Augmentin tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Available from:

SmithKline Beecham Limited

ATC code:

J01CR02

INN (International Name):

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Dosage:

875mg+ 125mg

Pharmaceutical form:

tablets film-coated

Units in package:

(14/2x7/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-05-30

Patient Information leaflet

QUALITATIVE AND QUANTITATIVE COMPOSITION
AUGMENTIN 625 mg tablets: Each tablet contains 500 mg
amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate).
AUGMENTIN 1 g tablets: Each tablet contains 875 mg amoxicillin
(as amoxicillin trihydrate) and 125 mg clavulanic acid (as
potassium clavulanate).
PHARMACEUTICAL FORM
AUGMENTIN 625 mg tablets: A white to off-white oval-shaped film-coated
tablet, debossed with
‘AC’ and a score line on one side and plain on the other side.
AUGMENTIN 1 g tablets: A white to off-white capsule-shaped film-coated
tablet, debossed with
‘AC’ on both sides and a score line on one side.
CLINICAL PARTICULARS
Indications
AUGMENTIN is an antibiotic agent with a notably broad spectrum of
activity against the commonly
occurring bacterial pathogens in general practice and hospital. 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.
AUGMENTIN should be used in accordance with local official
antibiotic-prescribing guidelines and
local susceptibility data.
AUGMENTIN oral presentations for twice daily dosing, are indicated for
short-term treatment of
bacterial infections at the following sites:
Upper respiratory tract infections (including ENT) e.g. tonsillitis,
sinusitis, otitis media.
Lower respiratory tract infections e.g. acute exacerbation of chronic
bronchitis, lobar and
bronchopneumonia.
Genito-urinary tract infections e.g. cystitis, urethritis,
pyelonephritis.
Skin and soft tissue infections, e.g. boils, abscesses, cellulitis,
wound infections.
Bone and joint infections e.g. osteomyelitis.
Dental infections e.g. dentoalveolar abscess
Other infections e.g. septic abortion, puerperal sepsis,
intra-abdominal sepsis.
Susceptibility to AUGMENTIN will vary with geography and time (see
Pharmacological Properties,
Pharmacodynamics for further information). Local susceptibility data
should be consulted where
available, and m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
AUGMENTIN BD TABLETS, Amoxicillin trihydrate - Potassium clavulanate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_AUGMENTIN_ 625 mg tablets: Each tablet contains 500 mg amoxicillin
(as amoxicillin
trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
_AUGMENTIN_ 1 g tablets: Each tablet contains 875 mg amoxicillin (as
amoxicillin
trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
3. PHARMACEUTICAL FORM
_AUGMENTIN_ 625 mg tablets: A white to off-white oval-shaped
film-coated tablet,
debossed with ‘AC’ and a score line on one side and plain on the
other side.
_AUGMENTIN_ 1 g tablets: A white to off-white capsule-shaped
film-coated tablet,
debossed with ‘AC’ on both sides and a score line on one side.
4. CLINICAL PARTICULARS
4.1 INDICATIONS
_AUGMENTIN_ is an antibiotic agent with a notably broad spectrum of
activity against the
commonly occurring bacterial pathogens in general practice and
hospital. 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.
_AUGMENTIN_ should be used in accordance with local official
antibiotic-prescribing
guidelines and local susceptibility data.
_AUGMENTIN_ oral presentations for twice daily dosing, are indicated
for short-term
treatment of bacterial infections at the following sites:
_Upper respiratory tract infections (including ENT) _e.g. tonsillitis,
sinusitis, otitis media.
_Lower respiratory tract infections _e.g. acute exacerbation of
chronic bronchitis, lobar and
bronchopneumonia.
_Genito-urinary tract infections _e.g. cystitis, urethritis,
pyelonephritis.
_Skin and soft tissue infections,_ e.g. boils, abscesses, cellulitis,
wound infections.
_Bone and joint infections_ e.g. osteomyelitis.
_Dental infections_ e.g. dentoalveolar abscess
_Other infections _e.g. septic abortion, puerperal sepsis,
intra-abdominal sepsis.
Susceptibility to _AUGMENTI