FELEXIN 250 FOR ORAL SUSPENSION 250 mg5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CEFALEXIN MONOHYDRATE EQV CEFALEXIN

Available from:

GOLDPLUS UNIVERSAL PTE LTD

ATC code:

J01DB01

Dosage:

5300mg/ 100ml

Pharmaceutical form:

POWDER, FOR SUSPENSION

Composition:

CEFALEXIN MONOHYDRATE EQV CEFALEXIN 5300mg/ 100ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

REMEDICA LTD

Authorization status:

ACTIVE

Authorization date:

1997-08-18

Summary of Product characteristics

P18-0039SR250SIN
003294
FELEXIN 250 MG/5 ML
PRODUCT NAME
Felexin 250 mg/5 ml powder for oral suspension
NAME
AND
STRENGTH
OF
ACTIVE
SUBSTANCE
Each 5 ml of oral suspension contains cefalexin
monohydrate equivalent to 250 mg cefalexin.
PRODUCT DESCRIPTION
Powder for oral suspension.
White
powder
that
after
reconstitution
gives
an
orange, flavoured suspension.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic
group:
Antibacterials
for
systemic use; Other beta-lactam antibacterials, ATC
code: J01DB01
_In vitro_
tests demonstrate that cephalosporins are
bactericidal because of their inhibition of cell-wall
synthesis.
Cefalexin is active against the following micro-
organisms
_in vitro_
:
Beta-haemolytic streptococci
Staphylococci,
including
coagulase-positive,
coagulase-negative
and
penicillinase-producing
strains
_Streptococcus pneumoniae_
_Escherichia coli_
Klebsiella species
Proteus mirabilis
_Haemophilus influenzae _
_Branhamella catarrhalis_
Most strains of enterococci (
_Streptococcus faecalis_
)
and a few strains of staphylococci are resistant to
cefalexin. It is not active against most strains of
_Enterobacter_
species,
_Morganella morganii_
and
_Pr. _
_vulgaris_
. It has no activity against
_Pseudomonas_
or
_Herellea_
species or
_Acinetobacter calcoaceticus_
.
Penicillin-resistant
_Streptococcus _
_pneumonia_
is
usually
cross-resistant
to
beta-lactam
antibiotics.
When tested
_in vitro_
methods, staphylococci exhibit
cross-resistance between cefalexin and methicillin-
type antibiotics.
PHARMACOKINETIC PROPERTIES
Cefalexin is acid stable.
Cefalexin is almost completely absorbed from the
gastro-intestinal
tract,
and
75-100%
is
rapidly
excreted in active form in the urine. Absorption is
slightly reduced if the drug is administered with
food. The half-life is approximately 60 minutes in
patients with normal renal function. Haemodialysis
and peritoneal dialysis will remove cefalexin from
the blood.
Peak
blood
levels
are
achieved
one
hour
after
administration, and therapeutic levels are maint