Pelox-400

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Pelox-400

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Method of action: Bactericidal

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 Pelox-400

Quick Facts

Property Description
Active ingredient Pefloxacin (Pefloxacine)
Form Tablet, Injection (solution for intravenous use)
Pharmacological class Fluoroquinolone Antibiotic
Common use Systemic bacterial infections
Origin Synthetic (chemically manufactured)

What is Pelox-400? Defining the Core Medicine

Pelox-400 is the brand name for a prescription-only medication containing the active compound Pefloxacin, which is also referred to as Pefloxacine in various regulatory contexts. This medicine is primarily classified as a potent antibiotic and is administered to combat various bacterial infections throughout the body. Pefloxacin is a synthetic therapeutic agent, meaning its active substance is entirely manufactured through chemical processes, and it is a single-ingredient product.

What Pharmacological Class and Type is Pelox-400?

Pelox-400 belongs to the highly specific class of Fluoroquinolone Antibiotics and is classified under the WHO Anatomical Therapeutic Chemical (ATC) code J01MA03. This classification indicates that the drug has broad-spectrum activity, making it suitable for addressing a wide range of different bacterial organisms. The medicine is prepared for patient use in key dosage forms, primarily as an oral tablet for ease of use, and also as a sterile solution for injection for intravenous administration, which is typically reserved for acute hospital settings.

What is the General Purpose of Pelox-400?

The overarching general purpose of Pelox-400 is to ensure the swift and effective elimination or destruction of pathogenic bacteria that cause illness, functioning as a bactericidal agent. The active ingredient works systemically, meaning it circulates throughout the entire body to provide comprehensive coverage against infection. Pefloxacin exhibits antibacterial activity against both Gram-negative organisms and staphylococci. This pharmacological profile means the medicine’s core benefit is the capacity to address and resolve underlying bacterial infections by killing the organisms responsible.

Regulatory References

  1. Pefloxacin Substance Data

What side effects are possible with Pelox-400?

Possible side effects and safety information

Pelox-400 (Pefloxacin) is a fluoroquinolone antibiotic and its official safety profile, as documented by government regulatory authorities, is structured by frequency and system-organ class.

Classification Examples of Documented Adverse Reactions
Common (Up to 1 in 10) Nausea and vomiting (Gastrointestinal Disorders).
Uncommon (Up to 1 in 100) Dizziness, headache, abdominal pain, diarrhea, rash, and pruritus (itching).
Rare (Up to 1 in 1,000) Tendinitis, Achilles tendon rupture, and photosensitivity (increased sensitivity to sunlight).

Serious Adverse Reactions and Safety Constraints

The most serious reactions associated with Pefloxacin and its class involve potentially disabling and long-lasting effects on multiple body systems, including the musculoskeletal and nervous systems. These include tendinitis and tendon rupture, often involving the Achilles tendon, as well as peripheral neuropathy, which may present as persistent pain, burning, tingling, or weakness. Other documented serious effects include severe diarrhea (Clostridioides difficile-associated diarrhea) and specific central nervous system effects.

Official regulatory documents place restrictions on use and identify specific risk factors. The risk of tendon disorders is explicitly documented to be increased in older adults (over 60 years of age) and in patients who are concurrently taking corticosteroid medications. Tendon-related issues may occur at any point, from within hours or days of starting treatment up to several months after stopping the medicine. The medicine is contraindicated in individuals with a known hypersensitivity to quinolones or a history of tendon disorders related to prior fluoroquinolone use.

Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Pelox-400 is defined as any exposure exceeding the officially recommended dose and is a serious medical event. The potential consequences of an overdose involve several key organ systems and can range in severity from concerning to life-threatening. Official regulatory documentation stresses the need for immediate professional medical attention in all instances of suspected or confirmed overdose.

Documented Overdose Manifestations

Symptoms of a Pelox-400 overdose typically progress across several domains. Early manifestations may include Gastrointestinal and Neurological Symptoms such as abdominal pain, nausea, vomiting, lethargy, drowsiness, dizziness, and headache. These presentations should not be dismissed, even if they appear mild.

More severe overdose is characterized by signs of Central Nervous System (CNS) Depression and Severe Neurotoxicity, which may include loss of consciousness, profound confusion, convulsions or seizures, and progression to coma. Additionally, severe cases may lead to Renal, Metabolic, and Cardiovascular Complications, such as acute kidney failure, metabolic acidosis, and low blood pressure (shock). In rare, severe instances, there is a risk of Gastrointestinal Bleeding and Perforation, which are life-threatening complications.

Required Emergency Actions

Seek emergency medical treatment or contact a doctor or poison control center immediately if an overdose is suspected or confirmed. This urgent action is required regardless of whether symptoms are present, as serious complications may have a delayed onset. Do not wait for symptoms to worsen. Following any exposure above the prescribed dosage, seek immediate medical attention if any unusual symptoms are experienced.

Therapeutic Uses of Pelox-400

What Pelox-400 Treats: Main Uses and Benefits

Pelox-400 (Pefloxacin) is an antibiotic commonly used across various medical domains to manage susceptible bacterial pathogens, and contributes to easing the overall symptom load in situations where patients experience acute or episodic changes. It is commonly used in areas where short-term symptom management is appropriate.

The medication is applied in addressing conditions characterized by periods of heightened symptoms, including complicated infections of the kidneys (pyelonephritis), prostate (prostatitis), skin and soft tissues (cellulitis), bone (osteomyelitis), and severe systemic infections (septicemia). It is applied in clinical settings that involve acute or unstable symptom patterns, such as deep-seated infections or those that cause significant symptomatic distress.

“The therapy is relevant for easing symptoms that interfere with daily functioning by reducing the physiological strain caused by bacterial infection.”

Pelox-400 supports general well-being during symptomatic phases. It offers symptomatic relief that helps patients cope more steadily with symptom fluctuations by easing symptoms related to systemic imbalance and localized discomfort, and assists with maintaining functional stability.


Quick Fact: Symptom Management in Acute Conditions
Symptom Axis Symptoms related to systemic imbalance and heightened physiological activity
Use Context Applied in scenarios where additional management of discomfort is required in severe, acute infections
Main Benefit Contributes to easing the overall symptom load and assists with maintaining functional stability

Regulatory References

  1. Summary of Product Characteristics (SPC) for Pefloxacin Tablets 400 mg

Eligibility and Restrictions for Use

Pelox-400 (Pefloxacin) eligibility is strictly defined by regulatory labeling, primarily permitting use in the adult population.

Populations for Whom Use is Contraindicated

Use is absolutely prohibited in several groups according to official prescribing information:

  • Hypersensitivity: Patients with a known allergy to Pefloxacin, other Quinolones, or any excipient.
  • Life Stage: Women who are pregnant or breastfeeding/lactating mothers.
  • Age Restriction: Children and adolescents (generally under 18 years) whose skeletal development is not yet complete.
  • Medical History: Individuals with a history of tendon damage related to prior quinolone use or those with Glucose-6 Phosphate Dehydrogenase (G6PD) deficiency.

Restricted or Conditional Use

Certain patient groups are eligible only with special caution or mandatory adjustment:

  • Organ Function: Patients with severe hepatic insufficiency require mandatory dosage adjustment. Caution is also necessary for those with renal impairment.
  • Comorbidities: Caution is required for older adults (due to increased risk of tendinopathy) and patients with a history of seizures, epilepsy, or Myasthenia Gravis. Official labeling also restricts use when administered concurrently with systemic corticosteroids.

These eligibility rules define the necessary boundaries for use as set forth by authoritative health agencies.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Pelox-400 (Pefloxacin) is formally documented in regulatory labeling across three primary areas: effects on absorption, effects on metabolic clearance, and additive pharmacodynamic risks.

Absorption-Interference (Timing-Based Restriction)

Co-administration with substances containing polyvalent cations significantly reduces Pefloxacin's gastrointestinal absorption through chelation. This category includes Antacids (those containing aluminum or magnesium), oral Iron salts, and Zinc salts. The regulatory documents mandate that these medications must be administered at least two to four hours apart from Pefloxacin to maintain adequate exposure. The absorption of Pefloxacin is also reduced when taken with Didanosine (DDI) and Sucralfate.

Metabolic and Clearance Interactions

Pefloxacin is documented to inhibit the metabolic clearance of certain co-administered medicines, resulting in elevated plasma concentrations of the interacting drug. This is most notably described for Theophylline and Caffeine, where the reduced clearance of Theophylline poses a documented risk of toxicity. Probenecid also increases Pefloxacin's own concentration by reducing its renal elimination. Conversely, co-administration with Rifampicin or certain Antineoplastic drugs may decrease Pefloxacin serum levels.

Pharmacodynamic and Restricted Combinations

The combination of Pefloxacin with some Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), particularly Fenbufen, carries a documented risk of Central Nervous System (CNS) excitation and convulsions. Pefloxacin also enhances the effects of Oral Anticoagulants, increasing the risk of bleeding. The combination with Tizanidine is formally designated as a contraindicated combination in some official labels.

Mechanism of Action

Targeted Disruption of Bacterial Genetic Integrity

Pelox-400 (Pefloxacin) initiates its action by selectively targeting two crucial bacterial enzymes: DNA gyrase ( Topoisomerase II) and Topoisomerase IV. The drug functions as an inhibitor by binding to and stabilizing the DNA-enzyme cleavage complex, which prevents the religation of bacterial DNA strands after they are cut. This targeted enzymatic blockade is the mechanism that triggers the drug's lethal effect.


Cascade of Lethal DNA Damage

The stabilization of these enzyme complexes leads to the rapid and irreversible accumulation of DNA double-strand breaks inside the pathogen. This molecular cascade results in the accumulation of irreparable DNA damage that leads to cellular death and dissolution. This specific, destructive process defines the drug as a bactericidal agent, which results in the direct killing of the bacteria rather than merely halting its growth.


️ Constraints on Mechanistic Efficacy

The action of this mechanism is limited by bacterial adaptations, primarily mutations within the GyrA and ParC subunits of the target enzymes which reduce drug binding affinity, and the operation of bacterial efflux pumps. These resistance mechanisms actively lower the drug concentration at the target site, preventing the lethal DNA-damage cascade.

Dosage and Administration Information

How to Use Pelox-400: Official Administration Guidelines

Pelox-400 (Pefloxacin) is an antibiotic approved for systemic administration via two official routes: the oral route as a 400 mg film-coated tablet and the intravenous (IV) route as a solution for injection. The guidelines for its use specify dose, frequency, and timing.

The standard adult dosing regimen is 400 mg twice daily (BID), providing a total daily dose of 800 mg. To rapidly achieve effective levels, an initial single loading dose of 800 mg may be administered. For specific, uncomplicated infections like gonococcal urethritis or acute cystitis, a single dose of 800 mg is the officially sanctioned regimen.


Contextual Timing

Oral tablets must be taken with meals or immediately following a full meal as a procedural requirement. Furthermore, a crucial constraint dictates that oral intake must be separated by more than two hours from medications or supplements containing multivalent cations (such as iron, zinc, or aluminum/magnesium antacids) to prevent reduced systemic absorption.

Population Adjustments

Dosing modifications are mandated for certain patient groups. Individuals with impaired hepatic function require dosage adjustment by lengthening the time interval between doses. A reduced daily dose of 400 mg per day may be applied for older adults (over 65 years). The medicine is not recommended for use in children and growing adolescents.

Recent Clinical Evidence

Pelox-400: Recent Clinical Evidence

Short-Term Pain Management

Studies have evaluated the drug's role in the management of short-term pain following surgical procedures. Research has been conducted to understand the drug's intended biological effect. Research has examined the onset and duration of effect compared to other available pain management options. Initial research has explored whether the drug is associated with changes in patient-reported pain scores. The findings from comparative studies with existing treatments are currently being analyzed.


Chronic Conditions and Inflammation

Research has investigated whether the drug affects measures of mobility and markers of inflammation over a 6-month observational period. Clinical research has assessed the outcomes of using the combination therapy in individuals with chronic back pain. Based on current research, evidence concerning the long-term impact on disease progression and quality of life remains limited.


Safety Profile and Administration

Specific research regarding the drug's safety profile in different patient populations, including those with pre-existing kidney conditions, has been reviewed. Study protocols have documented the conditions under which the drug was provided in clinical trials. Further study is required to fully evaluate the drug's properties across all patient sub-groups. Research is continuing to fully characterize the potential for adverse effects.

Frequently Asked Questions (FAQ)

Common questions about Pelox-400 (FAQ)

Q: Is Pelox-400 meant for long-term chronic use?

A: According to official regulatory documents, Pelox-400 is authorized for a limited duration of treatment, which is often up to 14 days.

The duration authorized depends on the specific bacterial infection for which the product is indicated.

Q: Are the common side effects of Pelox-400 considered permanent?

A: Official safety warnings state that some rare but serious adverse reactions, such as peripheral neuropathy, may be potentially long-lasting or irreversible.

However, the documentation does not indicate that the common, less serious side effects are permanent.

Q: Is it normal to feel tired or fatigued after first starting Pelox-400?

A: Official regulatory information documents asthenia (a medical term for physical weakness or lack of energy) as a possible adverse reaction associated with the medicine.

Q: Can Pelox-400 cause problems with sleep, such as insomnia or vivid dreams?

A: According to official safety summaries, insomnia (difficulty sleeping) is documented as a possible adverse reaction.

Q: Does Pelox-400 affect mood or mental state according to official documents?

A: Official regulatory documents state that Pelox-400 is associated with documented Central Nervous System (CNS) reactions.

These effects are reported to include changes in mental state such as anxiety and hallucinations.

Q: Is a mild rash after taking Pelox-400 always a sign of an allergic reaction?

A: Regulatory documentation lists a general rash as a possible uncommon side effect, which is separate from the signs of a formal hypersensitivity reaction (a severe allergy).

Q: Can long-term use of Pelox-400 lead to any reported issues with the liver or kidneys?

A: Official warnings require caution and state that dosage adjustment may be necessary for patients with pre-existing impaired hepatic function (liver issues) or renal impairment (kidney issues).

This suggests that these organs are important for the drug's metabolism.

Q: Does Pelox-400 need to build up in the body's system to achieve its full effect?

A: Regulatory guidelines mention that an initial loading dose may be administered in some situations.

The purpose of this loading dose is to rapidly achieve the effective concentrations needed for the drug to begin its work against the bacteria.

Q: Is it safe to drink coffee or caffeine products while using Pelox-400?

A: Official product information states that Pelox-400 is documented to inhibit the body's clearance of caffeine.

This pharmacokinetic interaction can lead to elevated concentrations of caffeine in the bloodstream.

Q: Are there any known interactions between Pelox-400 and common over-the-counter pain relievers?

A: Regulatory information indicates that co-administration with certain Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) is documented to increase the risk of Central Nervous System (CNS) excitation.

Q: Is it better to take Pelox-400 in the morning or at night according to usage guidelines?

A: Official administration instructions specify twice daily (BID) use.

Regulatory guidance advises that doses be separated by approximately 12 hours to help maintain consistent concentrations of the drug in the body.

Q: Is Pelox-400 considered a preventative medicine?

A: According to official therapeutic indications, Pelox-400 is approved solely for the treatment of documented or suspected systemic bacterial infections.

It is not listed as a preventative medicine.

Q: What happens if a person stops taking Pelox-400 suddenly?

A: Official guidance emphasizes the importance of completing the full prescribed treatment course for this antibiotic.

Discontinuing treatment early may potentially prevent the complete elimination of the infection and can increase the risk of the bacteria developing resistance.

Q: Is weight gain or weight loss listed as a documented side effect of Pelox-400?

A: Official regulatory documentation does not list weight gain or weight loss among the commonly observed or serious adverse effects of this medicine.

Q: If a person misses a single dose of Pelox-400, will it interrupt its effectiveness?

A: Official regulatory guidance addresses the procedure for a missed dose. Instructions often advise taking the missed dose as soon as it is remembered, unless it is nearly time for the next scheduled dose.

Q: Does Pelox-400 interfere with the effectiveness of common birth control methods?

A: Official regulatory documents do not specifically list an interaction between Pelox-400 and the effectiveness of common hormonal contraceptives.

Q: Is it safe to split the Pelox-400 tablet if it is difficult to swallow whole?

A: The official dosage form is a film-coated tablet, and there are no regulatory instructions provided that permit the tablet to be crushed, split, or chewed.

Q: Does consuming alcohol affect the safety profile of Pelox-400?

A: Official regulatory labeling does not contain a specific warning or contraindication against the consumption of alcohol while taking Pelox-400.

Q: If a person has a history of heart or blood pressure problems, is Pelox-400 contraindicated?

A: Official regulatory documents indicate that caution is necessary when the product is used in patients with known risk factors for QT interval prolongation, which relates to the heart’s electrical activity.

This warning applies to individuals with existing cardiac disease.

Q: Is Pelox-400 suitable for people who follow vegetarian or vegan diets?

A: Regulatory documents include a list of all non-medicinal components (excipients) found in the tablet.

However, the official product information does not usually include the specific source (such as animal or vegetable origin) of every component.

Q: Does being lactose intolerant affect how someone takes or responds to Pelox-400?

A: Official regulatory labeling states that the tablet contains lactose.

This is an important consideration for individuals with known rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

Q: Is Pelox-400 listed as a controlled substance in any major region?

A: Pelox-400 is classified as a prescription-only medicine.

It is not classified as a scheduled (controlled) substance under the US Controlled Substances Act (CSA).

Q: Is there a generic version of Pelox-400 available on the market yet?

A: Regulatory market summaries indicate that generic formulations containing Pefloxacin, the active ingredient in Pelox-400, are currently commercially available.

Q: Does the use of Pelox-400 require regular monitoring via blood tests?

A: Official safety warnings indicate that monitoring of blood counts may be necessary for some patients.

This is typically required when Pelox-400 is used for prolonged treatment periods.

How should Pelox-400 be stored and disposed of?

How to Store and Dispose of Pelox-400

The storage and disposal of Pelox-400 tablets must adhere strictly to documented regulatory requirements to maintain product stability and safety.

Official Storage Conditions

Requirement Condition
Temperature Store below 30 C.
Protection Protect from direct sunlight.
Container Rule Keep the tablets in the blisters in the provided carton.
Shelf Life 36 months when stored as directed.

Child Safety and Disposal

The medicine must be kept out of the reach of children.

Disposal of any unused or expired Pelox-400 must be managed in accordance with local regulations for pharmaceutical waste. The product should not be disposed of with household garbage or allowed to enter the sewage system.

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

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