RENOXITIN

Posology There are very limited clinical safety and efficacy data supporting the dose of cefoxitin. Therapeutic guidelines should be adhered to. Based on these very limited clinical data and some supporting pharmacokinetic/ pharmacodynamic data, the following may be appropriate: Adults and adolescents: 2g every 4- 6 hours to a maximum of 12g/ day.

Renal impairment 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: Creatinine clearance (mL/min) Dose Frequency 50 - 30 2 g Every 8 - 12 hours 29 - 10* 2 g Every 12 - 24 hours * 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.

Paediatric population There are insufficient data to recommend a posology in children aged up to 11 years. Method of administration Cefoxitin may be administered by slow intravenous injection over a period of 3 to 5 minutes. A solution of this medicinal product may also be administered by continuous intravenous infusion.

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Undesirable effects are classified by frequency and system organ class. 000), not known (cannot be estimated from the available data). Frequency of undesirable effects System organ class Frequency not known Immune system disorders Anaphylactic reaction Blood and lymphatic system disorders Eosinophilia Leukopenia Neutropenia (agranulocytosis) Anaemia (including haemolytic anaemia) Thrombocytopenia Bone marrow failure Vascular disorders Local thrombophlebitis after intravenous administration Gastrointestinal disorders Nausea Vomiting Diarrhoea Pseudomembranous colitis Nervous system disorders Encephalopathy (confusion, disorders of consciousness, seizure, abnormal movements)* Hepatobiliary disorders Transaminases increased Blood lactate dehydrogenase increased Blood alkaline phosphatase increased Skin and subcutaneous tissue disorders Rash Urticaria Pruritus Toxic epidermal necrolysis Angioedema Musculoskeletal and connective tissue disorders Myasthenia gravis exacerbation Frequency of undesirable effects System organ class Frequency not known Renal and urinary disorders 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 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.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store..

Hypersensitivity reactions As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefoxitin 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 cefoxitin, to other cephalosporins or to any other type of beta-lactam antibacterial agent. Caution should be used if cefoxitin is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

8). 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.

Non-susceptible microorganisms Prolonged use may result in the overgrowth of non-susceptible micro-organisms, which may require interruption of treatment or other appropriate measures. Risk of encephalopathy 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.

2). Concurrent treatment with diuretics or aminoglycosides 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.

Bacterial meningitis The use of cefoxitin in the treatment of meningitis is not substantiated by appropriate data. Therefore, cefoxitin is not indicated for the treatment of meningitis. Important information about excipients Renoxitin contains sodium.

17 mmol (or 50 mg) of sodium, per g equivalent to 2,5% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Interference with laboratory tests • Coombs test: false-positive results have been observed during treatment with cephalosporins.

This may also occur in patients treated with cefoxitin. • Glycosuria: false-positive results may be observed with reduction substances, however, no interaction has been observed with enzymatic methods. • Jaffe (picric acid) serum creatinine test may show falsely high creatinine values.

This may occur if cefoxitin serum concentrations exceed 100 mcg/ml. Do not perform this assay on serum samples taken less than 2 hours after administration of Renoxitin. • Urinary 17-hydroxy-corticosteroid: Porter Silber reaction may give moderate, falsely increased results in patients with high urinary concentrations of cefoxitin.

1. g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).