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COLOMYCIN

Information leaflet

                                                    Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Colomycin Injection 1 million International Units.
 Powder for solution for injection, infusion or inhalation.

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each vial contains 1 million International Units Colistimethate Sodium.

 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Powder for solution for injection, infusion or inhalation.

 Sterile white powder in a 10ml colourless glass vial with a red ‘flip-off’ cap.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Colomycin is indicated in the treatment of the following infections where sensitivity testing suggests that they are
 caused by susceptible bacteria:

 Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis (CF).

 Intravenous administration for the treatment of some serious infections caused by Gram-negative bacteria, including
 those of the lower respiratory tract and urinary tract, when more commonly used systemic antibacterial agents may be
 contra-indicated or may be ineffective because of bacterial resistance.

 4.2 Posology and method of administration

 SYSTEMIC TREATMENT
 Colomycin 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 (see section 6.6, Special precautions for disposal of a used medicinal product or waste materials
 derived from such a product and other handling of the product).

 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
 10–15 mg/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 for up to 12 days.

 Children and adults (including the 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.




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Date Printed 23/02/2012                               CRN 2097803                                         page number: 1
                                                    Irish Medicines Board




 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 below 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.

 SUGGESTED DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT

              Grade                  Creatinine clearance (ml/min)             Over 60kg bodyweight

               Mild                              20-50                       1-2 million units every 8hr

             Moderate                            10-20                      1 million units every 12-18 hr

              Severe                              <10                       1 million units every 18-24 hr


 AEROSOL INHALATION
 For local treatment of lower respiratory tract infections Colomycin powder is dissolved in 2-4 ml of water for injections
 or 0.9% sodium chloride intravenous infusion for use in a nebuliser attached to an air/oxygen supply (see section 6.6,
 Special precautions for disposal of a used medicinal product or waste materials derived from such a product and other
 handling of the product).

 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

 4.3 Contraindications

 Hypersensitivity to colistimethate sodium (colistin) or to polymyxin B.

 Patients with myasthenia gravis.

 4.4 Special warnings and precautions for use

 Use with extreme caution in patients with porphyria.

 Nephrotoxicity or neurotoxicity may occur if the recommended parenteral dose is exceeded.

 Use with caution in renal impairment (see section 4.2, Posology and method of administration). It is advisable to
 assess baseline renal function and to monitor during treatment. Serum colistimethate sodium concentrations should be
 monitored.
 Bronchospasm may occur on inhalation of antibiotics. This may be prevented or treated with appropriate use of beta2-
 agonists. If troublesome, treatment should be withdrawn.




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Date Printed 23/02/2012                               CRN 2097803                                         page number: 2
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