AMOKLAVIN DUO 400/57 amoxicillin 400mg (as trihydrate) and clavulanic acid 57mg (as potassium clavulanate) powder for oral suspension bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 91.823 mg/mL; potassium clavulanate, Quantity: 13.58 mg/mL

Available from:

Devatis Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Suspension, powder for

Composition:

Excipient Ingredients: xanthan gum; hypromellose; silicon dioxide; saccharin sodium; methyl hydroxybenzoate; succinic acid; colloidal anhydrous silica; Flavour

Administration route:

Oral

Units in package:

60 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) oral suspension is indicated in the short term treatment of the following bacterial infections when caused by sensitive organisms (see Microbiology):,Skin and Skin Structure Infections,Urinary Tract Infections (complicated and uncomplicated),Upper Respiratory Tract Infections including sinusitis and otitis media,Lower Respiratory Tract Infections including acute exacerbations of chronic bronchitis and community acquired pneumonia,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to AMOKLAVIN DUO 400/57. 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 AMOKLAVIN DUO 400/57, should not require the addition of another antibiotic due to the amoxicillin content of AMOKLAVIN DUO 400/57.

Product summary:

Visual Identification: White to cream coloured powder; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2014-12-15

Summary of Product characteristics

AMOKLAVIN DUO 400/57 SUSPENSION
PRODUCT INFORMATION
(AMOXICILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE)
NAME OF THE MEDICINE
AMOKLAVIN DUO 400/57 (amoxicillin and clavulanic acid) is a
combination product containing
the semisynthetic antibiotic, amoxicillin (as the trihydrate) and the
β-lactamase inhibitor, potassium
clavulanate (as the potassium salt of clavulanic acid). Chemically,
amoxicillin is D-(-)-α-amino-p-
hydroxybenzylpenicillin. It is susceptible to hydrolysis by
β-lactamases. Amoxicillin trihydrate may
be represented structurally as:
(Chemical formula: C
16
H
19
N
3
O
5
S, 3H
2
O; Molecular weight: 419.4; 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
_Z_
-(2
_R_
,5
_R_
)-3-(ß-
hydroxyethylidene) clavam-2-carboxylate, and may be represented
structurally as:
(Chemical formula: C
8
H
8
KNO
5
; Molecular weight: 237.3; CAS – 61177-45-5)
DESCRIPTION
Amoxicillin trihydrate is a white or almost white, crystalline powder
and is slightly soluble in water.
A 0.2% solution in water has a pH of 3.5 to 5.5.
Potassium clavulanate is supplied in diluted potassium clavulanate, a
dry mixture of potassium
clavulanate and silicon dioxide. Potassium clavulanate is a white or
almost white, hygroscopic,
crystalline powder and is freely soluble in water and has a pKa of 2.7
(clavulanic acid). Its
experimental partition coefficient is -1.5. A 1% solution in water has
a pH of 4.8 to 8.0.
AMOKLAVIN
DUO
400/57
oral
suspension
also
contains
hypromellose,
silica-colloidal
anhydrous (Aerosil 200), saccharin sodium, silicon dioxide (Syloid
AL-1 FP), xanthan gum, methyl
1
hydroxybenzoate, succinic acid, Golden Syrup Flavour 501118 AP0551 and
Orange 51941
AP0551.
The powder in a bottle is diluted with 52 mL water to make up to 60 mL
suspension. Each 5 mL of
suspension contains 40