Augmentin/Augmentin ES

Co-amoxiclav (amoxicillin & clavulanic acid).

Augmentin tablet: Each tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
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).
Augmentin ES suspension: Contains 600 mg amoxicillin (as amoxicillin trihydrate) and 42.9 mg clavulanic acid (as potassium clavulanate) per 5 ml, a 14:1 ratio.
Excipients/Inactive Ingredients: Augmentin tablet: Each tablet contains magnesium stearate, sodium starch glycollate, colloidal silica, microcrystalline cellulose, titanium dioxide (E171), hydroxypropyl methylcellulose, polyethylene glycol and silicone oil.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Augmentin dry powder for suspension contains xanthan gum, hydroxypropylmethylcellulose, colloidal silica, succinic acid, silicon dioxide, aspartame and dry flavours (raspberry, orange "1", orange "2" and golden syrup).
Augmentin ES suspension: Powder for suspension contains colloidal silicon dioxide, sodium carboxymethylcellulose-12, strawberry cream flavour, xanthan gum, aspartame and silicon dioxide.

Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors. Anatomical Therapeutic Chemical (ATC) code: J01CR02.
PHARMACOLOGY: Pharmacodynamics: Augmentin tablet: 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 high concentration of Amoxicillin effected on bactericidal in the body.
Clavulanate by itself has little antibacterial activity; however, in association with amoxicillin as Augmentin, it can be antibiotic agent of bacterial resistant Amoxicillin by producing β-lactamase for destroying. It can be treated the bacterial infection in with wide application in hospital and general practice.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in Augmentin suspension anticipates this defence mechanism by blocking the beta-lactamase enzymes, thus rendering the organisms sensitive 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.
Mechanism of Action: Augmentin ES suspension: Amoxicillin is a semisynthetic antibiotic with a broad spectrum antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is, however, susceptible to degradation by beta-lactamases, and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.
Clavulanate is a beta-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid mediated beta-lactamases frequently responsible for transferred drug resistance. It is generally less effective against chromosomally-mediated type 1 beta-lactamases.
The clavulanate component in Augmentin ES protects amoxicillin from degradation by beta-lactamase enzymes, and effectively extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and cephalosporins. Thus, Augmentin ES possesses the distinctive properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.
Pharmacodynamic Effects: In the list as follows, organisms are categorised according to their in vitro susceptibility to Augmentin. (See Table 1.)

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Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: 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 are therefore considered to be treated with Augmentin.
Pharmacokinetics: Augmentin tablet: The pharmacokinetics of the two components of Augmentin, amoxicillin and clavulanate are similar and both can well absorb in the digestive tract. Peak serum levels of both occur about 1 hour after oral administration. Absorption of Augmentin is optimised at the start of a meal. Augmentin has a mean elimination half-life of approximately one hour.
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.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Absorption: The two components of Augmentin suspension 228 mg/5 mL and 457 mg/5 mL, amoxicillin and clavulanate, are each fully dissociated in aqueous solution at physiological pH. Both components are rapidly and well absorbed by the oral route of administration. Absorption of Augmentin is optimised when taken at the start of a meal.
The mean AUC values for amoxicillin are essentially the same following twice a day dosing with the Augmentin 1g tablets (875/125 mg) or three times a day dosing with the Augmentin 625 mg tablets (500/125 mg), in adults. No differences between the 875 mg twice daily and 500 mg three times daily dosing regimens are seen when comparing the amoxicillin T_½, or C_max after normalisation for the different doses of amoxicillin administered. Similarly, no differences are seen for the clavulanate T_½, C_max or AUC values after appropriate dose normalisation.
The time of dosing of Augmentin relative to the start of a meal has no marked effects on the pharmacokinetics of amoxicillin in adults. In a study of the Augmentin 1g tablets (875/125 mg), the time of dosing relative to ingestion of a meal had a marked effect on the pharmacokinetics of clavulanate. For clavulanate AUC and C_max, the highest mean values and smallest inter-subject variabilities were achieved by administering Augmentin at the start of a meal, compared to the fasting state or 30 or 150 minutes after the start of a meal.
The mean C_max, T_max, T_½ and AUC values for amoxicillin and clavulanate are given as follows for Augmentin 1g tablets (an 875 mg/125 mg dose of amoxicillin/clavulanate) administered at the start of a meal. (See Table 2.)

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Amoxicillin serum concentrations achieved with Augmentin are similar to those produced by the oral administration of equivalent doses of amoxicillin alone.
Distribution: The pharmacokinetics of the two components of Augmentin are closely matched. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.
Doubling the dosage of Augmentin approximately doubles the serum levels achieved.
Augmentin ES suspension: Pharmacokinetic parameters are given as follows for Augmentin ES administered at 45 mg/kg every 12 hours to paediatric patients. (See Table 3.)

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The pharmacokinetics of the two components of Augmentin ES are closely matched. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.
Toxicology: Preclinical safety data: No further information of relevance.

Augmentin/Augmentin ES should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.
Augmentin tablet: Augmentin is indicated for short-term treatment of susceptible bacterial infections: 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 due to Escherichia coli, Proteus mirabilis or Enterococcus faecalis.
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 PHARMACOLOGY: Pharmacodynamics under Actions 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 β-lactamase producing organisms may therefore be treated with Augmentin.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Augmentin suspension (228 mg/5 mL and 457 mg/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 PHARMACOLOGY: Pharmacodynamics under Actions 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-producing organisms may be treated with Augmentin suspension 228 mg/5 mL and 457 mg/5 mL. These infections should not require the addition of another antibiotic resistant to beta-lactamases.
Augmentin ES suspension: Augmentin ES is indicated for the short-term treatment of bacterial infections in paediatric patients at the following sites when caused by Augmentin-susceptible organisms: Upper respiratory tract infections (including ENT) e.g. recurrent or persistent acute otitis media due to Streptococcus pneumoniae (penicillin MIC ≤ 4 µg/ml), Haemophilus influenzae^# and Moraxella catarrhalis^#. Such patients are often characterised by antibiotic exposure for acute otitis media within the preceding 3 months, and are either aged ≤ 2 years or attend daycare; tonsillo-pharyngitis and sinusitis, typically caused by Streptococcus pneumoniae, Haemophilus influenzae^#, Moraxella catarrhalis^# and Streptococcus pyogenes.
Lower respiratory tract infections e.g. lobar and bronchopneumonia typically caused by Streptococcus pneumoniae, Haemophilus influenzae^# and Moraxella catarrhalis^#.
Skin and soft tissue infections typically caused by Staphylococcus aureus^# and Streptococcus pyogenes.
Other Augmentin formulations are indicated for short-term treatment of bacterial infections at the following sites when caused by Augmentin-susceptible organisms: Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media typically caused by Streptococcus pneumoniae, Haemophilus influenzae^#, Moraxella catarrhalis^# and Streptococcus pyogenes.
Lower respiratory tract infections e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia typically caused by Streptococcus pneumoniae, Haemophilus influenzae^# and Moraxella catarrhalis^#.
Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis, female genital infections typically caused by Enterobacteriaceae^# (mainly Escherichia coli^#), Staphylococcus saprophyticus and Enterococcus species, and gonorrohoea caused by Neisseria gonorrhoeae^#.
Skin and soft tissue infections typically caused by Staphylococcus aureus^#, Streptococcus pyogenes and Bacteroides species^#.
^#Some members of these species of bacteria produce beta-lactamase, rendering them insensitive to amoxicillin alone (see PHARMACOLOGY: Pharmacodynamics: Pharmacodynamic Effects under Actions for further information).
Susceptibility to Augmentin ES will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.

Augmentin tablet and suspension 228 mg/5 mL and 457 mg/5 mL: 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/not exceed beyond 14 days without review.
Therapy can be started parenterally and continued with an oral preparation.
Augmentin tablet: Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.
Augmentin tablets are not recommended in children of 12 years and under.
Adults and children over 12 years: One Augmentin 1 g tablet every 12 hours.
One Augmentin 1 g tablet every 8 hours for severe infection.
Dosage in dental infections: Adults and children over 12 years: Augmentin 1 g tablet 2 times a day (or every 12 hours) for five to seven days.
Renal Impairment: No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 mL/min. The Augmentin 1g tablet should only be used in patients with a creatinine clearance (CrCl) rate of more than 30 mL/min.
Hepatic Impairment: Dose with caution; monitor hepatic function at regular intervals. Augmentin is contra-indicated in patients with a previous history of Augmentin-associated cholestatic jaundice/hepatic dysfunction.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Augmentin bottle presentations for suspension may be supplied with a plastic dosing device. For preparation of the suspensions see Instructions for use/handling under Cautions for Usage.
The usual recommended daily dosage is: Lower dose: 25/3.6 mg/kg/day in two divided doses for mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsillitis, lower respiratory infections and skin and soft tissue infections).
Higher dose: 45/6.4 mg/kg/day in two divided doses for the treatment of more serious infections (upper respiratory tract infections e.g. otitis media and sinusitis, lower respiratory tract infections e.g. bronchopneumonia and urinary tract infections).
No clinical data are available on doses above 45/6.4 mg/kg/day in children under 2 years.
There are no clinical data for Augmentin suspension 228 mg/5 mL and 457 mg/5 mL to make dosage recommendations for children under 2 months old.
The tables as follows give dosage guidance for children. (See Tables 4 and 5.)

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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 are insufficient data on which to base a dosage recommendation.
Augmentin ES suspension: Paediatric patients 3 months and older: The recommended dose for Augmentin ES is 90/6.4 mg/kg/day in 2 divided doses at 12-hourly intervals for 10 days (see chart as follows). There is no experience in paediatric patients weighing more than 40 kg, or in adults. There are no clinical data on Augmentin ES in children under 3 months of age. (See Table 6.)

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Augmentin ES does not contain the same amount of clavulanate (as the potassium salt) as any of the other Augmentin suspensions. Augmentin ES contains 42.9 mg of clavulanic acid per 5 ml whereas Augmentin 200 mg/5 ml suspension contains 28.5 mg of clavulanic acid per 5 ml and the 400 mg/5 ml suspension contains 57 mg of clavulanic acid per 5 ml. Therefore, Augmentin 200 mg/5 ml and 400 mg/5 ml suspensions should not be substituted for Augmentin ES, as they are not interchangeable.
Hepatic Impairment: Dose with caution; monitor hepatic function at regular intervals. There are insufficient data on which to base a dosage recommendation.
Renal Impairment: There are no dosing recommendations for Augmentin ES in patients with renal impairment.
Method of administration: Augmentin ES suspension: To minimise the potential for gastrointestinal intolerance, Augmentin ES should be taken 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.
SHAKE ORAL SUSPENSION WELL BEFORE USING.

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Symptoms/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 Precautions).
Augmentin/Augmentin ES can be removed from the circulation by haemodialysis.
Augmentin ES suspension: A prospective study of 51 paediatric patients at a poison control centre suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.

Augmentin/Augmentin ES is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.
Augmentin/Augmentin ES is contraindicated in patients with a previous history of Augmentin-associated jaundice/hepatic dysfunction.

Thai FDA mandatory warnings: 1. Do not use in patients with known hypersensitivity to this medicine.
2. This medicine may cause a serious hypersensitivity reaction which can be fatal.
3. In case of erythema rash, irritation or edema occur, discontinue this medicine and consult a physician.
4. In case of rash or flu-like symptoms, discontinue this medicine and promptly consult a physician.
5. In case of the following symptoms occur e.g. fever, rash, vesicles, exfoliation of skin and other mucous membrane such as in the mouth, throat, nose, reproductive organ and conjunctivitis, discontinue this medicine and consult a physician since this may be Stevens-Johnson syndrome.

Before initiating therapy with Augmentin/Augmentin ES, 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 (and more likely in individuals with a history of cephalosporin hypersensitivity because of cross-hypersensitivity - for Augmentin tablet only) (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/AUGMENTIN ES (see Adverse Reactions). If an allergic reaction occurs, Augmentin/Augmentin ES therapy must/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/Augmentin ES 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 (super infection) that can occur with fungi, bacteria and virus.
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 investigated etiology for timely appropriated treatment/investigated further.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving Augmentin and oral anticoagulants. Monitoring INR/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.
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 Overdosage).
Effects on ability to drive and use machines: Adverse effects on the ability to drive or operate machinery have not been observed.
Augmentin tablet and Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: 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.
Augmentin tablet: In general Amoxicillin-clavulanate is well tolerated. In case of prolonged treatment, should asset the renal function, hepatic and blood counting is advisable before and during therapy for the proper adjusting and reducing the risk for neurotoxic.
In patients with renal impairment Augmentin dosage should be adjusted as recommended in Dosage & Administration.
Augmentin suspensions contain 12.5 mg aspartame per 5 ml dose, which is a source of phenylalanine, and therefore should be used with caution in patients with phenylketonuria.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: In patients with renal impairment Augmentin suspension 228 mg/5 mL and 457 mg/5 mL are not recommended.
Augmentin 228 mg/5 mL and 457 mg/5 mL suspensions contain aspartame, which is a source of phenylalanine and so should be used with caution in patients with phenylketonuria.
Augmentin ES suspension: In general Augmentin ES is well tolerated and possesses the characteristic low toxicity of the penicillin group of antibiotics. Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy.
Augmentin ES should be used with caution in patients with evidence of hepatic dysfunction.
In patients with renal impairments, dosage of Augmentin should be adjusted according to the degree of impairment. No dosing recommendations can be made for Augmentin ES in renally impaired patients (see Dosage & Administration).
Augmentin ES contains aspartame (each 5 ml of suspension contains 7 mg of phenylalanine) and so should be used with caution in patients with phenylketonuria.

Use in pregnancy: As with all medicines, use should be avoided in pregnancy, (especially during the first trimester - for Augmentin tablet only), unless considered essential by the physician because it was reported that prophylactic treatment with Augmentin may be associated with an increased risk of necrotising enterocolitis in neonates. 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 preterm, premature rupture of the foetal membrane (pPROM).
Use in lactation: Augmentin/Augmentin ES 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.

Data from large clinical trials were 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 and <1/10; Uncommon: ≥1/1,000 to <1/100; Rare: ≥1/10,000 to <1/1,000; 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, serum sickness-like syndrome, hypersensitivity vasculitis.
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 Precautions).
Gastrointestinal disorders: 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) (see Precautions); Black hairy tongue (fungus); 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.
Augmentin tablet and Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Adults: Very Common: Diarrhoea.
Common: Nausea, vomiting.
Children: Common: Diarrhoea, nausea, vomiting.
Augmentin ES suspension: Common: Diarrhoea, nausea, vomiting.
Hepatobiliary disorders: Uncommon: A moderate rise in AST and/or ALT have 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.
Augmentin tablet: Clinical symptoms of cholestatic hepatitis may arise 2 to 4 weeks after starting or 1 to 2 weeks after stopping the treatment. Most symptoms are not severe and usually reversible. Deaths from liver failure have been reported but extremely rare.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL and Augmentin ES suspension: 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 exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS).
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued.
Renal and urinary disorders: Very rare: Interstitial nephritis, crystalluria (see Overdosage).

Avoid concomitant use with probenecid (for Augmentin tablet only). Concomitant use of probenecid is not recommended (for Augmentin suspension 228 mg/5 mL and 457 mg/5 mL and Augmentin ES suspension only). Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with Augmentin/Augmentin ES 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 drug skin reactions. There are no data on the concomitant use of Augmentin/Augmentin ES and allopurinol.
In common with other antibiotics, Augmentin may affect the normal gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives and patients should be advised to use barrier methods of contraception.
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.
Augmentin tablet: Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin-clavulanate and oral anticoagulants. Measuring INR should be undertaken when anticoagulants are prescribed concurrently. Adjustment in decrease dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. And increase the dose for adjusting INR after Augmentin have been ceased.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL and Augmentin ES suspension: 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.

Incompatibilities: None known.
Instructions for use/handling: Augmentin tablet: Blister pouches contain a desiccant sachet; do not remove or eat. Discard any opened and unused tablets after 14 days of opening from pouch.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL and Augmentin ES suspension: At time of use, the dry powder should be reconstituted to form an oral suspension, as detailed as follows: Invert and shake bottle to loosen powder.
Add volume of water (indicated as follows). Invert and shake well.
Alternatively, fill the bottle with water to just below the mark on bottle label.
Invert and shake well, then top up with water to the mark. Invert and shake again.
Allow to stand for 5 minutes to ensure full dispersion (for Augmentin suspension 228 mg/5 mL and 457 mg/5 mL only).
Shake well before taking each dose.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: Check the cap ring seal is intact before using. (See Tables 7 and 8.)

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A plastic dosing device may be supplied with the pack which can be used to measure the dose accordingly.
Discard any unused suspension after 7 days.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Augmentin ES suspension: For bottles with aluminum screw caps, check the cap seal is intact before using.
Alternatively, for bottles with a plastic child-resistant cap, check the foil-backed bottle seal is intact before using. (See Table 9.)

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Each 5 ml will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanate as the potassium salt.
Not all presentations are available in every country.

Augmentin tablet and Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: The storage conditions are detailed on the packaging.
Store in a dry place in the original packaging to protect from moisture.
Augmentin tablet: For Augmentin tablet packs with a storage temperature up to 30°C, use tablets within 14 days of opening.
Augmentin tablet packs contain desiccant sachets. Do not remove or eat.
Augmentin tablets should be stored in a dry place at 30°C or below and stored in un-opened, original packs.
Augmentin suspension 228 mg/5 mL and 457 mg/5 mL: The dry powder should be stored in unopened containers in a dry place at below 30°C.
Once reconstituted, the suspensions must be stored in a refrigerator (2°C to 8°C) and used within 7 days. Do not freeze (see also Instructions for use/handling under Cautions for Usage).
Augmentin ES suspension: The storage conditions are indicated on the packaging.
The powder for oral suspension should be stored in a well sealed container, in a dry place or at below 30°C. Reconstituted suspensions should be stored in a refrigerator (2-8°C) and used within 10 days.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

D