CHEMMART AMOXYCILLIN amoxicillin (as trihydrate) 250 mg capsules blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
08-07-2016
Summary of Product characteristics
(SPC)
18-11-2015
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
amoxicillin trihydrate
Available from:
Apotex Pty Ltd
INN (International Name):
amoxicillin trihydrate
Patient Information leaflet
CHEMMART AMOXYCILLIN
CAPSULES
_Contains the active ingredient amoxycillin_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE ASK YOUR
DOCTOR OR PHARMACIST IF YOU DO NOT
UNDERSTAND ANYTHING OR ARE
WORRIED ABOUT TAKING YOUR
MEDICINE.
This leaflet answers some common
questions about amoxycillin.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. Some more recent
information on the medicine may be
available. Speak to your pharmacist
or doctor to obtain the most up to
date information on the medicine.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Amoxycillin. It contains
the active ingredient, amoxycillin (as
trihydrate).
It is an antibiotic which used to treat
infections in different parts of the
body caused by bacteria.
Amoxycillin can also be used to
prevent infection.
Amoxycillin will not work against
infections caused by viruses such as
colds or the flu.
_HOW IT WORKS_
Amoxycillin is an antibiotic that
belongs to a group of medicines
called penicillins. These antibiotics
work by killing the bacteria that are
causing your infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
amoxycillin for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery, but make sure
you know how it affects you before
driving.
_USE IN CHILDREN_
Amoxycillin Suspension is a more
suitable f
Read the complete document
Summary of Product characteristics
Product Information – Australia
Chemmart Amoxycillin Capsules
Page 1
CHEMMART AMOXYCILLIN CAPSULES
NAME OF THE MEDICINE
Amoxycillin (as amoxycillin trihydrate)
Chemical Name:
(2_S_,5_R_,6_R_)-6[(_R_)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-
thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate
Structural Formula:
Molecular Formula:
C
16
H
19
N
3
O
5
S.3H
2
O
Molecular Weight:
419.4
CAS Registry Number:
61336-70-7
DESCRIPTION
Amoxycillin trihydrate is a white or almost white, crystalline powder,
slightly soluble in water and in
alcohol.
Amoxycillin trihydrate is a semisynthetic antibiotic and is a member
of the penicillinase-stable group of
penicillins derived from the penicillin nucleus, 6-aminopenicillanic
acid, isolated at Beecham Research
Laboratories.
Each Amoxycillin capsule contains 250 mg or 500 mg amoxycillin (as
trihydrate).
In
addition,
each
capsule
contains
the
following
inactive
ingredients:
magnesium
stearate,
microcrystalline cellulose, gelatin, sodium lauryl sulphate, colloidal
anhydrous silica, croscarmellose
sodium, iron oxide yellow, titanium dioxide,iron oxide red (500 mg
capsules) and iron oxide black
(500 mg capsules). The capsules are printed with TekPrint SW-9008
Black Ink (proprietary ingredient
# 2328).
PHARMACOLOGY
PHARMACOKINETICS
Amoxycillin is stable in the presence of gastric acid and is rapidly
and well absorbed after oral
administration, even in the presence of food. Amoxycillin diffuses
rapidly into most body tissues and
fluids, with the exception of brain and spinal fluid except when the
meninges are inflamed. Amoxycillin
has been shown to diffuse into sputum and saliva and is excreted
mainly via the urine where it exists in a
high concentration.
The amount to be found in the bile is variable depending on normal
biliary secretory function.
The half-life of amoxycillin is 61.3 minutes with normal renal
function, and in the absence of renal function
is 16 to 20 hours.
Amoxycillin is excreted in the urine both unchanged and as penicilloic
acid. About 75%
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