Kefsyn/Kefsyn 750 Special Precautions

Kefsyn FC tab: Hypersensitivity reactions: Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity. As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with Cefuroxime must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to Cefuroxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if Cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
Jarisch-Herxheimer reaction: The Jarisch-Herxheimer reaction has been seen following Cefuroxime axetil treatment of Lyme disease. It results directly from the bactericidal activity of Cefuroxime axetil on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.
Overgrowth of non-susceptible microorganisms: As with other antibiotics, use of Cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. Enterococci and Clostridium difficile), which may require interruption of treatment. Antibacterial agent-associated pseudomembranous colitis have been reported with nearly all antibacterial agents, including Cefuroxime and may range in severity from mild to life threatening. This diagnosis should be considered in patients with diarrhea during or subsequent to the administration of Cefuroxime. Discontinuation of therapy with Cefuroxime and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Interference with diagnostic tests: The development of a positive Coombs Test associated with the use of Cefuroxime may interfere with cross matching of blood. As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime axetil.
Cefuroxime axetil should be given with caution to patients with renal impairment, dosage reduction may be necessary.
Renal and haematological status should be monitored especially during prolonged and high dose therapy.
Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop serious diarrhea during or after antibiotic use.
Effects on ability to drive and use machines: Cefuroxime axetil has no reported influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed.
Kefsyn 750: Although Cefuroxime rarely produces alterations in kidney function, evaluation of renal status during treatment is recommended, especially in patients receiving the maximum doses.
Cephalosporins should be given with caution to patients receiving concurrent diuretics. Caution is advised in patients with marked to severe renal impairment; reduced dosages should be administered. As with other antibiotics, prolonged use of Cefuroxime results in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential.
In case superinfection occurs, appropriate measures should be taken.
Use in Children: Safety and effectiveness of Cefuroxime in children below 3 months of age have not been established.