IMIPENEM AND CILASTATIN FOR INJECTION, USP POWDER FOR SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

IMIPENEM; CILASTATIN (CILASTATIN SODIUM)

Предлага се от:

METHAPHARM INC

АТС код:

J01DH51

INN (Международно Name):

IMIPENEM AND CILASTATIN

дозиране:

250MG; 250MG

Лекарствена форма:

POWDER FOR SOLUTION

Композиция:

IMIPENEM 250MG; CILASTATIN (CILASTATIN SODIUM) 250MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

CARBAPENEMS

Каталог на резюме:

Active ingredient group (AIG) number: 0218820002; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2018-04-23

Данни за продукта

Page 1 of 48
PRODUCT
MONOGRAPH
IMIPENEM AND CILASTATIN FOR INJECTION, USP
Imipenem 250 mg and Cilastatin 250 mg (as cilastatin sodium) per vial
Imipenem 500 mg and Cilastatin 500 mg (as cilastatin sodium) per vial
Sterile Powder for intravenous Infusion
ANTIBIOTIC
Methapharm Inc.
Date of Revision: April 10, 2015
Brantford, Ontario, Canada
Control: 174843
Page 2 of 48 IMIPENEM AND CILASTATIN FOR INJECTION, USP
THERAPEUTIC
CLASSIFICATION
Antibiotic
ACTION
Imipenem exerts a bactericidal action by inhibiting cell wall
synthesis in aerobic and anaerobic
gram-positive and gram-negative bacteria.
IMIPENEM AND CILASTATIN FOR INJECTION, USP
(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.
INDICATIONS AND CLINICAL
USE
IMIPENEM AND CILASTATIN FOR INJECTION, USP
(imipenem and cilastatin sodium) may be
indicated in the treatment of serious infections when caused by
sensitive strains of bacteria.
Where considered n