18 Jun 2012

Augmentin 625mg (co-amoxiclav) - United Kingdom

Updated: 18 Jun 2012

Augmentin 625mg Tablets

Augmentin is indicated for the treatment of the following infections in adults and children:

• Acute bacterial sinusitis (adequately diagnosed)

• Acute otitis media

• Acute exacerbations of chronic bronchitis (adequately diagnosed)

• Community acquired pneumonia

• Cystitis

• Pyelonephritis

• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.

• Bone and joint infections, in particular osteomyelitis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Augmentin 625mg Description, Presentation and Dosage

Augmentin 625mg Description

Augmentin 625mg Drug Class Description

Combinations of penicillins, incl. beta-lactamase inhibitors - ATC code: J01CR02

Augmentin 625mg Drug Description

Augmentin 625 mg Tablets: Each tablet contains co-amoxiclav 500/125.

The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as potassium clavulanate.

Augmentin 625mg Generic Name

co-amoxiclav

Augmentin 625mg Presentation

Augmentin 625mg Presentation

Augmentin 625 mg Tablets:

Film-coated tablet

White to off-white, oval film-coated tablets debossed with 'AC' and a score line one side and plain on the other side.

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Augmentin 625mg Dosage

Augmentin 625mg Adult Dosage

Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.

The dose of Augmentin that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to antibacterial agents

• The severity and the site of the infection

• The age, weight and renal function of the patient as shown below.

The use of alternative presentations of Augmentin (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary.

For adults and children GREATER-THAN OR EQUAL TO (8805) 40 kg, this formulation of Augmentin provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below. For children < 40 kg, this formulation of Augmentin provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Augmentin is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.

The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review.

Adults and children GREATER-THAN OR EQUAL TO (8805) 40 kg

One 500 mg/125 mg dose taken three times a day.

Children < 40 kg

20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.

Children may be treated with Augmentin tablets, suspensions or paediatric sachets. Children aged 6 years and below should preferably be treated with Augmentin suspension or paediatric sachets.

No clinical data are available on doses of Augmentin 4:1 formulations higher than 40 mg/10 mg/kg per day in children under 2 years.

Elderly

No dose adjustment is considered necessary.

Renal impairment

Dose 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.

Adults and children GREATER-THAN OR EQUAL TO (8805) 40 kg

CrCl: 10-30 ml/min

500 mg/125 mg twice daily

CrCl < 10 ml/min

500 mg/125 mg once daily

Haemodialysis

500 mg/125 mg every 24 hours, plus 500 mg/125 mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased)

Children < 40 kg

CrCl: 10-30 ml/min

15 mg/3.75 mg/kg twice daily (maximum 500 mg/125 mg twice daily).

CrCl < 10 ml/min

15 mg/3.75 mg/kg as a single daily dose (maximum 500 mg/125 mg).

Haemodialysis

15 mg/3.75 mg/kg per day once daily.

Prior to haemodialysis 15 mg/3.75 mg/kg. In order to restore circulating drug levels, 15 mg/3.75 mg per kg should be administered after haemodialysis.

Hepatic impairment

Dose with caution and monitor hepatic function at regular intervals.

Method of administration

Augmentin is for oral use.

Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.

Therapy can be started parenterally according the SPC of the IV-formulation and continued with an oral preparation.

Augmentin 625mg Precautions, Reactions and Contraindications

Augmentin 625mg Special Precautions

Augmentin 625mg Special Precautions

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents.

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 and in atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted.

In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance.

This presentation of Augmentin is not suitable for use when there is a high risk that the presumptive pathogens have reduced susceptibility or resistance to beta-lactam agents that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid. This presentation should not be used to treat penicillin-resistant S. pneumoniae.

Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Amoxicillin/clavulanic acid 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.

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP). This reaction requires Augmentin discontinuation and contra-indicates any subsequent administration of amoxicillin.

Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment.

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. In 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.

Antibiotic-associated colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics. Should antibiotic-associated colitis occur, amoxicillin/clavulanic acid should immediately be discontinued, a physician be consulted and an appropriate therapy initiated. Anti-peristaltic medicinal products are contra-indicated in this situation.

Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy.

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin/clavulanic acid. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

In patients with renal impairment, the dose should be adjusted according to the degree of impairment.

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. In patients with bladder catheters, a regular check of patency should be maintained.

During treatment with amoxicillin, enzymatic glucose oxidase methods should be used whenever testing for the presence of glucose in urine because false positive results may occur with non-enzymatic methods.

The presence of Clavulanic acid in Augmentin may cause a non-specific binding of IgG and albumin by red cell membranes leading to a false positive Coombs test.

There have been reports of positive test results using the Bio-Rad Laboratories Platelia Aspergillus EIA test in patients receiving amoxicillin/clavulanic acid who were subsequently found to be free of Aspergillus infection. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses with Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive test results in patients receiving amoxicillin/clavulanic acid should be interpreted cautiously and confirmed by other diagnostic methods.

Augmentin 625mg Adverse Reactions

Augmentin 625mg Adverse Reactions

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.

The ADRs derived from clinical studies and post-marketing surveillance with Augmentin, sorted by MedDRA System Organ Class are listed below.

The following terminologies have been used in order to classify the occurrence of undesirable effects.

Very common (GREATER-THAN OR EQUAL TO (8805)1/10)

Common (GREATER-THAN OR EQUAL TO (8805)1/100 to <1/10)

Uncommon (GREATER-THAN OR EQUAL TO (8805)1/1,000 to <1/100)

Rare (GREATER-THAN OR EQUAL TO (8805)1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Infections and infestations

Mucocutaneous candidosis

Common

Overgrowth of non-susceptible organisms

Not known

Blood and lymphatic system disorders

Reversible leucopenia (including neutropenia)

Rare

Thrombocytopenia

Rare

Reversible agranulocytosis

Not known

Haemolytic anaemia

Not known

Prolongation of bleeding time and prothrombin time1

Not known

Immune system disorders10

Angioneurotic oedema

Not known

Anaphylaxis

Not known

Serum sickness-like syndrome

Not known

Hypersensitivity vasculitis

Not known

Nervous system disorders

Dizziness

Uncommon

Headache

Uncommon

Reversible hyperactivity

Not known

Convulsions2

Not known

Gastrointestinal disorders

Diarrhoea

Very common

Nausea3

Common

Vomiting

Common

Indigestion

Uncommon

Antibiotic-associated colitis4

Not known

Black hairy tongue

Not known

Hepatobiliary disorders

Rises in AST and/or ALT5

Uncommon

Hepatitis6

Not known

Cholestatic jaundice6

Not known

Skin and subcutaneous tissue disorders7

Skin rash

Uncommon

Pruritus

Uncommon

Urticaria

Uncommon

Erythema multiforme

Rare

Stevens-Johnson syndrome

Not known

Toxic epidermal necrolysis

Not known

Bullous exfoliative-dermatitis

Not known

Acute generalised exanthemous pustulosis (AGEP)9

Not known

Renal and urinary disorders

Interstitial nephritis

Not known

Crystalluria8

Not known

1 See section Precautions

2 See section Precautions

3 Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking Augmentin at the start of a meal.

4 Including pseudomembranous colitis and haemorrhagic colitis (see section Precautions)

5 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.

6 These events have been noted with other penicillins and cephalosporins (see section Precautions).

7 If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see section Precautions).

8 See section Overdose in the full SPC

9 See section Precautions

10 See sections ContraIndications and Precautions

Augmentin 625mg Contraindications

Augmentin 625mg Contraindications

Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.

History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.

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