Medazine 1 G/2 G Injection

Treatment: MEDAZINE INJECTION is indicated for the treatment of the infections due to susceptible organisms.

Prophylaxis: MEDAZINE INJECTION is indicated for the prevention of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated, potentially contaminated, or where the occurrence of post-operative infection could be especially serious.

MEDAZINE INJECTION may be administered intravenously or intramuscularly. The dose depends on the susceptibility of the infecting organism, the severity of the infection and the age, weight and renal function of the patient.

Treatment Dosage

Adults

The usual adult dosage is 1 g or 2 g of MEDAZINE INJECTION every 8 hours with a maximum of 3 g every 6 hours in very severe infections.

Dosage in Renal Insufficiency

In adults with renal insufficiency, an initial loading dose of 1 - 2 g may be given. After a loading dose, the recommendations for maintenance dosage may be used as a guide. In the patients undergoing haemodialysis, the loading dose of 1 - 2 g should be given after each haemodialysis, and the maintenance dose should be given as indicated in the table below.

MAINTENANCE DOSAGE OF MEDAZINE INJECTION IN ADULTS WITH REDUCED RENAL FUNCTION

CREATININE CLEARANCE (ml/min) DOSE FREQUENCY

50 u2013 30 1 u2013 2 g Every 8 u2013 12h

29 u2013 10 1 u2013 2 g Every 12 u2013 24h

9 u2013 5 0,5 u2013 1 g Every 12 u2013 24h

< 5 0,5 u2013 1 g Every 24 u2013 48h

Uncomplicated Gonorrhoea

For single dose therapy of uncomplicated gonorrhoea, including that caused by penicillinase-producing strains, the recommended dose is 2 g of MEDAZINE INJECTION intramuscularly given with 1 g of probenecid by mouth (at the same time or up to 1 hour before).

Children (2 years or older): 20 - 40 mg/kg every 6 hours or every 8 hours. In severe infections the total daily dosage may be increased to a maximum of 200 mg/kg but not to exceed 12 g per day. The use in children under 2 years of age is not recommended. In children with renal insufficiency the dose frequency should be reduced as indicated for adults. MEDAZINE INJECTION is not indicated 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.

Prophylaxis Dosage

For prophylactic use in surgery the following dosage is recommended:

Adults

The first dose of 2 g is administered intravenously u00bd to 1 hour pre-operatively. The second and third doses should be given as 2 g intravenously or intramuscularly at 6 hour intervals.

2 years of age and over Children

In case of infants and children, 30 - 40 mg/kg doses may be given at times designated above. Prophylactic therapy should not extend beyond 24 hours.

Hypersensitivity to cefoxitin or cephalosporins, pencillins or any other betalactam class of antibiotics, or any of the other ingredients of the product.

Porphyria.

Should be used with caution in:

• Persons with a history of gastrointestinal disease especially colitis.
• Children younger than 2 years, as safety and efficacy have not been established in this age group.

The diagnosis of pseudomembranous colitis caused by Clostridium difficile must be considered in patients who develop diarrhoea with the use of MEDAZINE INJECTION. This may be life-threatening and appropriate measures should be taken, including discontinuation of MEDAZINE INJECTION.

There is some clinical and laboratory evidence of partial cross-allergenicity between cephamycins and the other u03b2-lactam antibiotics, penicillins and cephalosporins.

Probenecid slows tubular excretion of cefoxitin and increases serum levels thereof.

Enhanced nephrotoxicity with a loop diuretic (e.g. furosemide) may occur. Aminoglycosides (e.g. gentamicin) and other potentially nephrotoxic medicines should be used with caution with MEDAZINE INJECTION.

Possible antagonism between MEDAZINE INJECTION and bacteriostatic antibacterial agents may also occur. MEDAZINE INJECTION may antagonise piperacillin and other u03b2-lactam antibiotics.

The safety of MEDAZINE INJECTION in pregnancy and lactation has not been established. Cefoxitin is excreted in breast milk.

Not specified in the provided text.

Side-effects:

Immune system disorders:

Less frequent: Hypersensitive reactions, anaphylaxis, eosonophilia.

Ear and labyrinth disorders:

Less frequent: Hearing loss.

General disorders and administrative site conditions:

Less frequent: Thrombophlebitis has occurred with intravenous administration. Pain, induration and tenderness after intramuscular injections have been reported.

Skin and subcutaneous tissue disorders:

Less frequent: Maculopapular rash (including exfoliative dermatitis), urticaria, pruritus, fever, toxic epidermal necrolysis, erythma multiforme, Stevens Johnsons Syndrome.

Cardiac disorders:

The following side-effect has been reported and its frequency is unknown: Hypotension.

Gastrointestinal disorders:

Frequent: Nausea, vomiting and diarrhoea have been reported.

Less frequent: Symptoms of pseudomembranous colitis can appear during or after MEDAZINE INJECTION treatment. Prolonged use may result in overgrowth of non-susceptible organisms.

Blood and the lymphatic system disorders:

Frequent: Transient leukopaenia, neutropaenia, thrombocytopaenia.

Less frequent: Haemolytic anaemia, hypoprothrombinaemia. The following side-effects have been reported and their frequencies are unknown: Agranulocytosis, Granulocytopaenia, aplastic anaemia, bone marrow depression, pancytopenia.

Investigations:

The following side-effect has been reported and its frequency is unknown: Some individuals, particularly those with uraemia, may develop positive direct Coombs tests during therapy with MEDAZINE INJECTION.

Hepato-biliary disorders:

The following side-effects have been reported and their frequencies are unknown: Transient elevations in AST, ALT, serum LDH, and serum alkaline phosphatase and jaundice have been reported.

Renal and urinary disorders:

Less frequent: Renal dysfunction. The following side-effect has been reported and its frequency is unknown: Elevations in serum creatinine and/or blood urea levels have been observed. Toxic nephropathy and acute renal failure have been reported.

Treatment is symptomatic and supportive.