APO-AMOXYCILLIN/CLAVULANIC ACID 500/125 amoxicillin (as trihydrate) 500mg and clavulanic acid (as potassium clavulanate) 125mg t

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

amoxicillin trihydrate,potassium clavulanate

Sẵn có từ:

Southern Cross Pharma Pty Ltd

INN (Tên quốc tế):

amoxicillin trihydrate,potassium clavulanate

Tình trạng ủy quyền:

Registered

Tờ rơi thông tin

C:Products/Amoxiclav/Apo/CMI Apo 9jul08 9/7/09
Page 1 of 8
APO-AMOXYCILLIN AND CLAVULANIC ACID 500 MG/125 MG
[AMOXICILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE]
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about this medicine.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you being given this
medication against the benefits it is expected to have for you.
If you have any concerns about being given this medicine, ask your
doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT APO-AMOXYCILLIN AND CLAVULANIC ACID 500 MG/125 MG IS USED FOR
APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets contain two
active ingredients.
One of these is from the penicillin group of antibiotics and is called
amoxicillin (from amoxicillin
trihydrate) and the other is clavulanic acid (from potassium
clavulanate). APO-Amoxycillin and
Clavulanic acid 500 mg/125 mg tablets are used to treat a wide range
of infections caused by
bacteria. These infections may affect the chest (bronchitis or
pneumonia), bladder (cystitis),
sinuses (sinusitis), the ears (otitis media) or the skin.
APO-Amoxycillin and Clavulanic acid 500
mg/125 mg tablets work by killing the bacteria that cause these
infections. APO-Amoxycillin
and Clavulanic acid 500 mg/125 mg tablets will not work against
infections caused by viruses
such as colds or the flu. Your doctor may prescribe APO-Amoxycillin
and Clavulanic acid 500
mg/125 mg tablets for another use. If you want more information ask
your doctor. There is no
evidence that APO-Amoxycillin and Clavulanic acid 500 mg/125 mg
tablets are addictive.
BEFORE TAKING APO-AMOXYCILLIN AND CLAVULANIC ACID 500 MG/125 MG FOR
THE
FIRST TIME
_Do not take APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets
if: _
_ _
C:Products/Amoxiclav/Apo/CMI Apo 9jul08 9/7/09
Page 2 of 8

you have had an allergic rea

Đặc tính sản phẩm

Product Information – Australia
APO-Amoxycillin and Clavulanic Acid 500 mg / 125 mg tablets
Page 1
APO-AMOXYCILLIN / CLAVULANIC ACID 500/125 TABLETS
NAME OF THE MEDICINE
Amoxycillin trihydrate and potassium clavulanate.
CHEMICAL NAMES:
Amoxycillin trihydrate:
(2S,5R,6R)-6-[(R)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-
dimethyl-7oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid
trihydrate.
Potassium Clavulanate:
potassium
(Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-
azabicyclo[3.2.0]heptane-2-carboxylate.
STRUCTURAL FORMULAE:
Amoxycillin trihydrate:
Potassium clavulanate:
MOLECULAR FORMULAE:
Amoxycillin trihydrate:
C
16
H
19
N
3
O
5
S.3H
2
0
Potassium clavulanate:
C
8
H
8
KNO
5
MOLECULAR WEIGHTS:
Amoxycillin trihydrate:
419.5
Potassium clavulanate:
237.3
CAS REGISTRY NUMBERS:
Amoxycillin trihydrate:
61336-70-7
Potassium clavulanate:
61177-45-5
Product Information – Australia
APO-Amoxycillin and Clavulanic Acid 500 mg / 125 mg tablets
Page 2
DESCRIPTION
Amoxycillin and Clavulanic Acid 500 mg / 125 mg is a combination
product containing the semi-synthetic
antibiotic, amoxycillin (as the trihydrate) and the β-lactamase
inhibitor, potassium clavulanate (the
potassium salt of clavulanic acid).
Amoxycillin is susceptible to hydrolysis by β-lactamases. Clavulanic
acid is produced by the fermentation
of _Streptomyces clavuligerus_. It is an irreversible inhibitor of
many β-lactamase enzymes except type 1
(Richmond). It is a β-lactam compound with only weak antibacterial
activity.
PHARMACOLOGY
ACTIONS: Semisynthetic penicillin antibiotic (amoxycillin) and
beta-lactamase inhibitor (clavulanic acid).
PHARMACOKINETICS
Pharmacokinetic parameters obtained for 875 mg/125 mg and 500 mg/125
mg amoxycillin/clavulanic
acid tablets show a linear relationship for both strengths.
Absorption: Amoxycillin and Clavulanic Acid tablets are stable in the
presence of gastric acid. The two
components are rapidly absorbed if administered before or with a meal,
but if given after meals, the
serum levels of clavulanic acid ar