Colimycin

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Colimycin

Treatment option: Infection, Cystic Fibrosis

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Colimycin

Property Description
Active ingredient Colistimethate Sodium (CMS)
Form Powder for solution (injection/inhalation)
Pharmacological class Polymyxin Class Antibiotic
General Purpose Treatment of severe multi-drug resistant Gram-negative infections
Origin Semi-synthetic

What is Colimycin and Its Pharmacological Class?

Colimycin is a powerful prescription-only medicine whose active ingredient is Colistimethate Sodium (CMS). This compound is classified as a polypeptide antibiotic and is a key agent within the Polymyxin class antibiotic group. The drug is derived from the bacterium Bacillus polymyxa, making it a semi-synthetic substance. Colistimethate Sodium functions as a prodrug, an inactive precursor that requires chemical conversion (in vivo hydrolysis) to its potent, bacteria-killing form, Colistin (or Polymyxin E). This prodrug status is a differentiating factor that impacts the drug’s stability and administration profile.


Form and General Purpose of Colistimethate Sodium

CMS is typically supplied as a sterile powder for solution which must be reconstituted with fluid (using an aqueous base) prior to administration. This medication's primary purpose is to act as a bactericidal agent against severe, pervasive infections. It is reserved as a last-resort antibiotic for managing illnesses caused by multi-drug resistant (MDR) Gram-negative bacteria, most notably Pseudomonas aeruginosa, which poses a significant challenge in patient groups like those with chronic pulmonary infections related to cystic fibrosis. The therapeutic value of Colistimethate Sodium is relevant where limited treatment options are available.


How is Colimycin Classified as a Bactericidal Agent?

The classification of Colimycin as a bactericidal agent is based on the fact that its active component, Colistin, directly kills the targeted bacteria. This action relies on a mechanism known as membrane disruption. Colistin works by physically attaching to the negatively charged lipopolysaccharide (LPS) on the bacterial surface, thereby breaking down the protective outer and inner cell membranes. This specific, destructive physiological action is effective, allowing it to eliminate pathogens that have developed resistance to other antibiotic classes.

Regulatory References

  1. European Public Assessment Report (EPAR) for Colobreathe

What side effects are possible with Colimycin?

Possible Side Effects and Safety Information

The safety profile of Colimycin (Colistimethate Sodium) is defined by officially documented adverse reactions, which are classified by regulatory agencies based on their frequency and the body system affected. The most critical safety considerations relate to potential toxicity.

Officially Documented Adverse Reactions

The primary safety concerns noted in regulatory documents are Nephrotoxicity (effects on the kidneys) and Neurotoxicity (effects on the nervous system). These effects are often dependent on the dose administered.

Classification System-Organ Class Examples of Officially Listed Reactions
Common (1% to 10%) Nervous System Disorders Transient neurological disturbances, including paresthesia (tingling/numbness) of the extremities and face, vertigo, dizziness, slurring of speech.
Uncommon/Not Known Renal and Urinary Disorders Impaired renal function, increased blood urea nitrogen (BUN) and creatinine.
Uncommon/Not Known Respiratory Disorders Respiratory arrest, apnea (cessation of breathing).
Uncommon/Not Known Gastrointestinal Disorders Diarrhea, including Clostridioides difficile-associated diarrhea (CDAD).
Uncommon/Not Known Immune System Disorders Hypersensitivity reactions, including urticaria or drug fever.

Serious Safety Considerations

Serious adverse reactions documented in official labeling include Respiratory Arrest or Apnea, particularly when co-administered with other medications that affect muscle control or in patients with impaired kidney function. Nephrotoxicity can lead to acute renal failure, which is generally reversible upon discontinuation of the medicine. Anaphylaxis is also listed as a serious hypersensitivity risk.

Population-Specific Safety Notes

The regulatory profile specifies a higher risk of toxic reactions for patients with impaired renal function, requiring mandatory dose reduction. Furthermore, official documents note that the drug crosses the placental barrier, requiring careful consideration for use during pregnancy.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosage of Colimycin (colistimethate sodium) is primarily associated with serious effects on the kidneys and the neuromuscular system.

Documented Overdose Presentations

Overexposure, typically from administering amounts that exceed the kidney's ability to excrete the drug, can lead to dangerously high blood levels. The critical clinical manifestations of overdose include:

  • Renal Insufficiency: A continuous cycle of rising drug levels and kidney impairment, which can progress to acute renal shutdown.
  • Muscle Weakness: A significant sign of neurotoxicity resulting from the drug interfering with nerve transmission at neuromuscular junctions.
  • Apnea (Respiratory Arrest): This is a severe, life-threatening consequence of profound muscle weakness affecting the breathing muscles.

When to Seek Immediate Medical Help

Immediate medical attention is required if any signs of impaired kidney function or neurological changes are observed. These symptoms indicate a potentially severe overdose state.

Signs indicating a need to seek urgent medical attention include:

  • A noticeable decrease in urine output.
  • Unexplained muscle weakness or slurred speech.
  • Any difficulty breathing or the onset of shallow breathing.

Special caution and dosage adjustments are necessary for individuals with pre-existing impaired renal function or advanced age, as these conditions significantly increase the risk of high serum levels and subsequent neurotoxicity, including apnea.

Therapeutic Uses of Colimycin

Colimycin (colistimethate sodium) is commonly used across therapeutic domains where additional symptomatic support is needed, applied in addressing conditions presenting with acute episodes used in situations involving certain distressing symptoms. The intravenous form is relevant for easing symptoms related to physical discomfort caused by selected aerobic Gram-negative pathogens. This medication is considered relevant for managing symptoms related to inflammatory or irritative states and systemic imbalance when a susceptible bacterium, such as Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae, is identified as the cause.

Colimycin plays a role in managing conditions characterized by periods of heightened symptoms, especially those involving multi-drug resistance. This clinical scenario often involves symptoms that create noticeable physiological strain. The medication may assist with maintaining functional stability in contexts involving heightened systemic burden.

The inhaled formulation, for example, may be part of symptomatic management for chronic pulmonary infections due to P. aeruginosa in patients with cystic fibrosis. For patients experiencing these difficult episodes, the support provided by this medication helps ease the overall symptom burden.

“Colimycin is commonly used to help with symptomatic management in settings marked by temporary physiological imbalance, contributing to the management of systemic and localized discomfort.”


Quick Fact: May provide supportive relief for Symptoms that Create Noticeable Physiological Strain

Eligibility and Restrictions for Use

Who can and cannot use Colimycin?

The population eligibility for Colimycin (Colistimethate Sodium) is strictly defined by regulatory documents, distinguishing between populations permitted for use, those for whom use is contraindicated, and those requiring conditional caution.

Contraindicated and Restricted Use

The medicine is contraindicated in patients with a known history of hypersensitivity to Colistimethate Sodium, Colistin, or any component of the formulation.

Conditional use is required for patients with Impaired Renal Function, where use is permitted but subject to the greatest caution. Similarly, patients with pre-existing conditions such as Myasthenia Gravis or Porphyria must only use the medicine with extreme caution if clearly necessary.

Age and Life-Stage Eligibility

Colimycin is generally approved for use in Adults and Pediatric Patients (children) for intravenous and intramuscular administration. However, for the inhaled formulation, the minimum eligible age is 6 years for patients with cystic fibrosis. Caution is advised for Infants under 1 year due to immature renal function.

For Pregnant Women, use is conditional and should only occur if the potential benefit justifies the potential risk. Use is generally not recommended for Nursing Women due to drug secretion into human milk.

What should I know about interactions with other medicines?

Official Interaction Profile

The official interaction profile for Colistimethate Sodium (CMS) is structured around two primary categories of risk documented in regulatory labeling.

1. Pharmacodynamic Interaction: Neuromuscular Blockade Potentiation

CMS exhibits an additive effect on the neuromuscular system. The co-administration of CMS with curariform muscle relaxants (e.g., tubocurarine, succinylcholine, decamethonium) is documented to potentiate their effects, raising the risk of respiratory arrest. This potentiation is also noted with other agents that interfere with nerve transmission, including certain antibiotics (such as aminoglycosides and Polymyxin B) and other substances like Ether or Sodium Citrate.

2. Pharmacokinetic/Toxicity Interaction: Additive Nephrotoxicity

The concomitant use of CMS with other medicinal products known to be nephrotoxic increases the overall risk or severity of kidney impairment. This additive toxicity can result in reduced renal clearance of the drug, leading to higher plasma concentrations of the active component, Colistin. Regulatory labels state that the co-administration of Sodium Cephalothin is a combination that should be avoided due to the documented potential for enhanced nephrotoxicity.

Administration Constraints and Specific Considerations

The risk of neuromuscular blockade and apnea is amplified in patients with impaired renal function (including the elderly), due to the drug’s reduced excretion. Additionally, a procedural constraint exists for the nebulised route of administration: Nebulised CMS and nebulised Dornase-alfa must be separated by at least one hour.

Mechanism of Action

How Colimycin Works — Mechanism of Action

The mechanism of Colimycin relies on its active component, Colistin, which employs an electrostatic interaction to bind to the Lipopolysaccharide (LPS) layer of the Gram-negative bacterial outer membrane. Colistin physically displaces the stabilizing Ca^2+ and Mg^2+ ions, causing the membrane structure to lose integrity and destabilize. The resulting disruption allows the molecule to penetrate and create pores in the inner membrane, leading to the rapid leakage of cellular contents (e.g., nucleotides and ions).

Colistimethate Sodium (CMS) is administered as an inactive prodrug that must undergo in vivo hydrolysis to generate the active form, Colistin, which is necessary to initiate the membrane-disrupting sequence. This activation ensures the generation of the active molecule required for binding to the anionic bacterial target. Beyond its direct membrane-disrupting action, Colistin binds to the Lipid A component of LPS, a molecule that acts as an endotoxin. Binding to this structure neutralizes the endotoxin, inhibiting its ability to initiate downstream inflammatory signaling. The mechanism's efficacy is critically dependent on the negative charge of the LPS target; therefore, resistance occurs when bacteria enzymatically modify the Lipid A structure to reduce this negative charge. This target alteration prevents the essential electrostatic binding of Colistin, rendering the bactericidal (cell-killing) action ineffective.

Dosage and Administration Information

Colistimethate Sodium (Colimycin) is administered according to specific clinical protocols that define its route, dosage, and preparation.

Administration Scope

Feature Administration Parameters
Route of Administration The medicine is used for intravenous (IV) infusion and nebulised inhalation. It may also be used via intrathecal or intraventricular injection for specific scenarios.
Dosing Schedule Standard adult systemic doses are either expressed in International Units (IU) (e.g., a 9 Million IU loading dose) or in milligrams of Colistin Base Activity (CBA) (e.g., 2.5 to 5.0 mg/kg/day). Maintenance doses are typically divided into two to four doses per day.
Preparation Requirements Supplied as a powder, the medicine must be reconstituted using a diluent such as Sterile Water for Injection. Reconstitution requires gentle swirling to prevent foaming.
Special Procedural Conditions Systemic administration requires delivery as a slow IV infusion lasting 30 to 60 minutes. The product is administered in a hospitalized setting or under medical supervision. For IV/IM use, the reconstituted solution should be used within 24 hours.

Population-Specific Rules

Dose adjustments are mandatory for patients with impaired kidney function (low Creatinine Clearance) to prevent accumulation, reflecting standard clinical constraints. For children le 40 kg, the systemic dose is calculated on a weight basis and typically divided into three daily doses.


Recent Clinical Evidence

Colimycin: Recent Clinical Evidence

Colimycin (Colistimethate Sodium, CMS) has been studied primarily in patients with infections caused by multi-drug resistant (MDR) Gram-negative bacteria, where treatment options are often limited. Research focuses on two main uses: inhaled therapy for chronic lung infection and intravenous therapy for severe systemic infections.


Evidence for Chronic Lung Infection (Inhaled Use)

For patients with Cystic Fibrosis (CF) who have chronic Pseudomonas aeruginosa infection, Randomized Controlled Trials (RCTs) and Systematic Reviews have been conducted. These studies monitored adult and pediatric populations, examining changes in lung function ( FEV1) and the frequency of pulmonary exacerbations. Findings often described patterns related to the maintenance of lung function over intermediate-term periods. However, long-term effects beyond the trial durations and evidence for the youngest patients remain areas of uncertainty.


Evidence for Severe Systemic Infections (Intravenous Use)

In critical care settings, intravenous Colimycin has been evaluated in observational cohort studies and small, open-label RCTs for severe illnesses like sepsis caused by MDR pathogens. Research examined endpoints such as all-cause mortality, bacteriological eradication, and favorable clinical outcome rates in critically ill adults. This evidence base is often characterized by high variability among patient cohorts and treatment protocols. A key limitation is the lack of large, double-blind RCTs for systemic MDR infections.


What Remains Uncertain About Colimycin Research

Scientific certainty remains low in several areas. Follow-up durations were limited for acute infections, meaning knowledge about long-term functional impact is incomplete. Data also show patterns related to variability in dosing, which presents a challenge in critically ill patients where the amount of drug reaching the infection site is known to be variable in research. Research in specific groups, such as those with conditions requiring dose adjustment, remains insufficient.

Frequently Asked Questions (FAQ)

Common questions about Colimycin (FAQ)

Q: Can taking Colimycin make you feel really tired?

Official prescribing information notes common neurological disturbances, such as dizziness and vertigo (a spinning sensation). Although general fatigue or tiredness is not explicitly listed as a frequent side effect, patients may experience these neurological effects.

Q: Is Colimycin safe to use during pregnancy or while breastfeeding?

Regulatory documents state that Colimycin is known to cross the placental barrier to the unborn baby. Use during pregnancy should only occur if the potential benefit is judged to justify the potential risk. Due to drug secretion into human milk, use is generally not recommended for nursing women, according to official labeling.

Q: Is it normal to have a metallic taste after taking Colimycin?

Official regulatory documents do not list a metallic taste or taste disturbance (dysgeusia) among the common or frequent side effects. However, other transient neurological disturbances and various gastrointestinal effects, such as diarrhea, are documented safety concerns.

Q: How long does Colimycin stay in your system after the last dose?

The speed at which Colimycin is cleared from the body is highly dependent on kidney function. The half-life is typically short in patients with normal kidney function. However, the clearance time is significantly prolonged in patients with impaired kidney function, requiring mandatory dose adjustments.

Q: Is there a generic version of Colimycin available?

Yes, official drug resources, such as those maintained by the FDA, confirm that generic versions of the active ingredient, Colistimethate Sodium for injection, are available.

Q: Is Colimycin used for UTIs or is it only for respiratory issues?

According to the official product indications, the medicine is indicated for treating infections caused by susceptible Gram-negative bacteria. This includes infections affecting the urinary tract, in addition to severe respiratory and other systemic infections.

Q: Is Colimycin used in veterinary medicine too?

Official documents confirm that Colistin (the active component of Colimycin) is used in veterinary medicine. It is administered for treating diseases caused by sensitive bacteria in specific animal populations.

Q: Is the powdered form of Colimycin only for inhalation?

No, the powdered form of Colimycin (Colistimethate Sodium) is supplied as a sterile powder for solution. After reconstitution with fluid, the resulting solution is approved for both intravenous (IV) injection/infusion into the vein and for nebulised inhalation into the lungs.

Q: Can patients with liver disease take Colimycin?

Since the drug is primarily eliminated by the kidneys, official warnings and dose adjustments are focused on patients with impaired kidney function. Liver-specific warnings are not a primary focus in the main prescribing information.

Q: What does the term 'Colimycin resistance' mean for treatment options?

Bacterial resistance to Colimycin can occur, which potentially reduces the number of effective antibiotic options available for the treatment of future infections. For this reason, official guidance stresses using the medicine only when it is clearly necessary.

How should Colimycin be stored and disposed of?

Storage and Disposal of Colistimethate Sodium

Storage Requirements

The unreconstituted powder must be stored at controlled room temperature, typically between 15 C to 30 C (59 F to 86 F), and must not exceed 25 C per some labeling. The vial must be kept in its original outer carton to protect from light.

Stability and Child Safety

Once reconstituted, the solution has time-sensitive stability. Depending on the concentration and storage temperature, it may be stable for 24 hours or up to 7 days under refrigeration (2 C to 8 C). The medicine must be stored out of the sight and reach of children.

Disposal

For solutions prepared for single-use nebulisation, any remaining solution must be discarded immediately. Unused or expired medication should be disposed of by mixing it with an undesirable substance (e.g., used coffee grounds) and placing the mixture into a sealed container before throwing it in the household trash, following standard regulatory guidance.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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