Colobreathe (Colistimethate Sodium)

What Is Colobreathe and What Is It Used For?

Colobreathe contains colistimethate sodium, a polymyxin antibiotic delivered as an inhaled dry powder specifically designed to control chronic Pseudomonas aeruginosa lung infections in patients with cystic fibrosis aged 6 years and older.

Colobreathe is an authorised inhaled antibiotic formulation developed for the management of persistent pulmonary infections caused by Pseudomonas aeruginosa in people living with cystic fibrosis (CF). Cystic fibrosis is a genetic condition that leads to the production of abnormally thick, sticky mucus in the lungs, creating an environment where bacteria, particularly P. aeruginosa, can colonise and thrive. Once established, these infections are extremely difficult to eradicate completely and typically require long-term suppressive antibiotic therapy.

Pseudomonas aeruginosa is one of the most clinically significant pathogens in cystic fibrosis. Studies show that nearly all patients with CF will become infected with this bacterium at some point in their lives, with some children acquiring it at a very young age while others develop infection later. Chronic P. aeruginosa infection is associated with accelerated lung function decline, increased frequency of pulmonary exacerbations, reduced quality of life, and increased mortality. Effective control of this infection is therefore a cornerstone of CF management.

The active substance in Colobreathe is colistimethate sodium, an inactive prodrug that is converted to colistin (polymyxin E) after administration. Colistin exerts its antibacterial effect by interacting with lipopolysaccharide (LPS) molecules and phospholipids in the outer cell membrane of Gram-negative bacteria. This interaction disrupts the structural integrity of the bacterial cell membrane, increasing its permeability and ultimately leading to cell lysis and death. This bactericidal mechanism makes colistin particularly effective against multidrug-resistant Gram-negative organisms, including P. aeruginosa strains that have become resistant to other antibiotic classes.

By delivering the antibiotic directly to the lungs through inhalation, Colobreathe achieves high local concentrations at the site of infection while minimising systemic absorption and the associated risk of systemic side effects such as nephrotoxicity (kidney damage) and neurotoxicity. The Turbospin dry powder inhaler device provides a convenient, portable, and battery-free method of drug delivery that does not require the lengthy nebulisation times associated with liquid formulations of colistimethate sodium.

What Should You Know Before Taking Colobreathe?

Colobreathe must not be used if you are allergic to colistimethate sodium, colistin sulphate, or any polymyxin antibiotic. Important warnings apply for patients with myasthenia gravis, porphyria, kidney problems, or nerve disorders. Your first dose should always be given under medical supervision.

Contraindications

Colobreathe is contraindicated in individuals with a known hypersensitivity to colistimethate sodium, colistin sulphate, or other polymyxin antibiotics. Allergic reactions to polymyxins can range from mild skin reactions to severe anaphylaxis, which may include facial swelling, throat tightness, difficulty breathing, widespread rash, and loss of consciousness. If you have previously experienced any allergic reaction to a polymyxin-class antibiotic, you must not use Colobreathe. Inform your prescribing physician about any history of drug allergies, particularly to antibiotics.

Warnings and Precautions

Before starting Colobreathe, discuss the following conditions with your doctor, as they may affect the safety of treatment:

• Previous adverse reactions to dry powder inhalers: If you have experienced negative reactions to other dry powder inhaler medications, inform your doctor before using Colobreathe, unless this has already been discussed with your prescribing physician
• Myasthenia gravis: This is a neuromuscular disorder characterised by muscle weakness and fatigue. Colistimethate sodium and other antibiotics can worsen myasthenia gravis symptoms and should be used with extreme caution in affected patients
• Porphyria: If you have this inherited metabolic disorder, special precautions may be necessary as some medications can trigger porphyria attacks
• Haemoptysis (blood in sputum): If you are currently coughing up blood or have a history of significant haemoptysis, discuss this with your doctor before starting Colobreathe
• Kidney problems: Colistin can be nephrotoxic, particularly when administered systemically. If you have any degree of renal impairment, careful monitoring is required
• Neurological conditions: Colistin has the potential to cause neurotoxic effects. Patients with pre-existing neurological conditions should use Colobreathe with caution

When you first start using Colobreathe, you may experience coughing, breathlessness, chest tightness, or wheezing. These respiratory symptoms are common with the initiation of inhaled dry-powder antibiotics and may decrease with continued use as the airways adapt. However, if these symptoms become severe or persistent, contact your doctor promptly, as your treatment plan may need to be adjusted. Your physician may prescribe a bronchodilator to be taken before your Colobreathe dose to help open the airways and reduce bronchospasm.

After each inhalation, you should rinse your mouth thoroughly with water and spit it out — do not swallow the rinse water. This simple measure significantly reduces the risk of developing oral candidiasis (thrush), a fungal superinfection that can occur during antibiotic therapy, and also helps mitigate the unpleasant taste associated with colistimethate sodium.

Children

Colobreathe is not recommended for children under 6 years of age as there is insufficient data on safety and efficacy in this age group, and the inhaler device requires a certain level of inspiratory effort and coordination that younger children may not be able to achieve reliably. For children aged 6 years and older with cystic fibrosis and chronic P. aeruginosa infection, Colobreathe can be used at the same dose as adults (one capsule twice daily). Side effects observed in paediatric patients have been similar in nature and frequency to those seen in adults.

Pregnancy and Breastfeeding

There is limited clinical data on the safety of Colobreathe during pregnancy. Animal studies are insufficient to draw definitive conclusions about reproductive toxicity. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using Colobreathe. Your physician will discuss the potential benefits of continuing treatment against the possible risks to you and your unborn child, taking into account the severity of your pulmonary infection and your overall health status.

Colistimethate sodium may be excreted in breast milk. Although the amount transferred is likely to be small given the inhaled route of administration, potential effects on the nursing infant cannot be entirely excluded. If you are breastfeeding, discuss the use of Colobreathe with your doctor so that a balanced decision can be made about whether to continue breastfeeding during treatment.

Driving and Using Machines

Colobreathe may cause dizziness, confusion, or visual disturbances in some patients. If you experience any of these symptoms, do not drive or operate machinery until they have completely resolved. Be particularly cautious during the initial period of treatment, when such effects are more likely to occur.

How Does Colobreathe Interact with Other Drugs?

Colobreathe can interact with aminoglycoside antibiotics, macrolide and fluoroquinolone antibiotics (especially in patients with myasthenia gravis), other forms of colistimethate sodium, and neuromuscular blocking agents used during general anaesthesia. Always inform your doctor about all medications you are taking.

Drug interactions are an important consideration with any antibiotic therapy. While Colobreathe is administered by inhalation and has lower systemic absorption compared to intravenous or nebulised colistimethate sodium, clinically relevant interactions can still occur. It is essential to inform your physician and pharmacist about all medications you are currently taking, have recently taken, or might take in the future, including prescription drugs, over-the-counter medicines, and herbal supplements.

Major Interactions

Additional Considerations

While the interactions listed above are the most clinically significant, it is worth noting that colistin can potentiate the effects of non-depolarising neuromuscular blockers such as suxamethonium (succinylcholine) and tubocurarine. If you require general anaesthesia for any reason, ensure your anaesthetist is fully informed about your Colobreathe treatment, as the dosing of neuromuscular blocking agents may need to be adjusted.

Concurrent use of other potentially nephrotoxic drugs — including non-steroidal anti-inflammatory drugs (NSAIDs), vancomycin, amphotericin B, and ciclosporin — should be undertaken with awareness of the cumulative risk of kidney injury. Regular monitoring of kidney function (serum creatinine and estimated GFR) is advisable when Colobreathe is used alongside any of these agents.

What Is the Correct Dosage of Colobreathe?

The recommended dose of Colobreathe for adults and children over 6 years is the contents of one capsule (1,662,500 IU, approximately 125 mg colistimethate sodium) inhaled twice daily, approximately 12 hours apart, using the Turbospin dry powder inhaler device.

Always use Colobreathe exactly as your doctor has prescribed. If you are unsure about any aspect of your dosing regimen, consult your physician or pharmacist for clarification. The dosage is the same for all eligible patients regardless of age or body weight, as the drug is delivered locally to the lungs and dosing does not need to be adjusted for body size in the way that systemic medications might.

Adults and Children Over 6 Years

Your doctor will determine how long you need to continue Colobreathe treatment. In most cases, therapy is intended to be long-term, as chronic P. aeruginosa infection in cystic fibrosis typically requires ongoing suppressive antibiotic treatment to maintain lung function and reduce the frequency of pulmonary exacerbations. Do not stop treatment prematurely unless your doctor advises you to do so.

Order of Treatments

If you are receiving multiple inhaled treatments for cystic fibrosis, they should be taken in the following order to optimise drug delivery and effectiveness:

1. Inhaled bronchodilators (e.g., salbutamol or formoterol) — to open the airways
2. Chest physiotherapy / airway clearance techniques — to mobilise and clear mucus
3. Other inhaled medications (e.g., dornase alfa, hypertonic saline) — as directed by your CF team
4. Colobreathe — inhale last to maximise antibiotic deposition in cleared airways

Your CF specialist team will review this treatment sequence with you and may make adjustments based on your individual needs and response to therapy.

How to Use the Turbospin Inhaler

Colobreathe capsules are designed exclusively for inhalation using the Turbospin device. Do not swallow the capsules. The Turbospin is an inspiratory flow-driven dry powder inhaler made of polypropylene and stainless steel. Your doctor or nurse will demonstrate the correct inhalation technique when you first start treatment. The following steps outline the procedure:

If the capsule becomes stuck in the chamber, tap gently on the inhaler body to dislodge it. Do not press the plunger repeatedly. If the capsule cannot be freed and the powder cannot be inhaled, discard the broken capsule along with any remaining powder and use a new capsule.

A small amount of gelatin capsule shell may occasionally enter your mouth or airways during inhalation. This is harmless, as gelatin is safe if swallowed or inhaled. The risk of capsule fragmentation increases if the capsule is pierced more than once.

Missed Dose

If you forget to take a dose of Colobreathe, take the missed dose as soon as you remember. However, if it is nearly time for your next scheduled dose, do not take two doses within 12 hours. Simply skip the missed dose and continue with your regular dosing schedule. Never take a double dose to make up for a missed one.

Overdose

If you inhale more Colobreathe than prescribed, or if you accidentally swallow a capsule, contact your doctor immediately for advice. Overdose via the inhalation route may lead to increased respiratory side effects. Accidental ingestion of the capsule is unlikely to cause significant systemic absorption, but medical evaluation is recommended as a precautionary measure.

What Are the Side Effects of Colobreathe?

Like all medicines, Colobreathe can cause side effects, although not everyone experiences them. The most common side effects are respiratory in nature, including coughing, breathlessness, throat irritation, voice changes, and an unpleasant taste. Serious allergic reactions are possible but uncommon.

Side effects associated with Colobreathe are predominantly related to the inhalation route of administration and typically affect the respiratory tract. Many patients find that these effects are most prominent when they first begin treatment and may diminish with continued use as the airways become accustomed to the medication. However, it is important to report any persistent or worsening symptoms to your healthcare provider.

The following side effects have been reported with Colobreathe. They are grouped by frequency according to the standard classification used in clinical trials:

The side effects described above have been observed at similar frequencies across all age groups studied. If any side effect becomes severe, or if you notice any effects not listed here, contact your doctor or pharmacist. Reporting suspected adverse reactions is important, as it contributes to the ongoing monitoring of the medicine's benefit-risk balance. In the UK, adverse reactions can be reported to the MHRA via the Yellow Card Scheme. In the EU, report to your national pharmacovigilance authority. In other countries, contact your local regulatory agency.

How Should You Store Colobreathe?

Store Colobreathe at or below 25°C (77°F) in its original blister packaging until immediately before use. The capsules are moisture-sensitive and must be protected from humidity. Keep out of sight and reach of children.

Proper storage of Colobreathe is essential to maintain the stability and efficacy of the medication. The dry powder formulation is sensitive to moisture, and exposure to humidity can compromise the integrity of the powder and reduce the effectiveness of the inhaled dose. Follow these storage guidelines carefully:

• Temperature: Store at or below 25°C (77°F). Do not refrigerate or freeze the capsules
• Packaging: Keep the capsules in their original blister packaging until immediately before use. This provides a moisture barrier that protects the powder
• Moisture protection: If you accidentally peel back the blister foil and expose any capsules, discard those capsules as they may have absorbed moisture
• Expiry date: Do not use Colobreathe after the expiry date printed on the outer carton and blister strip (EXP). The expiry date refers to the last day of the stated month
• Inhaler device: Discard the Turbospin inhaler after all capsules in the pack have been used. Each pack includes a new Turbospin device
• Children: Keep this medicine out of the sight and reach of children at all times
• Disposal: Do not dispose of medicines via wastewater or household waste. Return unused medicines to your pharmacist for proper disposal. This helps to protect the environment

What Does Colobreathe Contain?

Each Colobreathe capsule contains 1,662,500 IU (approximately 125 mg) of colistimethate sodium as the sole active ingredient. The capsule shell is made of gelatin with excipients including polyethylene glycol, sodium lauryl sulphate, and purified water.

Colobreathe is a deliberately simple formulation, containing no additional excipients beyond the capsule shell itself. This minimalist approach reduces the risk of excipient-related adverse effects and allergic reactions. The complete composition is as follows:

Active Ingredient

Colistimethate sodium — 1,662,500 IU per capsule, which corresponds to approximately 125 mg of the active substance. Colistimethate sodium is the inactive prodrug form of colistin (polymyxin E), which is converted to its active form upon contact with the moist environment of the respiratory tract.

Capsule Shell Components

• Gelatin: Forms the structural material of the hard capsule shell. Gelatin is a well-established pharmaceutical excipient derived from collagen
• Polyethylene glycol (PEG): Used as a plasticiser in the capsule shell to improve flexibility and integrity
• Sodium lauryl sulphate: A surfactant that aids in the manufacturing process of the capsule shell
• Purified water: Used during capsule shell manufacturing and present in trace amounts in the final product

Product Description

Colobreathe inhalation powder is supplied as small, hard, transparent gelatin capsules containing a fine white powder. The capsules are packed in blister strips within an outer carton, together with a Turbospin dry powder inhaler device (made of polypropylene and stainless steel). Available pack sizes include a 56-capsule pack (with one Turbospin device, providing a 4-week supply) and an 8-capsule pack (with one Turbospin device, providing a 4-day supply). Not all pack sizes may be marketed in every country. The marketing authorisation holder is Essential Pharma Limited (Malta).