COCLAVMOX 500/125, amoxicillin (as trihydrate) 500 mg and clavulanic acid (as potassium) 125 mg tablets blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

amoxicillin trihydrate, Quantity: 573.892 mg; potassium clavulanate, Quantity: 151.917 mg

Saatavilla:

Arrotex Pharmaceuticals Pty Ltd

INN (Kansainvälinen yleisnimi):

amoxicillin trihydrate,potassium clavulanate

Lääkemuoto:

Tablet, film coated

Koostumus:

Excipient Ingredients: magnesium stearate; isopropyl alcohol; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; dichloromethane; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose

Antoreitti:

Oral

Kpl paketissa:

10 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

COCLAVMOX 500/125 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 infections.,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.

Tuoteyhteenveto:

Visual Identification: White colored capsule shaped film coated tablet debossed with 'I 06' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2017-08-07

Valmisteyhteenveto

COCLAVMOX 875/125 AND COCLAVMOX 500/125 TABLETS
AMOXICILLIN AND CLAVULANIC ACID TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
COCLAVMOX tablets are combination products containing the
semisynthetic antibiotic,
amoxicillin (as trihydrate), and the β-lactamase inhibitor, potassium
Clavulanate (as the
potassium salt of clavulanic acid).
Chemically,
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-
carboxylic acid trihydrate. It is susceptible to hydrolysis by β
-lactamases. Amoxicillin
trihydrate may be represented structurally as:
CAS – 61336-70-7.
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.
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 a 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.
Potassium clavulanate is white to almost white, crystalline powder,
hygroscopic, freely
soluble in water, slightly soluble in alcohol, and very slightly
soluble in acetone. It having
pKa 2.7 & log P is -1.16.
COCLAVMOX
875/125
&
COCLAVMOX
500/125
tablets
also
contain
the
inactive
ingredients: Microcrystalline cellulose, magnesium stearate, sodium
starch glycollate Type A
and colloidal anhydrous silica. The tablet coating contains
hypromellose, titanium dioxide,
propylene