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:

250mg+ 125mg

Pharmaceutical form:

tablets film-coated

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-05-30

Patient Information leaflet

QUALITATIVE AND QUANTITATIVE COMPOSITION
_AUGMENTIN_ 375 mg tablets: Each tablet contains 250 mg amoxicillin
(as amoxicillin
trihydrate) and 125 mg clavulanic acid_ _(as potassium clavulanate).
_AUGMENTIN_ 625 mg tablets: Each tablet contains 500 mg amoxicillin
(as amoxicillin
trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
_AUGMENTIN_ suspension 156 mg/5 mL: When reconstituted each 5 mL
contains
125 mg amoxicillin (as amoxicillin trihydrate) and 31.25 mg clavulanic
acid_ _(as
potassium clavulanate).
_AUGMENTIN_ suspension 312 mg/5 mL: When reconstituted each 5 mL
contains
250 mg amoxicillin (as amoxicillin trihydrate) and 62.5 mg clavulanic
acid (as
potassium clavulanate).
PHARMACEUTICAL FORM
_AUGMENTIN_ 375 mg tablets: A white to off-white oval-shaped
film-coated tablet, debossed with ‘Augmentin’ on one side.
_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_ suspension 156 mg/5 mL: An off-white dry powder for
reconstitution in water to form a fruit flavoured suspension.
_AUGMENTIN_ suspension 312 mg/5 mL: An off-white dry powder for
reconstitution in water to form a fruit flavoured suspension.
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 three times 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 _

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
AUGMENTIN TID TABLETS AND SUSPENSION,
AMOXICILLIN TRIHYDRATE -
POTASSIUM CLAVULANATE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_AUGMENTIN_
375
mg
tablets:
Each
tablet
contains
250
mg
amoxicillin
(as
amoxicillin
trihydrate) and 125 mg clavulanic acid_ _(as potassium clavulanate).
_AUGMENTIN_
625
mg
tablets:
Each
tablet
contains
500
mg
amoxicillin
(as
amoxicillin
trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
_AUGMENTIN_ suspension 156 mg/5 mL: When reconstituted each 5 mL
contains 125 mg
amoxicillin (as amoxicillin trihydrate) and 31.25 mg clavulanic acid_
_(as potassium clavulanate).
_AUGMENTIN_ suspension 312 mg/5 mL: When reconstituted each 5 mL
contains 250 mg
amoxicillin (as amoxicillin trihydrate) and 62.5 mg clavulanic acid
(as potassium clavulanate).
3. PHARMACEUTICAL FORM
_AUGMENTIN_ 375 mg tablets: A white to off-white oval-shaped
film-coated tablet, debossed
with ‘Augmentin’ on one side.
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_ suspension 156 mg/5 mL: An off-white dry powder for
reconstitution in water
to from a fruit flavoured suspension.
_AUGMENTIN_ suspension 312 mg/5 mL: An off-white dry powder for
reconstitution in water
to form a fruit flavoured suspension.
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 three times daily dosing, are
indicated for short-term
treatment of bacterial in