Source: Medicines Authority (MT) Revision Year: 2019 Publisher: Phadisco Ltd., 185 Yiannou Kranidioti Avenue, CY-2234 Latsia, Cyprus Tel.:+357 22715000
Ceclor is indicated for the treatment of the following infections due to susceptible micro organisms:
Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of sinusitis
Otitis media
Skin and soft tissue infections
Urinary tract infections, including pyelonephritis and cystitis
Ceclor has been found to be effective in both acute and chronic urinary tract infections.
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.
Ceclor is administered orally.
The usual adult dosage is 250mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Doses of 4g per day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount.
Ceclor may be administered in the presence of impaired renal function. Under such conditions, dosage is usually unchanged (see ‘Special warning and special precautions for use’). Patients undergoing haemodialysis: Haemodialysis shortens serum half life by 25 30%. In patients undergoing regular haemodialysis, a loading dose of 250mg 1g administered prior to dialysis and a therapeutic dose of 250 500mg every six to eight hours maintained during interdialytic periods is recommended.
As for adults.
The usual recommended daily dosage for children is 20mg/kg/day in divided doses, every eight hours, as indicated. For bronchitis and pneumonia, the dosage is 20mg/kg/day in divided doses, administered 3 times daily. For otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours. Safety and efficacy have not been established for use ininfants aged less than one month.
Ceclor Suspension:
| 125mg/5ml | 250mg/5ml | |
| <1 year (9kg) | 2.5ml tid | |
| 15 years (18kg) | 5.0ml tid | |
| Over 5 years | 5.0ml tid |
In more serious infections, otitis media, sinusitis and infections caused by less susceptible organisms, 40mg/kg/day in divided doses is recommended, up to a daily maximum of 1g. In the treatment of beta haemolytic streptococcal infections, therapy should be continued for at least 10 days.
Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastro intestinal decontamination will not be necessary.
General management may consist of supportive therapy.
24 months.
Store at room temperature (≤25°C). Keep containers tightly closed and protect from light. After reconstitution, the suspension should be stored in a refrigerator (2-8°C) and be used within 14 days.
The product is filled into high density polyethylene bottles with screw caps containing 100ml of cefaclor.
When dilution is unavoidable, syrup BP should be used after the suspension has been prepared according to the manufacturer’s instruction.
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