Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with Cloxacillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems, or other beta-lactam agents. If an allergic reaction occurs, this product must be discontinued immediately and appropriate alternative therapy instituted.
Prescribing this medication in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Special precaution should be given to patients with asthma and history of seizure disorder.
Diarrhoea/pseudomembranous colitis caused by Clostridium difficile may occur. Therefore, patients suffering from diarrhoea must be closely followed.
Administration of high parenteral doses to patients with significantly reduced renal function or with injury to the blood-brain barrier can cause neurological complications in a form of spasms. If such symptoms appear, the dose must be decreased.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially "sodium-free".
Rapid intravenous administration of large doses of cloxacillin may cause hyperkalaemia, dysrhythmias, and cardiac arrest, particularly in patients with impaired renal function.
During long-term therapy, renal, hepatic and haematopoietic functions should be checked periodically.
The passage of any penicillin from blood into brain is facilitated by inflamed meninges and during cardiopulmonary bypass. In the presence of such factors, particularly in renal failure when high serum concentration can be attained, central nervous system adverse effects including myoclonia, convulsive seizures, and depressed consciousness can be expected. Although this complication has not been reported with cloxacillin, it should be anticipated.
Candidiasis and other superinfections may occur, especially in debilitated and malnourished patients, or those with low resistance to infection due to corticosteroids, immunosuppressors or irradiation. If superinfection occurs, institute appropriate measures.
Experience in premature and newborn infants is limited. Cautious administration of the drug to such patients and frequent evaluation of organ system function is recommended.
Effects on ability to drive and use machines: This product has no or negligible influence on the ability to drive and use machines.
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