Colomycin

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Colomycin

Treatment option: Infection, Cystic Fibrosis

Medically reviewed

Marina Burgos

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 Colomycin

What is Colomycin?

Colomycin is a medication containing the active ingredient colistimethate sodium, which belongs to a group of antibiotics known as polymyxins. It is primarily used to treat certain types of serious bacterial infections caused by specific Gram-negative bacteria.

Therapeutic Use

This medication is typically reserved for infections where other commonly used antibiotics may not be suitable or have proven ineffective. It works by targeting and disrupting the cell membrane of the bacteria, leading to the destruction of the infectious organism.

Common Applications

Colomycin is frequently utilized in the management of chronic chest infections in patients with specific underlying conditions, such as cystic fibrosis. In these cases, the medication is often used to manage long-term colonization by bacteria like Pseudomonas aeruginosa.

Method of Action

As an antibiotic, Colomycin is effective only against bacterial infections; it does not treat viral infections such as the common cold or flu. Its role is focused on treating sensitive strains of bacteria that are difficult to eliminate with broader-spectrum treatments.

Regulatory References

  1. Colistimethate Injection: MedlinePlus Drug Information
  2. Resurgence of Colistin: A Review... - NIH

What side effects are possible with Colomycin?

Possible side effects and safety information

The officially documented safety profile for colistimethate sodium (Colomycin) is structured around potential systemic toxicities, primarily involving the kidneys (nephrotoxicity) and the nervous system (neurotoxicity), as classified in government regulatory documents.


Key Adverse Reaction Categories

Adverse reactions are grouped according to the body system affected, with the most common being:

  • Nervous System Disorders: Manifested as paresthesia (tingling or numbness, particularly around the mouth and extremities), dizziness, or vertigo. These effects are often classified as Common in regulatory summaries and may be more likely during the initial phase of systemic therapy.
  • Renal and Urinary Disorders: The potential for nephrotoxicity, which can present as changes in kidney function or, in serious cases, Acute Renal Failure. This risk is documented as being dose-dependent.

Serious Reactions and Safety Constraints

The official prescribing information documents the potential for serious adverse reactions, including Respiratory Arrest (Apnoea) and Neuromuscular Blockade, which may result from severe neurotoxicity.

Special safety considerations are mandated for certain patient populations:

  • Renal Impairment: Patients with reduced kidney function face a significantly heightened risk of both neurotoxicity and nephrotoxicity, requiring specific safety protocols and dosage modification as stipulated in the official label.
  • Concomitant Therapy: The risk of toxicity is increased when Colomycin is used alongside other medicines that are known to be nephrotoxic or neuromuscular blocking agents.

This structure reflects the need for careful risk assessment, focusing on organ system involvement and risk amplification factors as outlined in official regulatory documentation.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents state that an overdose of Colomycin (Colistimethate sodium) is associated with serious systemic manifestations, typically when the administered amount exceeds the body's renal excretory capacity.

Documented Manifestations Overdose may present with various clinical signs, including neurological disturbances such as paresthesia (tingling or numbness, especially around the mouth and extremities), vertigo, slurred speech, and unsteadiness (ataxia). Signs of acute renal insufficiency are also documented, marked by diminishing urine output and elevations in BUN and serum creatinine.

Severe Outcomes and Emergency Actions The most critical documented consequences involve the respiratory and renal systems. Overdose may lead to muscular weakness resulting from neuromuscular blockade, which can escalate to apnea and respiratory arrest. Renal impairment can progress to acute renal failure or renal shutdown. If signs of impaired renal function or other serious effects occur, therapy must be discontinued immediately. Urgent medical attention must be sought for any severe symptoms, and contacting a poison control centre is advised. Treatment is supportive, focusing on the usual medical regimen for oliguria; dialysis may be considered for massive overdosage. The risk of toxicity is greater in patients with impaired renal function. No specific antidote is known.

Therapeutic Uses of Colomycin

What Colomycin treats: main uses and benefits

Colomycin contains the active substance colistimethate sodium, an antibiotic belonging to the polymyxin group. It is primarily used to treat serious bacterial infections caused by specific Gram-negative bacteria that are resistant to other classes of antibiotics.

Treatment of Respiratory Infections

One of the most common applications of Colomycin is in the management of chronic chest infections in patients with cystic fibrosis. In these cases, it is often administered via inhalation to target bacteria directly within the airways. It is specifically used to manage lung infections caused by Pseudomonas aeruginosa, a pathogen that frequently affects the respiratory systems of individuals with long-term lung conditions.

Systemic Bacterial Infections

When administered by injection or infusion, Colomycin is used to treat severe infections throughout the body. These may include:

  • Complex Urinary Tract Infections: Treatment of severe infections of the bladder or kidneys when other options are unsuitable.
  • Lower Respiratory Tract Infections: Management of severe pneumonia or hospital-acquired lung infections.
  • Abdominal Infections: Use in treating complicated infections within the abdominal cavity.
  • Septicemia: Treatment of bloodstream infections that require potent antibiotic intervention.

Benefits in Resistant Cases

The primary benefit of Colomycin is its efficacy against multidrug-resistant bacteria. Because it works by disrupting the cell membrane of the bacteria, it remains an essential option for treating "superbugs" that have developed resistance to more common antibiotics like penicillins or cephalosporins. By providing a targeted mechanism of action, it helps stabilize patients with complex clinical profiles who might otherwise have limited treatment options.

Eligibility and Restrictions for Use

Who can and cannot use Colomycin?

The eligibility profile for Colomycin (Colistimethate Sodium) is strictly governed by regulatory authorities and is determined by specific patient health statuses and conditions.

Absolute Contraindications

The medicine is contraindicated for patients with a known hypersensitivity to Colistimethate Sodium, Colistin, or any other drug in the polymyxin class of antibiotics. Due to the risk of inducing neuromuscular blockade, use is also effectively prohibited in patients with myasthenia gravis.

Restricted and Conditional Use

Use is permitted under restricted conditions for several populations. Patients with impaired renal function require mandatory dose modification and close monitoring, as kidney function governs the elimination of the medicine. Caution is also advised for individuals with bronchial hyperreactivity when the medicine is administered via inhalation.

Age and Physiological Status

Colomycin is generally permitted in adults and pediatric patients. However, older adults and infants under one year require careful assessment due to considerations of declining or immature renal function. The medicine is generally not recommended during pregnancy or lactation unless deemed necessary, based on limited data in these populations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of colistimethate sodium primarily around risks of enhanced neuromuscular blockade and additive organ toxicity.

Interaction Scope

Element Official Regulatory Documentation
Medicinal product categories with documented interactions Non-depolarizing muscle relaxants; other nephrotoxic or neurotoxic antibiotics (e.g., aminoglycosides); inhalation anesthetics; other nephrotoxic medicinal products.
Specific interacting medicines (if explicitly listed) Tubocurarine, gallamine, decamethonium, atracurium, sodium cephalothin.
Mechanistic basis of interactions (only if stated in label) Potentiation of the neuromuscular blocking effect; additive organ toxicity (nephrotoxicity and neurotoxicity); altered drug exposure due to reduced renal clearance.

Official Interaction Statements

Co-administration with non-depolarizing muscle relaxants (e.g., tubocurarine, decamethonium) or inhalation anesthetics may result in severe potentiation of the neuromuscular blocking effect, which carries an official risk of apnea and respiratory arrest.

The concomitant use of other nephrotoxic or neurotoxic medicinal products (including aminoglycosides and sodium cephalothin) is highly restricted as it may significantly increase the official risk and/or severity of kidney and nerve damage. Furthermore, when used with other nephrotoxic drugs, the clearance of colistin may be reduced, leading to higher serum concentrations and an associated increase in toxicity risk.

This risk of severe interactions, particularly neuromuscular blockade, is specifically noted in official labels as being increased in patients with impaired renal function due to reduced drug excretion.

Mechanism of Action

Colomycin (Colistin), a polymyxin class antimicrobial, executes its pharmacodynamic mechanism by targeting the outer membrane of susceptible Gram-negative bacteria. Specifically, the polycationic structure of Colomycin interacts electrostatically with the negatively charged lipopolysaccharide (LPS) component. This binding action displaces divalent cations, particularly magnesium and calcium, which are essential for maintaining the integrity and stability of the membrane structure.

The displacement of these cations immediately and profoundly increases the permeability of the outer membrane. This change compromises the overall structural barrier function of the cell, leading to membrane disruption. The subsequent cascade involves the leakage of critical intracellular contents, including nucleoside triphosphates, ions, and proteins, resulting in the rapid loss of cellular homeostasis and, ultimately, bacterial cell death.

Dosage and Administration Information

Colomycin (colistimethate sodium) is available as a lyophilized powder and must be prepared for administration via specific routes. There are distinct dosing standards based on the patient’s clinical status and region.

Official Routes and Dosing Standards

Approved Administration Routes Colomycin is used via Intravenous (IV) Infusion, Intramuscular (IM) Injection, and Inhalation (nebulized). The dose is expressed in either International Units (IU) or milligrams of Colistin Base Activity (CBA).

Route of Administration Standard Adult Dosing Frequency Preparation Note
Systemic (IV/IM) (Standard A) 2.5 to 5.0 mg CBA per kg per day Divided into 2 to 4 doses per day Administer IV infusion over 30 to 60 minutes
Systemic (IV) (Standard B) 9 Million IU (MIU) maintenance dose Divided into 2 to 3 doses per day A 9 MIU loading dose is recommended for critically ill patients.
Inhalation (Nebulized) 1 to 2 MIU per dose 2 to 3 times per day First inhaled dose should be given under medical supervision.

Administration and Adjustment Requirements

Dose Preparation and Handling The powder must be reconstituted with an appropriate sterile diluent, such as Water for Injection or 0.9% Sodium Chloride. Vials must be gently swirled to dissolve the powder; vigorous shaking should be avoided as it causes excessive frothing.

Population-Specific Rules Systemic use requires dose reduction in patients with renal impairment, as the drug is primarily eliminated by the kidneys. For individuals who are obese, the systemic dose should be calculated using Ideal Body Weight rather than actual body weight. No dose adjustment is generally required for older adults if their renal function is normal.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Colomycin

This overview summarizes the available research concerning Colomycin (colistimethate sodium), describing the types of studies conducted and what the resulting findings indicate, according to official and peer-reviewed sources. This information is intended to contextualize the evidence landscape and should not be used as clinical advice.


Evidence for Colomycin Use in Serious Systemic Infections

Research exploring the use of Colomycin for serious, life-threatening systemic infections caused by multi-drug resistant (MDR) Gram-negative bacteria is largely composed of observational studies and case series, with fewer Randomized Controlled Trials (RCTs). These studies tracked outcomes during the administration of intravenous colistimethate sodium in critically ill adults who often had high disease severity scores, including patients with sepsis and patients with underlying conditions such as hematological diseases. The research examined important outcomes related to physiological strain or stress, such as short-term mortality rates (e.g., within 30 days) and measured outcomes such as short-term clinical cure rates or microbiological clearance rates.

Data showed patterns related to heterogeneity, and outcomes were inconsistent across different study settings and patient populations. Some trials described patterns when comparing the use of Colomycin alone (monotherapy) versus using it in combination with another antibiotic (combination therapy). The existing evidence for serious systemic infections is assigned a coarse grading of Moderate, with the certainty remaining low for specific questions.


Evidence for Inhaled Colomycin in Chronic Pulmonary Infections

The research base for using inhaled Colomycin to manage chronic pulmonary infections, particularly in conditions like Cystic Fibrosis (CF) where Pseudomonas aeruginosa is common, includes Randomized Controlled Trials (RCTs) and comprehensive systematic reviews. These studies examined outcomes such as the frequency of pulmonary exacerbations (periods of heightened symptom activity) and tracked changes in pulmonary function (like FEV1).

RCTs consistently reported measurements of microbiological shifts; studies observed patterns related to shifts in bacterial load in the sputum of patients with chronic P. aeruginosa colonization. This evidence contributes to the broader evidence landscape and has a coarse grading of High for certain microbiological and functional measures.


Research Gaps and Uncertainty

Key areas remain that require further study. For the treatment of serious systemic infections, the lack of large, comparative RCTs means that the optimal use strategy (combination vs. monotherapy) is not fully established, and comparative evidence is lacking against other new or emerging antibiotics. Furthermore, there is a known limitation in the existing data concerning the impact of long-term use on the selection of antibiotic resistance. Research has evaluated the use of Colomycin over varying durations, but there is limited information for long-term outcomes and the durability of the reported effects beyond trial periods. Overall, findings describe group patterns, and research highlights what is known — and what is still uncertain — and does not determine whether an individual will respond similarly.

Key Studies & References

  1. Systematic Review and Meta-analysis of Colistin-based Combination Therapy vs. Monotherapy for Multidrug-Resistant Gram-Negative Infections (Supporting Systemic Use & Combination Data)
  2. Pediatric Cohort Studies and Guidelines on Colistimethate Sodium Use in Neonatal and Pediatric Patients (Supporting Special Populations Data)

Frequently Asked Questions (FAQ)

Common questions about Colomycin (FAQ)


Q: What is the difference between Colomycin, Colistin, and Colistimethate Sodium?

Colistimethate sodium is the official name for the drug's active ingredient, and it is supplied as an inactive form called a prodrug. This prodrug is converted within the body to the active medicine, Colistin, which performs the antibiotic action. Colomycin is a registered brand name for this medication.


Q: What are the typical signs of a kidney problem related to Colomycin use?

Official product information indicates that potential signs of impaired kidney function may include a diminishing urine output. Monitoring for changes in certain lab markers, such as BUN and serum creatinine, is part of the established medical protocol for tracking kidney function.


Q: Does nebulized Colomycin commonly cause breathing difficulties or chest tightness?

For the inhaled route, official patient information states that local side effects are possible. These potential effects may include a persistent cough, wheezing, and chest tightness (bronchospasm).


Q: Is it possible to take Colomycin for an extended period, such as months or years?

Studies have examined the long-term use of Colomycin and its impact on antibiotic resistance in certain patient populations. However, according to research overviews, limited information is currently available concerning the durability of its effects over very extended periods beyond those studied in clinical trials.


Q: What research evidence supports the use of nebulized Colomycin for non-CF bronchiectasis?

Research evidence, including systematic reviews, has focused on the use of inhaled Colomycin for managing chronic pulmonary infections, especially where Pseudomonas aeruginosa is present. These studies track outcomes such as shifts in the bacterial load and changes in lung function for various conditions.


Q: How is Colomycin different from other common antibiotics?

Colomycin is classified as a polymyxin antibiotic, a distinct class from many other common antibiotics. Official documentation states it has a narrow spectrum of activity and is indicated specifically for sensitive strains of certain Gram-negative bacteria.


Q: Is Colomycin used for skin or wound infections?

The systemic use of Colomycin is indicated for treating acute or chronic infections caused by susceptible Gram-negative bacteria. Regulatory documents state that this includes various infection sites, depending on the clinical assessment and the susceptibility of the bacteria.


Q: Are there serious but rare side effects associated with Colomycin?

Yes, the official safety profile documents serious adverse reactions with an unknown or rare incidence. These include events such as seizures, changes in vital signs like heart rate or blood pressure, and severe diarrhea (C. difficile-associated diarrhea).


Q: Can Colomycin cause a severe allergic reaction?

The official safety information includes a warning about the possibility of a severe allergic reaction (hypersensitivity). Signs listed in patient safety materials include a rash, hives, and swelling of the face or throat, which may be accompanied by trouble breathing.


Q: What is the risk of C. diff (Clostridioides difficile-associated diarrhea) with Colomycin?

As with many antibiotics, official patient safety information states that severe diarrhea, known as Clostridioides difficile-associated diarrhea (CDAD), may rarely occur with Colomycin. Reports indicate this condition may occur during treatment or even months after the course has has ended.


Q: Can Colomycin cause a change in my voice or a cough?

According to patient information for the inhaled form of the medicine, local side effects may include a persistent coughing and the development of a hoarse voice. These effects are listed as local side effects associated with inhaled administration.


Q: Does Colomycin affect muscle strength?

A severe side effect known as neuromuscular blockade can interfere with nerve transmission. This effect, which may result in muscle weakness, is primarily associated with overdosage or high drug concentrations.


Q: Is there a way to reduce the chance of kidney problems while using Colomycin?

Official prescribing information states that a necessary protocol to manage this risk is to reduce the dosage in proportion to the extent of pre-existing impaired kidney function. This protocol addresses the medicine's dose-dependent risk of kidney problems (nephrotoxicity).


Q: Can Colomycin interact with common pain relievers?

The drug interaction profile cautions against the concomitant use of other medicines known to be toxic to the kidneys (nephrotoxic). This category includes certain pain relievers, such as NSAIDs, which is described as potentially raising the risk of kidney-related problems.


Q: Is Colomycin safe for use during pregnancy?

The medicine is classified as Pregnancy Category C and is documented to be transferred across the placental barrier. Official labels state the medicine should only be used during pregnancy if the potential benefit of the medicine justifies the potential risk to the fetus.


Q: Is Colomycin safe for use while breastfeeding?

According to regulatory documents, the active component, Colistin, is excreted into human breast milk, though typically in small amounts. Official labels advise that caution should be exercised when the medicine is administered to nursing women.


Q: Are there any special handling or disposal requirements for Colomycin?

While general storage and disposal rules apply, official patient education sometimes includes information about using a bronchodilator medicine prior to inhalation to help reduce the risk of breathing difficulties. This is related to the inhaled formulation.


Q: What happens if bacteria become resistant to Colomycin?

Official research has focused on understanding bacterial resistance mechanisms. Studies have examined strategies, such as using Colomycin in combination with other antibiotics, to suppress the formation of colistin-resistant bacteria.


Q: Why is Colomycin often combined with other antibiotics?

Studies have examined the use of Colomycin in combination therapy to help enhance its antibacterial activity, minimize the emergence of resistance, and address bacterial biofilms. This strategy is frequently used in the clinical setting.


Q: Is Colomycin effectiveness affected by the specific strain of bacteria?

Yes, official product information states that the medicine is indicated for infections only due to sensitive strains of certain Gram-negative bacteria. Official product information notes that the medicine is not indicated for infections caused by organisms such as Proteus or Neisseria.


Q: What are the symptoms of an overdose of Colomycin?

Official regulatory documents list that symptoms of an overdose may include neurological effects such as confusion, dizziness, slurred speech, and loss of muscle control. Severe overdose can potentially lead to apnea (respiratory arrest).


Q: Can Colomycin cause an electrolyte imbalance?

Safety reviews have linked the medicine to pseudo-Bartter syndrome, a condition involving acid-base and electrolyte imbalances. This can present as low blood potassium (hypokalemia) or low blood calcium (hypocalcemia).


Q: Does Colomycin affect blood pressure or heart rate?

Official safety documentation states that side effects of unknown incidence have included changes in vital signs. These reported effects include an increase in blood pressure and a fast heartbeat.

How should Colomycin be stored and disposed of?

How to Store and Dispose of Colomycin

Storage of Colomycin (Colistimethate Sodium) is determined by whether it is the dry powder or the reconstituted solution.


Storage Requirements

Product State Storage Condition Mandatory Rule
Unreconstituted Powder Controlled room temperature (15 C to 30 C) Keep in original carton to protect from light.
Reconstituted Solution Refrigerated (2 C to 8 C) Use immediately, or within a limited time (e.g., 24 hours to 7 days, depending on regulatory label).

The reconstituted solution is for single use only. The medicine must be stored out of the sight and reach of children.

Disposal

Any unused portion of the solution must be discarded immediately. Unused or expired Colomycin must not be disposed of in household waste or wastewater. Disposal must follow local guidelines, typically involving return to a pharmacist or official collection program.

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

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