CEFOXITIN

‘Cefoxitin 1 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 1 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.

In children with renal insufficiency, the dosage frequency should be reduced as indicated for adults. Prophylactic Administration to Adults 2 g administered intramuscularly or intravenously just prior to surgery ½ to 1 hour before initial incision); then 2g every six hours.

Prophylactic therapy should not usually be given for more than 24 hours. Prophylactic administration for neonates, infants, and children In infants and children, 30-40 mg/kg doses may be given at same times as designated for adults.

However, in neonates, 30-40 mg/kg doses may be given ½ to 1 hour before initial incision and the second and third dose may be given every 8-12 hours. Clinical data are insufficient to recommend use of the intramuscular formulation in infants less than 3 months of age.

Obstetric and Gynaecological Surgery For patients undergoing caesarean section, a single 2 g dose is administered intravenously as soon as the cord is clamped. If necessary, a second and third dose of 2 g may be administered intravenously 4 hours and 8 hours after the first dose.

In gynaecological surgical procedures, a single prophylactic dose of 2 g intravenously or intramuscularly has been effective given ½ to 1 hour before surgery. In prolonged or heavily contaminated cases, additional 2g doses may be given at 6- hour intervals.

Prophylactic therapy does not ordinarily extend beyond 24 hours. Intravenous administration only For direct intravenous injection, ‘Cefoxitin 1 g Powder for Solution for Injection or Infusion’ may be slowly injected into the vein over a period of 3 to 5 minutes or may be given through the tubing when the patient is receiving parenteral solutions.

An intermittent intravenous infusion of ‘Cefoxitin 1 g Powder for Solution for Injection or Infusion’ may be employed when large amounts of fluid are to be given. However, during infusion of the solution containing ‘Cefoxitin 1 g Powder for Solution for Injection or Infusion’, it may be advisable temporarily to discontinue administration of any other infusion solution at the same site (by using an appropriate IV infusion set).

6 ‘Instructions for use and handling’). Intramuscular Administration Only ‘Cefoxitin 1 g Powder for Solution for Injection or Infusion’ is given by deep injection into a large muscle mass. Avoid injection into a blood vessel.

Note:

Some patients may be hypersensitive to lignocaine. Use in the elderly The dosage should be determined by the severity of the infection, the susceptibility of the causative organisms, the patient’s clinical condition and renal function.

Side Effects ‘Cefoxitin 1 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 1 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 1 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 1 g Powder for Solution for Injection or Infusion’, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. ‘Cefoxitin 1 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 1 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 1 g Powder for Solution for Injection or Infusion’ serum concentrations exceed 100 micrograms per ml. Serum samples from patients treated with ‘Cefoxitin 1 g Powder for Solution for Injection or Infusion’ should not be analysed for creatinine if withdrawn within two hours of drug administration.

High concentration of Cefoxitin in the urine may interfere with the measurement of 17- hydroxy-corticosteroids by the Porter-Silber reaction to give slight, falsely increased results. 35 sodium content for 1g and 2g respectively.

‘Cefoxitin 1 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 1 g Powder for Solution for Injection or Infusion’ should not be administered to patients who have shown hypersensitivity to cephalosporins.