COMOX 875/125, amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets strip pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 1004.31 mg; potassium clavulanate, Quantity: 151.917 mg

Available from:

Micro Labs Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; dichloromethane; microcrystalline cellulose; sodium starch glycollate; isopropyl alcohol; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

Alu/Alu strip packs of 10 tablets packed in monocarton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

COMOX 875/125 tablets are indicated for short-term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to Microbiology):,Urinary Tract Infections (complicated and uncomplicated),Lower Respiratory Tract Infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis,Upper Respiratory Tract Infections, such as sinusitis, otitis media and recurrent tonsillitis.,Skin and Skin Structure Infection.,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin and clavulanic acid tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

Product summary:

Visual Identification: White colored capsule shaped film coated tablet debossed with 'I 07' on one side and plain on other side.; Container Type: Strip Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-04-07

Summary of Product characteristics

COMOX 875/125 AND COMOX 500/125 TABLETS
AMOXICILLIN AND CLAVULANIC ACID TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
COMOX
tablets
a r e
c o m b i n a t i o n
p r o d u c t s
c o n t a i n i n g
t h e
s e m i s y n t h e t i c
a n t i b i o t i c ,
a m o x i c i l l i n
( a s
trihydrate) and the β-lactamase
i n h i b i t o r ,
p o t a s s i u m
Clavulanate (as
t h e
potassium salt of clavulanic acid).
C h e m i c a l l y ,
amoxicillin
trihydrate
is
(2S,5R,6R)-6-[[(2R)-2-Amino-2-(4–
hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-
car b o x yl i c
a c i d
trihydrate. It is susceptible to hydrolysis by β -lactamases.
Amoxicillin
trihydrate may be represented structurally as:
CAS – 61336-70-7.
C l a v u l a n i c
a c i d
i s
p r o d u c e d
b y
t h e
f e r m e n t a t i o n
o f
_Streptomyces clavuligerus_
.
It
i s
a n
irreversible inhibitor of many β-lactamase enzymes except type 1
(Richmond). It is a β -
lactam compound with only weak antibacterial activity.
Chemically
potassium
clavulanate
is
potassium
(2R,3Z,5R)-3-(2-hydroxyethylidene)-7-oxo-
4-oxa-1-azabicyclo[3.2.0]-heptane-2- carboxylate , and may be
represented structurally as:
CAS – 61177-45-5.
MOLECULAR FORMULA:
Amoxicillin trihydrate: C
16
H
19
N
3
O
5
S.3H
2
0
Potassium clavulanate: C
8
H
8
KNO
5
MOLECULAR WEIGHT:
Amoxicillin trihydrate: 419.4
Potassium clavulanate: 237.3
DESCRIPTION
Amoxicillin trihydrate is white to almost white, crystalline powder,
slightly soluble in water,
very slightly soluble in ethanol (96%), practically insoluble in fatty
oils. It dissolves in dilute
acids and dilute solutions of alkali hydroxides. It having pKa 9.48 &
log P is 0.76.
P o t a s s i u m
c l a v u l a n a t e
i s
w h i t e
t o
a l m o s t
w h i t e ,
c r ys t a l l i n e
p o w d e r ,
h y g r o s c o p i c ,
f r e e l y
soluble
in
water,
slightly
soluble
in
alcohol,
and
very
slightly
soluble
in
acetone.
It
having
pKa 2.7 & log P is -1.16.
COMOX
8 7 5 / 1 2 5
&
COMOX
500/125
tablets
also
contain
t h e
i n a c t i v e