Vaxcel Polymyxin E Dosage/Direction for Use

Parenteral administration: intravenous infusion.
Inhalation: nebuliser.
Systemic Treatment: Vaxcel Polymyxin E 1M IU Powder for Injection, Infusion or Inhalation can be given as a 50ml intravenous infusion over a period of 30 minutes. Patients with a totally implantable venous access device (TIVAD) in place may tolerate a bolus injection of up to 2 million units in 10ml given over a minimum of 5 minutes. The dose is determined by the severity and type of infection and the age, weight and renal function of the patient. Should clinical or bacteriological response be slow the dose may be increased as indicated by the patient's condition. Serum level estimations are recommended especially in renal impairment, neonates and cystic fibrosis patients. Levels of 10-15mg/l (approximately 125-200 units/ml) colistimethate sodium should be adequate for most infections. A minimum of 5 days treatment is generally recommended. For the treatment of respiratory exacerbations in cystic fibrosis patients, treatment should be continued up to 12 days.
Children and Adults (Including Elderly): Up to 60kg: 50,000 units/kg/day to a maximum of 75,000 units/kg/day. The total daily dose should be divided into three doses given at approximately 8-hour intervals.
Over 60kg: 1-2 million units three times a day. The maximum dose is 6 million units in 24 hours. Anomalous distribution in patients with cystic fibrosis may require higher doses in order to maintain therapeutic serum levels.
Renal Impairment: In moderate to severe renal impairment, excretion of colistimethate sodium is delayed. Therefore, the dose and dose interval should be adjusted in order to prevent accumulation.
The table as follows is a guide to dose regimen modifications in patients of 60kg bodyweight or greater. It is emphasised that further adjustments may have to be made based on blood levels and evidence of toxicity. (See Table 2.)

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Aerosol Inhalation: For local treatment of lower respiratory tract infections, Vaxcel Polymyxin E 1M IU Powder for Injection, Infusion or Inhalation is dissolved in 2-4ml of water for injections or 0.9% sodium chloride intravenous for use in a nebuliser attached to an air/oxygen supply. In small, uncontrolled clinical trials, doses of from 500,000 units twice daily up to 2 million units three times daily have been found to be safe and effective in patients with cystic fibrosis. The following recommended doses are for guidance only and should be adjusted according to clinical response: Children <2 years: 500,000-1 million units twice daily.
Children >2 years and adults: 1-2 million units twice daily.
Incompatibilities: Mixed infusions, injections and nebuliser solutions involving colistimethate sodium should be avoided.
Directions for Use: Parenteral Administration: The normal adult dose of 2 million units should be dissolved in 10-50ml of 0.9% sodium chloride intravenous infusion or water for injections to form a clear solution. The solution is for single use only and any remaining solution should be discarded.
Inhalation: The required amount of powder is dissolved preferably in 2-4 ml 0.9% sodium chloride solution and poured into the nebuliser. Alternatively, water for injections may be used. The solution will be slightly hazy and may froth if shaken. Usually jet or ultrasonic nebulisers are preferred for antibiotic delivery. These should produce the majority of their output in the respirable particle diameter range of 0.5-5.0 microns when used with a suitable compressor. The instructions of the manufacturers should be followed for the operation and care of the nebuliser and compressor. The output from the nebuliser may be vented to the open air or a filter may be fitted. Nebulisation should take place in a well-ventilated room. The solution is for single use only and any remaining solution should be discarded.