Source: Υπουργείο Υγείας (CY) Publisher: BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
Tricef is indicated for the treatment of the following infections caused by susceptible agents (see section 4.4 and 5.1):
Consideration should be given to national and/or local guidelines on the appropriate use of antibiotics.
The usual recommended posology is as follows:
Adults and children older than 12 years (or weighing more than 30 kg): 400 mg in a single daily dose. For the uncomplicated urinary tract infections a dose of 200 mg per day is effective.
Elderly: The same dose as recommended for adults, unless there is a severe renal impairment (see ahead).
Patients with renal impairment: The medicine may be administered to patients with impaired renal function. Doses indicated above may be given in patients with creatinine clearance of 20 mL/min or above. In patients whose creatinine clearance is less than 20 mL/min, it is recommended not to exceed a daily dose of 200 mg. This dose should also not be exceeded in patients undergoing chronic peritoneal dialysis or hemodialysis, since cefixime is slowly removed from circulation by dialysis.
In patients with impaired liver function, there is an increase on time required for reaching the maximum serum concentration of cefixime, however this does not require changes of posology in these patients.
Tricef tablet formulation is not intended for pediatric use.
Concomitant administration with food may increase the time required to reach the Cmax not interfering with AUC24 or T1/2β, effect with no clinical relevance.
There is no information about cases of overdose. Doses of 2 g in healthy adults caused moderate gastrointestinal effects as those seen with therapeutic doses.
In case of acute poisoning it is likely to occur diarrhea, vomiting and abdominal pain.
No specific antidote exists. Gastric lavage is indicated (if intake occurred for less than 2 hours) and the patient should be hydrated and, if necessary, electrolytically balanced.
Peritoneal dialysis and hemodialysis do not remove the antibiotic from the circulation in clinical significant quantities.
2 years.
Store at temperature below 30ºC.
Tricef tablets are conditioned in Alu/Alu blisters and inserted in cardboard box. Packs of 2, 6 or 8 tablets. Not all packs sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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