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

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

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

Saatavilla:

Micro Labs Pty Ltd

INN (Kansainvälinen yleisnimi):

amoxicillin trihydrate,potassium clavulanate

Lääkemuoto:

Tablet, film coated

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

Alu/Alu strip packs of 10 tablets packed in monocarton

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

AMOXYCLAV B&B 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 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 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

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2016-04-07

Valmisteyhteenveto

AMOXYCLAV B&B 875/125 AND AMOXYCLAV B&B 500/125 TABLETS
AMOXICILLIN AND CLAVULANIC ACID TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
AMOXYCLAV
B&B
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
antibiotic,
amoxicillin
(as trihydrate) and the β-lactamase
inhibitor,
potassium
Clavulanate
(as the 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.
AMOXYCLAV B&B 875/125
&
AMOXYCLAV
B&B 500/125 tablets also contain the
inactive ingredients: Mic