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Page 1 of 6

Program (ChAMP)

MONOGRAPH

Colistimethate Sodium (Intravenous) Monograph - Paediatric

Scope (Staff): Medical, Nursing, Pharmacy

Scope (Area):

This document should be read in conjunction with this DISCLAIMER

DESCRIPTION

Colistimethate sodium is a bactericidal polymyxin antibacterial (also known as polymixin E) It is a pro-drug of colistin base that binds to lipopolysaccharides in the bacterial cell wall changing its permeability.(1-4)

Colistimethate sodium is a High Risk Medicine.

INDICATIONS AND

RESTRICTIONS

Colistimethate sodium is used in the treatment of multi-drug resistant gram negative bacterial infections due to Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and

Acinetobacter spp.(1, 2, 4, 5)

IV: Restricted (red) antibiotic

ChAMP approval is required prior to prescription.

Nebulised: Monitored (orange) antibiotic

Refer to separate Inhaled Colistimethate Sodium monograph CONTRAINDICATIONS Hypersensitivity to colistimethate sodium, colistin, or any component of the formulation.(1, 4) PRECAUTIONS The ChAMP pharmacist or a clinical pharmacist should be consulted prior to prescribing (see dosage below).

The drug should prescribed as colistin base.(4)

As colistimethate sodium and colistin base are not interchangeable care must be taken not to use these terms interchangeably. The following table may be a useful guide.

International units of

Colistimethate sodium

Colistin base

1 million 33.33 mg

Calculate dosage for obese patients based on ideal body weight Refer to Guidelines for Drug Dosing in Overweight and Obese Children 2 to 18 years of Age for information on calculation of ideal body weight.(1, 3-5)

Colistimethate Sodium (Intravenous)

Monograph - Paediatric

Page 2 of 6 Program (ChAMP) Consider using actual weight if treating patients with severe burns.(1, 3, 5) Use of colistimethate sodium in patients with myasthenia gravis may worsen symptoms.(2) Use of colistimethate sodium in patients with neurological disease may increase the risk of neurotoxicity. Additionally renal impairment increases the risk of neurotoxicity, dose adjust accordingly and use with caution.(1)

FORMULATIONS Available at PCH:

Intravenous injection:

150mg colistin base (equivalent to 4.5 million units of

colistimethate sodium) powder for injection.

Inhalation:

33.33mg colistin base (equivalent to 1 million units of

colistimethate sodium) powder for reconstitution and nebulisation. Refer to separate Inhaled Colistimethate Sodium monograph.

Other preparations available:

Nil DOSAGE The doses listed below fall within the standard range. Higher doses may be prescribed for certain situations in consultation with an infectious diseases or clinical microbiology consultant.

Neonates (less than 30 days of age):

Not routinely used in neonates, contact Infectious Disease or

Microbiology consultants for advice.

Children (1 month to 18 years):

Consider using actual body weight for patients with severe burns.(2) IV dose calculations should be done in conjunction with a pharmacist and stated as colistin base. IV: Usual dose: 5 to 8 mg/kg/DAY (to a maximum of 450mg

DAILY) in three divided doses.(2, 3)

Note: Close monitoring for nephrotoxicity and neurotoxocity is required for all patients receiving colistimethate sodium.3

Inhalation:

All doses are expressed as colistin base and should be calculated based on ideal body weight.(3, 5)

Colistimethate Sodium (Intravenous)

Monograph - Paediatric

Page 3 of 6 Program (ChAMP) Please refer to the separate Inhaled Colistimethate Sodium monograph.

DOSAGE

ADJUSTMENT

Overweight and obese patients:

Dosage adjustments may be required in obese patients; doses should be calculated based on ideal body weight.(2, 3, 5) Refer to the Guidelines for Drug Dosing in Overweight and Obese Children 2 to 18 years of Age for information on how to calculate ideal body weight.

Dosage adjustment required in renal impairment:

Colistimethate sodium should be avoided in renal impairment where ever possible due to an increased risk of toxicity and worsening of renal impairment.(1) To calculate the estimated glomerular filtration rate (eGFR) use the following formula: eGFR (mL/min/1.73m2) = 36.5 x height (in cm)

Serum creatinine (micromol/L)

Clcr > 80mL/minute = normal dosing

Clcr 50 to 79mL/minute = 2.5 to 3.8mg/kg/DAY in two divided doses Clcr 30 to 49mL/minute = 2.5mg/kg/DAY in one OR two divided doses

Clcr 10 to 29mL/minute = 1.5mg/kg/dose 36 hourly

Clcr < 10mL/minute = avoid use.(1)

Contact pharmacy for advice on dose adjustment in patients on renal replacement therapy.

Dosage adjustment required in hepatic impairment:

Colistimethate sodium should be used cautiously in patients with hepatic impairment however no dosage adjustments are required.(5, 6) RECONSTITUTION Reconstitute each 150mg vial with 2mL of water for injection(1, 4,

7) to give a final concentration of 75mg/mL (negligible powder

volume). This should be swirled gently (not shaken) to avoid frothing.(1, 4, 7)

ADMINISTRATION

IV injection:

After reconstitution, give via slow IV injection over 3 to 5 minutes.(7)

IV infusion:

Colistimethate Sodium (Intravenous)

Monograph - Paediatric

Page 4 of 6 Program (ChAMP) After reconstitution, dilute further to a suitable volume with compatible fluid and infuse over 30 minutes.(4, 7) For patients with any degree of renal impairment, consider using a slower rate of infusion (e.g. over 1 to 2 hours).(7) MONITORING Renal function, urine output and full blood picture should be monitored at baseline and regularly during the course of treatment.(2, 4, 5) Therapeutic drug monitoring has been recommended but is not widely available. Contact ChAMP or Infectious Diseases for further information.

ADVERSE EFFECTS

Common: nephrotoxicity (includes increased serum creatinine, haematuria, proteinuria, oliguria and rarely tubular necrosis), neurotoxicity (e.g. paraesthesia, dizziness, muscle weakness, ataxia, confusion, visual effects), confusion, presyncope, psychosis, slurred speech, visual impairment.(2, 5) (5) Rare: hypersensitivity reactions (including skin rash), apnoea, sensory disorder.(2, 5)

COMPATIBLE FLUIDS Glucose 5%

Glucose/sodium chloride solutions

Sodium chloride.(7)

STORAGE Vial: store below 25°C.(7)

INTERACTIONS Colistimethate Sodium may interact with other medications; please consult PCH approved references (e.g. Clinical Pharmacology), your ward pharmacist or Pharmacy on extension 63546 for more information. Aminoglycosides: May enhance the nephrotoxic and the neuromuscular-blocking effect of Colistimethate.(1, 2) Vancomycin and other nephrotoxic drugs: May enhance the nephrotoxic effect of Colistimethate.(1) Clindamycin and lithium: may increase the neuromuscular blocking effect of colistin; use with caution and monitor for adverse effects.(1) Colistin: may prolong action of non-depolarising neuromuscular blockers; reduce dose of neuromuscular blocker and monitor its effects closely.(1, 2, 4)

Colistimethate Sodium (Intravenous)

Monograph - Paediatric

Page 5 of 6 Program (ChAMP) COMMENTS Each 150mg vial contains 1.09mmol of sodium.(7)

MANUFACTURER

SAFETY DATA SHEET

(SDS) To access to the Manufacturer SDS for this product, use the following link to ChemAlert.

**Please note: The information contained in this guideline is to assist with the preparation and administration

of colistimethate sodium. Any variations to the doses recommended should be clarified with the prescriber

prior to administration** Related CAHS internal policies, procedures and guidelines

Antimicrobial Stewardship Policy

ChAMP Empiric Guidelines and Monographs

KEMH Neonatal Medication Protocols

Guidelines for Drug Dosing in Overweight and Obese Children 2 to 18 years of Age References and related external legislation, policies, and guidelines

Colistimethate Sodium (Intravenous)

Monograph - Paediatric

Page 6 of 6 Program (ChAMP)

This document can be made available in

alternative formats on request for a person with a disability. File Path: W:\Safety & Quality\CAHS\CLOVERS MEDICAL Pharmacy\Procedures Protocols and

Guidelines\ChAMP

Document Owner: Head of Department Infectious Diseases

Reviewer / Team:

Date First Issued: October 2013 Last Reviewed: September 2020 Amendment Dates: December 2017, September 2020 Next Review Date: November 2023 Approved by: Medication Safety Committee Date: November 2020 Endorsed by: Chair, Drug and Therapeutics Committee Date: November 2020

Standards

Applicable: NSQHS Standards:

NSMHS: N/A

Child Safe Standards: N/A

Printed or personally saved electronic copies of this document are considered uncontrolledquotesdbs_dbs44.pdfusesText_44

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