Drugs List

Therapeutic Indications

Uses

Ps.aeruginosa lung infections in cystic fibrosis

Administration

For inhalation use only.

Contraindications

Myasthenia gravis
Pregnancy

Precautions and Warnings

Children under 6 years
Haemoptysis
Breastfeeding
Porphyria
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

Pregnancy

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal chest sounds
Anxiety
Arthralgia
Asthenia
Asthma
Bronchospasm (on inhalation)
Candidiasis (mouth or throat)
Chest discomfort
Chest pain
Chest tightness
Convulsions
Cough
Decreased appetite
Diarrhoea
Dysgeusia
Dysphonia
Dyspnoea
Ear congestion
Epistaxis
Fatigue
Flatulence
Forced expiratory volume decreased
Haemoptysis
Headache
Hypersalivation
Hypersensitivity reactions
Increased bronchial secretions
Loss of balance
Lower respiratory tract infection
Nausea
Nephrotoxicity
Pharyngolaryngeal pain
Productive cough
Proteinuria
Purulent sputum
Pyrexia
Rash
Somnolence
Sore mouth
Sore throat
Thirst
Tinnitus
Tooth ache
Unpleasant taste
Vomiting
Weight changes
Wheezing

Presentation

Powder for inhalation containing colistimethate sodium

Drugs List

Therapeutic Indications

Uses

Ps.aeruginosa lung infections in cystic fibrosis

Dosage

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

Adults

Children

Administration

For inhalation use only.

Contraindications

Myasthenia gravis
Pregnancy

Precautions and Warnings

Children under 6 years
Haemoptysis
Breastfeeding
Porphyria
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

Pregnancy

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal chest sounds
Anxiety
Arthralgia
Asthenia
Asthma
Bronchospasm (on inhalation)
Candidiasis (mouth or throat)
Chest discomfort
Chest pain
Chest tightness
Convulsions
Cough
Decreased appetite
Diarrhoea
Dysgeusia
Dysphonia
Dyspnoea
Ear congestion
Epistaxis
Fatigue
Flatulence
Forced expiratory volume decreased
Haemoptysis
Headache
Hypersalivation
Hypersensitivity reactions
Increased bronchial secretions
Loss of balance
Lower respiratory tract infection
Nausea
Nephrotoxicity
Pharyngolaryngeal pain
Productive cough
Proteinuria
Purulent sputum
Pyrexia
Rash
Somnolence
Sore mouth
Sore throat
Thirst
Tinnitus
Tooth ache
Unpleasant taste
Vomiting
Weight changes
Wheezing

Overdosage

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

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: www.nice.org.uk Last accessed: 04 July 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Colistimethate Last revised: 7 September 2013
Last accessed: 6 November 2015