Cefoxitin

There are extremely little data on the administration of cefoxitin in patients with renal impairment. Great caution is advised when cefoxitin is administered to these patients. In adults with renal impairment, an initial loading dose of 2 g can be administered.

After the loading dose, the following recommendations can be used as guide for maintenance treatment:

* In patients on haemodialysis, the loading dose of 2 g should be given after each haemodialysis, and the maintenance treatment should be given as indicated in the table above.

Renal function should be monitored during treatment if cefoxitin is given in combination with other potentially nephrotoxic antibiotics (especially aminoglycosides), or with furosemide or etacrynic acid diuretics.

False-positive results have been observed during treatment with cephalosporins. This may also occur in patients treated with cefoxitin.

Βeta-lactam antibiotics exposes to a risk of encephalopathy (confusion, disorders of consciousness, seizure, abnormal movements) and, particularly, in case of overdose or reduced renal function.

Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents and may occur with cefoxitin. These types of infection may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of the antibiotic. In such circumstances, the discontinuation of therapy with cefoxitin and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

Animal studies have not shown evidence of a teratogenic effect. As teratogenic effects have not been observed in animals, malformations are not expected in humans. To date, substances that have been found to cause malformations in humans have been shown to be teratogenic in animals during well-controlled studies on two animal species.

A large amount of clinical data on pregnant women indicate no malformative nor feto/neonatal toxicity of cefoxitin. Nevertheless, epidemiological studies would be required to verify the absence of risk.

Cefoxitin should therefore only be used during pregnancy if clinically needed.

Cefoxitin is excreted in human milk.

Breast-feeding should be discontinued during administration of cefoxitin to prevent any allergic reactions in the infant.

Cefoxitin has a major influence on the ability to drive and use machines especially because of the possible occurrence of encephalopathy.

Undesirable effects are classified by frequency and system organ class. The following terminologies have been used in order to classify the occurrence of undesirable effects: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1.000 to <1/100), rare (≥1/10.000 to <1/1.000), very rare (<1/10.000), not known (cannot be estimated from the available data).

Immune system disorders

Frequency not known: Anaphylactic reaction

Blood and lymphatic system disorders

Frequency not known: Eosinophilia, Leukopenia, Neutropenia (agranulocytosis), Anaemia (including haemolytic anaemia), Thrombocytopenia, Bone marrow failure

Vascular disorders

Frequency not known: Local thrombophlebitis after intravenous administration

Gastrointestinal disorders

Frequency not known: Nausea, Vomiting, Diarrhoea, Pseudomembranous colitis

Nervous system disorders

Frequency not known: Encephalopathy (confusion, disorders of consciousness, seizure, abnormal movements)*

Hepatobiliary disorders

Frequency not known: Transaminases increased, Blood lactate dehydrogenase increased, Blood alkaline phosphatase increased

Skin and subcutaneous tissue disorders

Frequency not known: Rash, Urticaria, Pruritus, Toxic epidermal necrolysis, Angioedema

Musculoskeletal and connective tissue disorders

Frequency not known: Myasthenia gravis exacerbation

Renal and urinary disorders

Frequency not known: Nephritis interstitial, Blood creatinine increased and/or BUN increased (especially in combination therapy with aminoglycosides and loop diuretics), Severe renal impairment

General disorders and administration site conditions

Frequency not known: Pyrexia, Local reaction

* Βeta-lactam antibiotics expose to a risk of encephalopathy (confusion, disorders of consciousness, seizure, abnormal movements) and, particularly, in case of overdose or reduced renal function.