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

AUGMENTIN infant drops 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 bronchitis, 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.

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 by AUGMENTIN.

Dosage depends on the 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 infant drops should be administered orally using the supplied dosing syringe. The syringe is graduated to permit accurate and reproducible volumes to be dispensed (Special precautions for disposal and other handling).

The usual recommended daily dosage is:

·       Lower dose: 20/5 mg/kg/day in three 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: 40/10 mg/kg/day in three 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).

For information, the volumes of AUGMENTIN infant drops which correspond to the weight of a child are shown below. For more severe infections where a higher dose is required the lower dose recommendations may be doubled.

Renal Impairment

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.

^# In more serious cases this dose may be doubled.

Hepatic Impairment
Dose with caution; monitor hepatic function at regular intervals.

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 Undesirable effetcs). 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).

AUGMENTIN suspensions contain 2.5 mg aspartame per 1 mL, which is a source 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 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.

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, 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.

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

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, 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.

Not known      Aseptic meningitis

Cardiac disorders

Very rare         Kounis syndrome (see Special Warnings and Precautions for use).

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). (See Special Warnings and Precautions for use).

                        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), 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 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

-GlaxoSmithKline - 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.

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 may be removed from the circulation by haemodialysis.

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 infant drops 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.

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.

No further information of relevance.

Xanthum gum, hydroxypropyl methylcellulose, aspartame, silicon dioxide, colloidal silica, succinic acid, raspberry, orange and golden syrup dry flavours.

For important information about some of these excipients see Special Warnings & Precautions for use.

None known.

 Do not take after the expiry date shown on the pack.

Store in a dry place in the original packaging to protect from moisture.

The dry powder should be stored in unopened containers in a dry place. Do not store above 30° C.
Reconstituted suspensions should be stored in a refrigerator (2-8°C) and used within seven days.

AUGMENTIN infant drops for suspension is supplied in clear glass bottles, with aluminum screw caps or glass bottles with a plastic child-resistant caps. containing powder for reconstitution.

Fill-lines are indicated on the bottle label. A syringe dosing device is also included.

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

•           Check cap seal is intact before use.

•           Invert and shake bottle to loosen powder.

•           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.

•           Shake well before taking each dose.

Once reconstituted, the adaptor that is supplied with the syringe dosing device should be inserted into the neck of the bottle before replacing the screw cap.

Discard any unused suspension after 7 days.

For administration of suspensions to children below 3 months, a syringe graduated to permit accurate and reproducible volumes to be dispensed, should be used.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Not all presentations are available in every country.