Ampicilla Powder for Oral Suspension 125mg5ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AMPICILLIN TRIHYDRATE

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

INN (Nama Antarabangsa):

AMPICILLIN TRIHYDRATE

Unit dalam pakej:

60 ml; 100 ml; 60 ml; 100 ml

Dikeluarkan oleh:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

Risalah maklumat

AMPICILLA POWDER FOR ORAL SUSPENSION
125MG/5ML
Ampicillin (125mg/5mL)
Page
1
of
2
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Ampicilla Powder for Oral
Suspension is used for
2.
How Ampicilla Powder for Oral
Suspension works
3.
Before you use Ampicilla Powder
for Oral Suspension
4.
How to use Ampicilla Powder for
Oral Suspension
5.
While
you
are
using
Ampicilla
Powder for Oral Suspension
6.
Side effects
7.
Storage and disposal of Ampicilla
Powder for Oral Suspension
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
AMPICILLA
POWDER
FOR
ORAL
SUSPENSION IS USED FOR
Ampicilla Powder for Oral Suspension
contains
ampicillin
which
used
to
kill bacteria that cause infections.
_ _
HOW
AMPICILLA
POWDER
FOR
ORAL
SUSPENSION WORKS
Ampicilla Powder for Oral Suspension
works by killing bacteria that cause the
infections
by
inhibit
the
cell
wall
synthesis of bacteria.
BEFORE YOU USE AMPICILLA POWDER FOR
ORAL SUSPENSION
_-When you must not use it _
Do not take Ampicilla Powder for Oral
Suspension
if
you
are
allergic
to
Ampicillin
or
beta-lactam
antibiotics
and
any
excipients
as
listed
in
the
leaflet.
_ _
_Pregnancy and Lactation _
Do not take Ampicilla Powder for Oral
Suspension if you are pregnant, trying
to get pregnant or think you may be
pregnant without discussing with your
doctor first. Ampicilla Powder for Oral
Suspension should only be used when
clearly needed.
Do not take Ampicilla Powder for Oral
Suspension if you are breast-feeding.
Ask
your
doctor
or
pharmacist
for
advice before taking any medicine.
_-Before you start to use it _
Tell your doctor if you have allergies to
ampicillin,
penicillins
or
any
other
antibiotics.
Your doctor needs to know before you
take
Ampicilla
Powder
for
Oral
Suspension if you have liver or kidney
impairment.
_-Taking other medicines _
Tell your doctor if you are taking any
other medicine, including any that you
buy
without
prescription
from
a
pharmacy, supermarket or health food
shop.
Some
of
medicine
may

Ciri produk

IDAMAN PHARMA MANUFACTURING
AMPICILLA POWDER FOR ORAL SUSPENSION
125MG/5ML
COMPOSITION
Each 5mL of reconstituted suspension contains AMPICILLIN TRIHYDRATE
equivalent to 125mg of AMPICILLIN.
DESCRIPTION
Powder: A white fine powder with strawberry odour.
Reconstituted
oral
suspension: A
lump
free
pinkish
suspension
with
a
strawberry odour.
ROUTE OF ADMINISTRATION:
Oral
PHARMACODYNAMICS
Ampicillin inhibits bacterial cell wall synthesis by binding to one or
more of
the
penicillin-binding
proteins
(PBPs)
which
in
turn
inhibit
the
final
transpeptidation step of peptidoglycan synthesis in bacterial cell
walls.
Bacteria eventually lyse due to ongoing activity of cell wall
autolytic
enzymes (autolysins and murein hydrolases) while cell wall assembly is
arrested.
PHARMACOKINETICS
ABSORPTION: Moderately well absorbed from the gastrointestinal tract
after
oral doses (50%). Food may reduce rate and extent of absorption. Time
to
peak plasma concentration: Approximately 1 - 2 hours.
DISTRIBUTION: Widely distributed crosses the placenta and enters
breast
milk (small amounts). There is little diffusion into the cerebrospinal
fluid
except
when
the
meninges
are
inflamed.
Plasma
protein
binding:
Approximately 20%.
METABOLISM: Metabolised to some extent to penicilloic acid.
EXCRETION: Via urine as unchanged drug (oral: approximately 20% - 40%;
parenteral: approximately 60% - 80%) within 6 hours and faeces (small
amounts). Plasma half-life: Approximately 1 - 1.5 hours, but this may
be
increased in neonates, the elderly, and patients with renal
impairment; in
severe renal impairment half lives of 7 - 20 hours have been reported.
INDICATIONS
Treatment of infections due to the susceptible strains of the
following:
a. Gram-negative organisms
- Shigella - Salmonella (incl. _S. typhosa_)
- _P. mirabilis_ - _H. influenza_
- _E. coli_ - _N. gonorrhoea_
- _N. meningitidis_
b. Gram-positive organisms
- Streptococci
- _Streptococcus pneumoniae_
- Non penicillinase producing staphylococci
DOSAGE AND ADMINISTRATION
Up to 2 years : 2.5mL to 5mL 6 h