ALPHACLAV DUO VIATRIS 500/125 amoxicillin 500 mg and clavulanic acid 125 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin trihydrate, Quantity: 575 mg; potassium clavulanate, Quantity: 148.875 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: propylene glycol; purified talc; hypromellose; microcrystalline cellulose; croscarmellose sodium; isopropyl alcohol; dichloromethane; ethylcellulose; magnesium stearate; titanium dioxide; hyprolose; industrial methylated spirit

Administration route:

Oral

Units in package:

10, 2, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Alphaclav Duo Viatris 500/125 amoxicillin 500 mg and clavulanic acid 125 mg 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. 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 should not require the addition of another antibiotic due to the amoxicillin content of these products.

Product summary:

Visual Identification: A white oval shaped film coated tablets with marking 'CA625' on one side; Container Type: Blister Pack; Container Material: PVC/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:

2017-01-17

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ALPHACLAV
® DUO VIATRIS 500/125 AND
ALPHACLAV
® DUO FORTE VIATRIS 875/125
(_amoxicillin / clavulanic acid) film coated tablets_
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALPHACLAV DUO VIATRIS 500/125 and ALPHACLAV DUO FORTE VIATRIS 875/125
tablets
(amoxicillin and clavulanic acid 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).
ALPHACLAV DUO VIATRIS 500/125 Tablets: each film coated tablet
contains 500mg amoxicillin as the
trihydrate and 125mg clavulanic acid as the potassium salt.
ALPHACLAV DUO FORTE VIATRIS 875/125 Tablets: each film coated tablet
contains 875mg amoxicillin
as the trihydrate and 125mg clavulanic acid as the potassium salt.
Excipients with known effect: c
ontains 25 mg of elemental potassium per tablet
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ALPHACLAV DUO FORTE VIATRIS 875/125 Tablets: A white elongated capsule
shaped film coated
tablet.
ALPHACLAV DUO VIATRIS 500/125 Tablets: A white, oval shaped, film
coated tablet with marking
“CA625” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALPHACLAV DUO VIATRIS 500/125 and ALPHACLAV DUO FORTE VIATRIS 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 (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 am