TRICEF Film-coated tablet Ref.[50285] Active ingredients: Cefixime

Tricef should be used with caution during pregnancy and lactation, the contraindications related to hypersensitivity to cefixime or its excipients should be respected, and also the dose reduction in renal impaired patients should be observed.

Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of cross-allergy between penicillins and cephalosporins, as severe reactions (including anaphylaxis) to both classes have been observed (see section 4.3).

Cases of severe skin reactions with cefixime, as toxic epidermal necrolysis, Stevens-Johnson syndrome or rash with eosinophilia and systemic symptoms (DRESS) were reported. If a severe adverse skin reaction occurs, the use of cefixime should be immediately discontinued and appropriate therapeutic measures should be triggered.

Like other cephalosporins, cefixime may also lead to acute renal impairment, including interstitial nephritis. When acute renal impairment occurs, cefixime should be discontinued and appropriate therapeutic measures should be adopted.

Tricef should be used with caution particularly in the presence of severe renal impairment (see section 5.2).

Prolonged use of cefixime may cause overgrowth of non-sensitive agents. The treatment with broad spectrum antibiotics alters the normal flora of the colon and can lead to the colonization by Clostridium strains. Studies indicate that the toxin produced by Clostridium difficile is the major cause of antibiotic associated diarrhea. The pseudomembranous colitis is associated with the use of broad spectrum antibiotics (macrolides, semi-synthetic penicillins, lincosamides and cephalosporins including cefixime). It is important to consider this diagnosis in patients who develop diarrhea associated with antibiotic use.

Some patients with severe diarrhea due to pseudomembranous colitis, developed during or after the use of cefixime, have been at risk of life, thus it should be considered (see section 4.8). In case of suspicion, the use of cefixime should be discontinued and appropriate treatment measures should be initiated. Digestive endoscopic procedures, such as sigmoidoscopy or bacteriological might be necessary. Treatment measures include fluids, electrolytes and protein supplements. If colitis does not ameliorate after drug discontinuation or if symptoms get worse, treatment with oral vancomycin is indicated. This is the antibiotic of choice in pseudomembranous colitis by C. difficile. Other causes of colitis should be excluded. The use of drugs that inhibit intestinal peristalsis is contraindicated.

Antacids do not interfere with the absorption of cefixime. The tubular reabsorption inhibitors such as probenecid may hinder the urinary excretion of cefixime by increasing the values of C_max and AUC₂₄.

The salicylates and other nonsteroidal anti-inflammatories can displace cefixime from of its plasma protein binding, thereby increasing the concentration of free fraction.

In common with most cephalosporins, increases in prothrombin times have been noted in a few patients. Thus, caution is recommended in the administration of cefixime in patients undergoing anticoagulant treatment and adjustment of frequency of monitoring of the International Normalized Ratio (INR).

The administration of cefixime may reduce the effectiveness of oral contraceptives. It is therefore recommended to take additional non-hormonal contraceptives measures.

False positive results can be observed in the urine glucose determination with cupric reagents, but not by those using glicoxidase. A false positive Coombs test may also be presented as it happens with most of cephalosporins.

In preclinical trials no differences were detected between the group of animals of control and the group that received the drug, with respect to fertility parameters, namely mating behavior, pregnancy rate, duration of pregnancy or delivery. The transplacental transfer of cefixime was about 1% of the dose administered to pregnant rats. The transfer through breast milk was about 1.5% of the total given to the mother.

Although animal experience does not suggest any kind of toxicity during pregnancy, the harmlessness of cefixime during pregnancy in humans is unclear. Tricef should not be used during pregnancy and lactation unless the doctor considers its use essential.

No effects were observed on the ability to drive and use machines.

The undesirable effects (according to the results of clinical trials) are listed in order of decreasing seriousness within each frequency class.
The frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

In this section the following convention was used for the classification of undesirable effects in terms of frequency: Very common (≥1/10), Common: (≥1/100, <1/10), Uncommon: (≥1/1,000, <1/100), Rare: (≥1/10,000, <1/1,000), Very rare: <1/10,000, Not known (cannot be estimated from the available data).

None known.