Effective Pseudomonas aeruginosa treatment for patients with cystic fibrosis (CF)^1,2

Presentation: Inhalation powder, hard transparent capsule containing 1,662,500 IU (equal to 125 mg) of colistimethate sodium. Indications: Management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial active substances. Dosage and administration: First dose should be administered under medical supervision to ensure proper administration. For inhalation use only using the Turbospin^® powder inhaler. Adults and children aged 6 years and older: One capsule to be inhaled twice daily, 12 hours apart. Children <6 years: Not recommended. Renal and Hepatic Impairment: No dose adjustment necessary. If other treatments are being taken, recommended order: inhaled bronchodilators; chest physiotherapy; other inhaled medicines; Colobreathe. Contraindications: Hypersensitivity to active substance, colistin sulphate or polymyxin B. Special warnings and precautions for use: Bronchospasm or coughing may occur on inhalation. These reactions may diminish with continued use or be ameliorated by treatment with beta²-agonists. If bronchospasm or coughing remains problematic, consider discontinuation of treatment. The use of colistimethate sodium in patients with clinically significant haemoptysis should be undertaken or continued only if the benefits of treatment are considered to outweigh the risks of inducing further haemorrhage. If acute respiratory exacerbations develop additional intravenous or oral antibacterial agent therapy should be considered. After each inhalation of Colobreathe, the mouth should be rinsed with water to reduce the risk of oral fungal super-infection and to reduce any unpleasant taste. There is very low transpulmonary absorption of colistimethate after inhalation of Colobreathe. Care should be taken in administering Colobreathe to patients who are known to have a propensity for nephrotoxic or neurotoxic events. Caution should be taken with concomitant use of Colobreathe and parenteral or nebulised colistimethate sodium. 

Caution should be taken with concomitant use of colistimethate sodium and potential nephrotoxic or neurotoxic medicinal products, including non-depolarising muscle relaxants. Use with extreme caution in patients with myasthenia gravis or porphyria. Interactions: In-vivo interaction studies have not been performed. No data available for use with other inhaled antibacterial agents. Use with caution with concomitant use of other formulations of colistimethate sodium due to possibility of summative toxicity. Concomitant use of inhaled colistimethate sodium with other medications that are potentially nephrotoxic or neurotoxic, such as aminoglycosides, or neuromuscular blocking products, such as curariform agents should be undertaken with caution. Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis. Pregnancy and lactation: Not recommended during pregnancy or in women of childbearing potential not using contraception. Risk/benefit assessment for woman and child should be made when woman is breastfeeding. Effects on ability to drive and use machines: Patients should be warned not to drive or operate machinery if symptoms of neurotoxicity occur such as dizziness, confusion or visual disturbances. Undesirable effects: Very Common (≥ 1/10): Dyspnoea, cough, dysphonia, throat irritation, dysgeusia. Common (≥ 1/100 to <1/10): Balance disorder, headache, tinnitus, haemoptysis, bronchospasm, asthma, wheezing, chest discomfort, lower respiratory tract infection, productive cough, crackles lung, vomiting, nausea, arthralgia, pyrexia, asthenia, fatigue, forced expiratory volume decreased. For further information on adverse events please consult the SmPC. Legal category: POM. Presentation & cost: 56 capsule pack and one Turbospin inhaler device £968.80. Marketing authorisation numbers: (56 [7 blisters of 8 capsules]); PLGB 41871/0023. For further information contact Essential Pharma Limited, 8a Crabtree Road, Egham, Surrey, TW20 8RN. Date of last revision: August 2024.