Source: Υπουργείο Υγείας (CY) Revision Year: 2013 Publisher: Codal Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus
Syntoclor is indicated for the treatment of the following bacterial infections when caused by susceptible micro-organisms:
Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, however, data establishing efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available.
The normal adult dosage is 250mg administered every eight hours, but in more severe infections or infections due to less susceptible organisms the dosage may be increased to 500mg administered every eight hours. The total daily dosage should not exceed 4g.
Dosage adjustment is not necessary.
Dosage adjustment with moderate to severe renal impairment is not usually necessary. The half life of cefaclor in anuric patients is 2.3 to 2.8 hours compared to 0.6 to 0.9 hours in normal patients. Clinical experience is limited, therefore close clinical supervision and appropriate laboratory testing should be performed.
The serum half life is reduced by about 25-30% by haemodialysis. For patients on regular haemodialysis a loading dose of 250mg to 1g should be administered immediately before dialysis. Dose of 250mg to 500mg should be administered every six to eight hours during interdialysis periods.
The safety and efficacy of cefaclor in children aged less than one (1) month have not been established.
The usual total daily dose is 20mg/kg bodyweight/day in equally divided doses every eight hours.
In bronchitis and pneumonia, the dose of 20mg/kg/day should be divided and administered every eight hours.
In otitis media and pharyngitis, the dose of 20mg/kg/day should be divided and administered every twelve hours.
For infections caused by less susceptible organisms or more severe infections and sinusitis, the dose may be increased to 40mg/kg/day in equally divided doses. The maximum daily dose should not exceed 1g.
Where the infection is due to beta haemolytic Streptococcus sp. the treatment should continue for at least ten (10) days.
Capsules are for oral administration. They can be taken with or without food.
Symptoms of overdose include diarrhoea, epigastric distress, nausea and vomiting.
If a very large dose, 5 times the normal total daily dose, has been ingested then decontamination of the gastro-intestinal tract is advised. Otherwise treatment is symptomatic and supportive.
36 months.
Store below 30°C, in the original package.
Capsules are in combination blisters of aluminium foil and polyvinylchloride film.
Cartons of 16, 100, 500 or 1000 capsules, with a patient information leaflet, are available.
Not all pack sizes may be marketed.
None.
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