Левомицетин Актитаб

Quick links

Choose a section

Quick links to important sections

Advertisements

Левомицетин Актитаб

Selected form

Advertisements
Advertisements

Overview of Левомицетин Актитаб

Property Description
Active ingredient Chloramphenicol
Form Oral tablets
Pharmacological class Amphenicol-class Antibacterial
General purpose Control of severe systemic bacterial infections
Origin Synthetic

Левомицетин Актитаб: Identity, Classification, and Composition

Левомицетин Актитаб is a specific pharmaceutical brand whose active substance is Chloramphenicol, an antimicrobial agent classified as an Amphenicol-class Antibacterial. This medicine is presented as a solid oral tablet, designed for internal, oral administration, and contains Chloramphenicol as its single-ingredient product. The formulation of this specific brand, including its proprietary tablet base, aims to optimize the bioavailability of the active component. Chloramphenicol, while originally isolated from Streptomyces venezuelae, is now predominantly produced through synthetic means for commercial applications.


General Purpose of Chloramphenicol: Beyond Routine Antibiotics

The overall purpose of this product is the control of bacterial infection through its powerful bacteriostatic effect, meaning it stops the replication and growth of susceptible bacteria. Chloramphenicol is clinically recognized for its effectiveness against a broad spectrum of microorganisms and its status is noted by its inclusion in the international List of Essential Medicines. Its unique characteristic of high lipid solubility allows it to penetrate biological barriers, distinguishing it from many routine antibiotics and enabling the suppression of systemic bacterial infections in challenging sites. Consequently, the use of medicines containing Chloramphenicol is typically reserved for managing serious, life-threatening infections, such as severe typhoid fever or meningitis when caused by susceptible strains, particularly when other less restrictive antimicrobial options have been deemed ineffective or inappropriate.

Regulatory References

  1. Chloramphenicol on WHO Essential Medicines List
Advertisements

What side effects are possible with Левомицетин Актитаб?

Possible Side Effects and Safety Information

Chloramphenicol (Левомицетин Актитаб) is associated with several serious and potentially life-threatening adverse reactions, which limit its use primarily to severe infections where other, safer antibiotics are inadequate or contraindicated.

Hematological and Bone Marrow Toxicity

The most significant safety concern is severe toxicity to the blood and bone marrow. This includes two main types of reactions:

  • Dose-Related Reversible Bone Marrow Suppression: A more common and predictable effect, leading to anemia, leukopenia, and thrombocytopenia. This is typically reversible upon discontinuation of the medication and is often linked to higher doses or prolonged treatment.
  • Idiosyncratic Aplastic Anemia: A rare, unpredictable, and often fatal reaction that is not dependent on the dose or duration of therapy. This toxicity may occur weeks or months after exposure and involves irreversible bone marrow failure.

Other Serious Adverse Reactions

  • Gray Baby Syndrome: A life-threatening toxicity unique to premature and newborn infants, characterized by abdominal distension, hypothermia, vasomotor collapse, and a gray or ashen color. This syndrome results from the inability of the immature liver to metabolize the drug efficiently.
  • Neurotoxicity: Prolonged use can lead to damage to the nervous system, potentially causing optic neuritis (which may result in vision loss) and peripheral neuropathy (numbness, tingling, or weakness in the extremities).

General Adverse Reactions

Less common side effects involve the gastrointestinal system (nausea, vomiting, diarrhea) and hypersensitivity reactions (skin rash, fever, or anaphylaxis).

Safety Considerations

The medication is contraindicated in patients with a history of hypersensitivity or acute porphyria. Due to the high risk of serious bone marrow suppression, caution and regular monitoring of blood counts are necessary during treatment. Use during the third trimester of pregnancy or while breastfeeding is generally discouraged due to the potential risk of Gray Baby Syndrome in the infant.

Advertisements

Overdose and Emergency Response

The official regulatory documents describe specific manifestations of overdose for Левомицетин Актитаб (Chloramphenicol) related to high drug exposure. Documented signs of toxicity include gastrointestinal effects such as nausea and vomiting, and significant dose-related effects on the hematopoietic system. These hematological manifestations often include reversible anemia, leukopenia (reduced white blood cells), and thrombocytopenia (reduced platelets).

A severe and potentially fatal outcome explicitly noted in regulatory labeling is Gray Syndrome, which affects neonates and infants due to their limited ability to metabolize the drug. This syndrome is characterized by symptoms like abdominal swelling, irregular respiration, and progressive circulatory collapse. Due to the severity of these potential outcomes, the regulatory requirement is to seek immediate medical attention or contact a Poison Control Center for any suspected overdose.

Management is restricted to symptomatic and supportive treatment and procedures to enhance drug elimination, as official documents state that no specific antidote is known. Patients with impaired hepatic or renal function are also listed as being at increased risk for toxicity due to reduced clearance.

Advertisements

Therapeutic Uses of Левомицетин Актитаб

Quick Facts: Uses of Levomycetin Actitab

  • Serious Bacterial Infections: Used for certain severe infections caused by susceptible bacteria when other therapies are not appropriate.
  • Rickettsial Diseases: Employed in the management of infections like rocky mountain spotted fever.
  • Typhoid Fever: Utilized as a treatment option for this condition when first-line drugs are ineffective or contraindicated.
  • Ocular Infections: May be used in external preparations to address certain bacterial eye infections.

Levomycetin Actitab, which contains the substance chloramphenicol, is an established antibiotic option reserved for the management of serious bacterial infections. Due to potential safety considerations, its use is typically restricted to situations where less toxic alternatives are ineffective, not tolerated, or are otherwise inappropriate for the patient's clinical needs.

The medication is utilized to address various severe infections caused by specific, susceptible organisms. This includes the management of typhoid fever, rickettsial diseases, and certain forms of bacterial meningitis. In ophthalmic (eye) formulations, the drug may be administered to assist in resolving specific superficial bacterial eye infections, such as bacterial conjunctivitis, that are sensitive to this treatment.

It is important that the determination to use this treatment is based on a healthcare professional’s assessment of the patient’s specific condition and bacterial susceptibility data. The drug works by targeting and supporting the cessation of bacterial growth in the body.

Regulatory References

  1. NIH MedlinePlus guidance
Advertisements

Eligibility and Restrictions for Use

Official Eligibility Profile for Левомицетин Актитаб (Chloramphenicol)

Official regulatory guidelines severely restrict the use of Левомицетин Актитаб to patient populations diagnosed with serious, life-threatening infections caused by susceptible organisms, and only when less hazardous alternatives are ineffective or contraindicated. The drug is subject to numerous eligibility restrictions, often requiring mandatory therapeutic drug monitoring.


Absolute Contraindications (Must Not Use)

  • Neonate infants (especially preterm infants) due to the risk of Gray Baby Syndrome.
  • Individuals with a history of hypersensitivity or toxic reaction to Chloramphenicol.
  • Patients with pre-existing bone-marrow depression, aplastic anaemia, or related blood dyscrasias.

Restricted and Conditional Use

Population Group Eligibility Restriction
Pediatric Patients Children under four years old require mandatory plasma concentration monitoring.
Older Adults & Hepatic Impairment Requires therapeutic plasma concentration monitoring and cautious dosing.
Pregnancy/Lactation Contraindicated in neonates. Not recommended for breastfeeding mothers; caution is required during the third trimester of pregnancy.

This profile dictates that use is reserved and is strictly prohibited in specific high-risk groups.

Advertisements

What should I know about interactions with other medicines?

The interaction profile of Левомицетин Актитаб (Chloramphenicol) includes specific prohibitions and pharmacokinetic effects as defined in regulatory labeling.

Contraindicated Combinations

Co-administration with other myelosuppressive agents or bone marrow depressants (including cytostatics) is formally contraindicated. This restriction is based on the documented additive risk of severe haematological toxicity, encompassing dose-related and potentially irreversible bone marrow suppression.


Pharmacokinetic and Exposure Effects

Chloramphenicol is documented as a potent inhibitor of Cytochrome P450 enzymes, specifically CYP2C19 and CYP3A4. This metabolic inhibition reduces the clearance of co-administered substrates, leading to increased plasma concentrations and the potential for toxicity.

  • Phenytoin: Co-administration results in significantly increased Phenytoin plasma concentrations.
  • Oral Anticoagulants (e.g., Warfarin): Inhibition of metabolism leads to the potentiation of the anticoagulant effect and increased bleeding risk.
  • Sulfonylureas (e.g., Tolbutamide): Inhibited metabolism may increase their pharmacological effect.

Pharmacodynamic Antagonism

The regulatory profile also describes pharmacodynamic antagonism. Chloramphenicol may interfere with the efficacy of live oral vaccines (such as the typhoid vaccine), requiring specific timing constraints. Additionally, it may antagonize the haematopoietic response to agents like Iron preparations, Vitamin B12, and Folic Acid.

Advertisements

Mechanism of Action

Targeted Inhibition of the Bacterial Protein Factory

The drug's primary mechanism involves directly engaging the bacterial 50S ribosomal subunit. It acts as a reversible inhibitor of the peptidyl transferase enzyme within this subunit, the site responsible for linking amino acids together. By occupying this catalytic center, the drug immediately halts the formation of new peptide bonds, thereby stopping the elongation of all bacterial protein chains and resulting in bacteriostasis (stoppage of bacterial proliferation).


Systemic Access through High Lipid Solubility

Chloramphenicol possesses a high degree of lipid solubility due to its small molecular structure, which is a key mechanistic enabler. This property allows the molecule to readily diffuse across lipid-rich biological membranes and barriers (such as the blood-brain barrier). This permeability allows the drug’s protein synthesis-inhibiting mechanism to reach pathogens sequestered in deep-seated, systemic tissues.


Functional Limitations via Bacterial Defense

The drug's mechanism is countered by specific bacterial defense strategies that reduce its target affinity or concentration. These limitations primarily include the enzymatic inactivation of the drug by Chloramphenicol acetyltransferase (CAT), and active removal from the cell by efflux pumps. These resistance mechanisms limit the bacteriostatic effect by preventing the drug from binding to the 50S subunit.

Advertisements

Dosage and Administration Information

The use of Левомицетин Актитаб, which contains the active substance Chloramphenicol, is characterized by specific parameters regarding its administration route and dosage. This medicine is available and used through several routes: oral tablets (e.g., Левомицетин Актитаб), intravenous (IV) injection for systemic effects, and topical (ophthalmic) preparations for localized use.

Administration and Dosing Schedule

The standard systemic dose for adults is 50 milligrams per kilogram of body weight per day. This total daily dose is required to be divided into four equal parts, establishing an every six hours (q6hr) frequency pattern. For severe infections, the initial dose may be escalated up to 100 mg/kg/day, but it is required that this maximum initial dose be reduced back to the standard 50 mg/kg/day as soon as possible.

Special Use Conditions

Oral Administration: The tablets or capsules are generally directed to be taken on an empty stomach (one hour before or two hours after a meal). The IV form must be administered as an intermittent infusion after dilution.

Dosage Adjustments: Dosage modification is required for patients with impaired liver or kidney function. Neonates and young infants also require a significantly reduced daily dose (e.g., 25 mg/kg/day or less) due to immature metabolic capacity. For all systemic use, Therapeutic Drug Monitoring (TDM)—the measurement of drug concentration in the plasma—is a required procedural step to guide appropriate dosing and control exposure.

Advertisements

Recent Clinical Evidence

Research evidence / Overview of Studies for Левомицетин Актитаб (Chloramphenicol)


Evidence for Use in Typhoid Fever (Enteric Fever)

Chloramphenicol was studied in research exploring typhoid fever, a condition characterized by fluctuating or episodic manifestations. Researchers used Randomized Controlled Trials (RCTs) and Systematic Reviews to explore its role, often comparing it against newer antibacterial agents. These studies monitored outcomes such as the measurement of fever resolution time, the clinical status measured during treatment, and the frequency of recurrence of symptoms after treatment. The research focused on populations of both adults and children, including those where the bacteria show multi-drug resistance.

Studies reported various measurements of fever resolution time and clinical status across the observed populations. Analysis of systematic reviews described patterns in the outcomes measured when comparing Chloramphenicol to alternative agents. What remains uncertain is the long-term symptom pattern stability and the rate of late recurrence of symptoms, as these outcomes are not well characterized in the existing evidence base. The relevance of some historical data is limited by evolving global resistance patterns of Salmonella.


Evidence for Use in Bacterial Meningitis

Chloramphenicol was evaluated in research exploring its role in bacterial meningitis. The available evidence includes RCTs and Comparative Observational Studies. Researchers examined severe outcomes such as outcomes related to survival and the development of neurological status monitored (lasting brain or nerve damage) in the observed populations. Study populations primarily consisted of pediatric patients (children) diagnosed with the condition.

Research indicates that the evidence base supporting this use is often described as having low methodological quality due to the presence of potential bias in the study designs. Evidence is limited for modern, high-quality RCTs that definitively characterize the comparative role of Chloramphenicol versus current first-line therapies. Long-term effects are not fully established, as consistent follow-up to fully characterize the permanence of neurological outcomes is often lacking.


What Remains Unclear in the Research Record

Comparative evidence is lacking in high-quality, modern trials that directly assess Chloramphenicol against current, less toxic first-line treatments for all approved indications. The evidence quality varies across studies, with many older trials having small sample sizes and methodological issues that introduce a risk of bias.

Key Studies & References Chloramphenicol: MedlinePlus Drug Information

Advertisements

Frequently Asked Questions (FAQ)

Common questions about Левомицетин Актитаб (FAQ)

Q: How quickly is Левомицетин Актитаб expected to start working?

A: Official research indicates that the active substance, Chloramphenicol, is absorbed relatively quickly. On average, significant concentrations can be measured in the body, particularly in the cerebrospinal fluid, within three to four hours after a dose. This high permeability is a characteristic that allows the drug to reach deep-seated tissues.

Q: Does Левомицетин Актитаб treat viral infections?

A: Official regulatory documents indicate that the active substance in Левомицетин Актитаб is classified strictly as an antibacterial agent. Its purpose is to control infections caused by susceptible bacteria. It is not indicated for the treatment of viral infections.

Q: What kind of side effects are most frequently reported with Левомицетин Актитаб?

A: According to official product labels, general side effects frequently include effects on the digestive system, such as nausea, vomiting, and diarrhea. The official label describes bone marrow suppression, which is a serious, dose-related safety concern.

Q: Can Левомицетин Актитаб cause dizziness or drowsiness?

A: Official information describes several effects on the nervous system, including less common reactions like headache and mental confusion. Dizziness is not listed as a primary side effect, but reports show it can be associated with anemia (decreased red blood cells), a possible serious safety concern listed in the regulatory documents.

Q: Is Левомицетин Актитаб safe to use during pregnancy?

A: Official regulatory documents state that the use of this medicine during pregnancy is not recommended. Specific caution is advised if use is considered necessary during the third trimester. This restriction is related to the potential for the serious toxicity known as Gray Baby Syndrome in the infant.

Q: What is the typical duration of treatment with Левомицетин Актитаб?

A: The total duration of treatment is determined by the healthcare professional based on the specific infection being addressed. While treatment lengths vary, official examples for certain topical uses describe short courses of therapy.

Q: What steps are officially recommended if a side effect is noticed?

A: Official guidance states that if any suspected side effects occur, especially unexpected ones, patients should seek attention from a healthcare professional immediately. The regulatory process requires that all suspected adverse reactions be reported to assist in ongoing safety monitoring.

Q: Is there a maximum amount of time a person can safely use Левомицетин Актитаб?

A: While official labels do not specify a single, universal maximum number of days, regulatory guidance emphasizes that treatment should be kept as short as possible. This precautionary measure is intended to help reduce the risk of serious side effects, including irreversible conditions like aplastic anemia.

Q: What does 'broad-spectrum antibiotic' mean in relation to Левомицетин Актитаб?

A: 'Broad-spectrum' is a classification used in regulatory science to describe antibiotics that are active against a wide range of bacteria. The active substance in this medicine is classified as broad-spectrum because it has shown effectiveness against many types of Gram-positive and Gram-negative bacteria.

Q: Are there any known interactions between Левомицетин Актитаб and alcohol?

A: For topical (eye/ear drop) formulations of the active substance, regulatory sources generally note that consuming alcohol is acceptable. For oral tablets, no explicit prohibition is widely described, but the advice of a healthcare professional is always the relevant guide when considering alcohol use.

Q: Is Левомицетин Актитаб used for skin or topical infections?

A: The active substance is manufactured in various preparations, including oral tablets, as well as topical forms like eye drops and ear drops. While the tablets are primarily reserved for severe systemic infections, the topical preparations are used for localized conditions such as ophthalmic (eye) infections.

Q: What are the common signs that Левомицетин Актитаб is not working for an infection?

A: Official product information instructs that if the symptoms of the infection being treated do not show improvement within a few days of beginning therapy, or if they appear to worsen, a re-evaluation is needed. This lack of improvement is an important sign that the drug may not be suppressing the infection effectively.

Q: What specific bacteria is Левомицетин Актитаб known to be effective against?

A: Regulatory classification defines the active substance as effective against a broad spectrum of bacteria. This includes Gram-positive bacteria like staphylococci and streptococci, and Gram-negative bacteria such as Salmonella and Escherichia coli. Its use is restricted to cases where these susceptible organisms cause severe, life-threatening infections.

Q: Is it mandatory to complete the full course of Левомицетин Актитаб even if symptoms improve?

A: Official guidelines generally advise that the medicine should be used for the entire duration prescribed by the healthcare professional. This practice is described in guidelines to help prevent the recurrence of the infection, even if the symptoms appear to clear up quickly.

Q: Does Левомицетин Актитаб affect contraception?

A: Official summaries based on regulatory data indicate that the active substance may potentially reduce the effectiveness of estrogen-containing hormonal contraceptives. This effect could result in an increased risk for pregnancy or unexpected bleeding.

Q: What happens if a person misses using Левомицетин Актитаб?

A: Official guidance for managing missed doses typically describes taking or applying the dose as soon as it is remembered. Following this, the remaining course of treatment should continue on the original schedule, maintaining the usual time between doses.

Q: Are there studies comparing the different formulations of Levomycetin?

A: While the main focus of official regulatory documents is the clinical effectiveness of the drug, some research literature has examined the characteristics of different drug formulations. These studies compare how various forms of the active substance, such as eye drops or niosomes, perform in different settings.

Q: Is Левомицетин Актитаб available in different strengths?

A: Official product information confirms that the active substance is supplied in various formulations and strengths. This includes different concentrations for topical use, such as 0.5% eye drops and 5% or 10% ear drops, in addition to the oral tablet form.

Q: What are the guidelines regarding driving or operating machinery while using Левомицетин Актитаб?

A: Official warnings are sometimes included regarding the use of vehicles or operating machinery. These warnings are related to potential side effects like blurred vision (especially with topical use) or effects on the central nervous system such as confusion. The guidance is to wait until any such effects have passed and you feel well enough to proceed.

Q: What is the difference between an adverse reaction and a side effect in official terms?

A: Regulatory documents often use the terms side effect and adverse reaction interchangeably in patient information. However, generally, 'side effect' refers to symptoms that commonly appear when taking a medicine, while 'adverse reaction' is frequently used to describe a severe, unexpected, and potentially rare outcome, such as aplastic anemia.

Advertisements

How should Левомицетин Актитаб be stored and disposed of?

How to Store and Dispose of Левомицетин Актитаб?

The storage and disposal of Левомицетин Актитаб (Chloramphenicol oral tablets) must adhere strictly to official regulatory guidelines to maintain the drug's stability and ensure environmental safety.


Official Storage and Handling Requirements

  • Temperature: Store the tablets at a temperature that does not exceed 30 C (86 F) and avoid excessive heat.
  • Protection: The product must be protected from moisture.
  • Container: Keep the medicine in the original container and ensure it is kept tightly closed.
  • Child Safety: The product must be stored out of the sight and reach of children.

Official Disposal Instructions

Any unused or expired medicine must be discarded in accordance with local requirements for pharmaceutical products. Regulatory instruction mandates that the product must not be thrown into wastewater or household waste.

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

Available in countries:

Equivalent of Левомицетин Актитаб found in:

A-Z Index: