CEFOXITIN

‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ may be administered intravenously or intramuscularly. ) Dosage and route of administration should be determined by severity of infection, susceptibility of the causative organisms, and condition of the patient.

Therapy may be started while awaiting the results of susceptibility testing.

Adults Dosage:

The usual adult dosage is 1 g or 2 g of ‘Cefoxitin Powder for Solution for Injection or Infusion’ every eight hours. ) Usual adult dosage Type of infection Dose Frequency Total daily dosage Uncomplicated 1g Every 8 hours (occasionally every 6 hours) 3g (4g) Moderately severe or severe 2g Every 8 hours (occasionally every 6 hours) 6g (8g) Infections generally needing antibiotics in higher dosage 3g (2g) Every 6 hours (Every 4 hours) 12g In adults with renal insufficiency, an initial loading dose of 1 g to 2 g may be given.

After a loading dose, the following recommendations for maintenance dosage may be used as a guide. 5-1 g Every 24-48 hours In the patients undergoing haemodialysis, the loading dose of 1 to 2g should be given after each haemodialysis, and the maintenance dose should be given as indicated in the table above.

Uncomplicated urinary tract infections In uncomplicated urinary tract infections due to susceptible organisms, 1 g intramuscularly twice a day for ten days has been shown to be effective. Uncomplicated gonorrhoea For single dose therapy of uncomplicated gonorrhoea, including that caused by penicillinase-producing strains, the recommended dose is 2 g of ‘Cefoxitin Powder for Solution for Injection or Infusion’ intramuscularly given with 1 g of probenecid by mouth (at the same time or up to one hour before) Neonates, infants and children Neonates * 0-1week of age 20-40mg/kg every 12 hours 1-4weeks of age 20-40mg/kg every 8 hours Infants * 20-40mg/kg every 6 hours or every 8 hours Children 20-40mg/kg every 6 hours or every 8 hours * Clinical data are insufficient to recommend use of the intramuscular formulation in infants less than 3 months of age.

In severe infections, the total daily dosage may be increased to 200 mg/kg, but not to exceed 12 g per day. ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ is not recommended for the therapy of meningitis. If meningitis is suspected an appropriate antibiotic should be used.

Side Effects ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ is generally well tolerated. Side effects have usually been mild and transient and treatment rarely needs to be stopped. The most common side effects have been local reactions following intravenous or intramuscular injection.

Local reactions Thrombophlebitis has occurred with intravenous administration. Pain, induration and tenderness after intramuscular injections have been reported. Allergic Rash (including exfoliative dermatitis and toxic epidermal necrolysis), urticaria, flushing, pruritus, eosinophilia, fever and other allergic reactions (including anaphylaxis, interstitial nephritis and angioedema) have been reported.

Cardiovascular Hypotension. Gastro-intestinal Diarrhoea, including pseudomembranous colitis can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely. Blood Eosinophilia, leucopenia including granulocytopenia, neutropenia, anaemia including haemolytic anaemia, thrombocytopenia and bone-marrow depression have been reported.

Some individuals, particularly those with azotaemia, may develop positive direct Coombs tests during therapy with ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’. Musculoskeletal Worsening myasthenia gravis (single case) Liver function Transient elevations in AST (SGOT), ALT (SGPT), serum LDH, serum alkaline phosphatase and jaundice have been reported.

Kidney function Elevations in serum creatinine and/or blood urea levels have been observed. Acute renal failure has been reported rarely. The role of ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ in changes in renal function tests is difficult to assess, since factors predisposing to pre-renal azotaemia or to impaired renal function usually have been present.

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.

There is some clinical and laboratory evidence of partial cross-allergenicity between cephamycins and other beta-lactam antibiotics, penicillins, and cephalosporins. Severe reactions (including anaphylaxis) have been reported with most beta-lactam antibiotics.

Before therapy with ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ should be given cautiously to penicillin-allergic patients.

Any patient who has demonstrated some form of allergy, particularly to drugs, should be given antibiotics cautiously. If an allergic reaction to ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ occurs, the drug should be discontinued.

Pseudomembranous colitis, reported with virtually all antibiotics, can range from mild to life threatening in severity. Antibiotics should be prescribed with caution in patients with a history of gastro-intestinal disease, particularly colitis.

Treatment- related diarrhoea should always be considered as a pointer to this diagnosis. While studies indicate that a toxin of Clostridium difficile is one of the primary causes of antibiotic-related colitis, other causes should be considered.

2 ‘Posology and method of administration’) because high and prolonged serum antibiotic concentrations can occur from usual doses. Interference with laboratory tests A false-positive reaction to glucose in the urine may occur with reducing substances but not with the use of specific glucose oxidase methods.

Using the Jaffe Technique, falsely high creatinine values in serum may occur if ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ serum concentrations exceed 100 micrograms per ml. Serum samples from patients treated with ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ should not be analysed for creatinine if withdrawn within two hours of drug administration.

‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ is contra-indicated in persons who have shown hypersensitivity to Cefoxitin. In the absence of clinical experience, ‘Cefoxitin 2 g Powder for Solution for Injection or Infusion’ should not be administered to patients who have shown hypersensitivity to cephalosporins.