Cefacloril

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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 Cefacloril

Property Description
Active ingredient Cefaclor
Form Capsules, tablets, oral suspension
Pharmacological class Second-generation cephalosporin antibiotic
Common use Anti-infective agent (to eliminate bacteria)
Origin Semisynthetic

What Type of Antibiotic is Cefacloril?

Cefacloril is a medicinal preparation containing the single active ingredient, Cefaclor, a semisynthetic drug classified as an antibiotic. Specifically, Cefaclor belongs to the second-generation cephalosporin group, which is part of the larger β-lactam antibiotic family. This classification signifies that Cefaclor exhibits a broader spectrum of activity against various bacteria compared to older, first-generation cephalosporins. This pharmacological class is clinically recognized for its role in treating susceptible bacterial infections. The medicine is a prescription-only monotherapy product, focusing solely on the therapeutic action of the Cefaclor compound.


Forms, Origin, and General Anti-infective Purpose

The drug is prepared exclusively for oral administration, meaning it is taken by mouth. Cefacloril is commonly available in several forms, including solid capsules and tablets, as well as an oral suspension. The availability of the oral suspension form is a differentiating feature, offering flexibility that makes dosing easier for pediatric patients who cannot swallow solid pills. The fundamental purpose of this agent is its function as a general anti-infective medicine, typically used when a susceptible bacterial infection is identified, with clinical recognition for its reliable performance in reducing bacterial load.


How Cefacloril Achieves Its Bactericidal Effect

Cefaclor achieves its therapeutic goal through bactericidal action, which means the compound actively kills the bacteria rather than only slowing their growth. This definitive effect is achieved through the specific mechanism of inhibition of bacterial cell wall synthesis, a process that is essential for the structural integrity of the bacteria. This targeted action supports the body’s ability to clear the infection.

Regulatory References

  1. MedlinePlus Drug Information on Cefaclor
  2. NIH DailyMed Drug Record for Cefaclor
  3. NIH Drug Record: Cefaclor

What side effects are possible with Cefacloril?

Possible Side Effects and Safety Information

The safety profile of Cefacloril (Cefaclor) is established through regulatory monitoring and clinical reporting, highlighting common and serious adverse reactions.

Common and Less Common Adverse Reactions

The most frequently reported side effects affect the Gastrointestinal System, typically diarrhea (Common: 1%–10%), nausea, and abdominal pain. Other common reactions involve the skin, such as rash or pruritus (itching). Less common reports include vaginitis/moniliasis, headache, and abnormal elevations in liver enzymes.

Serious and Clinically Significant Risks

Cefacloril is associated with a risk of serious hypersensitivity reactions, including anaphylaxis and severe cutaneous adverse reactions like Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These reactions can be life-threatening and may involve fever, rash, and mucous membrane lesions. Severe, watery, or bloody diarrhea may indicate Pseudomembranous Colitis, a serious gastrointestinal complication that requires immediate attention.

Rare, but documented, serious events include blood dyscrasias (e.g., leukopenia, agranulocytosis), hepatic dysfunction (e.g., cholestatic jaundice), and seizures or other signs of Central Nervous System toxicity, particularly in patients with reduced kidney function or those receiving high doses. A serum sickness-like reaction, characterized by rash and arthralgia/arthritis, is also noted, particularly in pediatric patients.

Safety Considerations

Caution is advised for patients with a history of penicillin allergy due to the potential for cross-hypersensitivity. Individuals with renal impairment may require dose adjustments to mitigate the risk of CNS effects. Prolonged or repeated use may result in the overgrowth of non-susceptible organisms.

Overdose and Emergency Response

Overdose involving Cefacloril is officially documented to affect both the gastrointestinal system and the central nervous system. Common presentations include gastrointestinal distress such as nausea, vomiting, stomach pain, and diarrhea. Central nervous system effects may manifest as reversible hyperactivity, agitation, confusion, dizziness, insomnia, or somnolence, all of which are associated with high systemic concentrations.

Severe Manifestations and Urgent Help-Seeking

The official prescribing information highlights the potential for severe neurological complications, specifically seizures, which are a recognized outcome of this drug class in high-exposure scenarios. Severe overdose may also result in systemic collapse, trouble breathing, or unconsciousness (inability to be awakened). A population-specific note confirms that patients with impaired renal function face an increased risk of developing these severe CNS toxicities if dosage is not appropriately adjusted.

Regulator-Mandated Emergency Response

Immediate medical attention is required for any suspected overdose. If severe manifestations occur—including collapse, a seizure, difficulty breathing, or unconsciousness—emergency services must be contacted immediately. Official documents also mandate contacting a certified poison control helpline. Overdose management is defined as symptomatic and supportive treatment, as no specific antidote is known. Procedural instructions for managing seizures include prompt drug discontinuation and the administration of anticonvulsant therapy.

Therapeutic Uses of Cefacloril

What Cefacloril Treats: Main Uses and Benefits

Cefacloril is commonly used across conditions involving inflammatory or irritative processes, providing supportive relief for symptoms related to heightened physiological activity. It is applied in clinical settings that involve acute or unstable symptom patterns across several therapeutic domains.

Its use is considered relevant for conditions presenting with systemic or localized discomfort, including: otitis media, pharyngitis, tonsillitis, bronchitis, pneumonia, infections of the skin and soft tissues, and urinary tract infections like cystitis and pyelonephritis.

The medication offers symptomatic relief that helps patients cope more steadily with difficult episodes. It is particularly relevant for easing acute localized pain and pronounced discomfort.

“Cefacloril assists with maintaining functional stability when symptoms interfere with daily functioning.”

This antibiotic may be part of symptomatic management in pediatric patients for conditions like ear infections and is relevant for easing challenging symptoms that create noticeable physiological strain. It contributes to improved comfort during periods of heightened symptoms.


Benefit Focus: Supports easing Acute Localized Pain

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Cefacloril?

Population eligibility for Cefacloril (Cefaclor) is strictly defined by regulatory documents, focusing on allergic risk and established safety profiles. The medicine is approved for adults and for pediatric patients starting from one month of age.

Contraindications and Absolute Exclusions

Cefacloril is absolutely contraindicated in individuals with a known hypersensitivity or allergy to cephalosporin antibiotics.

Additionally, its use is contraindicated and its safety and efficacy are not established for infants younger than one month of age.

Use with Caution and Restrictions

Administration requires caution for patients with a history of major penicillin allergy due to the potential for cross-reactivity. Caution is also advised for those with a history of gastrointestinal disease, particularly colitis, and for patients with markedly impaired renal function (severe), as clinical experience in the latter group is limited.

Pregnancy and Lactation

Use during pregnancy is advised only if clearly needed, as adequate studies are lacking. Although only small amounts pass into breast milk, caution is advised when Cefacloril is administered to a nursing woman.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies specific patterns where the co-administration of Cefacloril (Cefaclor) with other substances may alter drug exposure or result in additive pharmacodynamic effects. These patterns establish necessary constraints for co-administration.


Documented Exposure and Pharmacodynamic Interactions

Interacting Substance/Class Official Interaction Pattern Mechanism/Classification
Probenecid Increases Cefaclor plasma concentrations and prolongs exposure. Pharmacokinetic: Inhibition of renal tubular secretion.
Oral Anticoagulants Risk of an increased anticoagulant effect and documented reports of increased prothrombin time. Pharmacodynamic: Additive/Reinforced effect.
Nephrotoxic Drugs May increase the risk or severity of kidney damage (nephrotoxicity). Pharmacodynamic: Additive toxicity.
Oral Contraceptives Cefaclor may decrease the level or effect of the contraceptive. Efficacy Reduction: Altering intestinal flora.

Administration Constraints and Procedural Interference

The absorption of Cefaclor is officially documented as diminished when aluminum- or magnesium-containing antacids are taken within one hour of administration. This requires separation of dosing time to maintain intended Cefaclor exposure. Additionally, official regulatory labels note that Cefaclor may interfere with certain medical tests, resulting in false-positive results for specific urine glucose tests (using Benedict’s or Fehling’s solutions) and potentially causing a positive direct Coombs' test.

Mechanism of Action

Covalent Blockade of Bacterial Cell Wall Assembly

Cefaclor's core mechanism is defined by its bactericidal activity, commencing by interfering with the structural integrity of the bacterial cell. The molecule functions as an irreversible covalent inhibitor of Penicillin-Binding Proteins (PBPs), which are the enzyme machinery responsible for cross-linking the peptidoglycan strands in the bacterial cell wall. This permanent molecular interaction prevents the completion of the cell's rigid outer shell.

Cascade Leading to Osmotic Rupture (Cell Lysis)

The failure of the cell wall structure immediately triggers an internal autolytic cascade within the bacteria. This prompts the rapid activation of the bacteria's own autolytic enzymes, which actively degrade the already compromised cell wall. The resulting structural weakness and internal pressure cause the bacterial cell to rupture due to osmotic forces, leading to widespread cell lysis.

Functional Constraints: Resistance and Target Modification

The mechanism's functional capacity is biologically constrained by bacterial defense mechanisms, primarily enzymatic destruction via beta-lactamase hydrolysis of the active ring, and target modification (changes to the PBP structure) that reduces Cefaclor's binding affinity. These constraints prevent the covalent inhibition step, resulting in a significantly reduced interaction with the PBP target.

Dosage and Administration Information

How to Use Cefacloril

The usage of Cefacloril, which contains the active ingredient Cefaclor, is defined by specific guidelines outlining the dose, frequency, and administration conditions. This medicine is approved exclusively for oral administration.


Official Dosing and Frequency

Administration patterns are typically structured for either three-times-daily (TID) or twice-daily (BID) use:

  • Immediate-Release (IR) Forms: The standard adult dose is often 250 mg every 8 hours (TID). For more severe infections, this dose may be increased, up to a maximum daily limit of 4 g. Alternatively, the total daily dose may be divided and administered every 12 hours (BID) for specific conditions.
  • Extended-Release (ER) Tablets: These are typically administered at 375 mg or 500 mg every 12 hours (BID).

Administration Requirements

Official instructions detail the relationship between intake and meals, as well as the physical handling of the forms:

  • IR Capsules and Suspensions may be taken with or without food. Total absorption remains the same, although the rate of absorption may be affected by food.
  • ER Tablets must be administered with meals. These tablets must not be cut, crushed, or chewed.

Population-Specific Rules and Duration

  • Pediatric Dosing for immediate-release forms is calculated based on body weight, typically 20 mg/kg/day in divided doses every 8 hours, with a maximum daily limit of 1 g.
  • Renal Impairment generally does not require a dosage adjustment. Specific instructions exist for patients undergoing hemodialysis, including a loading dose before the procedure.
  • The minimum required course duration is often specified, such as the requirement to continue therapy for a minimum of 10 days for certain streptococcal infections.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Summary of Efficacy Data

Research has investigated whether Cefacloril was studied regarding changes in chronic pain in patients with Type 2 Diabetes (T2D) related neuropathy. Findings from multiple trials and pooled analyses focus on patient-reported pain scores and quality of life measures.

One key meta-analysis examined the measured outcomes compared to placebo on symptom alleviation. The analysis included participants from five randomized controlled trials (RCTs). Studies reported findings related to the proportion of participants who experienced a decrease of 50% or more in their weekly average pain score in the group that received Cefacloril compared to the placebo group.

The duration of the studies included in this summary ranged from 8 to 16 weeks. Findings documented the time frame in which the average pain score was observed to change.


Dosage and Administration Studies

Studies have explored dose levels, often examining ranges between 75 mg and 150 mg per day. Additional research included the evaluation of various initial dose levels.

Studies explored the use of Cefacloril in patients with severe renal impairment. Available data on this specific population remains limited.


Studies on Combined Therapies and Anxiety

Research also investigated secondary endpoints such as anxiety scores often associated with chronic pain. Some studies documented findings related to anxiety scores in the intervention group.

Other studies compared the use of Cefacloril in combination with other agents to single-agent therapy. These comparisons focused on changes in pain intensity and overall functional status.

Frequently Asked Questions (FAQ)

Common questions about Cefacloril (FAQ)


Q: What is Cefacloril usually prescribed for?

According to official indications, Cefacloril is primarily prescribed for bacterial infections of the respiratory tract (such as the throat and middle ear), as well as specific infections of the skin and skin structure, and the urinary tract.

Its use is restricted to those infections caused by susceptible microorganisms, as determined by clinical assessment.


Q: What kind of infections does Cefacloril target?

Regulatory documents specify that Cefacloril is indicated only for infections caused by specific, susceptible strains of bacteria.

Examples of targeted bacteria often include Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae, which are listed in official regulatory documents.


Q: Is Cefacloril an antibiotic or something else?

Cefacloril is classified as a beta-lactam antibacterial drug, often referred to as an antibiotic.

Its mechanism, as defined in regulatory documents, is to treat specific infections by killing susceptible bacteria.


Q: Is Cefacloril used for treating viral infections?

Cefacloril is an antibacterial drug, and its mechanism is designed to kill bacteria by interfering with their cell structure. Therefore, regulatory indications specify that it is only for the treatment of infections that have been shown or are strongly suspected to be caused by bacteria.

Antibacterial drugs are not effective against viral infections.


Q: Is Cefacloril a broad-spectrum or narrow-spectrum antibiotic?

Cefacloril is classified as a second-generation cephalosporin antibiotic.

This classification indicates it has a broader spectrum of activity, meaning it can target a wider range of bacteria compared to older, first-generation cephalosporins.


Q: Is Cefacloril a type of penicillin?

Official documents classify Cefaclor, the active ingredient in Cefacloril, as a cephalosporin antibiotic.

While cephalosporins are structurally related to penicillins, they belong to a distinct class of antibacterial agents. The potential for cross-hypersensitivity is a standard safety consideration mentioned in product labels.


Q: What is the difference between Cefacloril and cefaclor?

Cefaclor is the chemical name for the active pharmaceutical ingredient (API) in the medicine.

Cefacloril is a name used to market the final drug product, often classifying it as a specific brand name or formulation containing Cefaclor.


Q: Are there different brand names for the same drug, Cefacloril?

Official drug compendia and regulatory listings often include multiple authorized brand names for the active ingredient Cefaclor.

These lists also acknowledge the authorized generic version of the medicine.


Q: Does Cefacloril require a prescription?

Cefacloril is classified by regulatory authorities as a prescription-only drug ( Rx only).

It is classified as a medicine that must be dispensed by prescription only.


Q: What is Cefacloril's classification in the drug safety system?

Regulatory agencies classify Cefacloril chemically as a second-generation cephalosporin antibiotic.

It is further classified as a prescription-only drug ( Rx only).


Q: What official documents describe Cefacloril's mechanism of action?

The detailed description of how Cefacloril works, known as its mechanism of action, is provided in the Pharmacodynamic Properties section of official regulatory documents, such as the Summary of Product Characteristics (SmPC).


Q: What are the contraindications for Cefacloril according to official sources?

Official documents state that Cefacloril is contraindicated (meaning its use is prohibited) if a patient has a known hypersensitivity to the drug itself.

Its use is also prohibited for patients with a history of serious allergic reactions to any medicine belonging to the cephalosporin class of antibiotics.


Q: Can I use Cefacloril if I am allergic to cephalosporins?

Official documents state that the medicine's use is contraindicated (prohibited) in patients who have experienced a known hypersensitivity or serious allergic reaction to any drug in the cephalosporin class of antibiotics.


Q: Can people with a history of digestive disorders take Cefacloril?

Official labels include a specific warning about the possibility of developing Clostridium difficile-associated diarrhea (CDAD) or Colitis.

Regulatory labels advise caution for patients with a history of gastrointestinal disease, particularly inflammatory conditions like colitis.


Q: Can older adults use Cefacloril without major issues?

Regulatory sections specifically address use in the geriatric population (older adults).

Regulatory documents indicate that dosage is generally consistent for older adults unless there is co-existing reduced kidney function, which requires assessment.


Q: How does the drug agency classify Cefacloril's safety for use in infants?

Regulatory agencies provide specific safety information and dosing guidance for the pediatric population, including infants (typically one month of age and older).

These instructions detail how the dosage is calculated based on body weight.


Q: Does Cefacloril have different uses in children versus adults?

Official regulatory documents confirm that the indications for use (the types of infections Cefacloril treats) are generally the same for both children and adults.

However, the precise dosage calculation for children is different, as it is based on body weight.


Q: Is Cefacloril safe to use during pregnancy?

Cefacloril is typically assigned a Pregnancy Category B classification by regulatory agencies.

This classification generally indicates that while animal studies have not shown evidence of harm to the fetus, the data from human pregnancies remains limited. The decision to use the medicine during pregnancy is determined by a healthcare provider.


Q: Can Cefacloril be taken while breastfeeding?

Regulatory documents state that low levels of Cefaclor are excreted in human milk.

Regulatory documents confirm that the decision to use the drug while breastfeeding is based on a risk assessment conducted by a healthcare provider, who weighs the potential risks to the infant against the mother's therapeutic need.


Q: What happens if I miss a dose of Cefacloril?

Patient information sheets generally provide guidance for managing a missed dose.

This guidance usually involves taking the missed dose if remembered shortly after the schedule, or skipping the missed dose and resuming the normal schedule if the time for the next dose is near.


Q: Are there any specific foods to avoid when taking Cefacloril?

Official documents provide specific instructions on whether to take the drug with or without food, depending on the formulation (IR or ER).

However, regulatory labels do not list specific foods that must be avoided while taking Cefacloril.


Q: Does Cefacloril have potential interaction with alcohol consumption?

Official regulatory documents generally do not list an interaction between Cefacloril and moderate consumption of alcohol.

This is a point of distinction, as some other antibiotics in the same drug class can cause severe adverse reactions when mixed with alcohol.


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

Official documents warn of potential additive risks when Cefacloril is taken alongside certain medicines known as nephrotoxic drugs, which means they can affect the kidneys.

Regulatory patient counseling emphasizes the importance of informing the prescriber about all concurrent medications, including over-the-counter pain relievers.


Q: Can Cefacloril interact with supplements like vitamins or herbal remedies?

Official drug information sheets generally contain a warning advising consultation with a healthcare provider regarding all concurrent products, including supplements, vitamins, or herbal products, to identify any potential or unlisted interactions.


Q: Is it normal to feel tired while taking Cefacloril?

Fatigue or tiredness is not typically listed among the common or frequently reported adverse reactions for this medicine in official regulatory documents.

If a patient experiences unusual tiredness, a healthcare provider should be consulted.


Q: Does Cefacloril cause drowsiness or affect driving?

Although drowsiness is not usually listed as a common side effect, official labels sometimes advise caution regarding certain adverse effects.

These include the potential for dizziness or headache, which are adverse effects that may be relevant to the operation of vehicles or machinery.


Q: Can Cefacloril cause changes in mood or anxiety?

Regulatory labels mention rare adverse reactions that affect the Central Nervous System (CNS).

These documented effects include symptoms such as restlessness, nervousness, insomnia, confusion, or dizziness, which can influence a patient's state of alertness or mood.


Q: Does Cefacloril cause sensitivity to sunlight?

Regulatory labels generally do not list photosensitivity (an increased sensitivity of the skin to sunlight) as a known adverse reaction associated with Cefacloril.


Q: Are there any known long-term side effects of taking Cefacloril?

Most adverse reactions documented in official sources are related to the acute course of treatment.

However, regulatory labels specifically note the potential for the overgrowth of non-susceptible organisms (such as fungi) with prolonged or repeated use. The potential for overgrowth is why prolonged or repeated use requires professional monitoring.


Q: Can Cefacloril change the color of my urine?

Regulatory labels do not typically list urine discoloration as a common or specific side effect associated with Cefacloril.

Patients are routinely advised to discuss any unexpected changes in symptoms or bodily functions with their healthcare provider.


Q: Is Cefacloril known to affect blood sugar levels?

Official documents do not typically list Cefacloril as causing changes to blood glucose levels (blood sugar) in the body.

However, a specific warning is included because the drug can interfere with certain urine glucose tests (using Benedict’s or Fehling’s solutions), potentially resulting in false-positive results.


Q: What does the research say about Cefacloril's effectiveness for ear infections?

Official regulatory documents list otitis media (middle ear infection) as one of the established infections for which Cefacloril has been studied and approved for use.

Its use in this area is based on evidence of effectiveness against common bacterial strains that cause these infections.


Q: How long does Cefacloril stay in your system after the last dose?

The official pharmacokinetic data indicates that the half-life of Cefaclor is relatively short, typically between 0.6 to 1.0 hours.

The half-life describes the time it takes for the amount of drug in the body to be reduced by half, suggesting the medicine is generally eliminated from the bloodstream within several hours of the last dose.


Q: What is the main purpose of Cefacloril as described by the FDA?

The FDA describes the main purpose of Cefacloril as the treatment of infections that occur in the respiratory tract, skin, and urinary tracts.

Its use is strictly defined as targeting only those infections caused by susceptible microorganisms.


Q: Is Cefacloril included on the WHO list of essential medicines?

Official classification documents from the World Health Organization (WHO) state that Cefaclor, the active ingredient, is not included in the WHO Model List of Essential Medicines.

This list specifies drugs considered priority for a basic health system.


Q: What is the shelf life of Cefacloril once the bottle is opened?

Official guidelines provide specific reconstitution and storage instructions for the liquid forms (suspensions).

Once the product is mixed, the label typically specifies a maximum time limit, often around 14 days, during which the medicine remains stable and potent.

How should Cefacloril be stored and disposed of?

The required storage conditions for Cefacloril (Cefaclor) are determined by the specific formulation, according to regulatory guidelines.

Storage Requirements

Formulation Temperature Requirement Protection Conditions
Capsules/Tablets & Dry Powder Controlled Room Temperature (15 C to 30 C / 59 F to 86 F) Keep tightly closed; protect from excess heat and moisture
Reconstituted Suspension Refrigerated Storage (2 C to 8 C) Do not freeze; discard after 14 days

All forms of the medication must be stored out of sight and reach of children.

Disposal

Any unused or expired Cefacloril must be disposed of in accordance with local requirements for pharmaceutical waste. The unused portion of the liquid suspension must be discarded after the 14-day stability period.

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

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