PRIMAXIN IV 500 POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Commercializzato da:

MERCK CANADA INC

Codice ATC:

J01DH51

INN (Nome Internazionale):

IMIPENEM AND CILASTATIN

Dosaggio:

500MG; 500MG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG

Via di somministrazione:

INTRAVENOUS

Confezione:

25 VIALS

Tipo di ricetta:

Prescription

Area terapeutica:

CARBAPENEMS

Dettagli prodotto:

Active ingredient group (AIG) number: 0218820001; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2009-05-13

Scheda tecnica

PRODUCT MONOGRAPH
PRIMAXIN
®
(imipenem and cilastatin sodium for injection, USP)
I.V. Infusion
ANTIBIOTIC
MERCK FROSST CANADA LTD.
Kirkland, Quebec, Canada
CONTROL: 118199
DATE OF REVISION:
FEBRUARY 18, 2008
PRIMAXIN
®
is a Registered Trademark of Merck & Co., Inc. Used under license
1
NAME OF DRUG
PRIMAXIN
®
(imipenem and cilastatin sodium for injection, USP)
I.V. Infusion
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
Imipenem exerts a bactericidal action by inhibiting cell wall
synthesis in aerobic
and anaerobic gram-positive and gram-negative bacteria.
PRIMAXIN
®
(imipenem
and
cilastatin
sodium)
consists
of
two
components:
(1) imipenem, a derivative of thienamycin, a carbapenem antibiotic;
and (2)
cilastatin sodium, a specific inhibitor of dehydropeptidase-I a renal
enzyme which
metabolizes and inactivates imipenem. Cilastatin blocks the metabolism
of
imipenem in the kidney, so that concomitant administration of imipenem
and
cilastatin allows antibacterial levels of imipenem to be attained in
the urine.
Inhibition of cell-wall synthesis is achieved in gram-negative
bacteria by the
binding of imipenem to penicillin binding proteins (PBPs). In the case
of
_Escherichia coli_ and selected strains of _Pseudomonas aeruginosa_,
imipenem has
been shown to have highest affinity for PBP-2, PBP-1a and PBP-1b, with
lower
activity against PBP-3. The preferential binding of imipenem on PBP-2
and PBP-
1b leads to direct conversion of the individual cell to a spheroplast
resulting in
rapid lysis and cell death without filament formation. When imipenem
is removed
prior to complete killing of gram-negative species, the remaining
viable cells
show
a
measurable
lag,
termed
a
"post-antibiotic
effect"
(PAE),
prior
to
resumption of new growth.
2
INDICATIONS AND CLINICAL USE
PRIMAXIN
®
(imipenem and cilastatin sodium) may be indicated in the treatment
of serious infections when caused by sensitive strains of bacteria.
Where
considered necessary, therapy may be initiated on the basis of
clinical judgment
before results of sensitiv