Cefaklor

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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 Cefaklor

Property Description
Active Ingredient Cefaclor (as Cefaclor monohydrate)
Form Capsule, Tablet (Extended-Release), Oral Suspension
Pharmacological Class Second-Generation Cephalosporin Antibiotic
Common Purpose Systemic Anti-infective Agent
Origin Semisynthetic

Cefaclor: A Second-Generation Cephalosporin Antibiotic

Cefaclor is a semisynthetic beta-Lactam antibiotic prescribed for systemic use as an anti-infective agent. It is structurally classified within the family of cephalosporin antibiotics, specifically as a second-generation agent. This grouping allows for the effective targeting of a specific, expanded spectrum of bacterial organisms. The drug's profile is clinically recognized for its utility against susceptible pathogens, emphasizing its role in treating bacterial infections. As a powerful therapeutic tool, Cefaclor is available by prescription only, emphasizing its use under strict medical guidance.


Composition and Forms: The Active Ingredient and Flexibility of Cefaclor

The sole active component in this medicine is the substance Cefaclor, typically present as Cefaclor monohydrate. This molecule is the sole source of the medication's therapeutic activity and contains the core cephem skeleton characteristic of its class. Cefaclor is administered via the oral route and is produced in several distinct dosage forms, ensuring flexible delivery for patient needs. These forms include standard capsules, specific extended-release tablets, and a granulated powder that is reconstituted to create an oral suspension. The availability of the oral suspension is a key differentiator that allows for accurate dosing in patient groups, such as children (infants over one month old), who require liquid medication.


General Purpose: How Cefaclor Fights Bacterial Infections

The primary purpose of Cefaclor is the elimination of susceptible bacterial pathogens. Its fundamental action is bactericidal, meaning it actively kills the invading bacteria, distinguishing it from bacteriostatic agents. This lethal effect is achieved by inhibiting the synthesis of the bacterial cell wall, a structure essential for microbial survival. This mechanism is crucial for addressing the root cause of systemic bacterial infections.

Regulatory References

  1. Cefaclor Dosage Forms (MedlinePlus)

What side effects are possible with Cefaklor?

Possible Side Effects and Safety Information

Adverse Reaction Scope

Cefaklor's safety profile is dominated by Hypersensitivity reactions, Gastrointestinal disturbances, and, less commonly, effects on the Hepatobiliary and Central Nervous Systems.

Adverse Reaction Category Examples & Frequency
Common (1% to 10%) Diarrhea, Nausea, Vomiting, Rash, Eosinophilia
Uncommon (0.1% to 1%) Serum sickness-like reaction
Rare (0.01% to 0.1%) Transient hepatitis, Cholestatic jaundice, Dizziness, Hyperactivity, Thrombocytopenia

Serious and Clinically Significant Adverse Reactions

Regulatory documents highlight the potential for severe, life-threatening reactions. These include Anaphylaxis and severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Gastrointestinal risks include Pseudomembranous colitis, which may range from mild to life-threatening. Other rare but serious adverse effects involve the blood (Agranulocytosis, Aplastic Anemia) and the nervous system (Seizures, Neurotoxicity).

Safety Restrictions and Monitoring

Cefaklor is contraindicated in patients with a history of hypersensitivity to cephalosporins or a history of severe allergic reaction to penicillin, due to clinical evidence of partial cross-allergenicity. Caution is advised for patients with reduced renal function as this increases the risk of neurotoxicity (e.g., encephalopathy, seizures). Children have a higher reported incidence of serum sickness-like reactions. Prolonged or high-dose therapy necessitates monitoring of renal and hematological status. Additionally, this medication may cause a false-positive reaction for glucose in the urine (using copper reduction tests) and a positive Coombs' test.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the Cefaclor overdose profile primarily through its documented clinical manifestations and the required emergency actions. The most common anticipated signs of overdose are non-specific toxic symptoms affecting the digestive system, including nausea, vomiting, epigastric distress, and diarrhea. The severity of the gastrointestinal symptoms is noted in regulatory documents as being dose-related.


Severe Manifestations and Emergency Action

While gastrointestinal effects are common, the regulatory documentation highlights the potential for severe neurological outcomes associated with the cephalosporin class, such as seizures and neurotoxicity. This risk is specifically noted for patients with renal impairment and the elderly.

Regulatory guidance mandates that immediate medical attention is required and emergency services must be contacted if the affected individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened. Treatment is strictly symptomatic and supportive, as no specific antidote is known to be effective or beneficial. Management procedures may involve activated charcoal or gastric emptying (lavage), alongside support of the patient's airway and vital signs.

Therapeutic Uses of Cefaklor

Cefaclor is generally used to address bacterial infections across several body systems, focusing on conditions that present with distinct and often disruptive symptom patterns. Its primary benefit is providing anti-infective support, which generally contributes to easing the overall symptom load. This includes infections of the skin, ears, throat, lungs, and urinary tract.

This medication is considered relevant for conditions presenting with acute or disruptive symptom patterns, and is applied across domains where additional symptomatic support is needed. It is commonly used to help with infections such as otitis media, pharyngitis, tonsillitis, bronchitis, certain forms of pneumonia, and cystitis.

The supportive therapeutic benefit focuses on managing groups of symptoms related to physical discomfort and inflammatory states, which may interfere with daily functioning. In these acute scenarios, Cefaclor supports general well-being during symptomatic phases.

“Cefaclor offers symptomatic relief that may assist with maintaining functional stability.”


Quick Fact: Support for Acute Symptom Management

Cefaclor is commonly used when symptoms intensify and supportive relief is needed for acute upper and lower respiratory infections, which may be part of symptomatic management.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Cefaclor — Official Regulatory Information

The eligibility profile for Cefaclor, a second-generation cephalosporin, is strictly defined by regulatory documents, establishing who may use the medicine and under what conditions.


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed: Adults, Geriatric patients (with normal kidney function), and Pediatric patients ge 1 month of age (capsule/suspension forms).
Populations for whom use is contraindicated: Patients with known allergy or hypersensitivity to cephalosporin antibiotics or any component of the formulation.
Age-related eligibility rules: Safety is not established for infants < 1 month of age; the extended-release tablet is not established for pediatric patients < 16 years of age.
Condition-specific eligibility rules: Use requires caution in patients with a history of penicillin allergy and in those with markedly impaired renal function or a history of colitis.
Pregnancy and lactation eligibility status: Pregnancy: FDA Category B. Use is permitted only if clearly needed. Lactation: Caution is advised as trace amounts are excreted into breast milk.

Eligibility Classifications (High-Level)

Classification Definition based on Official Documents
Eligibility severity classification: Contraindicated (Cephalosporin Hypersensitivity); Caution/Conditional Use (Penicillin Allergy, Renal Impairment, Pregnancy).
Regulatory basis: US FDA Prescribing Information and European Summary of Product Characteristics (SmPC).

Connection to the overall eligibility profile: The regulatory documents establish that an absolute allergy to the drug class results in automatic ineligibility for Cefaclor. Eligibility is then extended to all age groups ge 1 month but is conditional upon organ function (kidneys, GI tract) and specific life stages (pregnancy/lactation) that require special caution as mandated by official labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Cefaklor may interact with certain medications and affect the results of specific laboratory tests. All patients should inform their healthcare providers about all other prescription, over-the-counter, and herbal products they are taking.

Interactions with Medications

Interacting Product Category Effect/Clinical Note
Oral Anticoagulants (e.g., Coumarin compounds like warfarin) There have been reports of an increased anticoagulant effect when cefaklor and oral anticoagulants are taken at the same time, which may lead to a risk of bleeding. If co-administered, the patient's prothrombin time/INR should be closely monitored and the anticoagulant dose adjusted as needed.
Probenecid Probenecid, a medicine commonly used for gout, reduces the renal excretion of cephalosporins like cefaklor. This may result in increased and prolonged concentrations of cefaklor in the blood serum.
Antacids (containing magnesium or aluminum) The absorption of the extended-release formulation of cefaklor is diminished. Administration of these antacids should be separated from the cefaklor dose by approximately one hour to minimize this effect.

Drug-to-Laboratory Test Interactions

Administration of cefaklor may lead to certain false results in laboratory tests, which is a known effect of the cephalosporin class of antibiotics. Patients may show a false-positive reaction for glucose in the urine when using tests based on copper reduction methods (such as Benedict’s solution, Fehling's solution, or Clinitest tablets). Enzyme-based tests (such as Clinistix or Tes-Tape) are not affected. Additionally, a positive direct Coombs' test has been reported in patients receiving cephalosporins. This result must be recognized when performing hematologic studies or transfusion cross-matching procedures.

Mechanism of Action

Covalent Inhibition of Bacterial Penicillin-Binding Proteins

Cefaclor is a bactericidal agent that targets the bacterial cell wall synthesis pathway. It functions as a substrate mimic, covalently binding to and achieving irreversible inhibition of specific Penicillin-Binding Proteins (PBPs) . These PBPs are bacterial enzymes—specifically transpeptidases—essential for the final stages of cell wall construction.

Disruption of Cell Wall Structure and Osmotic Integrity

The inhibition of PBPs blocks the cross-linking (transpeptidation) of peptidoglycan chains, resulting in the synthesis of a defective, structurally unsound cell wall. Since the wall cannot counteract the high internal osmotic pressure of the bacterium, the cell rapidly loses its structural integrity and ruptures (lysis). This cellular failure mechanism defines the drug's bactericidal effect.

Limitations Due to Target and Enzyme Modification

The biological action of this mechanism is constrained by known bacterial resistance factors. Organisms can circumvent the drug by producing beta-Lactamase enzymes that chemically hydrolyze and inactivate the Cefaclor molecule, or by altering the structure of the PBPs to reduce the drug's binding affinity.

Dosage and Administration Information

The medicine Cefaclor is designed exclusively for oral administration across all its available forms, which include capsules, oral suspension, and extended-release tablets. The specific dosing regimen and frequency are determined by the formulation and the treated infection.


Official Dosing and Frequency

Immediate-Release (IR) formulations (capsules and suspension) are typically administered every 8 hours (three times daily). The usual adult dose is 250 mg per administration, although the dosage may be increased up to 500 mg every 8 hours for managing more severe infections. Extended-Release (ER) tablets follow a schedule of administration every 12 hours (twice daily), with doses ranging from 375 mg to 750 mg.


Administration Conditions and Duration

Administration is governed by the dosage form. Extended-Release tablets must be taken with food or meals and solid forms—including the ER tablets and capsules—must be swallowed whole without being crushed, cut, or chewed. The Oral Suspension must first be reconstituted by adding the specified amount of water to the granulated powder and shaken well before each dose.

Treatment is typically maintained for 7 to 10 days. However, for infections caused by beta-haemolytic streptococci, the official instruction mandates that the medicine must be continued for a minimum of 10 full days.


Special Populations

For pediatric patients, the dose is calculated based on body weight, generally ranging from 20 mg/kg/day to 40 mg/kg/day in divided doses. Dosage adjustments are generally not required for patients with renal impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cefaclor

Evidence for Approved Infections

Research exploring Cefaclor was evaluated in numerous short-term Randomized Controlled Trials (RCTs) across its approved uses, including infections of the ear, throat, lungs, urinary tract, and skin. These studies were designed to track how symptoms evolved over short, defined time intervals, typically 7 to 10 days, and to monitor the rate of bacteriological eradication (the elimination of the specific pathogen). Findings describe patterns observed in these trials, with researchers assessing outcomes related to patient status and pathogen elimination rates. Trial reports described varying patterns when Cefaclor was evaluated in the context of these comparative studies.

The Research Landscape and Follow-up

The core research base is characterized by short-term trials with limited follow-up durations. This means there is limited information for long-term outcomes and the durability of the response. Most studies were designed to evaluate immediate clinical and bacteriological responses, not to track patients for months or years. Consequently, research provides context about group patterns but not individual predictions about long-term recurrence rates. Long-term effects are not fully established.

Evidence in Specific Patient Groups and Remaining Uncertainty

Cefaclor was evaluated in studies that included several specific patient groups. A significant portion of the core evidence for ear and throat infections included infants (over one month of age) and children. Studies also examined Cefaclor in older adults and, in specific cases, pregnant women to gather data on its use in these populations. The overall research base shows several patterns of limitation, including evidence quality that varies across studies, and findings that were sometimes mixed. Data for certain groups remain insufficient, and research is ongoing to address the clinical challenges presented by emerging bacterial resistance.

Frequently Asked Questions (FAQ)

Common questions about Cefaklor (FAQ)


Q: Does Cefaklor treat viral infections like the cold or flu?

According to official product information, Cefaklor is an antibacterial drug. It is prescribed solely to treat specific bacterial infections and is not effective against viruses, such as those that cause the common cold or influenza (flu).


Q: What is the general difference between Cefaklor and other cephalosporin antibiotics like Keflex?

Cefaklor is classified as a second-generation cephalosporin. This classification generally means it has an expanded spectrum of activity, particularly against certain types of Gram-negative bacteria, compared to first-generation cephalosporins like cephalexin (Keflex).


Q: Can Cefaklor cause an allergic reaction even if I've taken it before?

Yes, regulatory documents indicate that allergic reactions are possible, even upon re-exposure. Cases of hypersensitivity, including serum sickness-like reactions, have been reported more frequently during or after a second or subsequent course of therapy with Cefaklor.


Q: Can Cefaklor cause yeast infections or oral thrush in women?

Official information lists specific types of secondary infections as possible adverse effects, including moniliasis (a term for yeast/Candida infection) and vaginitis (vaginal inflammation/infection). These types of infections are sometimes referred to as 'superinfections'.


Q: Are there any side effects from Cefaklor that can affect the joints or cause joint pain?

Yes, joint pain (arthralgia) and arthritis are findings that have been reported as part of a serum sickness-like reaction associated with Cefaklor use. These are typically accompanied by symptoms such as a rash and fever.


Q: Can Cefaklor be taken at the same time as other common pain relievers?

Major interactions with common over-the-counter pain relievers such as ibuprofen are not consistently highlighted in regulatory warnings. However, professional resources suggest that combining cephalosporin antibiotics with certain non-steroidal anti-inflammatory drugs (NSAIDs) carries a potential for increased kidney-related side effects.


Q: Are there any known interactions between Cefaklor and alcohol?

While the official Cefaklor label may not explicitly list it, some drugs in the cephalosporin class have been linked to a disulfiram-like reaction when combined with alcohol. Regulatory reviews for this antibiotic class note that alcohol consumption is generally discouraged during therapy.


Q: Does Cefaklor interact with oral contraceptives (the birth control pill)?

Regulatory information indicates that Cefaklor may potentially decrease the effectiveness of oral contraceptives that contain estrogens. This may be due to the antibiotic altering the normal bacterial flora in the gut. The consideration of additional or alternative contraceptive strategies is a topic addressed in official guidance.


Q: How does Cefaklor affect the gut and beneficial bacteria in the body?

Official warnings state that antibacterial agents like Cefaklor alter the normal bacterial flora of the colon. This disruption is what can lead to the overgrowth of other organisms, such as C. difficile, which can cause serious diarrhea and colitis.


Q: Is there a risk of developing a second infection (superinfection) while on Cefaklor?

Official regulatory warnings for antibacterial drugs note that prolonged use can lead to a superinfection. This is a secondary infection by organisms that are not susceptible to Cefaklor, such as the bacteria that cause C. difficile colitis.


Q: Is Cefaklor effective against Staphylococcus bacteria?

Official product information indicates Cefaklor has demonstrated activity against many Gram-positive aerobic bacteria, including specific strains of staphylococci. This includes both coagulase-positive and coagulase-negative strains, as well as those that produce penicillinase.


Q: How is Cefaklor absorbed by the body, and what is its half-life?

After taking Cefaklor orally, it is rapidly and well absorbed. The drug reaches its highest concentration in the bloodstream approximately 0.5 to 1.0 hour after administration. The serum half-life in a normal subject is approximately 0.6 to 0.9 hours.


Q: Is it common for Cefaklor to cause headaches or dizziness?

Headache is listed as a common side effect for the Extended-Release (ER) tablet formulation of Cefaklor. Dizziness is listed in the official side effects tables but is described as less common—either uncommon (for the ER tablet) or rare (for the Immediate-Release forms).


Q: Can Cefaklor cause fever or chills as a side effect?

Official product documents list fever and chills as uncommon adverse effects reported with the Extended-Release (ER) tablet formulation. These symptoms can also be part of a more serious allergic response, such as a serum sickness-like reaction.


Q: What information is available about Cefaclor and its use for skin infections?

Cefaklor is formally indicated for the treatment of skin and skin structure infections caused by susceptible bacteria. These include specific strains of Staphylococcus aureus and Streptococcus pyogenes.

How should Cefaklor be stored and disposed of?

Storage and Disposal Requirements

Storage conditions for Cefaclor depend on the dosage form. Capsules and extended-release tablets must be stored at controlled room temperature, typically 15 C to 30 C (59 F to 86 F), in a tightly closed, light-resistant container. All forms must be kept out of the sight and reach of children.

Dosage Form Storage Environment Stability/Shelf-Life
Dry Granules Not exceeding 30 C Original expiry date
Reconstituted Suspension Refrigerator (2 C to 8 C); Do not freeze Discard after 14 days

Disposal instructions state that unused liquid suspension must be discarded after the 14-day stability period. Medication must not be disposed of via wastewater. Unused product may be mixed with an undesirable substance and placed in the household trash, following regulatory guidelines.

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

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