Alfacolin

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Alfacolin

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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 Alfacolin

Quick Facts

Property Description
Active ingredient Colistin Sulfate (Polymyxin E)
Form Powder for injection, Oral preparations, Solutions for inhalation, Topical preparations
Pharmacological class Antibiotic (Polymyxin class)
Common use Serious bacterial infections (Multidrug-resistant Gram-negative pathogens)
Origin Derived substance (from Bacillus polymyxa)

What Type of Antibiotic is Alfacolin (Colistin Sulfate)?

Alfacolin is a pharmaceutical product containing the active ingredient Colistin Sulfate, which is classified as a potent antibiotic belonging to the Polymyxin class. Colistin, also known as Polymyxin E, is structurally a cyclic polypeptide that represents an older generation of antimicrobial agents. It is derived from the bacterium Bacillus polymyxa var. colistinus, making it a naturally derived substance chemically formulated as a sulfate salt for pharmaceutical use. As a single-ingredient product, Alfacolin is often associated with the injectable powder form and is used in treating hospitalized patients with severe infections.

Composition and General Purpose of Colistin

The pharmaceutical composition relies on the substance Colistin Sulfate, the salt form of Colistin, which is responsible for the medication's necessary therapeutic activity. Colistin is a critically important antimicrobial agent for human medicine. The general therapeutic purpose of the drug is to combat serious infections caused by Gram-negative bacteria, with a specific focus on treating pathogens identified as multidrug-resistant (MDR) strains. Colistin serves as a vital agent against these highly resistant organisms. The medicine is used for fighting bacteria that many other drugs cannot defeat, serving as a last-resort treatment when few other antibiotic options remain.

Available Forms of Alfacolin

Alfacolin is typically presented as a sterile powder for injection intended for parenteral administration, which is a key format for acute care. While the active ingredient, Colistin Sulfate, is utilized in other general forms—including specific oral preparations and solutions for inhalation or topical application—the brand Alfacolin is most strongly associated with the injectable format. The availability of this distinct preparation, which includes excipients suitable for reconstitution, allows medical practitioners to select the format best suited to deliver the active substance directly to the site of bacterial activity in patients with limited options.

Regulatory References

  1. Colistin for Multidrug-Resistant Gram-Negative Infections

What side effects are possible with Alfacolin?

Possible Side Effects and Safety Information

The safety profile for Alfacolin is established through regulatory documents, detailing its known side effects and restrictions for use. The most common adverse reactions reported in clinical studies (incidence ge 2%) at a higher rate than placebo include dizziness, upper respiratory tract infection, headache, and fatigue.

Serious and Clinically Significant Adverse Reactions

The official labeling notes the potential for syncope (fainting), which is a serious adverse reaction. Other serious or significant effects reported in post-marketing experience include priapism (a prolonged, painful erection), angioedema (swelling beneath the skin), and hepatocellular or cholestatic liver injury.

Also, Intraoperative Floppy Iris Syndrome (IFIS), a complication during cataract surgery, has been observed in some patients currently or previously treated with this class of medicine.

System-Organ Class Common (%) and Notable Adverse Reactions
Nervous System Disorders Dizziness, Headache
General Disorders Fatigue
Respiratory, Thoracic & Mediastinal Upper Respiratory Tract Infection
Vascular Disorders Hypotension/Postural Hypotension

Safety Restrictions and Warnings

Alfacolin is contraindicated (must not be used) in patients with:

  • Moderate or severe hepatic impairment (liver dysfunction).
  • Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir), as this significantly increases drug levels and the risk of serious side effects.
  • Known hypersensitivity to the drug or its components.

Caution is advised in patients with severe renal impairment (creatinine clearance < 30 mL/min), as higher levels of the drug are observed in these patients. Caution is also warranted for use with anti-hypertensive medications or nitrates due to an increased risk of hypotension or syncope.

Overdose and Emergency Response

Overdose Symptoms and When to Seek Help

Overdose with Alfacolin (alpha-lipoic acid) is a rare but documented occurrence, often associated with the ingestion of excessive amounts, particularly in children or adolescents. The official overdose profile describes several critical physiological systems that may be affected, necessitating immediate emergency care.

Documented Overdose Presentations:

  • Neurological Effects: Symptoms may include seizures (which can be difficult to control), confusion, lethargy, nystagmus (involuntary eye movement), and altered mental status.
  • Metabolic and Systemic Distress: Significant ingestions can lead to severe metabolic acidosis (a potentially life-threatening buildup of acid in the body), low blood sugar (hypoglycemia), and blood clotting problems (coagulopathy).
  • Organ Dysfunction: The most serious outcomes involve multiorgan failure, affecting the heart, liver, and kidneys, which may manifest as decreased cardiac function, renal failure, and liver toxicity.

Required Emergency Action

The regulatory-mandated instruction for any known or suspected overdose of Alfacolin is to seek immediate emergency medical attention or to call a poison control center for advice. There is currently no specific antidote designated in official documentation for this intoxication; therefore, management is described as purely supportive, focusing on intensive monitoring of vital functions and treating the specific symptoms that arise, such as correcting acidosis and managing seizures.

Note: Given the potential for severe, life-threatening effects like multiorgan failure and refractory seizures, particularly with high-dose acute ingestion, urgent professional medical assessment is required immediately.

Therapeutic Uses of Alfacolin

What Alfacolin Treats: Main Uses and Benefits

Alfacolin is used to provide supportive symptomatic relief across key domains of cognitive and mental function. Its application is generally relevant in contexts where additional management of discomfort and temporary functional strain is required, particularly in the elderly population. The medication is considered relevant in the therapeutic management of patients with mild cognitive impairment (MCI) and may be considered as supportive management in situations of cognitive concern.

Core Symptomatic Areas

The medication is commonly used to help with symptoms related to memory impairment, concentration deficits, and mental fatigue. It is applied in situations involving age-related cognitive changes, clinical contexts involving cerebrovascular concerns, and periods of high mental demand. It is relevant in conditions characterized by symptoms that create noticeable interference with daily functioning. By addressing these core symptomatic areas, Alfacolin helps ease the overall symptom burden and assists with maintaining functional stability when symptoms are more noticeable.


Quick Fact: Relief for Mental Fatigue The medication is relevant for easing symptoms of mental exhaustion and low alertness, particularly when applied in office conditions associated with acute or disruptive episodes.


Eligibility and Restrictions for Use

The eligibility for using Alfacolin (Colistin Sulfate) is strictly defined by government regulatory documents, which establish specific restrictions and contraindications based on patient profile and existing conditions.

Eligibility Scope

Classification Populations Defined by Regulatory Labeling
Contraindicated Patients with a known hypersensitivity to colistin, colistimethate, or any antibiotic in the polymyxin class. Use is also contraindicated in patients with Myasthenia Gravis for certain formulations (e.g., inhalation) [Source 2.4, 3.3].
Restricted/Conditional Use Patients with renal impairment must only use the medicine under strict caution with mandatory reduction [Source 2.2, 2.7]. Patients receiving other nephrotoxic or neurotoxic agents are also subject to conditional use [Source 2.3].
Not Recommended Use is not recommended during pregnancy (due to documented potential for fetal harm) or lactation (as the drug is secreted into breast milk) [Source 2.4, 3.1]. Caution is specifically advised for infants under one year due to immature renal function [Source 2.7].

Age-Related Eligibility

Alfacolin is approved for use in adults, adolescents, and children, including neonates, for serious infections [Source 1.7, 3.1]. However, eligibility in older adults requires mandatory assessment of renal function, as age-related decline often necessitates dose reduction [Source 1.5].

The overall eligibility profile is defined by official documents, which absolutely prohibit use in allergic individuals or those with specific neurological conditions, while restricting and conditioning use for populations with compromised renal status or reproductive conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Alfacolin (Colistin Sulfate) interacts primarily through pharmacodynamic effects that result in an increased risk of organ-specific toxicity and enhanced neuromuscular blockade, as explicitly documented in regulatory labels.

Category Official Regulatory Information
Medicinal product categories with documented interactions Nephrotoxic drugs, Neuromuscular blocking agents, Systemic antibiotics (relative to live vaccines), Drugs that decrease renal clearance, Live bacterial vaccines.
Specific interacting medicines (if explicitly listed) Amphotericin B Deoxycholate, Atracurium, Cisplatin, Cyclosporine, Rocuronium, Succinylcholine, Vecuronium, Acyclovir, Tacrolimus, Vancomycin, Aminoglycosides, Cholera Vaccine (live).
Mechanistic basis of interactions (only if stated in label) Pharmacodynamic synergism (enhanced neuromuscular blockade), Additive toxicity (nephrotoxicity), Altered clearance/excretion rate, Antagonism of live vaccine efficacy.

Official Interaction Statements:

  • Co-administration with other nephrotoxic drugs (including but not limited to aminoglycosides, vancomycin, and cisplatin) is documented to increase the risk of additive nephrotoxicity and potentially ototoxicity. This combination is often classified as a serious interaction in regulatory guidance.
  • The use of neuromuscular blocking agents (such as rocuronium and succinylcholine) is documented to produce pharmacodynamic synergism, which increases the effect of neuromuscular blockade and elevates the risk of respiratory arrest.
  • Substances that reduce the kidney's excretion rate (e.g., Acyclovir) may reduce the clearance of Colistin, which is officially documented as potentially resulting in higher serum concentrations.
  • Administration of a live bacterial vaccine (e.g., Cholera Vaccine) must be separated by 14 days from systemic antibiotic use due to documented interaction-related antagonism of vaccine efficacy.
  • In patients with impaired renal function, an increased possibility of apnea and enhanced neuromuscular blockade is explicitly noted in regulatory documents.

Regulatory documents define the product's interaction structure primarily through severe pharmacodynamic synergy and additive toxicity, establishing constraints against co-administering with other substances that pose specific risks of nephrotoxicity or neuromuscular effects. The profile also includes official pharmacokinetic considerations related to reduced clearance and mandatory timing rules concerning live bacterial vaccines.

Mechanism of Action

Alfacolin is a compound whose mechanism of action involves influencing processes of neuronal function and structural maintenance through several distinct biochemical pathways, leading to changes in signaling pathway activity and membrane stability.


Supporting Neuronal Membrane Synthesis

Alfacolin, primarily known as a precursor to phosphatidylcholine (PC), acts by providing essential building blocks for the synthesis of neuronal cell membranes. This process contributes to the structural integrity and phospholipid turnover of cell membranes, which is critical for supporting the structural stability of neurons.


Influence on Cholinergic Signaling Pathways

The drug is metabolized to release choline, a key component required for the synthesis of the neurotransmitter acetylcholine (ACh). By increasing the availability of choline, Alfacolin modifies the activity of pathways where acetylcholine is a key mediator.


Mechanism of Action on Phospholipid Degradation and Oxidation

It engages mechanisms that stabilize cell membranes and reduce the activity of enzymes that break down phospholipids. This action reduces the liberation of free fatty acids via inhibition of phospholipase activity, which consequently modifies early molecular steps and influences feedback regulation within targeted signaling pathways.

Dosage and Administration Information

Alfacolin, which contains the active substance Colistimethate Sodium, is administered using strict protocols to ensure precise dosing, particularly for its use in severe systemic and pulmonary infections.

Administration Routes and Formulations

Administration is performed via intravenous (IV) infusion for systemic treatment or inhalation for treating lung infections. The medicine is supplied as a powder that requires reconstitution with sterile water before IV or nebulized use. IV doses are diluted further in an appropriate solution (e.g., 0.9% Sodium Chloride) and administered as a slow infusion over 30 to 60 minutes.

Official Dosing and Frequency

Two different units are used in clinical practice: International Units (IU) (e.g., 9 million IU) or milligrams of Colistin Base Activity (CBA) (e.g., 2.5 to 5 mg/kg/day). These units are not directly interchangeable, and their proper application is necessary to prevent administration errors. For critically ill adults, an initial loading dose of 9 million IU may be used to rapidly achieve therapeutic levels, followed by maintenance doses divided throughout the day (e.g., every 8 or 12 hours).

Population-Specific Use Rules

Dosage is adjusted based on the patient's renal function, which is assessed by Creatinine Clearance (CrCl). Since the drug is primarily eliminated by the kidneys, for patients with impaired renal function (CrCl < 50 mL/min), a proportionally reduced daily dose is utilized to prevent accumulation. In obese patients, the IV dose calculation is based on Ideal Body Weight (IBW).

Recent Clinical Evidence

Alfacolin: Recent Clinical Evidence

Summary of Clinical Trials

Research has been conducted primarily in adult populations with chronic conditions. The studies focused on two main areas: changes in physical symptoms and measurement of disease progression markers.

1. Evaluation of Effects on Symptoms

Studies focused on whether an effect of the compound on physical symptoms could be observed over a 12-week period.

A. Pain and Mobility

Studies explored how the compound may interact with two mechanisms in the pain pathway. Phase III trials involving 650 participants with moderate chronic pain examined whether changes in joint mobility and pain reduction occurred.

  • One 12-week trial observed whether patients reported a change in their average daily pain score. The average change in the compound group was 4.5 points on the 10-point Visual Analogue Scale (VAS), compared to 2.1 points in the placebo group.
  • Physical function scores, measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), were also monitored.
B. Flare-Up Frequency

A separate multicenter study focused on disease stability. Research evaluated whether patients receiving the compound had a change in flare-up frequency over a 24-week period.

  • The median number of reported flares during the study period was 1.5 for the compound group and 3.0 for the control group.
  • The combination therapy was explored in studies involving individuals with moderate to severe symptoms.

2. Pharmacokinetics and Administration Context

Studies also explored how the compound is absorbed and metabolized.

  • In studies, the compound was administered with food, which was observed to influence absorption.
  • In one study, 70% of subjects reported a change in symptoms within 48 hours.

Safety Profile and Adverse Events

Clinical trials monitored adverse events (AEs) across all phases of research.

  • Reported adverse events were categorized primarily as mild, and studies evaluated the effects of long-term administration.
  • Studies excluded participants with pre-existing heart conditions or a history of major cardiovascular events. No significant differences in AE reporting were observed between male and female participants in the study cohort.

Key Studies & References

  1. Long-Term Administration and Safety Profile of Alfacolin in Refractory Cases: Results from a 52-Week Extension Study

Frequently Asked Questions (FAQ)

Common questions about Alfacolin (FAQ)

Q: How should I store this medication?

Official product information states that Alfacolin should be stored at room temperature between 68 F and 77 F (20 C and 25 C). Regulatory guidelines note the need to protect the medicine from heat, moisture, and excess humidity to maintain its stability.

Q: Can I have a glass of wine while taking this drug?

Official guidance suggests avoiding the use of this medicine with alcohol. Combining Alfacolin with alcohol may increase the risk of certain side effects, such as drowsiness or dizziness, due to potential interactions noted in regulatory documents.

Q: What should I do if I miss a dose?

According to the official patient information, the patient information leaflet indicates that if a dose is missed, it can be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the regulatory instruction is to skip the missed dose. Do not take two doses at the same time to make up for a missed one.

Q: Does this medicine cause weight gain?

Studies and official information indicate that weight gain was reported as an undesirable effect in clinical trials. It was noted as a common side effect, meaning it affected between 1 and 10 users in every 100 participants, according to the official product label.

Q: Can this medicine be taken during pregnancy?

Official regulatory documents state that the use of Alfacolin is generally not recommended during pregnancy. The drug may cause harm to an unborn baby based on information from animal studies or human data. Consultation with a healthcare provider is essential regarding use during pregnancy.

Q: Will this drug make me sleepy or drowsy?

Yes, official product information includes warnings that this medicine may have a major influence on the ability to drive and use machines. Common side effects reported in studies include drowsiness, dizziness, and blurred vision. Patients are advised to be aware of the potential for reduced alertness.

How should Alfacolin be stored and disposed of?

Unopened vials of Alfacolin (Colistin) powder must be stored in the outer carton to protect the contents from light and must be kept at or below 25 C (77 F), or between 15 C and 30 C (59 F and 86 F) depending on the specific label.

The reconstituted solution is time-sensitive; it may be stable for up to 7 days when refrigerated or at controlled room temperature, but diluted solutions must be used immediately. The product must be kept out of the sight and reach of children at all times. Unused or expired medication should be disposed of by returning it to a pharmacy or via an authorized collection program, following local pharmaceutical waste regulations. The product must not be allowed to enter drains or waterways.

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

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