AMOXYCLAV B&B 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:

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

Available from:

Micro Labs Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

Alu/Alu strip packs of 10 tablets packed in monocarton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

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:

2017-08-07

Summary of Product characteristics

AMOXYCLAV B&B TABLETS
1
AUSTRALIAN
PRODUCT
INFORMATION-
AMOXYCLAV
B&B
875/125
AND
AMOXYCLAV
B&B
500/125
(AMOXICILLIN
AND
CLAVULANIC
ACID)
FILM-COATED
TABLETS
1.
NAME OF THE MEDICINE
Amoxicillin (as trihydrate) and clavulanic acid (as potassium).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMOXYCLAV B&B tablets are combination products containing the
semisynthetic antibiotic,
amoxicillin (as the trihydrate) and the β-lactamase inhibitor,
potassium clavulanate (as the
potassium salt of clavulanic acid).
AMOXYCLAV B&B 875/125 & AMOXYCLAV B&B 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 glycol, purified talc, ethylcellulose.
3.
PHARMACEUTICAL FORM
AMOXYCLAV B&B 500 /125 tablets contain amoxicillin (as trihydrate) 500
mg and clavulanic
acid (as potassium clavulanate) 125 mg. White colored capsule shaped
film coated tablet
debossed with ‘Ɩ 06’ on one side and plain on other side.
AMOXYCLAV B&B 875 /125 tablets contain amoxicillin (as trihydrate) 875
mg and clavulanic
acid (as potassium clavulanate) 125 mg. White colored capsule shaped
film coated tablet
debossed with ‘Ɩ 07’ on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AMOXYCLAV B&B 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 (uncomplicated and complicated)
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.
AMOXYC