MOXIPEN FOR ORAL SUSPENSION

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

AMOXYCILLIN TRIHYDRATE

Verfügbar ab:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Internationale Bezeichnung):

AMOXYCILLIN TRIHYDRATE

Einheiten im Paket:

60ml mL

Hergestellt von:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
___________________________________________________________________________________________________________________________
_
______________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What is Moxipen used for
2.
How Moxipen works
3.
Before you use Moxipen
4.
How to use Moxipen
5.
While you are using Moxipen
6.
Side Effects
7.
Storage and Disposal of Moxipen
8.
Product Description
9.
Manufacturer and Product Registration Holder
10.
Date of Revision
_ _
WHAT IS MOXIPEN USED FOR
It is used to treat bacterial infection in ear
and
throat,
urinary
tract,
skin
and
soft
tissues.
It
can
also
be
used
to
treat
sexually
transmitted infection and genital tract.
HOW MOXIPEN WORKS
Amoxycillin is the antibiotic which kills
bacteria in human body.
BEFORE YOU USE MOXIPEN
_-When you must not use it _
Do not use Moxipen if you:
•
allergic
to
Amoxycillin,
Penicillin
or
any other ingredients in this medicine.
Some of the symptoms of an allergic
reaction may include skin rash, itching
or
hives;
swelling
of
the
face,
lips,
mouth
or
throat
which
may
cause
difficulty
swallowing
or
breathing;
wheezing or shortness of breath.
•
have
viral
infection,
_infectious _
_mononucleosis _
which characterized by
fever, sore throat and fatigue.
_ _
_-Before you start to use it _
Tell your doctor or pharmacist before using
Moxipen if you:
•
are
allergic
to
any
other
medicines,
foods, dyes or preservatives.
•
kidney or liver problems.
•
glandular
fever
(mononucleosis)
or
a
blood disorder.
•
are pregnant or plan to pregnant.
•
are
breast-feeding
or
plan
to
start
breast-feeding.
_-Taking other medicines _
Tell your doctor or pharmacist if you are
taking or having recently taken any other
medicines.
This
includes
any
medicines
which
you
have
bought
without
a
prescription.
HOW TO USE MOXIPEN
_HOW MUCH TO USE _
_Adults _
_and _
_children _
_weighing _
_20kg _
_and _
_above : _
10ml- 20ml (250-500mg) every

Fachinformation

Important Information. Please read carefully
.
Moxipen
CAPSULE / POWDER FOR ORAL SUSPENSION_ _
_ _
COMPOSITION
Moxipen Capsule
Each capsule contains Amoxycillin Trihydrate equivalent to Amoxycillin
Anhydrous 250 mg.
Moxipen Oral Suspension
Each 5 mL reconstituted suspension contains Amoxycillin Trihydrate
equivalent to Amoxycillin Anhydrous 125 mg. Sodium Benzoate 0.1%
w/v as preservative.
PHARMACODYNAMICS
Amoxycillin is bactericidal and has a broad-spectrum activity which is
effective against both Gram-positive and Gram-negative organisms,
including
_Haemolytic _
_streptococci_,
_Diplococcus _
_pneumoniae_,
non-
penicillinase-producing
_Staphylococci_,
_Bacillus _
_anthracis_,
_Clostridia_
spp,
_Corynebacterium _
_xerose_,
and
most
strains
of
_Enterococci_,
_Haemophilus influenza_, _ Neisseria gonorrhoea_, _ Neisseria
meningitidis_,
_Proteus mirabilis_, many strains of _Salmonella_, and _Escherichia
coli_. It is
less effective than ampicillin against _Shigella_ spp., and more
effective
against _Streptococci_ and _Salmonella_ spp.
PHARMACOKINETICS
Amoxycillin is resistant to inactivation by gastric acid. It is more
rapidly
and more completely absorbed than ampicillin when given orally. The
presence of food in the stomach does not appear to reduce the total
amount absorbed. About 20% is bound to plasma proteins and plasma
half-lives of 1 to 1.5 hours have been reported. Amoxicillin is widely
distributed at varying concentrations in body tissues and fluids. It
crosses the placenta; small amounts are distributed into breast milk.
About 60% of an oral dose of amoxicillin is excreted unchanged in the
urine in 6 hours by glomerular filtration and tubular secretion. High
concentrations have been reported in bile; some may be excreted in the
faeces.
INDICATIONS
MOXIPEN is indicated in the treatment of:
Ear and Throat Infections: Caused by streptococci, pneumococci, non-
penicillinase-producing staphylococci and _Haemophilus influenza_;
Genitourinary Tract Infections: Caused by _ Escherichia coli,_ _
Proteus _
_mirabilis