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Colistimethate sodium dry powder inhalation

Updated 2 Feb 2023 | Polymyxins


Powder for inhalation containing colistimethate sodium

Drugs List

  • colistimethate sodium 1662500unit inhalation powder capsules with device
  • COLOBREATHE 1662500unit inhalation powder capsules with device
  • Therapeutic Indications


    Ps.aeruginosa lung infections in cystic fibrosis


    One capsule (1,662,500 units) is approximately 125mg of colistimethate sodium.


    One capsule (1,662,500 units) to be inhaled twice daily. The dose interval should be as close to 12 hours as possible.


    Children 6 to 18 years
    One capsule (1,662,500 units) to be inhaled twice daily. The dose interval should be as close to 12 hours as possible.

    Children under 6 years


    For inhalation use only.


    Myasthenia gravis

    Precautions and Warnings

    Children under 6 years
    Renal impairment

    Advise ability to drive/operate machinery may be affected by side effects
    Consult national/regional policy on the use of anti-infectives
    Close medical supervision during initial dosing
    Monitor patient during initiation for bronchial hyperresponsiveness
    Monitor respiratory function
    May cause bronchospasm
    Nephrotoxicity or neurotoxicity may occur if recommended dose is exceeded
    Prolonged use may result in superinfection with non-susceptible organisms
    Discontinue if drug-related rash or other hypersensitivity reactions occur
    Bronchodilator therapy may be used to reduce bronchospasm
    Advise patient to rinse mouth with water after each dose

    Pregnancy and Lactation


    Colistimethate is contraindicated during pregnancy.

    Although the manufacturers suggest colistimethate sodium should only be used during pregnancy if the benefit to the mother outweighs the potential risk to the foetus, some sources suggest that use during pregnancy is probably safe.

    There is no adequate data on the use of colistimethate during human pregnancy. Single dose studies in human pregnancy show that colistimethate crosses the placental barrier and there is a risk of foetal toxicity if repeated doses are given to pregnant patients.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Use colistimethate with caution in breastfeeding.

    Colistimethate is secreted in breast milk. Colistin is poorly absorbed orally, it is unlikely to be absorbed in appreciable amounts by the infant.
    However, modification of bowel flora, direct effects on the infant and interference with culture results cannot be excluded.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abnormal chest sounds
    Bronchospasm (on inhalation)
    Candidiasis (mouth or throat)
    Chest discomfort
    Chest pain
    Chest tightness
    Decreased appetite
    Ear congestion
    Forced expiratory volume decreased
    Hypersensitivity reactions
    Increased bronchial secretions
    Loss of balance
    Lower respiratory tract infection
    Pharyngolaryngeal pain
    Productive cough
    Purulent sputum
    Sore mouth
    Sore throat
    Tooth ache
    Unpleasant taste
    Weight changes


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2013

    Reference Sources

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press. Accessed on 6 November 2015.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics: Colobreathe. Forest Laboratories UK Limited. Revised June 2015.

    NICE Evidence Services Available at: Last accessed: 04 July 2017

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Colistimethate Last revised: 7 September 2013
    Last accessed: 6 November 2015

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