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Drug Details

Negaban 1 g, powder for solution for injection/infusion.

• Presentation
  Powder for solution for injection/infusion. Vial containing a white to pale yellow sterile solid.
• Description
  1 g of temocillin as temocillin sodium.
• Indications
  Negaban is indicated for the treatment of septicaemia, urinary tract infection and lower respiratory tract infection where susceptible gram-negative bacilli are suspected or confirmed. In mixed infections where gram-positive or anaerobic bacteria are also liable to be implicated, co-administration with other appropriate antibacterial agents should be considered. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
• Adult Dosage
  

  Adults (including the elderly): The usual dosage is 1-2 g every 12 hours.

  Children: Insufficient data are available to recommend an appropriate dosage regime.

  Dosage in patients with impaired renal or hepatic functions (adults): Temocillin is mainly excreted renally and unchanged. Excretion is reduced in renal impairment and half-life is increased according to the severity of renal failure. In moderate and severe renal failure, dose adjustments are necessary in accordance with the following regimen:

  Creatinine clearance (ml/min)	Dosage per administration	Interval between administrations
  More than 60	1 to 2 g	12 h
  60 to 30	1 g	12 h
  30 to 10	1 g	24 h
  Less than 10	1 g or 500 mg	48 h or 24 h

  In case of hemodialysis: as a rule, the I.M. route should be avoided, considering the patient's treatment with heparin. I.V. injection of Negaban is recommended, using water for injection as solvent: 1 g (I.V.) every 48 hours, preferably at the end of the hemodialysis. In case of daily hemodialysis: 500 mg (I.V.) after each hemodialysis.

  In case of continuous peritoneal dialysis in ambulatory patients: 1 g Negaban I.M. every 48 hours.

  These data are based on studies where creatinine clearance was used to estimate the degree of renal impairment.

  Limited experience in patients with impaired hepatic function has not indicated a need for a reduction in dosage.

  
  Method of administration:

  Negaban may be administered by intravenous injection, intermittent intravenous infusion or intramuscular injection.

  Intravenous solutions: Negaban solutions should be administered by slow injection into the vein (3-4 minutes) or as an intravenous infusion over a period of 30-40 minutes.

  Intramuscular injection: Negaban may be given intramuscularly after reconstitution. If pain is experienced at the site of I.M. injection, a sterile solution of lidocaine hydrochloride 0.5-1% may be used in place of Water for Injections.

• Contra Indications
  

  The use of Negaban is contraindicated in patients with a history of allergic reactions to any of the penicillins or any other type of beta-lactam drug.

• Special Precautions
  

  Serious and occasionally fatal anaphylactic reactions have been reported in patients receiving therapy with penicillins. If an allergic reaction occurs during therapy with Negaban, the drug must be discontinued.

  Cross-allergy with cephalosporins is frequent (10 to 15%).

  In patients with kidney failure, the posology must be adapted to the degree of insufficiency. Posology and Method of Administration.

  Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. These reactions have sometimes been assessed with abnormalities of coagulation tests and are more likely to occur in patients with renal failure. If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.

  As with any antibiotic, temocillin may be associated with induced pseudomembranous colitis, although animal studies have never shown any induction of Clostridium difficile infection. In case of severe, persistent diarrhoea, caution is recommended, Negaban must be discontinued and suitable therapy be initiated (eg oral metronidazole or oral vancomycin). Preparations which inhibit peristalsis are contra-indicated.

  As with other antibiotics, the possibility of emergence of resistant organisms which might cause superinfections should be kept in mind, particularly during prolonged treatment. Microbiological follow-up may be required to detect any important superinfection. If this occurs, appropriate measures should be taken.

  As with other penicillins, patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously.

  Periodic electrolyte determinations should be made in patients with low potassium reserves and the possibility of hypokalaemia should be kept in mind with patients who have potentially low potassium reserves and who are receiving cytotoxic therapy or diuretics. Modest elevations of indices of liver function may be observed.

  1 vial of Negaban 1 g contains 5 mmol of sodium.

• Interactions
  

  None known.
  

• Adverse Drug Reactions
  

  Undesirable effects are typical of the injectable penicillins: they may include diarrhoea, pain at the site of I.M. injection, occasionally rash, either urticarial or erythematous.

  Certain reactions such as fever, arthralgia or myalgia, sometimes develop more than 48 hours after the start of the treatment. In any case, discontinuance of treatment and recourse to another appropriate antibiotic therapy are essential.

  In common with other ß-lactam antibiotics angioedema and anaphylaxis have been reported.

  There is also a risk of phlebitis and thrombophlebitis with intravenous administration of β-lactam antibiotics, although to a lesser extent in the case of Negaban.

  In patients suffering from renal failure, neurological disorders with convulsions have been reported following the I.V. injection of high doses of penicillin.