Levocin 5mg/ml Solution for IV Infusion

Land: Filippinerne

Sprog: engelsk

Kilde: FDA (Food And Drug Administration)

Aktiv bestanddel:

Levofloxacin (As Hemihydrate)

Tilgængelig fra:

Getz Pharma (Phils.) Inc.; Distributor: Getz Pharma (Phils.) Inc.

INN (International Name):

Levofloxacin (As Hemihydrate)

Dosering:

5mg/ml

Lægemiddelform:

Solution for IV Infusion

Enheder i pakken:

Type II USP Clear Vial with Blue Color Flip-off Seal having the word 'Flip off' Embossed on Top with Plastic Hanger x 100mL (Box of 1's), Type II USP Clear Vial with Blue Color Flip-off Seal having the word 'Flip off' Embossed on Top with Plastic Hanger x 100mL (Box

Fremstillet af:

Getz Pharma (Private), Limited, Pakistan

Autorisation dato:

2020-05-11

Produktets egenskaber

DESCRIPTION
Levofloxacin (Levocin) is a synthetic broad-spectrum antibacterial
agent. Chemically,
levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)
(S)-enantiomer of the
racemic drug substance ofloxacin with a chemical name of:
(-)-(S)-9-fluoro-2, 3-dihydro-3-
methyl-10- (4-methyl-piperazinyl)-7-oxo-7H pyrido [1,2,3,-de] [1,4]
benzoxazine-6-carboxylic
acid. The molecular formula is C
18
H
20
FN
3
O
4
and the structural formula is:
FORMULATION
Levofloxacin (Levocin) IV is available as:
Levofloxacin (Levocin) IV Infusion 500mg/100mL
Each mL solution for infusion contains:
Levofloxacin ... 5mg (as Hemihydrate)
Levofloxacin (Levocin) IV Infusion 750mg/150mL
Each mL solution for infusion contains:
Levofloxacin ... 5mg (as Hemihydrate)
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone
antimicrobial agent.
The antibacterial activity of ofloxacin resides primarily in the
L-isomer. The main mechanism
of action of levofloxacin involves the inhibition of bacterial
topoisomerase IV and DNA gyrase
(both of which are type II topoisomerases), enzymes required for DNA
replication, transcription,
repair and recombination.
Levofloxacin has _in-vitro_ activity against the following
gram-negative and gram positive
microorganisms. It is often bactericidal at concentrations equal to or
slightly greater than inhibitory
concentration. It is generally considered to be about twice as active
as its isomer, ofloxacin.
MICROBIOLOGY
Levofloxacin has been shown to be active against most strains of the
following
micro-organisms.
COMMONLY SUSCEPTIBLE SPECIES
Aerobic Gram-positive bacteria
_Staphylococcus aureus_ methicillin-susceptible.
_Staphylococcus saprophyticus._
_Streptococci, group C and G._
_Streptococcus agalactiae._
_Streptococcus pneumoniae._
_Streptococcus pyogenes._
Aerobic Gram-negative bacteria
_Burkholderia cepacia._
_Eikenella corrodens._
_Haemophilus influenzae._
_Haemophilus para-influenzae._
_Klebsiella oxytoca._
_Klebsiella pneumoniae._
_Moraxell