AUGMENTIN 375 mg and AUGMENTIN 625 mg TABLETS

Amoxicillin trihydrate - Potassium clavulanate

QUALITATIVE AND QUANTITATIVE COMPOSITION
AUGMENTIN 375 mg tablets: A white to off-white oval-shaped film-coated tablet, debossed
with ‘Augmentin’ on one side
Each tablet contains 250 mg amoxicillin (as amoxicillin trihydrate Ph. Eur.) and 125 mg
clavulanic acid (as potassium clavulanate Ph. Eur.).
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.
Each tablet contains 500 mg amoxicillin (as amoxicillin trihydrate Ph. Eur.) and 125 mg
clavulanic acid (as potassium clavulanate Ph. Eur.).
CLINICAL INFORMATION
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 are indicated for short-term treatment of bacterial infections at
the following sites:
Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections e.g. acute exacerbation of chronic obstructive pulmonary
disease (AECOPD)/acute exacerbation of chronic bronchitis (AECB), 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. 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 microbiological sampling and susceptibility testing performed
where necessary.
Infections caused by amoxicillin susceptible organisms are amenable to AUGMENTIN treatment
due to its amoxicillin content. Mixed infections caused by amoxicillin susceptible organisms in
conjunction with AUGMENTIN susceptible beta-lactamase producing organisms may therefore
be treated with AUGMENTIN.
Dosage and Administration

Pharmaceutical form: Film-coated tablet and, Powder for oral suspension

Dosage depends on the age, weight and renal function of the patient and the severity of the
infection.

Dosages are expressed throughout in terms of amoxicillin/clavulanate content except when doses
are stated in terms of an individual component.

To minimise potential gastrointestinal intolerance, administer at the start of a meal.

The absorption of AUGMENTIN is optimised when taken at the start of a meal.

Treatment should not be extended beyond 14 days without review.

Therapy can be started parenterally and continued with an oral preparation.

AUGMENTIN suspensions may be supplied with a plastic dosing device. For preparation of the
suspensions see Use and Handling.

Adults and Children over 12 years

AUGMENTIN tablets are not recommended in children of 12 years and under. The usual
recommended daily dosage is:
Mild - Moderate infections One AUGMENTIN 375 mg tablet every 8 hours.

Severe infections Two AUGMENTIN 375 mg tablets every 8 hours.

OR
One AUGMENTIN 625 mg tablet every 8 hours.

Renal Impairment
Adults
Dosage adjustments are based on the maximum recommended level of amoxicillin.
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30
mL/min.
 CrCl 10-30 mL/min The usual recommended dose of AUGMENTIN 375 mg
OR AUGMENTIN 625 mg tablets given every 12 hours.
CrCl < 10 mL/min The usual recommended dose of AUGMENTIN 375 mg
OR AUGMENTIN 625 mg tablets given every 24 hours.
Haemodialysis The usual recommended dose of AUGMENTIN 375 mg
OR AUGMENTIN 625 mg tablets given every 24 hours,
plus a further dose during dialysis, to be repeated at the
end of dialysis (as serum concentrations of both
amoxicillin and clavulanic acid are decreased).
Children
Dosage adjustments are based on the maximum recommended level of amoxicillin.
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30
mL/min.
CrCl 10-30 mL/min 15/3.75 mg/kg every 12 hours (maximum 500/125 mg
every 12 hours).
CrCl < 10 mL/min 15/3.75 mg/kg every 24 hours (maximum 500/125 mg).
Haemodialysis 15/3.75 mg/kg every 24 hours. Prior to haemodialysis
15/3.75 mg/kg should be administered. In order to restore
circulating drug levels, 15/3.75 mg/kg should be
administered after haemodialysis.
Hepatic Impairment
Administer with caution; monitor hepatic function at regular intervals.
Each AUGMENTIN 375 mg tablet contains 0.63 mmol (25 mg) of potassium.
Contraindications
AUGMENTIN is contra-indicated in patients with a history of hypersensitivity to beta-lactams,
e.g. penicillins and cephalosporins.
AUGMENTIN is contra-indicated 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). Hypersensitivity reactions can also progress to Kounis syndrome, a serious
allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions
can include chest pain occurring in association with an allergic reaction to AUGMENTIN (see
Adverse Reactions). Drug-induced enterocolitis syndrome has been reported mainly in children
receiving AUGMENTIN (see Adverse Reactions). Drug-induced enterocolitis syndrome is an
allergic reaction with the leading symptom of protracted vomiting (1-4 hours after medicinal
product administration) in the absence of allergic skin or respiratory symptoms. Further
symptoms could comprise abdominal pain, lethargy, diarrhoea, hypotension or leucocytosis with
neutrophilia. In severe cases, drug-induced enterocolitis syndrome can progress to shock. If an
allergic reaction occurs, AUGMENTIN therapy should 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.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in
severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in
patients who develop diarrhoea during or after antibiotic use. If prolonged or significant
diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued
immediately and the patient investigated further.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients
receiving AUGMENTIN and oral anticoagulants. Appropriate monitoring should be undertaken
when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants
may be necessary to maintain the desired level of anticoagulation.
Changes in liver function tests have been observed in some patients receiving AUGMENTIN.
The clinical significance of these changes is uncertain but AUGMENTIN should be used with
caution in patients with evidence of hepatic dysfunction.
Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely.
Signs and symptoms may not become apparent for up to six weeks after treatment has ceased.
In patients with renal impairment AUGMENTIN dosage should be adjusted as recommended in
the Dosage and Administration section.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly
with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to
maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin
crystalluria (see Overdose).
Interactions
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular
secretion of amoxicillin. Concomitant use with AUGMENTIN may result in increased and
prolonged blood levels of amoxicillin but not of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of
allergic skin reactions. There are no data on the concomitant use of AUGMENTIN and
allopurinol.
In common with other antibiotics, AUGMENTIN may affect the gut flora, leading to lower
oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
In the literature there are rare cases of increased international normalised ratio in patients
maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co
administration is necessary, the prothrombin time or international normalised ratio should be
carefully monitored with the addition or withdrawal of AUGMENTIN.
In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active
metabolite mycophenolic acid of approximately 50% has been reported following
commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not
accurately represent changes in overall MPA exposure.
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.
Pregnancy and Lactation
Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with
orally and parenterally administered AUGMENTIN have shown no teratogenic effects. In a
single study in women with pre-term, premature rupture of the foetal membrane (pPROM), it
was reported that prophylactic treatment with AUGMENTIN may be associated with an
increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be
avoided in pregnancy, especially during the first trimester, unless considered essential by the
physician.
AUGMENTIN may be administered during the period of lactation. With the exception of the risk
of sensitisation, associated with the excretion of trace quantities in breast milk, there are no
known detrimental effects for the breast-fed infant.
Effects on Ability to Drive and Use Machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Adverse Reactions
Data from large clinical trials was used to determine the frequency of very common to rare
undesirable effects. The frequencies assigned to all other undesirable effects (i.e. those occurring
at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate
rather than a true frequency.
The following convention has been used for the classification of frequency:
very common ≥1/10
common ≥1/100 to <1/10
uncommon ≥1/1000 to <1/100
rare ≥1/10,000 to <1/1000
very rare <1/10,000.
Infections and infestations
Common Mucocutaneous candidiasis
Blood and lymphatic system disorders
Rare Reversible leucopenia (including neutropenia) and thrombocytopenia.
Very rare Reversible agranulocytosis and haemolytic anaemia. Prolongation of
bleeding time and prothrombin time
Immune system disorders
Very Rare Angioneurotic oedema, anaphylaxis (see Warnings and Precautions),
serum sickness-like syndrome, hypersensitivity vasculitis (see also Skin
and subcutaneous tissue disorders).
Nervous system disorders
Uncommon Dizziness, headache
Very rare Reversible hyperactivity, aseptic meningitis, convulsions. Convulsions
may occur in patients with impaired renal function or in those receiving
high doses.
Cardiac disorders

Very rare Kounis syndrome (see Warnings and Precautions).

Gastrointestinal disorders
Adults
Very common Diarrhoea
Common Nausea, vomiting
Children
Common Diarrhoea, nausea, vomiting
All populations
Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are
evident, they may be reduced by taking AUGMENTIN at the start of a meal.
Uncommon Indigestion
Very rare Antibiotic-associated colitis (including pseudomembranous colitis and
haemorrhagic colitis), drug-induced enterocolitis syndrome.(see Warnings
and Precautions).
Black hairy tongue
Superficial tooth discolouration has been reported very rarely in children.
Good oral hygiene may help to prevent tooth discolouration as it can
usually be removed by brushing.

Hepatobiliary disorders
Uncommon A moderate rise in AST and/or ALT has been noted in patients treated
with beta-lactam class antibiotics, but the significance of these findings is
unknown.
Very rare Hepatitis and cholestatic jaundice. These events have been noted with
other penicillins and cephalosporins.
Hepatic events have been reported predominantly in males and elderly patients and may be
associated with prolonged treatment. These events have been very rarely reported in children.
Signs and symptoms usually occur during or shortly after treatment but in some cases may not
become apparent until several weeks after treatment has ceased. These are usually reversible.
Hepatic events may be severe and in extremely rare circumstances, deaths have been reported.
These have almost always occurred in patients with serious underlying disease or taking
concomitant medications known to have the potential for hepatic effects.
Skin and subcutaneous tissue disorders
Uncommon Skin rash, pruritus, urticaria
Rare Erythema multiforme
Very rare Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous
exfoliative-dermatitis, acute generalised exanthemous pustulosis (AGEP),
drug reaction with eosinophilia and systemic symptoms (DRESS), and
symmetrical drug-related intertriginous and flexural exanthema (SDRIFE)
(baboon syndrome) (see also Immune system disorders).
If any hypersensitivity dermatitis reaction occurs, treatment should be
discontinued.
Linear IgA disease.

Renal and urinary disorders

Very rare Interstitial nephritis, crystalluria (see Overdose)
Overdose
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident.
Gastrointestinal symptoms may be treated symptomatically with attention to the water electrolyte
balance.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Warnings
and Precautions).
AUGMENTIN can be removed from the circulation by haemodialysis.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
ATC code: J01CR02.
Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors.
Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before
it can act on the pathogen. The clavulanate in AUGMENTIN anticipates this defence mechanism
by blocking the beta-lactamase enzymes, thus rendering the organisms susceptible to
amoxicillin’s rapid bactericidal effect at concentrations readily attainable in the body.
Clavulanate by itself has little antibacterial activity; however, in association with amoxicillin as
AUGMENTIN it produces an antibiotic agent of broad-spectrum with wide application in
hospital and general practice.
In the list below, organisms are categorised according to their in vitro susceptibility to
AUGMENTIN.
In vitro susceptibility of micro-organisms to AUGMENTIN

Where clinical efficacy of AUGMENTIN has been demonstrated in clinical trials this is
indicated with an asterisk (*).

Organisms that do not produce beta-lactamase are identified (with †). If an isolate is
susceptible to amoxicillin, it can be considered susceptible to AUGMENTIN.
Commonly susceptible species
Gram-positive aerobes:
Bacillius anthracis
Enterococcus faecalis
Listeria monocytogenes
Nocardia asteroides
Streptococcus pyogenes*†
Streptococcus agalactiae*†
Streptococcus spp. (other beta-hemolytic)*†
Staphylococcus aureus (methicillin susceptible)*
Staphylococcus saprophyticus (methicillin susceptible)
Coagulase negative staphylococcus (methicillin susceptible)
Gram-negative aerobes:
Bordetella pertussis
Haemophilus influenzae*
Haemophilus parainfluenzae
Helicobacter pylori
Moraxella catarrhalis*
Neisseria gonorrhoeae
Pasteurella multocida
Vibrio cholerae
Other:
Borrelia burgdorferi
Leptospira ictterohaemorrhagiae
Treponema pallidum
Gram positive anaerobes:
Clostridium spp.
Peptococcus niger
Peptostreptococcus magnus
Peptostreptococcus micros
Peptostreptococcus spp.
Gram-negative anaerobes:
Bacteroides fragilis
Bacteroides spp.
Capnocytophaga spp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacterium spp.
Porphyromonas spp.
Prevotella spp.
Species for which acquired resistance may be a problem
Gram-negative aerobes:
Escherichia coli*
Klebsiella oxytoca
Klebsiella pneumoniae*
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris
Proteus spp.
Salmonella spp.
Shigella spp.
Gram-positive aerobes:
Corynebacterium spp.
Enterococcus faecium
Streptococcus pneumoniae*†
 Viridans group streptococcus
Inherently resistant organisms
Gram-negative aerobes:
Acinetobacter spp.
Citrobacter freundii
Enterobacter spp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas spp.
Serratia spp.
Stenotrophomas maltophilia
Yersinia enterolitica
Others:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetti
Mycoplasma spp.
Pharmacokinetics
The pharmacokinetics of the two components of AUGMENTIN are closely matched. Peak serum
levels of both occur about 1 hour after oral administration. Absorption of AUGMENTIN is
optimised at the start of a meal.
Doubling the dosage of AUGMENTIN approximately doubles the serum levels achieved.
Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in
the serum.
Non-Clinical Information
No further information of relevance.
PHARMACEUTICAL INFORMATION
List of Excipients
AUGMENTIN tablets contain magnesium stearate, sodium starch glycollate, colloidal silica,
microcrystalline cellulose, titanium dioxide (E171), hydroxypropyl methylcellulose,
polyethylene glycol and dimeticone (silicone oil).
Shelf Life
The expiry date is indicated on the packaging.
Storage
The storage conditions are detailed on the packaging.
Do not take after the expiry date shown on the pack.
Store in a dry place in the original packaging to protect from moisture.
AUGMENTIN tablet packs contain desiccant sachets. Do not remove or eat.
Nature and Contents of Container
Tablets are supplied in a carton containing blister packs.
Each blister pack is stored within a sealed pouch, with a desiccant sachet.
Incompatibilities

None known.

Use and Handling

Blister pouches contains a desiccant sachet; do not remove or eat. Discard any opened and
unused tablets after storing as directed in the Special Precautions for Storage section.
MANUFACTURER
SmithKline Beecham Pharmaceuticals
Clarendon Road, Worthing
West Sussex BN14 8QH
United Kingdom

Version number: GDS29/IPI19

Date of issue: 07 September 2023

Trade marks are owned by or licensed to the GSK group of companies.