AUGMENTIN 1000/62.5 MG PROLONGED RELEASE FILM-COAT
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
AMOXICILLIN TRIHYDRATE AMOXICILLIN SODIUM CLAVULANATE POTASSIUM
Available from:
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
Dosage:
562.5/437. Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2005-02-25
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin 1000/62.5mg film coated prolonged release tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablet containing 1000mg amoxicillin, 562.5mg as amoxicillin trihydrate, and 437.5mg as amoxicillin sodium and
62.5mg clavulanic acid as potassium clavulanate (16:1).
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
A white capsule shaped film coated tablet debossed with 1000/62.5 on one side and a bisect break line on the other.
4 CLINICAL PARTICULARS
GENERAL DESCRIPTION
Amoxicillin-clavulanate SR (the beta-lactam antibacterial amoxicillin coformulated with the beta-lactamase inhibitor
clavulanate) is an antibiotic agent with a notably broad spectrum of activity against the commonly-occurring bacterial
pathogens in general and hospital practice. The beta-lactamase inhibitory action of clavulanate extends the spectrum of
amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics.
Amoxicillin-clavulanate SR is a sustained release tablet that provides an extended amoxicillin pharmacokinetic profile.
The Amoxicillin-clavulanate SR formulation extends the spectrum of Amoxicillin-clavulanate to include the majority
of _S. pneumoniae _where resistance is mediated by penicillin-binding proteins (penicillin-resistant _S. pneumoniae_, or
PRSP).
4.1 THERAPEUTIC INDICATIONS
Amoxicillin-clavulanate SR is indicated for short-term treatment of bacterial infections at the following sites when
caused by amoxicillin-clavulanate SR-susceptible organisms:
Respiratory Tract Infections, e.g. community-acquired pneumonia, acute exacerbations of chronic bronchitis and acute
bacterial sinusitis, typically caused _by Streptococcus pneumoniae _(including penicillin-resistant _S. pneumoniae _-
PRSP_),
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