Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus.
Medoclor is indicated in children and adults for the treatment of mild infections caused by microorganisms sensitive to cefaclor (see sections 4.4 and 5.1):
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Medoclor should be administered for at least 10 days in the treatment of infections caused by β-hemolytic streptococci.
The usual 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 maximum dose and duration of treatment for adults is 4 g/day for up to 28 days. The total daily dose may, however, not exceed 4 grams. Doses up to 4 g per day were found to be safe when administered to normal subjects for 28 days.
The recommended daily dose for children is 20 mg/kg/day in aliquots administered every 8 hours. In otitis media infections provoked by less susceptible organisms, 40 mg/kg/day should be used, without exceeding the recommended dose of 1 g per day.
Safety and efficacy of cefaclor has not been established for children less than 1 month.
For patients with creatinine clearance less than 10 ml/min. only ¼ of the daily dose should be administered.
For a creatinine clearance of between 10 ml/min and 40 ml/min ½ of the daily dose may be sufficient.
When the clearance is greater than 40 mL/min, there is no need for the dose to be adjusted. In patients with compromised renal function the half-life of cefaclor is no longer than 3 hours. In this situation, there is no accumulation of cefaclor at normal dosage. In patients undergoing hemodialysis, the half-life is 2.1 hours.
The capsules should be taken with a small amount of liquid.
The suspension should be measured using the supplied measuring 5 ml spoon and then ingested. For the reconstitution of the suspension, see section 6.6.
Symptoms of overdose include nausea, vomiting, epigastric pain and diarrhea. The severity of the last two is dose-dependent. Other symptoms like an allergic reaction or any other intoxication may occur, most likely caused by an underlying disease.
Attempts to remove cefaclor from the gastrointestinal tract are necessary only if cefaclor is taken more than 5 times the usual dose.
Protect the airway and support ventilation and perfusion.
Carefully follow the vital signs, blood gases, serum electrolytes, etc. and keep it within acceptable limits. Absorption from the gastrointestinal tract can be reduced by activated carbon, which is often more effective than emesis or laxation.
Activated carbon can be used instead of or in addition to gastric emptying. A gastrointestinal lavage is only useful if it is performed shortly after the overdose (about 1 to 2 hours). Repeated giving activated charcoal is accelerating the elimination of already absorbed drugs.
Forced diuresis, peritoneal dialysis or hemoperfusion with active carbon proved to be useful in cefaclor overdose.
Capsules: 36 months.
Granules for oral suspension: 24 months.
Following reconstitution 14 days at 2°C-8°C or 7 days below 25°C.
Capsules: Store below 30°C
Granules for suspension: Store in the original package before reconstitution.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Capsules are in combination blisters of aluminium foil and polyvinylchloride film. Cartons of 16, 500 or 1000 capsules, with a patient information leaflet, are available. Medoclor 500mg capsules are also available in cartons of 20 capsules.
Granules for oral suspension is in amber type III glass bottles with aluminium tamper evident closure. Bottles with sufficient powder for 60ml or 100ml of suspension following reconstitution are available, in a carton with a patient information leaflet and a 5ml spoon.
Not all pack sizes may be marketed.
Capsules: No special requirements for disposal.
Granules for suspension: To reconstitute add potable water to the line on the label.
Replace cap and shake vigorously. Allow any foam to settle and add more water if necessary to the line on the label, replace cap and shake.
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