GNH USA

Europe — EMA

Kolneb

GNH USA supplies Kolneb (Colistimethate Sodium), a Polymyxin antibiotic for chronic Pseudomonas aeruginosa lung infection in cystic fibrosis patients.

Colistimethate Sodium

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What is Colistimethate Sodium?

Colistimethate Sodium, the active ingredient in Kolneb, is a Polymyxin antibiotic presented as an inhalation for inhalation use. It treats chronic Pseudomonas aeruginosa lung infection in cystic fibrosis patients.

GNH USA supplies Kolneb as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies, clinics and research institutions worldwide.

What is Colistimethate Sodium used for?

Kolneb is a polymyxin antibiotic used to manage chronic bacterial airway infections in cystic fibrosis. - Chronic Pseudomonas aeruginosa lung infection in cystic fibrosis: reduces bacterial burden and helps preserve lung function. - Persistent airway colonisation by Pseudomonas aeruginosa in cystic fibrosis: aids in long‑term suppression of the pathogen. - Multidrug‑resistant Gram‑negative respiratory infections in cystic fibrosis: provides an alternative option when other agents fail.

What are the side effects of Colistimethate Sodium?

Kolneb may cause a range of adverse reactions, most of which are related to its local pulmonary administration and systemic absorption.

Common Side Effects: - Cough: irritation of the airways may provoke a persistent cough. - Bronchospasm: transient narrowing of the bronchial tubes can occur during inhalation. - Throat irritation: patients often report soreness or a burning sensation in the throat. - Taste disturbance: a metallic or salty taste is frequently noted.

Serious or Rare Side Effects: - Anaphylaxis: severe allergic reaction requiring immediate medical attention. - Respiratory failure: marked decline in breathing function, especially in vulnerable patients. - Nephrotoxicity: systemic absorption can impair kidney function. - Ototoxicity: potential hearing loss or balance disturbances, particularly with high cumulative exposure.

What precautions apply to Colistimethate Sodium?

Before prescribing Kolneb, clinicians should evaluate patient‑specific risk factors and monitor for potential complications. - Renal function monitoring: assess serum creatinine and eGFR regularly due to possible nephrotoxicity. - Auditory assessment: perform baseline and periodic hearing tests to detect ototoxic effects. - Bronchospasm risk: pre‑treat with bronchodilators in patients with reactive airway disease. - Hepatic impairment: use caution in patients with cystic fibrosis‑related liver disease. - Store at room temperature: keep in the original container, protect from moisture and light.

What does Colistimethate Sodium interact with?

Colistimethate Sodium can interact with several drug classes, influencing safety and efficacy.

Major Interactions (Avoid): - Neuromuscular blocking agents (e.g., vecuronium): increased risk of muscle weakness and respiratory compromise. - Aminoglycosides (e.g., gentamicin): additive nephrotoxicity and ototoxicity.

Moderate Interactions (Monitor Closely): - Loop diuretics (e.g., furosemide): may enhance renal toxicity; monitor renal parameters. - Non‑steroidal anti‑inflammatory drugs (NSAIDs): potential for increased kidney injury; assess renal function. - Rifampin: may reduce colistin plasma levels, diminishing efficacy; consider therapeutic drug monitoring.

Frequently asked questions

What is Kolneb used for?+
Kolneb is an inhaled formulation of colistimethate sodium indicated for the treatment of chronic Pseudomonas aeruginosa lung infection in patients with cystic fibrosis. It is designed to deliver the antibiotic directly to the airways, helping to reduce bacterial load and support lung function.
How does colistimethate sodium work?+
Colistimethate sodium binds to lipopolysaccharides and phospholipids in the outer membrane of Gram‑negative bacteria. This binding disrupts membrane integrity, increases permeability, and leads to leakage of cellular contents, ultimately causing bacterial cell death.
What is the usual dose of Kolneb?+
The specific dose and treatment schedule for Kolneb are determined by the prescribing clinician based on the patient’s age, weight, severity of infection, and pulmonary function. Healthcare providers tailor the regimen to achieve optimal therapeutic effect while minimizing risk.
Is Kolneb safe to use during pregnancy or breastfeeding?+
The safety of colistimethate sodium in pregnancy and lactation has not been definitively established. It should be used only if the potential benefit justifies any potential risk to the fetus or infant, and the decision should be made by a qualified healthcare professional.
How do I order Kolneb from GNH USA?+
To order Kolneb, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.
How does Kolneb compare with other treatments for Pseudomonas infection?+
Kolneb delivers colistimethate sodium directly to the lungs, offering higher local concentrations than systemic antibiotics and reducing systemic exposure. Compared with intravenous colistin, inhalation can achieve effective airway levels with a lower risk of systemic nephrotoxicity, making it a preferred option for chronic airway infection in cystic fibrosis.
What are the storage and handling requirements for Kolneb?+
Kolneb should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture and direct sunlight. Do not freeze. Before use, ensure the inhalation device is clean and follow the manufacturer’s instructions for reconstitution or preparation if required.
How is Kolneb administered?+
Kolneb is administered by inhalation using a nebulizer or a compatible inhalation device as directed by the prescriber. The patient inhales the aerosolized solution, allowing the drug to reach the lower respiratory tract. Proper technique and device maintenance are essential for optimal delivery.
What are the most serious risks associated with Kolneb?+
The most serious risks include anaphylactic reactions, respiratory failure, nephrotoxicity, and ototoxicity. Patients should be monitored for signs of allergic response, changes in kidney function, hearing loss, or worsening respiratory status, and the drug should be discontinued if severe adverse events occur.
Who should not use Kolneb?+
Kolneb is contraindicated in individuals with a known hypersensitivity to colistimethate sodium or any component of the formulation. It should also be avoided in patients with severe renal impairment where systemic absorption could exacerbate kidney injury, unless the prescriber determines the benefits outweigh the risks.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Colistimethate Sodium
Route
Inhalation Use
Manufacturer
Teva Nederland B.V.
Origin
EU

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