Colobreathe (colistimethate sodium dry powder for inhalation): risk of capsule breakage - new instructions for use
- Medicines and Healthcare products Regulatory Agency
- 17 November 2014
- Therapeutic area:
- Paediatrics and neonatology and Respiratory disease and allergy
We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device.
Article date: November 2014
The instructions for inhaler use have been revised to reduce this risk. Demonstrate the new inhaler instructions to patients and carers and supervise the first dose (see below).
Colobreathe (colistimethate sodium dry powder for inhalation) is indicated for the management of chronic Pseudomonas aeruginosa lung infections in patients with cystic fibrosis aged 6 years and older. We remind you to consider official guidance on the appropriate use of antibiotics when prescribing Colobreathe.
Colistimethate sodium is inhaled as a powder from a gelatine capsule using the supplied inhaler device. A piston within the inhaler pierces the capsule allowing the capsule contents to be inhaled.
To date, we have received 26 Yellow Card reports of capsules shattering when pierced. The filter in the inhaler catches pieces of broken capsule shell more than 2 mm wide. However, smaller pieces could be swallowed or inhaled. Some reports of broken capsules have been associated with throat irritation and coughing, although there are no serious safety concerns and patients need not be alarmed if this happens.
The manufacturer has revised the instructions for inhaler use to reduce the risk of capsules breaking. These revised instructions have been included in the patient information leaflet and summary of product characteristics (see below).
Advice for healthcare professionals:
- Demonstrate the new inhaler instructions to patients. The key points are:
- insert the capsule widest end first into the inhaler chamber.
- pierce the capsule gradually using a two-step process
- only pierce each capsule once
- Supervise patients taking their first dose.
- Tell patients and carers to refer to the instructions in the patient information leaflet that comes in the pack.
Colobreathe patient information leaflet (with updated instructions for use)
Article citation: Drug Safety Update volume 8 issue 4, November 2014: A2
 Yellow Card reports are reports of suspected adverse drug reactions (ADRs) taken from all spontaneous and study sources. Spontaneous reports are those submitted voluntarily by healthcare professionals and members of the public in the UK. The number of reports received should not be used to determine the incidence of an ADR. This is because neither the total number of ADRs occurring, nor the number of patients using the drug is known. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, and the extent of use of a particular drug, and may be stimulated by publicity about a drug
Published: 17 November 2014