Source: Υπουργείο Υγείας (CY) Revision Year: 2013 Publisher: Codal-Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus
Syntoclav has a broad spectrum of activity against bacterial pathogens that are common in both hospital and general practice, including organisms that are insensitive to amoxicillin alone due to beta-lactamase production. A more detailed list of sensitive species is given under “Pharmacodynamics”.
Syntoclav is indicated for the short term therapy of bacterial infections believed to be caused by beta-lactamase producing organisms resistant to amoxicillin alone. It is also indicated for the treatment of infections of mixed aetiology where organisms are a mixture of amoxicillin sensitive and beta lactamase producing, thus removing the necessity for dual antibiotic therapy.
Infections of the upper respiratory tract, such as otitis media, sinusitis and recurrent tonsillitis. Common causative organisms include Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Streptococcus pneumoniae and Streptococcus pyogenes.
Infections of the lower respiratory tract such as bronchopneumonia and severe acute exacerbation in chronic bronchitis. Common causative organisms include Haemophilus influenzae, Moraxella (Branhamella) catarrhalis and Streptococcus pneumoniae.
Infection of skin and soft tissue, such as dental abscess, animal bites and cellulitis. Common causative organisms include Bacteroides sp., Staphylococcus aureus and Streptococcus pyogenes.
Infections of the abdomen and the genital-urinary tract, such as cystitis, recurrent or complicated cystitis, intra-abdominal sepsis, pelvic sepsis, pueperal sepsis and septic abortion. Common causative organisms include the Enterobacteriaceae, commonly Escherichia coli, Enterococcus sp. and Staphylococcus saprophyticus.
Before the initiation of the treatment, bacteriological studies to determine the causative microorganism(s) and its susceptibility to Syntoclav should be performed. Therapy may be initiated prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe that the infection is caused by beta-lactamase producing microorganisms. Once the results are known therapy should be adjusted, if appropriate.
In mild to moderate infections, 1 × 375mg tablet three times a day in equally divided doses. In severe infections, 1 × 625mg tablet three times a day in equally divided doses.
For dental infections the recommended dosage is 1 × 375mg tablet three times a day in equally divided doses for five days.
Children under twelve years of age: The use of tablets is not recommended for children aged less than twelve years of age. The suspension forms are recommended for use in such patients.
The recommended dosage is calculated on a weight basis, where the recommended dose is amoxicillin 20mg and clavulanic acid 5mg per kilogram bodyweight per day. This is administered in divided doses every eight hours. In more severe infections the dosage may be increased to a maximum of amoxicillin 40mg and clavulanic acid 10mg per kilogram bodyweight per day.
Dosage for children aged less than one year should be calculated on bodyweight.
Aged 1-6 years, body weight 10Kg-18Kg: 5ml Syntoclav suspension (125/31), three times a day in equally divided doses.
Age 6-12 years, body weight 18Kg-40Kg: 5ml Syntoclav Forte suspension (250/62), three times a day in equally divided doses.
No dosage adjustment is necessary unless there is renal or hepatic impairment.
There is insufficient clinical data for definitive dosage guidance. Therefore Syntoclav should be administered with caution in such patients and the hepatic function should be periodically monitored.
Mild renal impairment, creatinine clearance greater than 30ml/minute: normal recommended dosage may be used.
Moderate renal impairment, creatinine clearance 10ml/minute to 30ml/minute: the normal recommended dosage should be administered, but the dosage interval prolonged to every twelve hours.
Severe renal impairment, creatinine clearance less than 10ml/minute: dosage should not exceed 1 × 375mg tablet every twelve hours (adult) or 5ml (125/31) suspension every twelve hours (child).
Syntoclav tablets and suspension are for oral administration. The suspension should be shaken before administration of the dose. Potential gastrointestinal upset can be minimised by administering the dose before a meal.
The duration of therapy should be appropriate to the severity and type of infection, but should not exceed fourteen days without a clinical review. For most infections a seven day course of treatment is adequate.
Symptoms of overdose are likely to be gastrointestinal disturbances and fluid and electrolyte imbalance. Also, crystalluria due to amoxicillin overdose has been reported. There is no specific antidote. In case of recent overdose gastric lavage and/or activated charcoal may be useful. Treatment should be symptomatic and supportive, with particular attention to the restoration of fluid electrolyte balance.
Amoxicillin is dialysable.
Syntoclav 375mg and 625mg film-coated tablets: Thirty six (36) months.
Syntoclav 125/31 and Syntoclav Forte 250/62 powder for oral suspension: Twenty four (24) months. Following reconstitution the suspension has a shelf life of seven (7) days.
Film-coated tablets: Store in a dry place protected from light at a temperature not exceeding 25°C.
Powder for suspension: Store in a dry place protected from light at a temperature not exceeding 25°C. Following reconstitution the suspension should be stored in a refrigerator (2°C-8°C).
Film-coated tablets 375mg and 625mg: Tropicalised blisters, of aluminium-polyvinylchloride-aluminium, packs of 16 and 20 tablets with patient information leaflet are available.
Powder for suspension: Amber (type III) glass bottles, sealed with an aluminium roll on, pilfer proof cap, containing powder to give 60ml or 100ml of suspension when reconstituted as directed. Bottle, with patient information leaflet and plastic measuring spoon, is supplied in a carton.
Film-coated tablets: No further instructions.
Powder for suspension: The powder should be reconstituted at the time of dispensing. To reconstitute, add potable water to the fill line on the label, replace the cap and shake well. Allow any foam to settle and add sufficient water to make up to the fill line if necessary. Shake the bottle well before dispensing a dose.
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