Augmentin 625mg Duo Tablet(1000 mg)(625mg)
Augmentin 625 Duo Tablet(1000 mg)
Amoreycillin(500mgt clewulanic Acid (125 mg)
Augmentin 625mg Tablet is penicillin type of antibiotic that helps your body fight infection Coused by bacterio. It is used to treat infection of the lung g-(pneumonia); ear, nasal Sinus, urinary tract, skin and soft tissu. It will not work for viral infetion Such as tue Common Cold.
Qualitative and quantitative composition
Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet
White to off-white, oval shaped tablet debossed with 'AC' and a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
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Augmentin 625mg Tablets
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GlaxoSmithKline UK
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Active ingredient
co-amoxiclav
Legal Category
POM: Prescription only medicine
Patient Leaflet
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This information is intended for use by health professionals
1. Name of the medicinal product
Augmentin 625 mg Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
3. Pharmaceutical form Film-coated tablet
White to off-white, oval shaped tablet debossed with 'AC' and a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4. Clinical particulars
Therapeutic indications
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.
Posology and method of administration
Posology
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 ≥ 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 ≥ 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.
As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Augmentin tablets.
The table below presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administering a single 500/125 mg tablet.
Body weight [kg]
40
35
30
25
Single dose recommended [mg/kg body weight] (see above)
Amoxicillin [mg/kg body weight] per single dose (1 film-coated tablet)
12.5
14.3
16.7
20.0
6.67 – 20
Clavulanic acid [mg/kg body weight] per single dose (1 film-coated tablet)
3.1
3.6
4.2
5.0
1.67 - 5
Children aged 6 years and below or weighing less than 25 kg 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 ≥ 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.
Augmentin should be administered with a meal to minimise potential gastrointestinal intolerance.
Therapy can be started parenterally according the SPC of the IV formulation and continued with an oral preparation.
Contraindications
Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients listed in section 6.1.
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.
Special warnings and precautions for use
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents (see sections 4.3 and 4.8).
Serious and occasionally fatal hypersensitivity 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 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 contraindicates any subsequent administration of amoxicillin.
Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment.
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 time | Not known |
Immune system disorders | |
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 |
Convulsions | Not known |
Aeseptic meningitis | Not known |
Gastrointestinal disorders | |
Diarrhoea | Very common |
Nausea | Common |
Vomiting | Common |
Indigestion | Uncommon |
Antibiotic-associated colitis | Not known |
Black hairy tongue | Not known |
Hepatobiliary disorders | |
Rises in AST and/or ALT | Uncommon |
Hepatitis | Not known |
Cholestatic jaundice | Not known |
Skin and subcutaneous tissue disorders | |
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) | Not known |
Drug reaction with eosinophilia and systemic symptoms (DRESS) | Not known |
Renal and urinary disorders | |
Interstitial nephritis | Not known |
Crystalluria | Not known |
Pharmaceutical particulars
List of excipients
Tablet core
Magnesium stearate
Sodium starch glycolate, Type A
Colloidal anhydrous silica
Microcrystalline cellulose
Tablet film-coat
Titanium dioxide
Hypromellose
Macrogol (4000, 6000)
Dimeticone
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