AUGMENTIN Co-Amoxiclav 400mg / 57mg per 5mL Powder for Suspension 35mL Strawberry Cream

Augmentin: Amoxicillin-clavulanate should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. Adult formulations: Co-amoxiclav is indicated for short term treatment of bacterial infections at the following sites when caused by amoxicillin-clavulanate-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^#.
Genitourinary tract infections e.g. cystitis, urethritis, pyelonephritis and female genital infections typically caused by Enterobacteriaceae^# (mainly Escherichia coli^#), Staphylococcus saprophyticus and Enterococcus species and gonorrhea caused by Neisseria gonnorhoeae^#.
Skin and soft tissue infections typically caused by Staphylococcus aureus^#, Streptococcus pyogenes and Bacteroides species^#.
Bone and joint infections e.g. osteomyelitis typically caused by Staphylococcus aureus^#, where more prolonged therapy may be appropriate.
Dental infections e.g. dentoalveolar abscess
Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis.
Pediatric formulations: Co-amoxiclav is indicated for short term treatment of bacterial infections at the following sites when caused by amoxicillin-clavulanate sensitive 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^#.
Genitourinary tract infections e.g. cystitis, urethritis, pyelonephritis, female genital infections typically caused by Enterobacteriaceae^# (mainly Escherichia coli^#), Staphylococcus saprophyticus and Enterococcus species and gonorrhea caused by Neisseria gonorrhoeae^#.
Skin and soft tissue infections typically caused by Staphylococcus aureus^#, Streptococcus pyogenes and Bacteroides species^#.
Amoxicillin-clavulanate Paediatric three times daily: The paediatric three times daily dosing regimen is also indicated for the following infections: Bone and joint infections e.g. osteomyelitis typically caused by Staphylococcus aureus^#, where more prolonged therapy may be appropriate.
Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis.
All formulations: ^#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 amoxicillin-clavulanate will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. Infection caused by amoxicillin-susceptible organisms are amenable to co-amoxiclav treatment due to its amoxicillin content. Mixed infections caused by amoxicillin-susceptible organisms in conjunction with amoxicillin-clavulanate-susceptible beta-lactamase-producing organisms may therefore be treated by co-amoxiclav.
Augmentin ES: Co-amoxiclav (Augmentin) should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.
Co-amoxiclav (Augmentin ES) is indicated for the short-term treatment of bacterial infections in paediatric patients at the following sites when caused by Co-amoxiclav (Augmentin)-susceptible organisms: Upper respiratory tract infections (including ENT) e.g. recurrent or persistent acute otitis media due to Streptococcus pneumoniae (penicillin minimum inhibitory concentration (MIC) less than or equal to 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 Co-amoxiclav (Augmentin) formulations are indicated for short-term treatment of bacterial infections at the following sites when caused by Co-amoxiclav (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 gonorrhoea 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 Pharmacologic Properties: Pharmacodynamics: Pharmacodynamic effects under Actions for further information).
Susceptibility to Co-amoxiclav (Augmentin) will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.

Augmentin: 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 co-amoxiclav 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 co-amoxiclav 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.
Adults: See Table 4.

Two co-amoxiclav 250/125 mg tablets should not be substituted for one co-amoxiclav 500/125 mg tablet since they are not equivalent.
Children: Dosage should be expressed in terms of the age of the child and either in mg/kg/day (given in 2 or 3 divided doses) or ml of suspension per dose or equivalent for other presentations.
Children weighing 40 kg and over should be dosed according to the adult recommendations.
Children up to 12 years: See Table 5.

The lower dose is recommended for infections such as skin and soft tissue and recurrent tonsillitis.
The higher dose is recommended for infections such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections.
No clinical data are available on doses of these formulations higher than 40/10 mg/kg/day (4:1) or 45/6.4 mg/kg/day (7:1) in children under 2 years.
There are no clinical data for the 7:1 formulation in patients under 2 months of age. Dosing recommendations in this population therefore cannot be made.
The 8:1 ratio formulation is recommended for dosing at 40/50 to 80/10 mg/kg/day (in three divided doses) in children aged 1 to 30 months, depending upon severity of infection.
Premature: No dosage recommendation can be made for this category.
Elderly: No adjustment needed; dose as for adults. If there is evidence of renal impairment, dose should be adjusted as for renally impaired adults.
Renal Impairment: Dosage adjustments are based on the maximum recommended level of amoxicillin.
Adults: See Table 6.

 

Children: See Table 7.

In the majority of cases, parenteral therapy, where available, may be preferred.
Haemodialysis: Adults: 1 times 500/125 mg or 2 times 250/125 mg every 24 hours, plus 1 dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased)⁽⁺⁾.
⁽⁺⁾The 875/125 mg and 1000/125 mg presentations should only be used in patients with a creatinine clearance of more than 30 mL/min.
Children: 15/3.75 mg/kg/day given as a single daily dose.
Prior to haemodialysis one additional dose of 15/3.75 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15/3.75 mg/kg should be administered after haemodialysis.
Hepatic Impairment: Dose with caution; monitor hepatic function at regular intervals.
There are insufficient data on which to base a dosage recommendation.
Augmentin ES: Paediatric patients 3 months and older: The recommended dose for Co-amoxiclav (Augmentin ES) is 90/6.4 mg/kg/day in 2 divided doses at 12-hourly intervals for 10 days (see Table 8). There is no experience in paediatric patients weighing >40 kg, or in adults. There are no clinical data on Co-amoxiclav (Augmentin ES) in children under 3 months of age. (See Table 8.)

Co-amoxiclav (Augmentin ES) does not contain the same amount of clavulanate (as the potassium salt) as any of the other Co-amoxiclav (Augmentin) suspensions. Co-amoxiclav (Augmentin ES) contains 42.9 mg of clavulanic acid per 5 mL whereas Co-amoxiclav (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, Co-amoxiclav (Augmentin) 200 mg/5 mL and 400 mg/5 mL suspensions should not be substituted for Co-amoxiclav (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 Co-amoxiclav (Augmentin ES) in patients with renal impairment.
Method of Administration: To minimise the potential for gastrointestinal intolerance, Co-amoxiclav (Augmentin ES) should be taken at the start of a meal. The absorption of Co-amoxiclav (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.

May be taken with or without food: Best taken at the start of meals for better absorption & to reduce GI discomfort.

Co-amoxiclav contraindicated in patients with a history of hypersensitivity to beta-lactams e.g. penicillins and cephalosporins; in patients with a previous history of amoxicillin-clavulanate-associated jaundice/hepatic dysfunction.

Before initiating therapy with co-amoxiclav, 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. If an allergic reaction occurs, co-amoxiclav therapy should be discontinued and appropriate alternative therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, i.v. steroids and airway management, including intubation may also be required.
Co-amoxiclav 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, co-amoxiclav 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 amoxicillin-clavulanate 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.
Co-amoxiclav should be used with caution in patients with evidence of hepatic dysfunction.
In patients with renal impairment, dosage should be adjusted according to the degree of impairment (see Renal Impairment under Dosage & Administration).
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).
Augmentin: Co-amoxiclav Suspensions/Sachets/Chewable tablets (where applicable), contains aspartame, which is a source of phenylalanine and should be used with caution in patients with phenylketonuria.
Augmentin ES: No dosing recommendations can be made for Co-amoxiclav (Augmentin ES) in renally impaired patients (see Dosage & Administration).
Co-amoxiclav (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.
Effects on Ability to Drive and Use Machines: Adverse effects on the ability to drive or 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 and <1/10; uncommon >1/1000 and <1/100; rare >1/10,000 and <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 (see Precautions). 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 and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
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 Co-amoxiclav (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, 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⁺.
⁺This statement is core safety for the syrup, suspension and chewable tablet formulations.
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.
Children (additional statement): These events have been very rarely reported in children.
All Populations: 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).
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued.
Renal and Urinary Disorders: Very Rare: Interstitial nephritis, crystalluria (see Overdosage).

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with amoxicillin-clavulanate 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 co-amoxiclav and allopurinol.
In common with other antibiotics, co-amoxiclav 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 amoxicillin.
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