NIMEDINE Imipenem + Cilastatin (500+500) mgvial Powder for Solution for Infusion

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

IMIPENEM MONOHYDRATE; CILASTATIN SODIUM

Dostępny od:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (International Nazwa):

IMIPENEM MONOHYDRATE; CILASTATIN SODIUM

Sztuk w opakowaniu:

1 Vials

Wyprodukowano przez:

ANFARM HELLAS S.A.

Charakterystyka produktu

NIMEDINE IMIPENEM + CILASTATIN (500+500) MG/VIAL POWDER FOR SOLUTION
FOR INFUSION
Imipenem and Cilastatin (500+500) mg
PRODUCT DESCRIPTION
White to almost white or light (pale) yellow powder.
After dilution: Range from colorless to yellow. Variations of color
within this range do not affect the
potency of the product.
COMPOSITION
Each vial contains 530 mg of Imipenem monohydrate and 530 mg of
Cilastatin sodium corresponding
to 500 mg of Imipenem and 500 mg of Cilastatin.
PHARMACODYNAMICS
Pharmacotherapeutic group: Antibacterials for systemic use,
carbapenems, ATC code: J01D H51
Mechanism of action
NIMEDINE consists of two components: imipenem and cilastatin sodium in
a 1:1 ratio by weight.
Imipenem,
also
referred
to
as
N-formimidoyl-thienamycin,
is
a
semi-synthetic
derivative
of
thienamycin, the parent compound produced by the filamentous bacterium
_Streptomyces cattleya_.
Imipenem exerts its bactericidal activity by inhibiting bacterial cell
wall synthesis in Gram-positive
and Gram-negative bacteria through binding to penicillin-binding
proteins (PBPs).
Cilastatin sodium is a competitive, reversible and specific inhibitor
of dehydropeptidase-I, the renal
enzyme which metabolizes and inactivates imipenem. It is devoid of
intrinsic antibacterial activity
and does not affect the antibacterial activity of imipenem.
Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Similar to other beta-lactam antibacterial agents, the time that
imipenem concentrations exceed
the MIC (T>MIC) has been shown to best correlate with efficacy.
Mechanism of resistance
Resistance to imipenem may be due to the following:
• Decreased permeability of the outer membrane of Gram-negative
bacteria (due to diminished
production of porins)
• Imipenem may be actively removed from the cell with an efflux pump
• Reduced affinity of PBPs to imipenem
• Imipenem is stable to hydrolysis by most beta-lactamases,
including penicillinases and
cephalosporinases produced by gram-positive and gram-negative
bacteria, with the exception of
relatively r