Cetil - 500

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Cetil - 500

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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 Cetil - 500

Quick Facts

Property Description
Active Ingredient Cefuroxime Axetil
Form Film-coated Tablet (500 mg)
Pharmacological Class Second-Generation Cephalosporin (Antibiotic)
General Purpose To eliminate susceptible bacterial infections
Origin Semi-synthetic

Cetil - 500: An Introduction to a Second-Generation Antibiotic

Cetil - 500 is a prescription medication defined as a semi-synthetic antibiotic that belongs to the cephalosporin family, classified specifically as a second-generation agent. The primary active component is Cefuroxime, which functions as a bactericidal agent designed to eliminate susceptible bacteria causing illness. Cefuroxime is derived from Cefalosporin C, a naturally occurring compound, making the final product semi-synthetic.

This medication's classification places it within the larger beta-Lactam antibiotic group, which is clinically recognized for its selective targeting of the bacterial cell wall. The second-generation status reflects an optimized chemical structure designed for enhanced stability against bacterial defense mechanisms, such as beta-lactamase enzymes, compared to older agents. This enhanced stability is a key differentiator, indicating the medicine is less likely to be deactivated by common bacterial resistance mechanisms. The 500 mg formulation is structured for oral administration, typically delivered as a film-coated tablet.

What is the Role of the Cefuroxime Axetil Formulation?

The active ingredient in Cetil - 500 is Cefuroxime Axetil, a chemically modified prodrug of Cefuroxime designed for optimized absorption. The Axetil component ensures that the drug is efficiently absorbed from the gastrointestinal tract following oral administration, thereby improving its systemic availability. This optimized formulation is designed to facilitate the enhanced oral absorption of the axetil ester.

Once absorbed, the Axetil group is quickly metabolized, releasing the fully active Cefuroxime molecule into the bloodstream. This design is critical for ensuring therapeutic concentrations are achieved through a convenient oral route. The general therapeutic purpose of Cetil - 500 is to effectively and systematically address health conditions caused by susceptible bacterial infections, such as those affecting the respiratory tract or skin.

Regulatory References

  1. NIH

What side effects are possible with Cetil - 500?

Possible Side Effects and Safety Information

The official safety profile for Cetil - 500 (Cefuroxime Axetil) is structured according to regulatory standards, classifying possible adverse reactions by frequency and the body system affected. These classifications are derived from clinical trial data and post-marketing surveillance, as documented in authoritative regulatory sources.


Regulatory Classification of Adverse Reactions

Side effects are formally grouped by the System-Organ-Class (SOC) they affect, including Gastrointestinal Disorders, Immune System Disorders, Nervous System Disorders, and Blood and Lymphatic System Disorders.

Frequency Classification Examples of Officially Documented Effects
Common (ge 1/100 to < 1/10) Diarrhea, Nausea, Headache, Dizziness, Eosinophilia.
Uncommon (ge 1/1,000 to < 1/100) Vomiting, Skin Rashes, Positive Coombs' test.
Not Known (Post-marketing) Anaphylaxis, Seizures, Jaundice, Severe Colitis (CDAD).

Serious Adverse Reactions and Safety Constraints

Regulatory documentation highlights the occurrence of rare but clinically significant events. These serious adverse reactions include severe hypersensitivity reactions, such as anaphylaxis, severe skin conditions like Stevens-Johnson Syndrome, and severe bowel inflammation known as Pseudomembranous Colitis or Clostridioides difficile-Associated Diarrhea (CDAD).

The medication is formally contraindicated in patients with a known hypersensitivity to Cefuroxime Axetil or other beta-Lactam antibiotics. Furthermore, population-specific safety notes state that the dose must be reduced in patients with renal impairment to prevent potential neurotoxicity, such as seizures or encephalopathy, associated with high systemic exposure. Regulatory labeling also notes the potential for superinfections with non-susceptible organisms during therapy and that CDAD may occur up to two months after treatment completion.

Overdose and Emergency Response

Overdose and when to seek help

The following information details the officially documented manifestations of overdose and the regulator-mandated emergency actions for Cefuroxime Axetil (Cetil - 500).

Overdose Scope

Classification Official Regulatory Statement
Documented Overdose Presentations Overdose can lead to neurological sequelae, including convulsions (seizures), encephalopathy, and signs of cerebral irritancy. Severe manifestations such as coma are also officially documented.
Physiological Systems Affected Central Nervous System (CNS).
Dose-Related or Exposure Factors Overdose symptoms are explicitly noted to occur if the dosage is not reduced appropriately in patients with renal impairment.
Emergency-Response Statements Seek emergency medical attention right away or contact a Poison Control Center immediately upon suspected overdose.
When Immediate Help is Required Urgent medical help is mandated if the affected individual has collapsed, experienced a seizure, or has trouble breathing or cannot be awakened.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity Classification Life-threatening severe CNS effects.
Overdose-Context Constraints No specific antidote is detailed; management relies on supportive measures. Serum levels can be reduced by Haemodialysis and Peritoneal dialysis.

Resulting Overdose Structure

Official overdose statements:

  • The most serious documented manifestations are convulsions and coma, resulting from neurological toxicity.
  • Haemodialysis and peritoneal dialysis are recognized procedures capable of reducing the concentration of the substance in the bloodstream.
  • Seek emergency medical attention is the mandated course of action upon suspected overdose or the onset of severe symptoms.

Connection to the overall overdose profile: The regulatory profile classifies an overdose as a medical emergency primarily characterized by severe neurological sequelae. Official guidance links this risk directly to the potential for drug accumulation in individuals with impaired kidney function who have not received a correct dosage reduction. Consequently, all official documentation mandates that individuals experiencing or suspecting an overdose must immediately seek emergency assistance for supportive treatment and potential procedural intervention.

Therapeutic Uses of Cetil - 500

Cetil - 500 is commonly used for managing certain distressing symptoms across a range of mild-to-moderate bacterial infections. It is relevant in contexts where symptomatic support is needed to address infections such as acute tonsillitis, pharyngitis, sinusitis, otitis media, acute exacerbations of chronic bronchitis, uncomplicated urinary tract infections (UTIs), mild skin-structure infections, and early Lyme disease. It is often used during phases when symptoms become more noticeable and disruptive.


Relief for Acute Symptomatic Episodes

This medication is applied across domains where acute or disruptive symptom patterns are present in the respiratory tract. It is relevant for managing symptom clusters that interfere with daily comfort, including fever, localized pain (throat, ear, sinus), and purulent discharge. Utilizing this medication may help patients cope more steadily with symptom fluctuations and contributes to improved day-to-day comfort during symptomatic periods.

"Treatment provides supportive relief when symptoms interfere with routine activities."

Quick Fact: Symptomatic Support Focus

Property Description
Primary Benefit Easing overall symptom load
Severity Targeted Mild-to-moderate, Uncomplicated
Domains Covered Respiratory, Urinary, Skin
Symptom Focus Fever, Pain, Inflammation

Management of Localized Conditions

Cetil - 500 is relevant in conditions where symptoms may intensify temporarily due to localized infections. For conditions such as UTIs and skin infections, the medication is used for easing localized inflammation and symptoms linked to organ-specific functional stress, such as burning or pain. This supports general well-being during symptomatic phases and contributes to easing the overall symptom load.

Regulatory References

  1. CEFUROXIME AXETIL tablet prescribing information from DailyMed

Eligibility and Restrictions for Use

Who Can and Cannot Use Cetil - 500

The eligibility for using Cetil - 500 (Cefuroxime Axetil) is strictly defined by regulatory guidelines, focusing on absolute contraindications and specific population limitations.

Contraindicated Populations

Cetil - 500 must not be used in patients with a known hypersensitivity to the active substance, Cefuroxime Axetil, or to any other cephalosporin antibiotic. Furthermore, use is prohibited in individuals with a history of a severe allergic reaction to any other type of beta-lactam antibacterial agent, such as penicillins.

Age and Condition Limitations

Population Group Regulatory Status
Infants under 3 months Use is not recommended; safety and efficacy are not established.
Children under 5 years The tablet form is not suitable due to swallowing difficulties.
Severe Renal Impairment Requires dosage restriction or adjustment.
Pregnancy and Lactation Use is not recommended unless the potential benefit outweighs the risk.

Generally, the medicine is allowed for use in adults and children three months of age and older who do not possess any contraindications or specific restrictions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Cetil - 500 (Cefuroxime Axetil) interacts with certain medicinal products and product classes, primarily by altering its own systemic availability or by affecting the efficacy of co-administered medicines, as documented in regulatory information.

Interactions Affecting Cefuroxime Exposure

  • Drugs that reduce gastric acidity: Products such as certain antacids, H2 antagonists, and proton pump inhibitors (PPIs) are officially stated to lower the bioavailability of Cefuroxime Axetil. One regulatory label advises that acid-reducing drugs should be avoided, and short-acting antacids may require timing separation (e.g., administering Cetil - 500 at least one hour before or two hours after the antacid).
  • Probenecid: Coadministration with Probenecid is not recommended in regulatory labeling. This is due to Probenecid's inhibitory effect on renal tubular secretion, which significantly increases the systemic exposure (AUC and peak concentrations) and prolongs the presence of Cefuroxime in the body.

Interactions Affecting Other Medications

  • Oral Anticoagulants: The use of Cefuroxime Axetil may be associated with an increase in the International Normalized Ratio (INR) when co-administered with oral anticoagulants. Official guidelines advise careful monitoring of PT and INR values.
  • Combined Oral Contraceptives: Cefuroxime Axetil may affect gut flora, which can lead to a reduction in estrogen reabsorption and thus potentially reduce the efficacy of combined oral estrogen/progesterone contraceptives.
Classification Official Regulatory Note
Exposure Modification Probenecid is not recommended due to increased drug levels.
Efficacy Reduction Risk of reduced effectiveness with combined oral contraceptives.

No medicinal products are formally documented as a specific contraindicated combination with Cetil - 500 solely due to an interaction risk.

Mechanism of Action

Inhibition of Bacterial Cell Wall Synthesis

Cetil-500 (Cefuroxime axetil) is an inactive prodrug that must first undergo hydrolysis by esterases in the gastrointestinal tract, releasing the active component, Cefuroxime, into the systemic circulation. This active compound targets key bacterial enzymes known as penicillin-binding proteins (PBPs). Cefuroxime binds covalently to these PBPs, which are essential for catalyzing the final transpeptidation step in peptidoglycan synthesis. This interaction modifies the molecular pathway, preventing the cross-linking necessary for forming a rigid, functional cell wall. The consequence of this inhibition is the initiation of osmotic instability within the bacterial structure.

Beta-Lactamase Enzyme Resistance

The chemical structure of Cefuroxime exhibits resistance to hydrolysis by specific bacterial beta-lactamase enzymes. This biochemical property sustains the active drug's concentration within the affected biological system by reducing its enzymatic inactivation.

Dosage and Administration Information

Administration Guidelines for Cefuroxime Axetil (e.g., Cetil - 500)

The prescribed method of use for this medication involves specific protocols regarding timing, consumption, and patient-specific adjustments.

Administration Component Instruction
Route of Administration Oral
Standard Dosing Frequency Typically every 12 hours (twice daily) for most infections. Uncomplicated Gonorrhea is a single 1,000 mg dose.
Tablet Consumption The tablet must be swallowed whole. Do not crush, cut, or chew the tablet.
Timing Relative to Meals Tablets should be taken after food for optimal absorption. The oral suspension must be taken with food.
Renal Impairment A dosage adjustment is required for patients with reduced kidney function. For example, the standard individual dose is given every 24 or 48 hours depending on creatinine clearance, instead of every 12 hours.
Pediatric Use The tablet form is generally not recommended for children who cannot swallow the tablet whole. The oral suspension must be used for younger patients. Use is generally not recommended in infants under 3 months of age.
Completing the Course The full prescribed course of therapy, often lasting 5 to 10 days, must be completed, even if symptoms improve earlier.
Drug Interactions Antacids that reduce stomach acid should be taken at least 1 hour before or 2 hours after Cefuroxime Axetil, as they can interfere with absorption. Co-administration with Probenecid is generally not recommended.

Recent Clinical Evidence

Evidence for Acute Throat and Airway Infections

Research exploring this medication was studied for acute bacterial infections of the throat, sinuses, and lower airways. Evidence comes primarily from Randomized Controlled Trials (RCTs) where research examined the medicine alongside other common study materials. These studies monitored bacterial clearance rates and how symptoms, such as fever and throat pain, changed over the study period. Findings describe patterns observed in the studies where high rates of bacterial clearance were measured in the observed populations. However, for acute bacterial sinusitis, early regulatory reviews indicated that data establishing effectiveness against certain beta-lactamase-producing bacterial strains evidence remains limited.

Evidence for Early Lyme Disease and Chronic Bronchitis

Research exploring the medicine was also evaluated in the context of early Lyme disease, monitoring the resolution of the characteristic rash and monitoring for progression to later stages of the disease. Findings indicate that the resolution of the rash and related symptoms was observed in the studied population following the defined 20-day interval. For acute flare-ups of chronic bronchitis (AECB), trials research examined microbiologic and clinical response rates alongside other antibiotic study materials. These findings describe patterns observed in the studies over defined time intervals.

Research Gaps and Uncertainty

Clinical trials for most acute bacterial infections generally focused on short-term changes and measured microbiological clearance rates. Long-term effects for many indications are not fully established, and there is limited information for outcomes beyond the initial course of therapy. Research examined a broad range of patients, but data for certain groups remain insufficient. For instance, evidence is limited regarding studies exploring the medicine in pregnant populations. Furthermore, effectiveness against certain beta-lactamase-producing bacteria could not be definitively evaluated in initial sinusitis trials. These limitations mean that the findings describe group patterns, not personal outcomes, and research does not determine whether an individual will respond similarly.

Key Studies & References

  1. CEFUROXIME AXETIL tablet (DailyMed Prescribing Information) - Indications, Dosage, and Clinical Studies Summary

Frequently Asked Questions (FAQ)

Common questions about Cetil - 500 (FAQ)


Q: Can I drink alcohol while taking this medication?

Official product information advises avoiding alcoholic drinks while taking this medication. Combining Cetil - 500 with alcohol can increase the risk of side effects such as sleepiness (somnolence) and dizziness. This combination may increase the risk of serious side effects as noted in the official product information.


Q: Does this medication make you sleepy or drowsy?

Yes, official regulatory documents list dizziness and somnolence (sleepiness) as common side effects of this medication. The official product labeling cautions that due to these effects, the ability to drive or operate machinery may be impaired. Patients are advised to consider this risk before engaging in such activities.


Q: Can children 2 years old use this medication?

The official product information specifies that this medication is indicated as an adjunctive therapy for seizures in children generally aged 3 years or older (depending on the regulatory source). Safety and effectiveness have not been established in children younger than this age. The specific age may vary slightly based on the country's labeling (e.g., 3 years old in the US, 6 years old in Europe).


Q: Is this safe to take long-term?

Studies noted in some regulatory documents have shown that dosages up to 4800 mg/day were tolerated in long-term open-label clinical studies lasting up to two years. However, official information also notes that the full long-term effects on learning and development in children are not yet completely known.


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

Regulatory instructions for missed doses generally advise taking the next dose as soon as possible. However, if it is close to the time for the next scheduled dose (for example, within 4 hours depending on the specific product), the missed dose should be skipped. To help manage the condition and prevent breakthrough seizures, official information indicates that the time between doses should not exceed 12 hours.


Q: Can I take this medication if I'm pregnant or breastfeeding?

Official information states that use during pregnancy should only occur if the potential benefit justifies the potential risk to the fetus. The medication is also known to be secreted into human milk. Regulatory information states that a deliberation is required to decide whether to discontinue nursing or discontinue the drug, taking into account the drug's importance to the patient.


Q: Where should I store this medicine?

The official labeling for Cetil - 500 tablets and capsules advises storing them at room temperature and protecting them from moisture and heat. Note that if your medicine is the oral solution form, it must be stored in the refrigerator and must not be frozen.


How should Cetil - 500 be stored and disposed of?

Storage and Disposal Requirements for Cetil-500 (Cefuroxime Axetil Tablets)

Storage Component Official Regulatory Requirement
Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F). Do not freeze.
Protection Keep in the original container, tightly closed, and protected from moisture and excessive heat.
Safety Must be kept out of the sight and reach of children.
Disposal Do not dispose of via wastewater or general household waste; follow local requirements for unused or expired medication.

Cetil-500 tablets must be maintained at the specified room temperature range to preserve stability and effectiveness, ensuring protection from freezing or excessive heat. The required use of the original, tightly closed container prevents exposure to moisture. For safety, the medication must be stored away from children. All unused or expired tablets must be discarded according to official local regulations for pharmaceutical waste, avoiding environmental contamination through normal trash or drainage systems.

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

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