Cefila

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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 Cefila

What is Cefila?

Cefila is an oral antibiotic medication belonging to the class of drugs known as third-generation cephalosporins. It contains the active ingredient cefixime, which is used to manage various types of bacterial infections.

Therapeutic Classification

As a cephalosporin antibiotic, Cefila is categorized as a beta-lactam. It is distinguished from earlier generations of cephalosporins by its enhanced stability against certain bacterial enzymes and its broader spectrum of activity against diverse organisms.

Mechanism of Action

Cefila works by interfering with the synthesis of the bacterial cell wall. Bacteria require a solid cell wall to survive and protect themselves from their environment. By inhibiting the final transpeptidation step of peptidoglycan synthesis, the medication prevents the bacteria from properly forming this wall, leading to the eventual rupture and death of the bacterial cell.

Spectrum of Activity

This medication is effective against a variety of gram-positive and gram-negative bacteria. It is commonly utilized in clinical settings to address infections involving the following systems:

  • Respiratory Tract: Including certain types of pneumonia and bronchitis.
  • Ears, Nose, and Throat: Such as middle ear infections (otitis media), pharyngitis, and tonsillitis.
  • Urinary Tract: Including uncomplicated infections of the bladder and kidneys.
  • Other Infections: It may also be used for specific sexually transmitted infections, such as uncomplicated gonorrhea.

Cefila is only effective against bacterial infections; it does not treat viral infections such as the common cold or the flu.

What side effects are possible with Cefila?

Cefila: Possible Side Effects and Safety Information

Adverse Reaction Scope

The most commonly reported adverse reactions associated with Cefila (cefixime) are gastrointestinal events, including diarrhea (up to 16% in clinical trials), nausea (up to 7%), loose stools, abdominal pain, and vomiting. Most of these effects are generally mild and transient.

Serious and Clinically Significant Adverse Reactions

Regulatory warnings highlight the risk of severe and potentially fatal Hypersensitivity Reactions, which include anaphylaxis, angioedema, and severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). Cefila is contraindicated in patients with a known hypersensitivity to the drug or other cephalosporins, and cross-hypersensitivity with penicillin has been documented.

Another serious risk is Clostridioides difficile-associated diarrhea (CDAD), which may occur during or after therapy and can range from mild diarrhea to fatal colitis. Other severe, though less common, effects reported post-marketing include drug-induced hemolytic anemia, acute renal failure, and neurotoxicity (e.g., seizures or encephalopathy), particularly in patients with pre-existing renal impairment or following overdose.

Safety Considerations

Population-Specific Safety: Dose adjustment is required for patients with renal impairment to mitigate the risk of adverse reactions, including encephalopathy. Caution is advised for patients with a history of penicillin allergy due to the potential for cross-reactivity.

Restrictions: The drug should be discontinued immediately if signs of an allergic reaction or severe skin reaction occur. Cefila may interact with certain laboratory tests, specifically causing false positive results for urine glucose using cupric sulfate tests.

This safety information establishes the profile of risks, emphasizing the need for monitoring and immediate action regarding potentially life-threatening allergic and gastrointestinal complications, as documented in official regulatory sources.

Overdose and Emergency Response

Overdose and When to Seek Help

Cefila (Cefixime) overdosage involves documented risks associated with high systemic drug concentrations. Immediate medical attention must be sought if an overdose is suspected or if severe symptoms occur, as required by regulatory guidance.


Documented Manifestations

Manifestations noted for this class of antibiotic, particularly at high doses, involve the Central Nervous System (CNS), with the potential for seizures being the primary concern. Other documented systemic effects include the possibility of transient elevations in BUN or creatinine, which are indicators of renal function. Adverse reactions observed in regulatory studies using high single doses did not significantly differ from those reported at normal therapeutic doses.


Emergency Management and Treatment

The official management approach is defined by the absence of a specific pharmacological reversal agent, as regulatory documentation states that no specific antidote exists. Management is therefore based on providing symptomatic and supportive treatment. Procedural steps such as gastric lavage may be indicated. If drug-associated seizures occur, the medication must be discontinued, and anticonvulsant therapy can be administered if clinically necessary. Patients should note that Cefixime is not removed in significant quantities by interventions such as hemodialysis or peritoneal dialysis.


Risk Considerations

Patients with pre-existing renal impairment are documented to be at an increased risk for severe CNS manifestations like seizures, particularly if the standard dosage was not appropriately reduced. This population requires careful clinical monitoring.

Therapeutic Uses of Cefila

What Cefila Treats: Main Uses and Benefits

Cefila (Cefixime) is commonly used to help with conditions involving bacterial infection of the airways and ears. This medication is applied across domains where additional symptomatic support is needed. It is considered relevant for managing conditions such as acute bronchitis, Otitis Media (middle ear infection), uncomplicated urinary tract infections (UTIs), and certain uncomplicated sexually transmitted infections, notably gonorrhea.

The drug helps address symptom clusters that may become intense or disruptive, including ear pain, fever, sore throat, and dysuria (painful urination). This therapeutic application contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional stability. It is relevant when supportive symptom management is appropriate during phases when symptoms become more noticeable.


Quick Fact: Management of Acute Symptom Domains

Therapeutic Benefit Symptoms Targeted Context of Use
Supports stability Painful urination, ear pain, fever Acute, uncomplicated bacterial episodes
Eases symptom load Sore throat, discolored sputum Respiratory and urinary tract infections

Regulatory References

  1. NIH MedlinePlus overview of Cefixime

Eligibility and Restrictions for Use

Cefila's (Cefixime) eligibility for use is determined by precise population rules established in official governmental regulatory documentation. The information below reflects eligibility as defined by regulatory authorities.

Populations Who Must Not Use Cefila

The medicine is contraindicated for patients with a known hypersensitivity or allergy to Cefixime or any other cephalosporin antibacterial agent.

Eligibility and Restrictions by Population

Eligibility Domain Official Regulatory Status
Age Approved for adults and pediatric patients six months and older. Safety is not established for infants younger than six months.
Organ Function Patients with markedly impaired renal function require caution and special management due to restricted use.
Prior Allergy History Use with caution in patients with a history of penicillin allergy due to documented cross-sensitivity risk.
Pregnancy Use is permitted only if clearly needed and the potential benefit outweighs risks.
Lactation Consideration should be given to discontinuing nursing temporarily during treatment.

Eligibility also requires caution for patients with a history of gastrointestinal disease.

What should I know about interactions with other medicines?

Cefila Interactions with other medicines and products

Official regulatory documents detail specific drug-drug interactions, which impose constraints on co-administration with Cefila.

Documented Interactions

Interacting Product Category Specific Medicines Listed Regulatory Constraint/Requirement
Oral Anticoagulants Warfarin and related compounds Requires close monitoring of Prothrombin Time (PT) or International Normalized Ratio (INR) due to a reported increase in these values.
Anticonvulsants Carbamazepine Requires monitoring of Carbamazepine plasma concentrations as elevated levels have been reported with concomitant use.
Agents Affecting Renal Elimination Probenecid Use may lead to a clinically significant increase in Cefila serum concentrations by reducing its renal excretion.
Live Vaccines Typhoid Vaccine Live Avoid co-administration as the antibacterial action may interfere with the intended immune response and reduce the vaccine's effectiveness.
Hormonal Contraceptives (Specific product not listed) Reduced efficacy of hormonal contraception may occur, requiring the use of supplementary non-hormonal methods.

Other Interaction Notes

The use of Cefila may result in a false-positive result in the direct Coombs’ test. Additionally, certain non-enzymatic urine glucose tests may also show false-positive results.

Mechanism of Action

How Cefila Works

Cefila's primary action involves acting as an irreversible inhibitor of specific bacterial enzymes known as Penicillin-Binding Proteins (PBPs), which are localized on the cell membrane of susceptible microorganisms. These PBPs are required to catalyze the final cross-linking steps of peptidoglycan synthesis, which forms the core structural component of the microbial cell wall.

By covalently binding to and inactivating the PBPs, Cefila blocks the completion of the cell wall structure. This mechanistic blockade results in a compromised structural integrity that cannot withstand internal osmotic pressure, leading directly to the lysis (rupture) and death of the susceptible microbial cell. The drug's molecular structure also provides stability against degradation by certain beta-lactamase defensive enzymes, ensuring that the inhibitory interaction with PBPs is maintained. This combination of structural disruption and enzyme resistance leads to the system-level physiological consequence of reducing the population of susceptible microorganisms throughout the body.

Dosage and Administration Information

How to Use Cefila: Official Administration Guidelines

Cefila (Cefixime) is officially approved exclusively for oral administration, available in multiple dosage forms including tablets, capsules, and a powder for oral suspension. The medication can be taken without regard to food, meaning administration may occur with or without meals.

The standard adult dosing regimen is established at 400 mg daily. This total daily amount may be administered either as a single dose or as two equal 200 mg doses taken every 12 hours. A specific single 400 mg dose is also the official regimen for certain uncomplicated infections. If a dose is missed, it should be taken as soon as remembered, unless it is close to the time for the next scheduled dose, in which case the missed dose is skipped.

For the oral suspension, the powder must be reconstituted with the specified volume of water and must be shaken well immediately before each individual dose is measured using a calibrated device. The duration of use is set by specific requirements, as treatment for infections caused by Streptococcus pyogenes requires a minimum course of 10 days.

Official instructions include modifications for specific populations. For pediatric patients 6 months and older, the daily dose is weight-based, typically 8 mg/kg per day. Adults with established renal impairment (CrCl le 60 mL/min) must receive a reduced daily dose to account for decreased kidney function. The administration protocol is defined by this fixed oral route and standardized daily dosing, which is subject to mandatory adjustment for renal function.

Recent Clinical Evidence

Research evidence / Overview of Studies for Cefila


Evidence for use in Uncomplicated Urinary Tract Infections (UTIs)

The research for uncomplicated urinary tract infections involves short-term randomized controlled trials (RCTs) and comparative studies. These studies were used in research exploring how symptoms change over time, focusing on non-pregnant adult women and some pediatric patients who had acute, uncomplicated UTIs. Researchers typically monitored two primary outcomes: the clinical response, which describes how patient-reported outcomes related to physical discomfort like painful urination evolved, and microbiological eradication, which measures the clearance of the specific bacteria from urine samples.

Studies report measurements of outcomes related to clinical response following different short courses of treatment. Findings describe patterns observed in the studies regarding the speed and completeness of bacterial clearance when compared to other oral antimicrobial agents. However, follow-up durations were limited, meaning long-term outcomes are not fully established regarding the durability of effects. Furthermore, evidence quality varies across studies when considering the use of Cefila against bacteria that may have greater resistance to common antibiotics.


Evidence for use in Otitis Media (Middle Ear Infection)

For middle ear infections, the evidence base is built upon multicenter Randomized Controlled Trials and comparison studies. These trials were applied in research contexts involving fluctuating or unstable symptoms typical of this condition in children. The study populations were mainly pediatric patients (children older than six months), and research examined clinical cure status and bacteriologic outcomes, often comparing Cefila against standard treatments like amoxicillin.

Studies report how symptoms evolved in the observed populations, and findings describe patterns related to the clearance of common middle ear pathogens like Haemophilus influenzae and Moraxella catarrhalis. Regulatory reviews have noted that for infections caused by certain pathogens, such as Streptococcus pneumoniae, overall reported outcomes were approximately 10% lower than for the specific comparator drug used in those trials.


Evidence for use in Respiratory Tract Infections

Research on Cefila for acute exacerbations of chronic bronchitis (AECB) was conducted in adult patients experiencing periods of heightened symptom activity. The main studies were comparative trials where researchers monitored outcomes related to physical discomfort and systemic or functional imbalance. Specifically, studies explored short-term symptom changes, such as measurements of improvement in cough, sputum characteristics, and breathing difficulty.

Findings indicate patterns related to a clinically favorable status (cure or improvement) observed over defined time intervals. Some research has explored shorter treatment courses (e.g., five days) compared to standard courses (e.g., 7 to 10 days), with some studies reporting similar short-term clinical responses between the two durations. Nonetheless, evidence quality varies across studies regarding the outcomes in all subgroups of chronic bronchitis severity, and the data for certain groups, such as older adults, remain insufficient in the initial clinical studies.

Frequently Asked Questions (FAQ)

Common questions about Cefila (FAQ)


Q: What is Cefila used for besides the main things?

According to official regulatory documents, Cefila (cefixime) is indicated for use in treating specific bacterial infections.

These uses include uncomplicated urinary tract infections, pharyngitis and tonsillitis, acute flare-ups of chronic bronchitis, and uncomplicated gonorrhea (cervical/urethral).

Q: Does Cefila make you feel tired?

Official product labeling indicates that general tiredness or fatigue is not listed as one of the commonly reported adverse reactions observed in clinical studies.

Reviews of adverse reactions focus on frequency and severity as reported in official documents.

Q: How long does it take for Cefila to start working?

Studies on Cefila's activity indicate that the concentration of the active drug in the blood reaches its peak level between three and eight hours after a single dose.

This peak is when the medicine is circulating at its highest level in the body, consistent with its expected therapeutic action.

Q: Does Cefila interact with supplements like Vitamin D?

Official drug interaction data lists constraints when Cefila is co-administered with certain prescription drugs and vaccines.

No specific interaction with common vitamins or dietary supplements, such as Vitamin D, is listed in the official product labeling.

Q: Is it normal to feel a bit dizzy after starting Cefila?

Dizziness is described in official reports as a central nervous system-related adverse reaction that has been noted in post-marketing reports.

Dizziness is a reported adverse reaction, and information regarding all side effects is typically reviewed by a healthcare professional.

Q: Can Cefila be crushed or split?

Official guidance for Cefila capsules specifies that they should be swallowed whole and should not be cut, broken, or chewed before taking.

Official guidance suggests that questions about altering the tablet form should be directed to a healthcare provider or pharmacist.

Q: How quickly does Cefila leave your system?

The time it takes for Cefila to be cleared from the body is measured by its elimination half-life, which is typically between three and four hours.

Studies show the drug is removed from the system mostly unchanged, with the kidneys and liver performing the primary clearance functions.

Q: Are there different brand names for the medicine Cefila?

The active ingredient in Cefila is generically known as cefixime.

While Cefila is a brand name, this ingredient has also been marketed globally under other brand names, such as Suprax.

Q: Can Cefila interact with over-the-counter pain relievers?

When examining official interaction data, Cefila is known to interact with specific anticoagulants and other prescription drugs.

However, the regulatory documents do not list a specific interaction with widely available over-the-counter pain relievers, such as acetaminophen or ibuprofen.

Q: What does 'contraindication' mean for Cefila?

The term 'contraindication' is used in regulatory documents to describe conditions or situations in which Cefila is not recommended for use because the risks are considered to be substantially greater than any potential benefits.

A known allergy to Cefila or similar medicines is a primary example of a contraindication.

Q: Does Cefila affect blood pressure?

The official drug labeling details adverse reactions observed in clinical trials and post-marketing reports.

Changes in blood pressure, such as hypotension (low) or hypertension (high), are not listed among the common or serious adverse events reported for Cefila.

Q: Can Cefila be taken with antacids?

Official information on drug interactions indicates that co-administration with antacids may potentially reduce the absorption of Cefila into the body.

Official information suggests separating the administration of antacids from Cefila by at least two hours, as co-administration may potentially reduce absorption.

Q: Why is Cefila only available by prescription?

Cefila is classified as a potent beta-lactam class antibiotic, which is one reason its availability is restricted to prescription-only status.

This restriction is in place to support appropriate use against susceptible bacterial infections and to guide management of antibiotic resistance.

Q: Can people with liver problems take Cefila?

Official reports indicate that Cefila is primarily cleared by the kidneys, not the liver.

While transient elevations in liver enzymes have been noted, dose adjustment is generally not required for those with impaired liver function, and official documents mention that caution may be appropriate.

Q: Do you need to stop Cefila gradually?

Regulatory guidance for antibiotics emphasizes the importance of completing the full course.

The recommended approach is to take Cefila for the full course duration as prescribed. Stopping the medicine early or changing the dosage without professional review is not advised, as this may be associated with the return of the infection.

How should Cefila be stored and disposed of?

How to Store and Dispose of Cefila (Cefixime)

Storage requirements for Cefila depend on the dosage form and preparation status to maintain product stability.

Dosage Form Temperature Requirement Stability Constraint
Tablets / Dry Powder Controlled Room Temperature (20 C to 25 C) Protect from heat, moisture, and light.
Reconstituted Suspension Refrigerated (2 C to 8 C) Discard after 14 days; do not freeze.

All forms of this medication must be stored in the original container, kept tightly closed, and secured out of the reach of children. The reconstituted suspension must be shaken well before each use. Disposal of unused or expired product must follow applicable waste disposal regulations, such as utilizing an approved drug take-back program.

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

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