a_S
_)-26-[[2-(diethylamino)ethyl]sulfonyl]-
8,9,14,15,24,25,26,26a-octahydro-14-hydroxy-3-isopropyl-4,12-dimethyl-3_H_-21,18-
nitrilo-1_H_,22_H_-pyrrolo[2,1-_c_
][1,8,4,19]-dioxadiazacyclotetracosine-1,7,16,22(4_H_,17_H _)-
tetrone.
®
®
53
67
9
10
Dalfopristin has an empirical formula of C
H
N O S, a molecular weight of 690.85 and
the following structural formula:
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Quinupristin and dalfopristin are the m