AUGMENTIN ES should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.

AUGMENTIN ES is indicated for the treatment of paediatric patients with recurrent or persistent acute otitis media due to Streptococcus pneumoniae (penicillin minimum inhibitory concentration (MIC) less than or equal to 2 mg/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.

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 below). 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.

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 clavulanate per 5 mL whereas AUGMENTIN 200 mg/5 mL suspension contains 28.5 mg of clavulanate per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanate 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 

Administer 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

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.

Note: SHAKE ORAL SUSPENSION WELL BEFORE USING

Before initiating therapy with AUGMENTIN ES, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy.  These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity. 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 ES (see Undesirable effects). Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving AUGMENTIN ES (see Undesirable effects). DIES 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, diarrhoea, hypotension or leucocytosis with neutrophilia. In severe cases, drug-induced enterocolitis syndrome can progress to shock. If an allergic reaction occurs, AUGMENTIN ES therapy should be discontinued and appropriate alternative therapy instituted.

Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation may also be required.

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.

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.

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.

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.

AUGMENTIN ES should be used with caution in patients with evidence of hepatic dysfunction.

In patients with renal impairment, 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 (Posology and mode of administration).

In patients with reduced urine output, crystalluria (including acute renal injury) 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. In patients with bladder catheters, a regular check of patency should be maintained (see Undesirable effects and Overdose).

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.

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with 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 skin reactions. There are no data on the concomitant use of AUGMENTIN ES 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 Category B: 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, unless considered essential by the physician.

Use in Lactation 

AUGMENTIN ES may be administered during the period of lactation. With the exception of the risk of sensitization, associated with the excretion of trace quantities in breast milk, there are no known detrimental effects for the breast-fed infant.

Adverse effects on the ability to operate machinery have not been observed.

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 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 Special 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 Special warnings and precautions for use).

Not known        Aseptic meningitis

Gastrointestinal disorders

Common            Diarrhoea, nausea, vomiting

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)

                           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.

Not known:          Drug-induced enterocolitis syndrome, (see Special warnings and precautions for use),Pancreatitis acute

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.

Not Known       Linear IgA disease

Renal and urinary disorders

Very rare          Interstitial nephritis

Not known        Crystalluria (including acute renal injury) (see Overdose).

To report any side effect(s):

Kingdom of Saudi Arabia

-National Pharmacovigilance centre (NPC)

·       Fax: +966-11-205-7662

• Reporting Hotline:19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa

-GSK - Head Office, Jeddah

• Tel: +966-12-6536666
• Mobile: +966-56-904-9882
• Email: saudi.safety@gsk.com
• Website: https://gskpro.com/en-sa/
• P.O Box 55850, Jeddah 21544, Saudi Arabia.

For any information about this medicinal product, please contact:

GSK - Head Office, Jeddah

• Tel:  +966-12-6536666
• Mobile: +966-56-904-9882
• Email: gcc.medinfo@gsk.com    
• Website: https://gskpro.com/en-sa/
• P.O. Box 55850, Jeddah 21544, Saudi Arabia

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 Special warnings and precautions for use).

AUGMENTIN ES can be removed from the circulation by haemodialysis.

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.

ATC Code 

Anatomical Therapeutic Chemical (ATC) code: J01CR02.

Pharmacotherapeutic group: Combinations of penicillins, incl. beta-lactamase inhibitors.

Mechanism of Action

Amoxicillin is a semisynthetic antibiotic with a broad spectrum of 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.

Clavulanic acid 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.

5.1.2 Pharmacodynamic Effects In the list below, organisms are categorised according to their in vitro susceptibility to AUGMENTIN.

Pharmacokinetic parameters are given below for AUGMENTIN ES administered at 45 mg/kg every 12 hours to paediatric patients

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.

No further information of relevance.

Orange flavour

Powder for oral suspension: colloidal silicon dioxide, orange flavour, golden syrup flavour, xanthan gum, aspartame, hydroxypropylmethylcellulose and silicon dioxide.

Strawberry cream flavour

AUGMENTIN ES powder for suspension contains colloidal silicon dioxide, sodium carboxymethylcellulose-12, strawberry cream flavour, xanthan gum, aspartame, and silicon dioxide.

For important information about some of these excipients (see Special Warnings and Precautions).

None known.

The powder for oral suspension should be stored in a well sealed container, in a dry place at or below 30°C. Reconstituted suspensions should be stored in a refrigerator (2-8°C) and used within 10 days.

AUGMENTIN ES powder for oral suspension, is supplied in clear glass bottles containing dry powder for reconstitution. Bottles may be supplied with either an aluminium screw cap with a ring seal or a plastic child-resistant cap with a removable foil-backed seal on the bottle. Fill-lines are indicated on the bottle label. Bottles may be supplied with a plastic dosing device.

Orange flavour

The dry powder is filled into glass bottles with polypropylene caps.

Strawberry cream flavour

The dry powder is filled into glass bottles with aluminium caps with a PVC or Polyolefin liner.

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.

At time of use, the dry powder should be reconstituted to form an oral suspension, as detailed below:

• Invert and shake bottle to loosen powder.

• Add volume of water (indicated below). 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.

• Shake well before taking each dose.

A dosing device may be supplied with the pack, which can be used to measure the dose accurately.

Discard unused suspension after 10 days.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements .Not all presentations are available in every country.

Augmentin is registered trademarks of the GlaxoSmithKline group of companies

© 2024 GlaxoSmithKline, all rights reserved.

INSTRUCTIONS TO THE PATIENT

THIS IS A MEDICAMENT

Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.

Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.

The Doctor and the Pharmacist are experts in medicine, its benefits and risks.

Do not by yourself interrupt the period of treatment prescribed for you.

Do not repeat the same prescription without consulting your doctor.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

Council of Arab Health Ministers

Union of Arab Pharmacists