Augmentin powder for oral suspension with mixed fruit flavour

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:

200mg/5ml+ 28,5mg/5ml

Pharmaceutical form:

powder for oral suspension with mixed fruit flavour

Units in package:

70ml glass bottle with measuring device

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-06-13

Patient Information leaflet

6200000
0051490
Children aged 2 months to under 2 years
AUGMENTIN suspension 457 mg/5 mL
Body Weight
(kg)
Lower dose at 25/3.6 mg/kg/day
(mL every 12 hours)
Higher dose at 45/6.4 mg/kg/day
(mL every 12 hours)
2
3
4
5
6
7
8
9
10
11
12
13
14
15
0.3
0.5
0.6
0.8
0.9
1.1
1.3
1.4
1.6
1.7
1.9
2.0
2.2
2.3
0.6
0.8
1.1
1.4
1.7
2.0
2.3
2.5
2.8
3.1
3.4
3.7
3.9
4.2
Renal Impairment
No adjustment in dose is required in patients with creatinine
clearance greater than 30 mL/min.
_AUGMENTIN_ suspension 228 mg/5 mL and 457 mg/5 mL are not recommended
in patients with a creatinine clearance of less
than 30 mL/min.
Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals.
There is, as yet, insufficient evidence on which to base a dosage
recommendation.
Contraindications
_AUGMENTIN_ is contraindicated in patients with a history of
hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.
_AUGMENTIN_ is contraindicated in patients with a previous history of
_AUGMENTIN_-associated jaundice/hepatic dysfunction.
Warnings and Precautions
Before initiating therapy with _AUGMENTIN_, careful enquiry should be
made concerning previous hypersensitivity reactions to
penicillins, cephalosporins or other allergens.
Serious and occasionally fatal hypersensitivity reactions (including
anaphylactoid and severe cutaneous adverse reactions) have
been reported in patients on penicillin therapy. These reactions are
more likely to occur in individuals with a history of penicillin
hypersensitivity (see _Contraindications_). If an allergic reaction
occurs, _AUGMENTIN _therapy must be discontinued and appropriate
alternative therapy instituted. Serious anaphylactic reactions require
immediate emergency treatment with adrenaline. Oxygen,
intravenous (i.v.) steroids and airway management (including
intubation) may also be required.
_AUGMENTIN_ should be avoided if infectious mononucleosis is suspected
since the occurrence of a morbilliform rash has been
associated with this condition following the use of amoxicillin.
Pr

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
AUGMENTIN
SUSPENSION 228 MG/5 ML AND 457 MG/5 ML – MIXED FRUIT
FLAVOUR, AMOXICILLIN TRIHYDRATE – POTASSIUM CLAVULANATE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_AUGMENTIN _ suspension 228 mg/5 mL: When reconstituted each 5 mL
contains 200 mg
amoxicillin (as amoxicillin trihydrate) and 28.5 mg clavulanic acid
(as potassium clavulanate).
_AUGMENTIN _ suspension 457 mg/5 mL: When reconstituted each 5 mL
contains 400 mg
amoxicillin (as amoxicillin trihydrate) and 57 mg clavulanic acid (as
potassium clavulanate).
3. PHARMACEUTICAL FORM
A white to off-white dry powder for reconstitution in water to form an
off-white mixed-fruit
flavoured suspension.
4. CLINICAL PARTICULARS
4.1 INDICATIONS
_AUGMENTIN_ should be used in accordance with local official
antibiotic-prescribing guidelines
and local susceptibility data.
_AUGMENTIN_ suspension (228 mg/5 ml and 457mg/5 ml), for twice daily
oral dosing, is
indicated for short term treatment of bacterial infections at the
following sites when amoxicillin
resistant beta-lactamase producing strains are suspected as the cause.
In other situations,
amoxicillin alone should be considered.
_Upper respiratory tract infections (including ENT)_ e.g. recurrent
tonsillitis, sinusitis, otitis
media.
_Lower respiratory tract infections_ e.g. acute exacerbations of
chronic bronchitis, lobar and
bronchopneumonia.
_Urinary tract infections_ e.g. cystitis, urethritis, pyelonephritis
_Skin and soft tissue infections_ e.g. cellulitis, animal bites.
_Dental infections_ e.g. severe dental abscess with spreading
cellulitis.
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 microbiological sampling and
susceptibility testing performed
where necessary.
Mixed infections caused by amoxicillin-susceptible organisms in
conjunction with _AUGMENTIN_
susceptible beta-lactamase