Levomicetin-EM

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Levomicetin-EM

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 Levomicetin-EM

Property Description
Active ingredient Chloramphenicol (INN)
Form Solution, tablets, capsules, eye drops, ointment
Pharmacological class Antibiotic (Phenicol class)
Common purpose To inhibit the growth of susceptible bacteria
Origin Synthetic

Levomicetin-EM: Definition and Pharmacological Class

Levomicetin-EM is a pharmaceutical preparation whose active component is the antibiotic substance Chloramphenicol, recognized by the International Nonproprietary Name (INN). This compound is formally classified within the Phenicol class of anti-infective agents, a group generally known for its broad applicability. Chloramphenicol is of synthetic origin, having been manufactured chemically since its initial isolation. The medicine is clinically recognized for its ability to address infections where bacteria show susceptibility. Chloramphenicol is considered effective against a wide array of Gram-positive and Gram-negative bacteria. This property confirms that the medicine is utilized to fight infections caused by many different types of bacteria. It is defined as a bacteriostatic agent, meaning its primary function is to inhibit the growth and multiplication of susceptible bacteria rather than directly killing them.

Composition, Forms, and General Purpose

The core composition of Levomicetin-EM utilizes Chloramphenicol, chemically classified as a nitrobenzene derivative, alongside a necessary base or vehicle that determines its final presentation. Levomicetin-EM is commonly encountered as a solution—often an alcohol solution for skin application or an aqueous preparation for ocular use—distinguishing its therapeutic access. The medicine is also manufactured in other high-level dosage forms, which include tablets, capsules, and powder for injection. Chloramphenicol is recognized on essential medicine listings, which highlight that the drug is considered a necessary agent for addressing priority health needs globally. The general purpose of administering the medicine is to successfully contain bacterial infections caused by susceptible microorganisms, helping to suppress the infectious load across various anatomical sites.

Regulatory References

  1. Phenicol class
  2. Gram-positive and Gram-negative bacteria
  3. bacteriostatic agent
  4. World Health Organization (WHO) lists Chloramphenicol on its Essential Medicines List

What side effects are possible with Levomicetin-EM?

Possible Side Effects and Safety Information

Official regulatory information emphasizes that chloramphenicol, the active ingredient in Levomicetin-EM eye drops, can be systemically absorbed from the eye, which is the basis for its potential risks.

Serious and Clinically Significant Adverse Reactions

The most critical safety concern is the rare but officially documented risk of aplastic anaemia (a severe form of bone marrow failure), including fatal cases, reported following topical (eye drop) use. This risk is acknowledged even though the drug is administered locally. Other severe reactions include bone marrow hypoplasia and major hypersensitivity reactions such as angioedema and anaphylaxis (frequency classified as not known).

Common and Local Side Effects

The most frequent adverse effects are local and transient, typically occurring immediately after application. These include eye disorders such as transient irritation, burning, stinging, and sensitivity reactions like itching and dermatitis. Transient blurring of vision may also occur.

Safety Restrictions and Population Considerations

The product is contraindicated in patients with a known personal or family history of blood dyscrasias, including aplastic anaemia, and in those with myelosuppression from previous chloramphenicol exposure. Concomitant use with other drugs known to depress bone marrow function must be avoided. The safety of use during pregnancy and lactation has not been established and is generally not recommended due to potential systemic absorption.

Some formulations contain the excipient boron, which has specific regulatory warnings regarding use in children younger than two years old due to a theoretical, dose-related risk to future fertility, based on animal studies. Prolonged use beyond the prescribed duration is officially discouraged.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory information for Levomicetin-EM (Chloramphenicol) defines overdose by severe, systemic toxicity, particularly involving cardiovascular and hematologic systems. Documented overdose manifestations include nausea, vomiting, diarrhea, headache, confusion, and hypotension (low blood pressure). Severe toxicity is frequently associated with excessive serum drug levels, sometimes exceeding 25 mu g/mL.

Serious or Life-Threatening Outcomes

Overdosage may lead to potentially fatal blood dyscrasias, including aplastic anaemia, and severe cardiovascular effects, such as vasomotor collapse and circulatory collapse. A distinct, life-threatening complication is Grey Baby Syndrome, which primarily affects premature and newborn infants. This condition progresses rapidly, presenting with pallid cyanosis, low body temperature, flaccidity, and ultimate cardiovascular collapse.

Emergency Actions and Seeking Medical Attention

Immediate medical attention must be sought if any signs of Grey Baby Syndrome are suspected in an infant. The official labeling states that the medicine should be promptly withdrawn upon recognition of toxic hematologic changes. No specific pharmacological antidote is explicitly documented for Chloramphenicol overdose. Management is primarily symptomatic and supportive, and charcoal haemoperfusion is noted as a procedural measure that may assist in removing the drug in serious overdosage situations.

Therapeutic Uses of Levomicetin-EM

What Levomicetin-EM Treats: Main Uses and Benefits

Levomicetin-EM (Chloramphenicol) may be part of symptomatic management across various clinical contexts, ranging from addressing localized discomfort to supporting patients during serious systemic episodes. This medicine is relevant for easing symptoms related to physical discomfort that often appear suddenly, contributing to easing the overall symptom load when symptoms become momentarily overwhelming. Levomicetin-EM is commonly used across conditions presenting with systemic or localized discomfort, and is relevant in situations involving inflammatory or irritative processes or where symptoms may intensify temporarily.

Relief for Sudden Symptom Discomfort

This domain applies to situations involving certain distressing symptoms that create noticeable physiological strain. The medicine is commonly used to help with symptoms associated with acute or episodic changes, and may assist with maintaining functional stability when symptoms become momentarily overwhelming. It is applicable across domains where additional symptomatic support is needed.

Easing Symptom Clusters and Functional Strain

Levomicetin-EM is applied in scenarios requiring assistance to address symptom clusters that may become intense or disruptive. It supports patients during difficult episodes by easing distress related to symptoms that interfere with daily functioning, which may help patients cope more steadily with symptom fluctuations.

“It provides supportive relief that may assist with maintaining a sense of stability when symptoms are more noticeable.”


Quick Fact: Applicable for managing symptoms that interfere with daily functioning

Support for Episodic and Fluctuating Conditions

It is relevant in contexts marked by increased discomfort or tension, such as in conditions involving episodic or fluctuating manifestations. It provides supportive relief that supports general well-being during symptomatic phases.

Regulatory References

  1. NIH StatPearls

Eligibility and Restrictions for Use

Levomicetin-EM (Chloramphenicol) use is defined by strict population eligibility rules set by official regulatory agencies. The medicine is contraindicated and must not be used by individuals with a history of bone marrow suppression, myelosuppression, or other blood dyscrasias. It is also absolutely prohibited for use in newborns and premature infants due to the serious risk of Gray Syndrome.

Eligibility Restrictions

The therapeutic use of Levomicetin-EM is typically reserved for treating serious infections where alternative, safer antibiotics are unavailable or contraindicated. Use is generally not recommended during pregnancy or lactation.

For patients with hepatic impairment or renal impairment, the official label mandates dose adjustments and close monitoring. All children (outside the newborn period) and older adults require special monitoring and caution as detailed in official regulatory documents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interaction Scope

Category Description
Medicinal product categories with documented interactions Myelosuppressive Agents, Bactericidal Antibiotics, Calcineurin Inhibitors, Oral Anticoagulants, Anticonvulsants, and Sulfonylureas.
Specific interacting medicines (if explicitly listed) Lurasidone, Warfarin, Phenytoin, Tacrolimus, Cyclosporine, Tolbutamide, Vilazodone, and Red Yeast Rice.
Mechanistic basis of interactions Documented as a potent inhibitor of the metabolic enzymes CYP3A4 and CYP2C19, which results in the reduced clearance and increased plasma exposure of co-administered substrates.
Timing-based interaction rules No explicit mandatory administration separation interval is consistently documented in official labeling.
Population-specific interaction notes Patients with hepatic impairment may experience a higher risk of side effects due to reduced drug clearance, which increases the severity of exposure-related drug interactions.
Interaction-related restrictions Co-administration with Lurasidone is classified as a contraindicated combination. Avoidance is advised for agents that depress bone marrow function due to the risk of additive hematologic toxicity.

Official Interaction Statements:

  • Levomicetin-EM is documented to reduce the clearance and increase the plasma exposure of numerous co-administered medicines through metabolic enzyme inhibition.
  • The Lurasidone combination is officially classified as a contraindicated combination by regulatory sources.
  • Regulatory documents advise avoidance of agents that depress bone marrow function due to the risk of additive toxicity.
  • A pharmacodynamic interaction is noted with certain bactericidal antibiotics, which may result in interference with effectiveness.

Regulatory documents define the product's interaction structure primarily through its activity as a metabolic enzyme inhibitor (CYP3A4/2C19) and the resultant requirement for caution or prohibition with numerous susceptible medicines. This structure is reinforced by the critical warning regarding additive pharmacodynamic toxicity (myelosuppression) that forms a central restriction on its use in combination therapy.

Mechanism of Action

Targeted Inhibition of Bacterial Protein Synthesis

Levomicetin-EM (Chloramphenicol) works by targeting the core protein-manufacturing machinery of susceptible bacteria: the 70S ribosome. The drug operates as an inhibitor, binding reversibly and with high affinity to the 50S ribosomal subunit . This molecular interaction physically blocks the Peptidyl Transferase Center, thereby preventing the formation of new peptide bonds and halting the elongation of polypeptide chains. This specific action prevents the bacteria from manufacturing the essential structural components and enzymes needed for their survival and multiplication.


Resulting Bacteriostasis and Mechanism Limitations

The functional consequence of the interrupted protein synthesis is bacteriostasis, meaning the existing bacterial population is prevented from multiplying, which supports the regulation of the microbial burden. However, the mechanism is limited by bacterial countermeasures, such as the production of the Chloramphenicol Acetyltransferase (CAT) enzyme, which chemically inactivates the drug. Additional constraints include ribosomal mutations and efflux pumps that structurally prevent the drug from reaching its target and exerting its inhibitory action.

Dosage and Administration Information

Instruction Map: How to use Levomicetin-EM — Official Administration Guidelines

The administration of Levomicetin-EM (Chloramphenicol) is strictly governed by protocols that define the route, dosage, frequency, and preparation requirements for proper use.


Administration Scope

Property Official Instruction Detail
Route of Administration Systemic use is restricted to Oral (capsules/suspension) or Intravenous (IV) injection. Topical use is approved for ocular and otic administration. The intramuscular route is not recommended for systemic therapy.
Dosing Schedule (Systemic) The standard adult and pediatric systemic dose is 50 mg/kg of body weight daily, divided into separate doses at set intervals. In instances of severe infection, a dose of up to 100 mg/kg/day may be administered initially, but this regimen must be reduced as soon as clinically feasible.
Timing in Relation to Meals The oral dosage form is best taken on an empty stomach with water, typically one hour before or two hours after a meal.
Preparation Requirements The powder for intravenous administration (chloramphenicol sodium succinate) requires reconstitution with an aqueous diluent to a concentration of 100 mg/mL before injection.
Age-Group Administration Rules Neonates (infants under two weeks old) require a significantly lower total daily dose, commonly 25 mg/kg/day. Dose adjustments are also necessary for adults with documented hepatic or renal impairment.
Special Procedural Conditions The reconstituted IV solution must be administered slowly over a period of at least one minute. For courses longer than 48 hours, Therapeutic Drug Monitoring (TDM) is recommended by several official formularies.

Instruction Classifications (High-Level)

Classification Official Pattern
Administration Method Type Systemic (Oral/IV) and Topical (Ocular/Otic).
Frequency Pattern Every 6 hours (q6hr) for systemic use. Topical ocular drops may start at every two hours, reducing frequency as appropriate.
Course Duration Systemic duration is limited to the minimum time required. Topical ocular treatment typically continues for at least 48 hours after resolution of symptoms, generally not exceeding 10 to 14 days.

Connection to the overall use protocol

The administration protocols strictly define the route, amount, timing, and preparation necessary for Levomicetin-EM usage. This structure ensures the medicine is utilized in accordance with the exact specifications detailed in the prescribing information, including mandatory adjustments for patient factors and defined procedural steps for injection and monitoring.

Recent Clinical Evidence

Evidence for Systemic and Reserved Uses

Research has examined the use of Levomicetin-EM for severe systemic infections, including Enteric Fever (Typhoid) and Bacterial Meningitis. The core evidence is often derived from systematic reviews and meta-analyses of older controlled clinical trials involving hospitalized adults and children. Studies monitored critical outcomes related to systemic or functional imbalance, such as patient survival and rates of treatment failure. The research has also explored comparative measurements. Evidence quality varies across studies, and a key limitation is the limited comparative evidence against current, less-toxic standard-of-care treatments. Research also examined specific, reserved uses for infections like severe Pneumonia in young children, where findings support evaluation in defined scenarios when first-line therapies are not utilized.

Evidence for Topical Ocular Infections

In its topical form, the medicine was studied for acute superficial eye infections, such as bacterial conjunctivitis, using Randomized Controlled Trials (RCTs). These trials examined patient-reported experiences and outcomes related to visible physical discomfort. Studies monitored the time elapsed until clinical cure. Research highlights changes measured during the study period but reported patterns where the rate of clinical resolution was similar to or near the spontaneous resolution observed in control groups for mild cases. The evidence is limited by the fact that many mild superficial eye infections resolve naturally, making the observed research findings less certain.

Limitations and Research Gaps

Long-term effects are not fully established across most indications, as the follow-up durations used in regulatory-supporting studies were limited. Data for certain special groups remain insufficient, and comparative evidence is lacking for older adults or patients with multiple co-occurring health conditions. Findings were mixed across global trials regarding the medicine's placement within the evidence landscape, and research is ongoing to clarify its use in light of changing patterns of antibiotic resistance. Research findings describe group patterns, not personal outcomes, and do not suggest definitive individual response patterns.

Key Studies & References

  1. Trend of Changes in Chloramphenicol Resistance during the Years 2017–2020: A Retrospective Report from Israel

Frequently Asked Questions (FAQ)

Common questions about Levomicetin-EM (FAQ)

Q: What are the signs or symptoms of Gray Syndrome, which is a known risk in infants?

Regulatory documents state that Gray Syndrome is a severe and rare reaction reported in infants given chloramphenicol. Symptoms may include a change to an ashen gray skin color, vomiting, and abdominal distention. Other serious signs can involve hypotension (low blood pressure), irregular breathing, and circulatory collapse. This is why the use of this medicine is absolutely prohibited in newborns and premature infants.


Q: How quickly do the common side effects like eye irritation typically resolve after using the eye drops?

Official product information notes that local side effects, such as transient blurring of vision and general eye irritation, may occur immediately following application. Official labeling advises against driving or operating machinery until vision has fully cleared. This suggests that these common effects usually resolve rapidly.


Q: Can you tell me more about the CYP450 enzyme inhibition and how it affects other medications?

Levomicetin-EM is known to inhibit certain CYP450 enzymes in the body, such as CYP3A4 and CYP2C19. This system of enzymes is primarily responsible for metabolizing (breaking down) many other medications. When the breakdown is slowed, it can lead to increased plasma exposure of those co-administered drugs. This raises the potential risk of side effects or toxicity from those other medicines.


Q: What do I do if I accidentally miss a scheduled dose?

Official patient information suggests that a missed dose should be taken as soon as it is remembered. However, if it is almost time for your next scheduled dose, the missed dose should be skipped, and the regular schedule continued. It is important not to take a double dose to compensate for the forgotten one.


Q: What is the difference between the powder for injection (Chloramphenicol Sodium Succinate) and the active form (Chloramphenicol)?

The powder for injection is actually an inactive form of the medicine called a prodrug (Chloramphenicol Sodium Succinate). It must be chemically broken down by enzymes in the body into the active form (Chloramphenicol) before it can start to work against bacteria. This conversion process is necessary for the intravenous administration.

How should Levomicetin-EM be stored and disposed of?

How to Store and Dispose of Levomicetin-EM

For the finished Levomicetin-EM product, stability testing dictates the labeled storage requirements to ensure the medicine remains effective and safe throughout its shelf life. Official regulatory requirements mandate that storage conditions, including temperature, must maintain the product's quality, though specific labeled temperatures are determined by the manufacturer's testing.

Any storage constraints after dilution, reconstitution, or initial opening must be followed exactly as stated on the product labeling. These 'in-use' stability periods are established by regulatory-mandated studies.

Regarding disposal, Levomicetin-EM must be discarded strictly in accordance with local and national regulations for pharmaceutical waste. Do not dispose of this medication via household waste or wastewater unless specifically instructed by an authorized drug take-back program. All medications should be stored in a location inaccessible to children.

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

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