Levometil

Quick links to important sections

Levometil

Selected form

Treatment option:

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 Levometil

Property Description
Active ingredient Chloramphenicol, Dioxomethyltetrahydropyrimidine
Form Ointment (Topical preparation)
Pharmacological class Combined antimicrobial and reparative agent
Common use Supporting healing of compromised tissue
Origin Synthetic compound

Defining Levometil: Classification and Entity

Levometil is a specialized, dual-action medication classified as a combined antimicrobial and reparative preparation, intended exclusively for topical use. This preparation is specifically recognized as a combination product, integrating two distinct active pharmaceutical ingredients to ensure a simultaneous therapeutic effect. The overall pharmacological class of the preparation is designated under the ATX code D03AX, representing drugs that promote the healing and scarring of wounds.

Core Composition: Ingredients, Form, and Origin

The Levometil formulation is standardized as an ointment, a topical preparation designed for cutaneous application, typically using a water-soluble base, such as polyethylene glycol, which also facilitates the adsorption of wound exudate. The two primary synthetic compounds in the formulation are Chloramphenicol and Dioxomethyltetrahydropyrimidine (known as Methyluracil). Chloramphenicol, a broad-spectrum antibiotic, exerts bacteriostatic activity by inhibiting bacterial protein synthesis. This means the medicine works by stopping the growth and reproduction of susceptible bacteria at the site of application.

General Purpose: Dual Action and Therapeutic Benefit

The general purpose of Levometil is to accelerate recovery at the application site by combining localized bacterial inhibition with the active promotion of tissue repair. This dual action is the core functional benefit, differentiating it from single-agent formulations. While Chloramphenicol provides the necessary bacteriostatic effect, Dioxomethyltetrahydropyrimidine provides a eutrophic action, directly influencing the metabolic processes required for effective cellular growth and healing. This combined approach is recognized for its application in wound care management, ensuring the preparation is optimized to manage localized conditions where both microbial control and enhanced cellular regeneration are necessary for successful tissue repair.

Regulatory References

  1. Chloramphenicol - StatPearls - NCBI Bookshelf - NIH

What side effects are possible with Levometil?

Possible Side Effects and Safety Information: Levometil

This section summarizes the adverse reactions and safety information documented in official government regulatory documents for Levometil (levofloxacin).


Serious and Potentially Irreversible Adverse Reactions

Official safety information emphasizes the risk of serious and potentially long-lasting adverse reactions. These include:

  • Musculoskeletal and Nervous System Effects: Tendinitis and tendon rupture (which can be delayed or bilateral), peripheral neuropathy (nerve damage that may be irreversible), and serious Central Nervous System effects (e.g., seizures, psychoses, memory impairment).
  • Cardiac and Organ Risks: Prolongation of the QT interval, leading to a serious abnormal heart rhythm (Torsade de pointes); severe, sometimes fatal hepatotoxicity (liver damage); and severe hypersensitivity reactions (anaphylaxis) which may occur after the first dose.

These severe reactions have been documented to occur from hours to weeks after starting treatment and may persist for long periods after discontinuation.


Common Adverse Reactions

The most frequently reported adverse reactions, documented as occurring in 3% or more of patients in regulatory data, are nausea, headache, diarrhea, insomnia, constipation, and dizziness. Other less common reactions (uncommon/rare) involve psychiatric disturbances (e.g., anxiety), skin reactions, and blood disorders.


Population-Specific Safety Notes

Safety data specifies heightened risk in certain patient groups:

  • Elderly Patients (Age 60+): Increased risk of tendinitis and tendon rupture, especially when also taking corticosteroids.
  • Diabetic Patients: Risk of severe blood sugar disturbances (dysglycaemia), including both hypoglycemia and hyperglycemia, which may lead to hypoglycaemic coma.
  • Patients with Pre-existing Conditions: Contraindicated in individuals with a history of tendon disorders related to fluoroquinolones, myasthenia gravis, or epilepsy, due to the risk of exacerbating these conditions.

Overdose and Emergency Response

The official regulatory profile for Levometil overdose focuses on the risks associated with the systemic absorption of the active component, Chloramphenicol, even following topical use. This structure outlines the documented manifestations and mandates the urgency of seeking medical assistance.

Documented Overdose Manifestations and Severe Outcomes

Overdose, often linked to excessive systemic exposure, may manifest with gastrointestinal symptoms, including nausea, vomiting, and abdominal distension. Systemic effects can involve hypotension and hypothermia. The most severe documented consequences affect the hematologic system, including bone marrow hypoplasia and the risk of aplastic anemia, which is often irreversible and potentially fatal. Overdose situations may lead to cardiovascular collapse or coma.

Emergency Actions and Required Monitoring

Regulatory mandates state that individuals must seek immediate medical advice if an overdose is suspected or if symptoms worsen at any time. Urgent medical assistance is required for any manifestation of severe or life-threatening symptoms. Treatment is defined as symptomatic and supportive, as no specific antidote is officially documented. In cases of prolonged exposure, routine blood profile monitoring is required to detect early hematologic changes.

Population-Specific Risks

A specific, high-risk consideration applies to neonates and premature infants, who are susceptible to a severe reaction known as Grey Syndrome, which is characterized by vasomotor collapse and irregular respiration.

Therapeutic Uses of Levometil

What Levometil Treats: Main Uses and Benefits

Managing the Symptoms of Localized Wound Infection

The antibiotic component of this medication is applied in contexts where additional symptomatic support is needed for infections. This medication is commonly used to relieve the pronounced signs of bacterial infection in open wounds, such as excessive redness, swelling, heat, and pus formation. When applied, the medication may assist with addressing the infection. The medication is relevant for easing symptoms related to inflammatory or irritative states.


Supporting Stalled and Slow Wound Healing

Levometil is relevant in conditions involving episodic or fluctuating manifestations, such as when a skin break is not healing properly, is stalled, or contains dead tissue. It supports the damaged skin by assisting in the management of symptoms that interfere with daily comfort and supports the wound's natural progression toward closure. This action contributes to improved day-to-day comfort and assists with maintaining functional stability.

“The medication is generally applied in settings where symptoms create noticeable functional strain due to both infection and compromised tissue repair.”

This product is commonly applied across conditions presenting with acute episodes, including infected cuts, abrasions, burns, surgical wound sites, and certain types of skin ulcers. It is used in settings where supportive symptomatic assistance is needed and helps maintain a sense of stability when symptoms are more noticeable.


Quick Fact: Relief for Inflammatory Symptoms

Levometil is applied when symptoms are related to inflammatory or irritative states caused by bacterial contamination, offering supportive relief to ease the overall symptom burden during symptomatic periods.

Regulatory References

  1. NIH StatPearls overview on Chloramphenicol

Eligibility and Restrictions for Use

Official Eligibility and Restrictions

Levometil eligibility is strictly defined by regulatory documentation concerning age, physiological state, and pre-existing medical conditions. The medicine is generally permitted for use by adults and older children (typically 2 years and above) who have no listed contraindications.

Groups Who Must Not Use Levometil (Contraindicated)

Use is absolutely prohibited in specific populations, as defined in official labeling:

  • Individuals with known hypersensitivity to Chloramphenicol, Dioxomethyltetrahydropyrimidine, or other components.
  • Patients with a personal or family history of bone marrow hypoplasia or other severe blood disorders (e.g., aplastic anemia).
  • Patients diagnosed with acute porphyria.

Populations for Whom Use is Restricted or Not Recommended

Use is conditional and generally advised against for certain groups:

Population Group Regulatory Status Restriction Context
Infants/Neonates (under 2 years) Not Recommended Restricted due to documented systemic absorption risks.
Pregnant Women Avoided/Conditional Generally not recommended, particularly near term.
Breastfeeding Women Not Recommended Drug may pass into breast milk.

Additionally, conditional caution is advised for patients with severe hepatic or renal impairment and those using other medications known to suppress bone marrow function. The older adult population is generally eligible for use without age-specific dose modification.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents define the interaction profile of Levometil based on the potential for systemic absorption of its active component, Chloramphenicol. This structure outlines necessary co-administration constraints, particularly concerning agents that affect bone marrow function and metabolic enzymes.

Documented Interaction Restrictions

Category Regulatory Requirement
Bone Marrow Depressants Co-administration with drugs liable to depress bone marrow function must be avoided due to the risk of additive toxicity.
Hepatic Enzyme Substrates The active component is an inhibitor of CYP2C9, CYP2C19, and CYP3A4 enzymes, which may lead to increased plasma concentrations of co-administered drugs metabolized by these pathways.
Other Bacteriostatics Co-administration with other bacteriostatic antibiotics should be avoided due to the potential for antagonism.

Other Specific Interactions

The medicine may decrease the therapeutic response to nutrient supplements, specifically Iron and Vitamin B12 supplements. Furthermore, the component inhibits the enzyme Chymotrypsin when co-administered. For patients with hepatic impairment, caution is noted regarding the management of co-administered drugs, as reduced metabolism may enhance the effect of Chloramphenicol on other drug levels, as stated in prescribing guidelines.

Mechanism of Action

Levometil is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) that principally targets the sodium-dependent noradrenaline transporter (NET) and the sodium-dependent serotonin transporter (SERT) in the central nervous system. Levometil functions as a reuptake inhibitor by binding to these transporters, which consequently blocks the re-entry of the neurotransmitters norepinephrine (NE) and serotonin (5-HT) into the presynaptic neuron.

This blockade causes an accumulation of NE and 5-HT within the synaptic cleft. The resultant elevation in synaptic neurotransmitter concentrations leads to enhanced and prolonged activation of postsynaptic adrenergic and serotonergic receptors. This increased monoaminergic neurotransmission across various brain regions constitutes the primary molecular and cellular pathway of its action, leading to system-level physiological modulation of monoamine-dependent regulatory processes within the central nervous system.

Dosage and Administration Information

How to Use Levometil: Official Administration Guidelines

This section details the standardized administration of Levometil (Chloramphenicol and Dioxomethyltetrahydropyrimidine) ointment as outlined in official documentation.


General Use Protocol

The medicine is intended exclusively for external, topical application to the affected area. The dosing regimen is generally once per day, typically applied via a fresh sterile dressing to the wound. This daily application must continue until the wound is clean of purulent-necrotic masses, which marks the completion of the primary antimicrobial phase.

Dosing and Duration Constraints

The total duration of the treatment course is generally limited, often spanning 5 to 7 days. The ointment is specifically used for a defined initial course, such as 4 days, after which a transition to agents focused on tissue restoration is recommended. A crucial dosing constraint is that the daily applied amount, when treating large wound surfaces, must not exceed the equivalent of 3 grams of the chloramphenicol component.


Special Administration Procedures

Procedural Requirement Detail (Official Labeling)
Application Method Ointment is used to impregnate sterile gauze napkins to fill the wound space, or may be introduced via a catheter/drainage tube into deep cavities.
Temperature Condition If the ointment is introduced into a cavity, it must be pre-heated to 35-36 °C for proper application.
Population Use Approved for use in adults and children over 3 years of age.

These instructions define a time-limited, daily, and highly procedural administration sequence for the ointment, ensuring adherence to the usage parameters set forth by official guidelines.

Recent Clinical Evidence

Research evidence / Overview of studies for Levometil

Levometil is a topical ointment that combines two active ingredients: the antibiotic Chloramphenicol and Dioxomethyltetrahydropyrimidine. Research into this specific combination was observed in research exploring the context of compromised or damaged skin. The available evidence landscape includes both studies focused on the combined product and systematic reviews focused on the individual antibiotic component.


Evidence for Use in Supporting Healing of Infected Wounds

Research exploring how symptoms change over time has included a mix of pre-clinical animal models and clinical evaluations involving human participants. These studies typically observe wounds that are characterized by fluctuating or episodic manifestations, often presenting with pus formation or other signs of inflammatory or irritative states. Researchers examined outcomes related to wound-healing metrics and the presence of bacteria, consistent with the overall outcomes linked to inflammatory or irritative states.

How Research Assesses Wound Cleansing and Infection Rates

Studies relevant in trials assessing short-term or episodic symptom patterns tracked specific endpoints like the rate of wound clearance from necrotic (dead) or purulent (pus-filled) material. Researchers also monitored microbiological remission rates. Studies report how symptoms evolved in the observed populations with measurements related to wound cleansing. However, evidence is limited because comparative evidence is lacking from high-quality human randomized controlled trials specifically designed to evaluate this two-ingredient combination product against an inactive control. The existing human data often comes from studies where Levometil was evaluated in a comparator group against an alternative therapy.


Evidence for Use in Supporting Tissue Regeneration and Repair

This research primarily consists of pre-clinical studies utilizing animal models (e.g., rats). Researchers used these models to track the product's effect on tissue growth, focusing on outcomes capturing phases of heightened symptom activity associated with healing. Objective wound metrics were monitored to track the overall rate of wound area reduction and the process of epithelialization (skin coverage).

Findings from these models research highlights changes measured during the study period, specifically noting patterns related to wound metrics through the stages of healing when the combination product was evaluated in the animal models. This research provides context but not individual predictions, as the results apply only to the populations studied (non-human models).

Key Studies & References

  1. ATC Code D03AX: Other preparations for treatment of wounds and ulcers (Pharmacological Classification)

Frequently Asked Questions (FAQ)

Common questions about Levometil (FAQ)

Q: What is Levometil used for?

Levometil (Levocetirizine Dihydrochloride) is an antihistamine used to treat symptoms associated with seasonal and perennial allergic rhinitis (hay fever), as well as chronic idiopathic urticaria (hives without a known cause). It works by blocking a natural substance called histamine that your body makes during an allergic reaction.


Q: How should I take Levometil?

Levometil is typically taken once daily in the evening, with or without food. You should follow the exact dosing instructions provided by your healthcare provider or as indicated on the prescription label. Do not crush, chew, or break the extended-release tablets; swallow them whole.


Q: What are the common side effects of Levometil?

The most common side effects reported with Levometil include:

  • Drowsiness or fatigue
  • Dry mouth
  • Headache
  • Sore throat (pharyngitis)

If you experience any severe or persistent side effects, contact your healthcare provider.


Q: Can Levometil cause drowsiness?

Yes, Levometil can cause drowsiness or sleepiness, particularly at higher doses or when first starting the medication. Because of this potential effect, it is usually recommended to take Levometil in the evening. Patients should be cautious when driving or operating machinery until they know how the medication affects them.


Q: Can I drink alcohol while taking Levometil?

You should avoid drinking alcohol while taking Levometil. Alcohol can increase the central nervous system depressant effects of the medication, which may lead to increased drowsiness, dizziness, or impaired judgment and coordination.


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

If you are pregnant, planning to become pregnant, or breastfeeding, you should consult with your healthcare provider before using Levometil. Your doctor will weigh the potential benefits against the risks to determine if this medication is appropriate for you in this situation.


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

If you miss a dose of Levometil, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time to make up for a missed dose.

How should Levometil be stored and disposed of?

Official Storage Requirements

Levometil Ointment must be stored in accordance with regulatory instructions to ensure its stability. The product requires a controlled storage temperature not exceeding 25°C and must be kept in a dry place. It is a mandatory requirement to not allow the ointment to freeze, as freezing can compromise its formulation. For security, the medication must be stored out of the sight and reach of children.

Handling and Disposal

To maintain quality, the ointment should be kept in its original packaging until use. Unused or expired Levometil must be disposed of following official guidelines. The preferred method is using a drug take-back program. If a program is unavailable, the product should be mixed with an undesirable substance (such as coffee grounds) and placed in a sealed container before being discarded in the household trash. It is officially restricted to not dispose of this medication by flushing it down a toilet or pouring it down a drain.

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

Available in countries:

Equivalent of Levometil found in:

A-Z Index: