Kefral

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Kefral

What Type of Medicine is Kefral? (Identity and Classification)

Property Description
Active ingredient Cefaclor
Form Oral (capsules, suspension, modified-release tablets)
Pharmacological class Second-generation cephalosporin antibiotic
Common use Treatment of bacterial infections
Origin Semisynthetic beta-lactam antimicrobial

Kefral is a pharmaceutical product containing the active ingredient Cefaclor, classified as a semisynthetic beta-lactam antimicrobial designed for the general treatment of bacterial infections. Specifically, Cefaclor is designated as a second-generation cephalosporin antibiotic, a classification clinically recognized for its reliable efficacy against a defined spectrum of bacterial pathogens.

The drug entity Kefral is fundamentally defined by Cefaclor, a compound belonging to the cephalosporin antibiotic family. This classification signifies its specific chemical structure and its role as a broad-spectrum agent effective against a range of susceptible bacteria. The medicine’s overarching purpose is to provide a bactericidal action, eliminating the bacterial causes of illness. The second-generation designation reflects its profile of activity, offering broader coverage than earlier agents.


Forms, Composition, and Action Principle (Preparation and Function)

Kefral is a single-ingredient product supplied for oral administration in several dosage forms, including capsules, powder for oral suspension, and specialized modified-release tablets. The core composition centers on Cefaclor, which may be prepared as either the anhydrous or monohydrate form in these preparations.

The availability of forms like the oral suspension and granules is important for ensuring the medicine can be accurately delivered across all target audience groups, particularly pediatric patients who may require liquid formulations. The medicine’s high-level mechanism of effect involves Cefaclor acting as a cell wall inhibitor. This means that its primary pharmacological action is to disrupt the structural integrity of the pathogen, leading to its destruction.

What side effects are possible with Kefral?

Possible Side Effects and Safety Information

The safety profile of Kefral (Cefaclor) is based on official government regulatory documents which classify adverse reactions by frequency and the body system affected. All documented effects reflect potential outcomes reported during clinical use and post-marketing surveillance.

Documented Adverse Reactions by Frequency

Adverse reactions are classified according to frequency, which may vary by formulation and regulatory region:

  • Common Reactions: Officially listed effects occurring frequently include diarrhea, certain skin rashes (morbilliform eruptions), and eosinophilia. Genital pruritus and vaginitis are also classified as common in some official labels.
  • Uncommon to Rare Reactions: These include nausea and vomiting, changes in blood counts like thrombocytopenia, temporary effects on the liver such as transient hepatitis, and rare kidney effects like reversible interstitial nephritis.

Serious Safety Considerations

The most significant adverse reactions documented in regulatory labeling are often related to severe hypersensitivity and gastrointestinal complications:

  • Severe Hypersensitivity: Rare, but potentially fatal, reactions such as anaphylaxis are listed. Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), have also been officially documented.
  • Gastrointestinal Risk: The risk of severe diarrhea due to pseudomembranous colitis is officially noted, with onset possible during or after treatment.

Population and Contextual Safety Notes

Official labels address specific safety constraints and population considerations:

  • Contraindication: Kefral is officially contraindicated in patients with a known allergy to the cephalosporin group of antibiotics.
  • Cross-Hypersensitivity: Caution is documented for patients with a history of penicillin allergy due to the recognized risk of cross-hypersensitivity among beta-lactam antimicrobials.
  • Pediatric Notes: Serum-sickness-like reactions have been reported more frequently and in more severe forms in pediatric patients. These reactions often occur during or following a subsequent course of treatment. Neurotoxicity, including the risk of seizures, is a consideration in patients with renal impairment.

Overdose and Emergency Response

Kefral Overdose and when to seek help — Official Regulatory Information

The anticipated clinical presentation of a Kefral (Cefaclor) overdose is centered on non-specific gastrointestinal manifestations, which include nausea, vomiting, diarrhea, and epigastric distress. Regulatory documents note that the severity of these symptoms is dose related.

A potential serious outcome associated with the cephalosporin class is neurotoxicity, including seizures. This risk is elevated for patients with existing renal impairment, where drug levels may accumulate.


Emergency Actions and Supportive Management

Emergency Action: Immediate medical attention is required upon the first sign of an adverse drug reaction. Government guidance specifies that emergency services must be called if the individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened.

Supportive Management: Overdose treatment is strictly supportive, requiring the meticulous monitoring and maintenance of vital signs and serum electrolytes. Activated charcoal is the described measure to decrease absorption. Gastric lavage is necessary only if the ingested amount exceeds five times the normal total daily dose. No specific antidote is known, and procedures like hemodialysis are not established as beneficial.

Therapeutic Uses of Kefral

What Kefral Treats: Main Uses and Benefits

Kefral (Cefaclor) is a prescribed agent used across therapeutic domains to manage acute symptomatic episodes caused by susceptible bacterial infections. It is applied in clinical settings that involve acute or unstable symptom patterns where short-term symptomatic assistance is needed to address increased discomfort and temporary functional strain.

This medication is commonly used across conditions presenting with acute episodes, including pneumonia, sinusitis, otitis media, and infections of the urinary tract and skin structures.


Relief for Systemic and Localized Discomfort

Kefral helps address symptom clusters that may become intense or disruptive, particularly those related to systemic imbalance (like fever and malaise) and localized discomfort (such as ear pain, sore throat, and painful urination). It is commonly used when symptoms intensify and supportive relief is needed during phases when symptoms become more noticeable.

“Applied during phases when symptoms become temporarily overwhelming, Kefral generally supports the body during the acute symptomatic phase.”

The medicine helps patients cope more steadily with symptom fluctuations.

Quick Fact: Management of Symptoms Related to Inflammatory States Kefral is relevant for easing symptoms related to inflammatory or irritative states, such as localized redness and swelling, which may interfere with daily functioning.

Regulatory References

  1. U.S. National Library of Medicine MedlinePlus overview

Eligibility and Restrictions for Use

Eligibility and Contraindications for Kefral (Cefaclor)

Official regulatory documents strictly define the populations that may and may not use Kefral, focusing on hypersensitivity and specific clinical conditions.

Absolute Contraindication:

Kefral is contraindicated (must not be used) in any patient with a known allergy or severe hypersensitivity reaction to the cephalosporin class of antibiotics. Due to the risk of cross-allergenicity, caution should also be exercised when administering the drug to individuals with a documented history of severe allergic reactions to penicillins.

Age and Development:

  • Infants less than 1 month of age are generally ineligible, as the safety and effectiveness of the capsule and suspension forms have not been established in this population.
  • Children less than 16 years of age are ineligible for the extended-release tablet form, as its safety and effectiveness have not been established in this age group.

Restrictions and Cautions:

Use requires caution and close monitoring in patients with certain pre-existing conditions:

  • Markedly impaired renal function (kidney health), as clinical experience is limited.
  • A history of gastrointestinal disease, particularly colitis.
  • Pregnancy and Lactation: The drug should be used during pregnancy only if clearly needed, and caution should be exercised when administered to a nursing mother.

What should I know about interactions with other medicines?

Kefral (Cefaclor) has officially documented interaction patterns that primarily affect drug exposure and physiological systems. Co-administration with the gout medication Probenecid results in a pharmacokinetic interaction; Probenecid inhibits the renal tubular secretion of Cefaclor, which leads to increased and prolonged plasma concentrations. Conversely, the absorption of Kefral is diminished when taken simultaneously with aluminum- or magnesium-containing antacids. To manage this exposure alteration, official guidelines require that these mineral-based products be administered at least one hour before or after Kefral.

Certain combinations carry a risk of additive effects on physiological systems. The medicine's use with oral anticoagulants (such as Warfarin) is associated with an increased risk of bleeding due to interference with prothrombin activity, a risk noted to be higher in malnourished or seriously ill patients. Furthermore, combining Kefral with other nephrotoxic agents, including certain aminoglycoside antibiotics, carries a documented risk of additive kidney toxicity. A key restriction involves live microbial products: Live Typhoid Vaccine Oral should not be co-administered with Kefral, as the antibiotic action will prevent the required therapeutic response, necessitating a separation interval (typically three days) between the antibiotic course and the vaccine. These interactions define specific constraints on co-administration found in regulatory documents.

Mechanism of Action

How Kefral Works

Kefral (Cefaclor) initiates its effect by acting as a highly specific irreversible inhibitor of Penicillin-Binding Proteins (PBPs), which are essential bacterial enzymes necessary for building the cell wall. The drug's molecular structure binds covalently to and neutralizes these proteins, resulting in the immediate and permanent cessation of their function in cell wall construction.

By blocking the PBP-mediated transpeptidation (cross-linking) of the peptidoglycan layer, Cefaclor causes the formation of a structurally defective cell wall. This fundamental structural failure causes the bacterial cell to burst due to the uncontrolled influx of water caused by internal osmotic pressure, leading to a bactericidal action characterized by irreversible cellular destruction.

The drug's mechanism is constrained by resistance mechanisms, primarily the production of beta-lactamase enzymes that chemically hydrolyze the drug, rendering Cefaclor inactive before it can reach its targets. The mechanism's functional consequence is reduced when bacteria develop altered PBPs that exhibit a reduced binding affinity for the drug.

Dosage and Administration Information

How Kefral is Used: Official Administration Guidelines

Kefral (Cefaclor) is administered exclusively via the oral route across all its approved dosage forms, which include immediate-release (IR) capsules, powder for oral suspension, and extended-release (ER) tablets. Official guidelines establish specific schedules and conditions for its intake.


Standard Dosing and Frequency

The standard adult regimen for IR forms is typically 250 mg every 8 hours (three times daily), although higher doses up to 500 mg every 8 hours may be specified for more severe usage scenarios. ER tablets follow an every 12 hours (twice daily) schedule, commonly at 375 mg or 500 mg doses. The maximum labeled daily intake should not exceed 4,000 mg.


Contextual and Population-Specific Instructions

The use of Kefral is subject to form-specific intake rules. IR forms can be consumed with or without food, as total absorption remains constant. However, ER tablets must be taken with a meal or shortly after eating, and they must be swallowed whole without crushing or chewing to maintain their release mechanism. The oral suspension requires thorough shaking before each use.

For pediatric use (in children one month and older), dosing follows a weight-based regimen (20 to 40 mg/kg/day) given in divided doses. Dosage is generally not altered in adult patients with moderate kidney impairment, although specific supplemental doses are required following haemodialysis sessions.


Duration Requirements

Treatment is typically continued for 7 to 10 days. Regulatory documents mandate a minimum course of 10 full days when the medicine is used for infections caused by Streptococcus pyogenes.

Recent Clinical Evidence

Research evidence / Overview of Studies for Kefral (Cefaclor)


Evidence for Infections of the Ear, Throat, and Tonsils

Clinical evaluation of Kefral (Cefaclor) for infections such as otitis media (middle ear infection) and pharyngitis/tonsillitis has mainly involved Randomized Controlled Trials (RCTs) and systematic reviews. These studies were used in research exploring how symptoms change over time, often comparing Cefaclor against other antibiotic agents or different treatment durations. Outcomes related to physical discomfort and microbiological status measurements were assessed.

Findings describe patterns observed in these studies, where outcomes related to clinical status were measured shortly after treatment completion. Some comparative trials described patterns in the measured outcomes when Cefaclor was compared to certain other antibiotic classes. However, evidence remains limited and heterogeneous regarding the overall findings when evaluating Cefaclor against first-line treatments like penicillin for pharyngitis.


Evidence for Lower Respiratory Tract Infections

Cefaclor was studied for its use in lower respiratory tract infections, including pneumonia and acute exacerbations of bronchitis. Research examined symptomatic responses, such as changes in cough and fever, as well as microbiological status measurements. Data show patterns related to similar outcome measurements when compared to some older oral antibiotics. However, data for certain groups, such as those with very severe pneumonia, remain insufficient, and the applicability of results from older trials is a factor explored in research uncertainty due to the recognized prevalence of non-bacterial causes for some acute respiratory conditions.


Key Limitations and Areas of Research Uncertainty

Research highlights that comparative evidence is sometimes lacking against the most recently approved first-line antibiotics. Follow-up durations were limited in many initial studies, meaning long-term effects are not fully established. Additionally, due to its historical status, data for certain groups (subgroups) remain insufficient, particularly in the context of evolving antibiotic resistance patterns. Study results reflect the specific conditions under which they were conducted, and findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Kefral (FAQ)

Q: Can Kefral affect my mood or cause changes in behavior?

Official regulatory documents indicate that this medicine may rarely cause reversible effects on the central nervous system. These effects may include nervousness, agitation, confusion, and somnolence (drowsiness). The product information lists these as potential but uncommon adverse reactions.

Q: What are the most common side effects people report when taking Kefral?

According to official regulatory documents, the most common adverse reactions reported include diarrhea, a higher count of white blood cells known as eosinophilia, and genital pruritus/vaginitis. These effects are classified as common in the official product information.

Q: Is Kefral approved for use in children?

Official information states that the safety and effectiveness of the immediate-release forms (capsules and suspension) have been established for use in children one month of age and older. However, the extended-release tablet form is not established for use in children under 16 years of age.

Q: Is Kefral a type of antibiotic or a different kind of medicine?

Kefral contains the active ingredient Cefaclor, which is officially classified as a second-generation cephalosporin antibiotic. This classification means it is a type of medicine specifically designed to treat bacterial infections.

Q: How does Kefral interact with birth control pills?

Regulatory information notes that this medicine may decrease the effectiveness of hormonal contraceptives (such as birth control pills or patches) by altering the natural balance of intestinal flora. Because of this potential change, additional forms of contraception may be warranted due to the described mechanism.

Q: Does taking Kefral require any special diet changes?

Official administration guidelines state that no special diet is mandated when taking this medicine. The only requirement related to food is that the extended-release tablet form must be taken with a meal to ensure proper absorption.

Q: What happens if I suddenly stop taking Kefral?

Official guidelines emphasize the importance of completing the full course of treatment, even if symptoms improve. This is done to help prevent the risk of recurrent infection or the development of bacterial resistance.

Q: Is there a maximum amount of time Kefral is generally used for?

Regulatory documents specify that treatment is typically intended for a short course, usually 7 to 10 days. A minimum treatment course of 10 full days is required when the medicine is used for certain specific infections, such as those caused by Streptococcus pyogenes.

Q: Can Kefral be taken if I have diabetes?

Official regulatory notes indicate that in patients with high blood sugar (diabetes), this medicine may interfere with certain urine glucose lab tests. Alternative testing methods may be needed, according to regulatory notes.

Q: How long does Kefral stay in your system after you stop taking it?

Pharmacokinetic data provides information on how the drug moves through the body. In subjects with normal kidney function, the serum half-life—the time it takes for half of the drug to be eliminated—is typically very short, ranging from 0.6 to 0.9 hour (36 to 54 minutes).

Q: Can Kefral cause sleep disturbances or insomnia?

Official documents list potential effects on the central nervous system, including insomnia (difficulty sleeping) and somnolence (drowsiness or feeling sleepy). These are generally noted as rare and reversible adverse effects.

Q: Why is Kefral sometimes used alongside other medicines?

This medicine is sometimes used in combination with another medication called Probenecid. This co-administration is a documented strategy used to increase and prolong the concentration of Kefral in the blood by inhibiting its renal excretion (how it is removed by the kidneys).

Q: Is it possible to develop a tolerance to Kefral over time?

The mechanism of action is subject to certain bacterial defense mechanisms, which can lead to reduced effectiveness. These mechanisms include the production of beta-lactamase enzymes or the development of altered Penicillin-Binding Proteins (PBPs), which effectively reduce the drug’s power against the pathogen.

Q: Can Kefral affect my ability to drive or operate machinery?

Official documents caution patients to be careful when driving or operating machinery until they are certain of how the medicine affects them. This caution is noted because the medicine may rarely cause side effects such as dizziness or drowsiness.

Q: Does Kefral have a risk of misuse or dependence?

Regulatory bodies classify this medicine as a cephalosporin antibiotic, and it is not listed in regulatory schedules as having a known risk of misuse or dependence.

Q: Is Kefral safe to take during pregnancy?

This medicine is assigned FDA Pregnancy Category B. Its use during pregnancy is described as being warranted only if clearly needed, based on a consideration that the potential benefits of treatment outweigh any potential risks.

Q: What are the typical conditions or patient profiles for which Kefral is considered?

The medicine is officially indicated for treating a variety of bacterial infections. These include otitis media (middle ear infections), lower respiratory infections (such as certain types of pneumonia), and pharyngitis/tonsillitis, when caused by susceptible types of bacteria.

Q: Can Kefral interfere with vaccinations?

Official documents specifically list an interaction with the Live Typhoid Vaccine Oral. The antibiotic action of this medicine can prevent the required therapeutic response from this specific type of live vaccine.

Q: What is the evidence regarding Kefral's use in specific patient groups?

Research evidence notes limitations in the available data for certain patient subgroups. For example, data regarding use in very severe pneumonia remains insufficient, and there are noted limitations regarding the long-term effects of treatment.

Q: Is Kefral a controlled substance?

Official classification information indicates that this medicine is a cephalosporin antibiotic. It is not classified as a federally controlled substance by regulatory bodies.

Q: Does taking Kefral impact fertility?

Data from animal studies examining the active ingredient have generally failed to show evidence of impaired fertility. However, regulatory documents note that there are no controlled human data available regarding effects on fertility.

Q: Why is the drug named Kefral?

The active ingredient in Kefral is Cefaclor. Its name is derived from its chemical structure, specifically the components cepha (from the cephalosporanic acid core) and chlor (from the presence of a chlorine group in the molecule).

Q: If I have liver problems, can I still take Kefral?

Official references for this medicine state that no specific dosage adjustments are typically provided for adult patients who have pre-existing hepatic (liver) impairment. However, use is typically subject to medical review.

Q: How long did the clinical trials for Kefral last?

Research evidence notes that the follow-up periods in many of the initial clinical studies for this medicine were limited in duration. This meant that long-term effects following the use of the medicine were not fully established by those original trials.

Q: What are the signs that Kefral might be working for me?

Clinical evaluation described in research evidence often includes assessing symptomatic responses. These responses include changes in signs of infection such as fever and cough as treatment progresses.

Q: Is it true that Kefral is only for short-term use?

Official guidelines specify that treatment is typically intended for a short course, generally continuing for 7 to 10 days. A minimum of 10 full days is required for treating certain specific types of bacterial infection.

Q: Does Kefral interact with common pain relievers like ibuprofen or acetaminophen?

Official interaction summaries and regulatory documents generally indicate no known interaction between this medicine and common over-the-counter pain relievers such as ibuprofen or acetaminophen.

How should Kefral be stored and disposed of?

How to Store and Dispose of Kefral (Cefaclor)

Official labeling mandates distinct storage conditions based on the dosage form. Kefral capsules and tablets must be stored at controlled room temperature, typically 20°C to 25°C, and protected from excess heat, moisture, and light. Solid forms must not be frozen. The reconstituted oral suspension, however, must be kept in the refrigerator and discarded after 14 days.

All forms of the medication must be kept in their original, tightly closed container and secured out of the sight and reach of children. For disposal, unused or expired Kefral should be taken to a drug take-back program. If this is unavailable, it must be mixed with an unappealing substance, sealed, and thrown into household trash, avoiding disposal in sinks or toilets.

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

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