Cloracef

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Medically reviewed

Rosario Oropesa

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 Cloracef

Quick Facts

Property Description
Active ingredient Cefaclor
Form Capsule, Tablet (Extended-Release), Powder for Oral Suspension
Pharmacological class beta-Lactam antibiotic; Second-generation cephalosporin
General Purpose To eliminate susceptible bacterial pathogens
Origin Semisynthetic

What Type of Medicine is Cloracef?

Cloracef is a prescription-only (Rx) anti-infective agent used for systemic treatment, meaning it is absorbed into the bloodstream to combat infections. The medication belongs to the cephalosporin family, classified specifically as a second-generation cephalosporin, reflecting its characteristic spectrum of activity against various bacteria. The drug is clinically recognized for its effectiveness against a range of common pathogens.


What is the Active Ingredient and Form of Cloracef?

Its sole active ingredient is Cefaclor, a semisynthetic compound that serves as the therapeutic agent, making Cloracef a single-ingredient product. Cefaclor is formulated exclusively for oral administration and is available in several oral dosage forms to suit different patient needs. These forms include traditional capsules, tablets (which may feature an extended-release formulation for gradual drug absorption), and a dry powder for oral suspension that is mixed before use. This suspension form is a differentiating factor as it allows for precise dosing and easier administration, particularly to pediatric patients.


How Does Cloracef Generally Benefit the Patient?

The general purpose of this antibiotic is to resolve bacterial infections by directly eliminating the causative microorganisms. Cefaclor's effect is bactericidal, meaning it actively kills the bacteria, rather than simply inhibiting their growth. This is achieved by interfering with the integrity of the bacterial cell wall, a mechanism shared by other beta-Lactam antibiotics. Clinical evidence supports the efficacy and bactericidal nature of second-generation cephalosporins, affirming the drug's established therapeutic importance in treating susceptible bacteria.

Regulatory References

  1. National Library of Medicine

What side effects are possible with Cloracef?

Possible Side Effects and Safety Information

The safety profile of Cloracef is based on comprehensive data from regulatory authorities, classifying documented adverse reactions primarily by frequency and the body system affected. Understanding these categories is essential for recognizing the medicine's risk profile.


Adverse Reactions by Frequency and System-Organ Class

The most commonly reported side effects (Common) affect the Gastrointestinal system (such as diarrhea, nausea, and vomiting) and the Skin and subcutaneous tissue (such as morbilliform rash and pruritus). Uncommon reactions may include transient elevations of liver enzymes and blood abnormalities like eosinophilia.

Rare but documented reactions include significant blood disorders like neutropenia and a condition known as serum sickness-like reaction, which involves fever, rash, and joint pain. Neurotoxicity, including seizures and encephalopathy, has also been reported rarely, particularly in patients with kidney impairment or those receiving higher doses.


Serious Safety Considerations

Serious adverse reactions, though rare, are critical components of the safety profile. These include severe allergic responses such as anaphylactic shock and severe blistering skin reactions like Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (TEN). Severe pseudomembranous colitis and kidney inflammation (nephritis) have also been noted.

Safety Restrictions and Special Populations

Cloracef is formally contraindicated in individuals with a known history of hypersensitivity (allergic reaction) to any cephalosporin antibiotic or other components of the formulation. Caution is advised in patients with a history of penicillin allergy due to the potential for cross-reactivity. The medicine is contraindicated for use in infants under 1 month of age. Furthermore, caution is necessary when administering the drug to patients with markedly impaired renal function, as the risk of adverse events, including neurotoxicity, may be increased. Concurrent use with oral anticoagulants requires close laboratory monitoring due to the risk of an increased anticoagulant effect.

Overdose and Emergency Response

Overdose and When to Seek Help

The officially documented profile for a Cefaclor (Cloracef) overdose primarily outlines gastrointestinal and neurological manifestations, as defined in regulatory labeling. Typical overdose presentations include nausea, vomiting, diarrhea, and dose-related epigastric distress.

Serious or life-threatening outcomes involve the Central Nervous System (CNS). Regulatory sources note the risk of seizures, encephalopathy, and myoclonus, particularly linking these severe effects to patients with markedly impaired renal function and elderly patients who may have received excessive doses. Such CNS manifestations necessitate immediate intervention.

Required Emergency Actions

Immediate medical attention is required for any suspected overdose. The official regulatory guidance states that users must call emergency services immediately if the individual has collapsed, had a seizure, has trouble breathing, or can't be awakened. Furthermore, the poison control helpline should be contacted at once.

Supportive Management

Treatment is defined as symptomatic and supportive. There is no specific antidote known. For large ingestions (e.g., more than five times the normal daily dose), regulatory text describes procedures such as gastric lavage and the administration of activated charcoal to reduce absorption. Careful clinical observation and laboratory studies are necessary, and in certain cases, hemodialysis may be utilized to shorten the drug's serum half-life.

Therapeutic Uses of Cloracef

What Cloracef Treats: Main Uses and Benefits

Cloracef may be relevant for assisting with symptomatic distress across several common bacterial conditions. It is used to address the underlying bacterial cause of the illness, which provides support that helps ease the overall symptom burden and assists with maintaining functional stability.

This medication is applied across domains where additional symptomatic support is needed, including infections of the middle ear (otitis media), the upper and lower respiratory tracts (such as pharyngitis, tonsillitis, pneumonia, and bronchitis), the urinary tract, and uncomplicated skin structures. Cloracef helps address symptom clusters that may become intense or disruptive, such as pronounced physical discomfort, fever, localized swelling, and discomfort during urination.

It is commonly used when short-term symptomatic assistance is needed, such as during episodes of bacterial exacerbations of chronic conditions or acute onset of community-acquired disease. “The medication is applied to offer supportive relief that may help patients cope more steadily with symptom fluctuations.” This supportive approach contributes to easing the overall symptom load and supports general well-being during symptomatic phases.

Quick Fact: Support for Acute Discomfort
Primary Focus Symptoms related to inflammatory or irritative states
Main Benefit Supports maintenance of functional stability during acute episodes
Typical Context Conditions characterized by periods of heightened symptoms

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Cloracef eligibility is strictly defined by regulatory authorities based on allergy status, age, and pre-existing health conditions.

Absolute Prohibitions (Contraindicated)

The medicine must not be used by individuals with a known allergy to the cephalosporin class of antibiotics or to the active ingredient, Cefaclor. Use is also strictly contraindicated for infants under the age of one month because safety and effectiveness in neonates have not been established.

Established and Restricted Use

Use is established for the general adult population and for children age one month and older (capsule and suspension forms). However, the Extended-Release tablet is restricted to patients age 16 years and older.

Conditional Use (Caution Required)

Regulatory documents require that Cloracef be administered with caution in specific populations. This includes patients with a history of severe penicillin allergy due to the risk of cross-hypersensitivity. Caution is also necessary for those with markedly impaired renal function or a history of gastrointestinal disease, particularly colitis. Additionally, safety during pregnancy is not established, and caution is required during lactation due to drug excretion into breast milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Cloracef (Cefaclor) documents several interactions primarily affecting drug exposure, renal clearance, and pharmacodynamic outcomes. This information is based strictly on governmental prescribing labels and summaries.

Documented Interaction Patterns

Interacting Substance Official Interaction Description
Probenecid Reduces renal tubular secretion, resulting in increased and prolonged Cefaclor serum concentrations.
Warfarin (Oral anticoagulant) The anticoagulant effect may be enhanced, potentially increasing prothrombin time.
Aluminum/Magnesium Antacids Co-administration leads to diminished Cefaclor absorption and lower plasma levels. Timing separation is required: antacids must not be administered within 1 hour of Cefaclor.
Estrogen-containing Oral Contraceptives Co-administration may decrease contraceptive efficacy.
Aminoglycosides May lead to an increased risk of nephrotoxic effects.

Interactions with Laboratory Tests

Cefaclor is documented to interfere with specific laboratory tests. It may cause a false-positive reaction for glucose in the urine when copper sulfate solutions (such as Clinitest) are used. A positive direct Coombs’ test has also been reported during treatment.

Mechanism of Action

Cloracef is a selective inhibitor that acts primarily by targeting Farnesyl Pyrophosphate Synthase (FPPS) within bone-resorbing cells, specifically osteoclasts. The compound is internalized by the osteoclast via endocytosis and accumulates at the tissue site of high mineral turnover.

Once inside the cell, Cloracef's active metabolite interferes with the mevalonate pathway by binding directly to and inhibiting FPPS. This enzyme is critical for catalyzing the synthesis of farnesyl pyrophosphate (FPP) and geranylgeranyl pyrophosphate (GGPP), which are necessary intermediates.

The depletion of FPP and GGPP prevents the crucial prenylation of small signaling GTPases, such as Ras, Rho, and Rac. Since these GTPases cannot be prenylated, they cannot be anchored to the cell membrane. This lack of membrane attachment disrupts the downstream signaling cascades that govern the osteoclast's cytoskeletal organization, resulting in the failure of the ruffled border formation and subsequent loss of cellular adhesion to the bone surface. The physiological consequence of this intracellular cascade failure is a reduction in the rate of Ca^2+ mobilization and H^+ secretion.

Dosage and Administration Information

How Cloracef is Used: Official Administration Guidelines

Cloracef (Cefaclor) is administered orally and its usage is guided by the specific formulation to ensure correct absorption and therapeutic delivery.


Dosing and Frequency Patterns

The standard adult dose for the immediate-release forms (capsules, suspension) is typically 250 mg every eight hours (three times daily). This regimen may be increased up to 500 mg every eight hours for more severe clinical scenarios. In contrast, the extended-release tablets are administered on a twice-daily basis, with doses of 375 mg or 500 mg every 12 hours, depending on the intended use. The maximum total daily dose for adults should not exceed 4 grams.

Administration Conditions and Course Duration

Administration conditions depend on the dosage form. Immediate-release capsules and the oral suspension may be taken without regard to food, though food can delay the peak concentration. The extended-release tablets, however, must be taken with food to prevent a reduction in bioavailability. The extended-release tablets must be swallowed whole and not cut, crushed, or chewed.


Administration Constraint Application Principle
With Food Mandatory for Extended-Release Tablets
Swallow Whole Required for Extended-Release Tablets
Duration Minimum of 7 to 10 days (10 days for specific streptococcal infections)

Population-Specific Use

For pediatric patients, the dose is calculated based on body weight, typically ranging from 20 mg/kg/day to 40 mg/kg/day, divided and given every 8 or 12 hours, with a maximum daily dose of 1 gram. The labeling indicates that dose adjustments are generally not required for individuals with moderate to severe renal impairment.

Recent Clinical Evidence

Cloracef: Recent Clinical Evidence

Research involves Cloracef (cefaclor), a second-generation cephalosporin antibiotic. Studies have investigated this compound for infections caused by certain susceptible bacteria, including those affecting the respiratory tract, urinary tract, and skin.

Phase 3 Clinical Trial Findings

Early clinical experience involved numerous trials with thousands of adult and pediatric participants across various countries. These studies assessed the compound's use across several bacterial infection types, including otitis media, lower respiratory tract infections, and uncomplicated skin infections.

  • Observed Response Rates: Pooled data from earlier studies indicated high rates of favorable clinical responses in several key infection areas, with observed responses for lower respiratory tract infections and otitis media showing particular consistency.
  • Study Comparisons: Clinical trials have explored the safety and patient outcomes of Cloracef in comparison to other existing antibiotics, particularly in the context of acute bacterial exacerbations of chronic bronchitis (ABECB).

Pharmacologic Action

Cloracef is part of the beta-lactam class of antibiotics. Its mechanism of action involves inhibiting the bacteria's ability to build and maintain their cell walls, which leads to the death of the susceptible bacterial cell. This effect is targeted at certain Gram-positive and Gram-negative bacteria.

Other Investigational Uses

Research has also explored the compound's use in specialized areas, such as:

  • Prophylactic Use: Studies have investigated the use of Cloracef as part of a preventive oral antibiotic regimen, particularly to help prevent secondary bacterial infections following specific surgical procedures.
  • Allergy Testing: The compound has been included in clinical trials designed to refine the diagnostic approach for testing cephalosporin allergies and cross-reactivity with other related antibiotics.

Key Studies & References

  1. Cefaclor Capsules USP - FDA Labeling
  2. Clinical Policy: Infectious Disease Agents: Antibiotics - Cephalosporins (Authoritative Clinical Guideline/Policy)

Frequently Asked Questions (FAQ)

Common questions about Cloracef (FAQ)


Q: Does Cloracef make you feel tired or sleepy?

According to official regulatory documents, fatigue and drowsiness (somnolence) are rarely reported side effects associated with Cloracef (Cefaclor). Other central nervous system effects, such as nervousness and dizziness, have also been reported rarely in the product information.


Q: Can children take Cloracef, and is there a liquid form?

Official prescribing information states that Cefaclor is indicated for use in children aged one month and older. The medication is available in an oral dosage form of a powder for suspension, which is mixed to create a liquid that can be easily administered.


Q: Can older adults take Cloracef without special concerns?

Caution is generally advised for older adults, particularly if they have underlying conditions such as severe kidney impairment or pre-existing central nervous system disorders. The labeling indicates that caution is necessary in these patient groups due to the potential for increased risk of adverse neurological events.


Q: Does Cloracef affect liver function or blood tests?

Official information indicates that Cloracef can cause transient elevations in liver enzymes (like AST and ALT), which have been reported as uncommon reactions. It is also known to interfere with certain laboratory tests, potentially causing a false-positive reaction for glucose in the urine or a positive direct Coombs’ test.


Q: Can someone with kidney problems take Cloracef?

Official labeling notes that dose adjustments are generally not required for moderate to severe renal impairment. However, caution is necessary, particularly with markedly impaired renal function, due to the potential for increased risk of adverse events like neurotoxicity (effects on the nervous system).


Q: Will Cloracef affect the effectiveness of birth control pills?

Regulatory documents indicate that when Cloracef is taken alongside estrogen-containing oral contraceptives, there is a potential for decreased contraceptive efficacy.


Q: How should Cloracef be stored once I open the bottle/package?

The dry powder for suspension must be stored in its tightly closed container at room temperature before mixing. Once mixed into a liquid, the suspension must be refrigerated and the remaining liquid must be discarded after 14 days of refrigeration.


Q: Can Cloracef cause yeast infections?

Yes, official safety data confirms that yeast infections (such as vaginal moniliasis or vaginitis) have been reported as a side effect. This may be due to the fact that antibiotics can disrupt the body's natural balance of microbial flora.


Q: Is it possible to develop resistance to Cloracef over time?

To reduce the development of drug-resistant bacteria, official guidelines state that Cloracef should only be used to treat infections proven or strongly suspected to be caused by bacteria. Antibiotics, in general, carry a risk of bacteria becoming resistant.


Q: How often do people report serious side effects from Cloracef?

Regulatory documents categorize adverse reactions by frequency. Common side effects occur in 1% to 10% of patients, while serious reactions, such as anaphylaxis (a severe allergic reaction), are categorized as rare (less than 0.1% of patients).


Q: Is Cloracef safe for women who are breastfeeding?

Cefaclor, the active ingredient, is known to be excreted into human milk in small amounts. Official labeling notes that caution is required when the medicine is administered to a woman who is breastfeeding.


Q: Is Cloracef related to other 'cefa' or 'ceph' antibiotics?

Yes, Cloracef belongs to the cephalosporin class of antibiotics. This classification is the reason why many drug names in this family, including Cefaclor, share the 'cef' or 'ceph' prefix.


Q: What happens if you miss a dose of Cloracef?

Official patient information generally addresses missed doses by instructing the patient to take the dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, the recommendation is usually to continue with the regular schedule and not double the dose.


Q: What kind of research has been done on Cloracef for ear infections?

Official labeling confirms that Cloracef is an indicated treatment for otitis media (middle ear infections). It is used to target infections caused by specific types of susceptible bacteria, such as H. influenzae and S. pneumoniae.


Q: Can Cloracef cause dizziness or lightheadedness?

Yes, official safety reporting includes dizziness and lightheadedness as side effects. Although they are documented, these effects are reported rarely by patients taking the medication.


Q: What should I do if the side effects from Cloracef seem worse than my original illness?

Official warnings state that the drug should be discontinued immediately if a severe allergic reaction occurs. For other serious or concerning side effects, reporting them to a healthcare professional is generally required.


Q: How does Cloracef target and kill bacteria?

Cloracef is a beta-lactam antibiotic that is bactericidal (actively kills bacteria). It works by inhibiting the ability of susceptible bacteria to build and maintain their protective cell walls, which results in the death of the bacteria.


Q: Is Cloracef used to prevent infections in certain situations?

Cloracef is primarily intended to treat existing infections. Regulatory documents state that its use should be reserved for treating infections that are proven or strongly suspected to be bacterial, rather than for general prevention.


Q: Are there any known studies on Cloracef use during pregnancy?

Cloracef is classified as FDA Pregnancy Category B. While animal reproduction studies have failed to demonstrate a risk to the fetus, official documents state that there are no adequate and well-controlled studies of Cefaclor in pregnant women.


Q: What are the general contraindications for taking Cloracef?

The medication is contraindicated for use in individuals with a known history of hypersensitivity (allergic reaction) to any drug in the cephalosporin class of antibiotics or to the active ingredient Cefaclor.


Q: Can Cloracef be taken with antacids or heartburn medication?

Regulatory labeling specifies that antacids containing aluminum or magnesium must not be administered within one hour of a Cloracef dose. This separation is necessary because these antacids can reduce the amount of the antibiotic absorbed.


Q: What is the reason some people develop diarrhea after taking Cloracef?

Diarrhea is a common side effect of Cloracef because antibiotics can disrupt the natural balance of bacteria in the colon. This change in flora can, in rare cases, lead to the overgrowth of certain organisms, such as Clostridium difficile.


Q: Do researchers know exactly how Cloracef affects the body's natural flora?

Official warnings acknowledge that treatment with antibacterial agents alters the normal bacterial flora of the colon. This change is cited as a cause of certain issues, such as C. difficile-associated diarrhea (CDAD).


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

Cloracef is classified as a second-generation cephalosporin antibiotic. This means it has a defined spectrum of activity that targets a variety of both Gram-positive and Gram-negative bacteria.


Q: What scientific evidence supports the use of Cloracef for UTIs?

Cloracef is officially indicated for the treatment of urinary tract infections (UTIs), including both cystitis and pyelonephritis. This use is supported by its efficacy against susceptible common UTI-causing bacteria, such as E. coli.


Q: Are there any required monitoring tests while taking Cloracef?

If Cloracef is used concurrently with oral anticoagulants (blood thinners like Warfarin), official labeling notes that close laboratory monitoring is required due to the potential for an enhanced anticoagulant effect.


Q: How should I dispose of unused Cloracef?

Disposal of unused product should be carried out in accordance with local regulations or established drug take-back programs. If a program is unavailable, instructions often recommend mixing the unused product with an undesirable substance, sealing it, and discarding it with household trash.

How should Cloracef be stored and disposed of?

Storage and Disposal of Cefaclor (Cloracef)

Official storage conditions vary depending on the product's state. The dry powder for oral suspension must be stored at controlled room temperature, between 15 C and 30 C (59 F and 86 F), in its tightly closed original container. Once reconstituted, the liquid suspension must be stored in a refrigerator and must not be frozen.

Product State Storage Requirement
Dry Powder Controlled Room Temperature (15 C-30 C)
Mixed Suspension Refrigerated (Do Not Freeze)

Storage of the mixed suspension is limited to 14 days under refrigeration, after which any unused portion must be discarded. The medication must be kept out of the reach of children. Disposal of the unused product should follow local regulations.

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

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