Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: RENASCIENCE PHARMA LIMITED, 11 George Street West, Luton, LU1 2BJ, United Kingdom
Hypersensitivity to the active substance, to any other cephalosporin antibiotics or to any of the excipients listed in section 6.1.
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
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.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents and may occur with Cefoxitin (see section 4.8). 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.
Prolonged use may result in the overgrowth of non-susceptible micro-organisms, which may require interruption of treatment or other appropriate measures.
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.
In patients with renal impairment, dosage adjustment should be based on the creatinine clearance and serum creatinine (see section 4.2).
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.
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.
Renoxitin contains sodium.
This medicinal product contains 2.17 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.
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.
There are numerous reports of potentiation of oral anticoagulant activity in patients on antibiotic therapy. The infectious or inflammatory disease background, the age and general condition of the patient appear to be risk factors. In these circumstances, it can be difficult to establish whether the infectious pathology or its treatment has caused the uncontrolled INR. However, certain classes of antibiotics are more involved, including fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and certain cephalosporins.
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.
Renoxitin should therefore only be used during pregnancy if clinically needed.
Cefoxitin is excreted in human milk.
Breast-feeding should be discontinued during administration of Renoxitin to prevent any allergic reactions in the infant.
Renoxitin has a major influence on the ability to drive and use machines especially because of the possible occurrence of encephalopathy (see sections 4.4, 4.8 and 4.9).
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).
Frequency not known: Anaphylactic reaction
Frequency not known: Eosinophilia, Leukopenia, Neutropenia (agranulocytosis), Anaemia (including haemolytic anaemia), Thrombocytopenia, Bone marrow failure
Frequency not known: Local thrombophlebitis after intravenous administration
Frequency not known: Nausea, Vomiting, Diarrhoea, Pseudomembranous colitis
Frequency not known: Encephalopathy (confusion, disorders of consciousness, seizure, abnormal movements)*
Frequency not known: Transaminases increased, Blood lactate dehydrogenase increased, Blood alkaline phosphatase increased
Frequency not known: Rash, Urticaria, Pruritus, Toxic epidermal necrolysis, Angioedema
Frequency not known: Myasthenia gravis exacerbation
Frequency not known: Nephritis interstitial, Blood creatinine increased and/or BUN increased (especially in combination therapy with aminoglycosides and loop diuretics), Severe renal impairment
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.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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