Soficlor

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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 Soficlor

Quick Facts

Property Description
Active ingredient Cefaclor
Form Capsule, Tablet, Oral Suspension
Pharmacological class Second-Generation Cephalosporin Antibiotic
General purpose Resolving bacterial infections
Origin Semisynthetic

What Type of Medicine is Soficlor?

Soficlor is a pharmaceutical product containing the active ingredient Cefaclor, a substance fundamentally classified as an antibiotic. It belongs to the cephalosporin family of antibacterial agents, specifically recognized as a second-generation cephalosporin. Cefaclor is categorized as a semisynthetic compound, meaning its molecular structure is chemically derived from natural precursors for optimized stability and absorption. The cephalosporin classification confirms a beta-lactam structure that is essential for its antibacterial function. The classification as a second-generation agent is clinically recognized to provide a broader spectrum of activity than many first-generation counterparts, making it a reliable option for fighting a typical range of susceptible bacterial infections.


Composition and Available Forms of Cefaclor

The medicine is a single active ingredient product, typically containing Cefaclor monohydrate. This active substance is combined with pharmaceutical excipients to create preparations suitable for oral administration. Soficlor is commercially available in several standard dosage forms, including the traditional solid capsule and tablet formats. A differentiating factor for Cefaclor is its availability as a powder for oral suspension, a form pharmacologically supported for its rapid dissolution and suitability for patient groups, such as children, who require precise liquid dosing. The use of an oral suspension is a key feature when treating a common scenario like pediatric infections.


General Purpose of Soficlor

The general purpose of Soficlor is to address health issues caused by susceptible bacterial infections. Cefaclor functions as a bactericidal agent, meaning its primary mechanism is to actively eliminate bacteria rather than merely inhibiting their growth. This is achieved by directly interfering with the final stage of bacterial cell wall synthesis, a process critical for the microorganism's structural integrity. This decisive mechanism of action provides the overall therapeutic benefit of resolving infections caused by sensitive bacterial strains, establishing Cefaclor as a standard agent in the therapeutic class.

What side effects are possible with Soficlor?

Possible side effects and safety information

The safety profile of Soficlor, which contains the active ingredient Cefaclor, is formally documented by regulatory authorities based on classification by frequency and the organ systems affected. Adverse reactions are grouped by System-Organ-Classes, encompassing major systems such as the Gastrointestinal tract, the Skin and subcutaneous tissue, and the Immune system.


Frequency and System-Organ Classifications

The most frequently reported adverse reactions are classified as Common and typically involve the gastrointestinal system, primarily diarrhea. Other common reactions include skin effects such as rash, and the blood disorder eosinophilia. Less frequent, or Uncommon, effects may include nausea, vomiting, and colitis.


Serious Adverse Reactions and Safety Constraints

Official labeling documents the potential for rare but serious adverse reactions, which include acute anaphylaxis, a severe immune response. Other critical events include severe skin conditions like Stevens-Johnson syndrome and certain serious blood disorders. The label also notes the risk of Clostridioides difficile-associated diarrhea (CDAD), a form of severe colitis that can occur during or following antibacterial therapy.

Soficlor is officially contraindicated in individuals with known hypersensitivity to Cefaclor or to any other cephalosporin antibiotic. A key safety consideration is the documented risk of cross-hypersensitivity in patients with a history of penicillin allergy. Use is also noted for caution in individuals with markedly impaired renal function.

Overdose and Emergency Response

An overdose of Soficlor (Cefaclor) is primarily associated with gastrointestinal toxic symptoms as documented in regulatory information. These manifestations commonly include nausea, vomiting, diarrhea, and epigastric distress (stomach pain). Official labeling notes that the severity of the gastrointestinal symptoms is related to the dose ingested.

Immediate medical attention must be sought, and emergency services should be called immediately if specific life-threatening clinical signs are present. These mandated emergency triggers include collapse, trouble breathing, the occurrence of a seizure (convulsions), or a state of being unarousable (unconsciousness).

The official management approach is symptomatic and supportive therapy, as no specific antidote is known for Cefaclor overdose. Officially described supportive procedures may include the administration of activated charcoal to potentially decrease absorption or gastric lavage (stomach emptying), the latter being typically reserved for ingestion of very large quantities. Regulatory documents also note that procedures such as hemodialysis and peritoneal dialysis have not been demonstrated to be beneficial in these situations. Furthermore, a caution is noted that the risk of neurotoxicity and seizures may be increased in patients with pre-existing renal impairment.

Therapeutic Uses of Soficlor

What Soficlor Treats: Main Uses and Benefits

Soficlor is commonly used to address conditions presenting with systemic or localized discomfort. This medication is applied across domains where additional symptomatic support is needed, primarily addressing lower and upper respiratory tract infections (such as pneumonia and bronchitis), ear, nose, and throat issues (including otitis media and pharyngitis), as well as uncomplicated urinary tract and skin structure infections.

The therapeutic benefit is the improvement of the condition, which helps manage symptom clusters that may become intense or disruptive, such as fever, sore throat, ear pain, and localized swelling. This supports the patient during difficult episodes by easing distress and assists with maintaining functional stability.

“The medication is commonly used to help address conditions presenting with systemic or localized discomfort.”

The support is relevant in contexts involving heightened systemic burden, particularly in pediatric scenarios or conditions where symptoms may intensify temporarily in adults.

Quick Fact: Symptom Management
Soficlor is relevant for conditions presenting with acute episodes and helps maintain a sense of stability when symptoms are more noticeable.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Soficlor — official regulatory information

Category Official Regulatory Status (Based on Labeling)
Populations for whom use is allowed Adults and Children (aged 1 month and older). Older Adults with normal renal function.
Populations for whom use is contraindicated Patients with a known major allergy or hypersensitivity to Cefaclor or any other cephalosporin antibiotic. Patients with a history of severe, immediate-type reactions to penicillin. Infants under 1 month of age.
Condition-specific eligibility rules Use in markedly impaired renal function requires caution. Use in patients with a history of gastrointestinal disease, particularly colitis, is conditional and requires caution.
Pregnancy and lactation eligibility status Classified as Pregnancy Category B by the US FDA. Use during pregnancy is recommended only if clearly needed. Small amounts are detected in human milk, and caution should be exercised while breastfeeding.
Age-related eligibility rules Safety and effectiveness are not established for infants less than one month of age. The extended-release (ER) tablet formulation is not established for use in children younger than 16 years of age.

Connection to the overall eligibility profile:

Regulatory documents define who can and cannot use the medicine by establishing explicit contraindications based on hypersensitivity and setting a minimum age threshold for established use. For other groups, such as those with markedly impaired renal function or a history of colitis, the label mandates that the medicine be used with caution, thereby classifying the permissible use as conditional rather than standard.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Soficlor (Cefaclor) defines specific interaction patterns that affect its systemic exposure and the action of co-administered medications, without listing any combinations as strictly contraindicated based on interaction risk.


Drug–Drug Interactions

Co-administration with Probenecid results in a pharmacokinetic interaction where the drug's plasma levels are increased. This occurs because Probenecid inhibits the renal tubular secretion of Cefaclor, leading to a prolonged elimination half-life and higher systemic exposure. A pharmacodynamic interaction is also documented with oral anticoagulants, such as Warfarin, where regulatory documents note rare reports of an increased prothrombin time (INR) with or without clinical bleeding.


Administration-Timing and Product Interactions

The absorption of the extended-release tablet formulation is sensitive to administration timing and specific co-administered products. The extent of absorption is diminished if antacids containing magnesium or aluminum hydroxide are taken within one hour of the extended-release tablet. Therefore, a mandatory separation of administration time is required for this combination. Conversely, the absorption of the extended-release formulation is enhanced when the product is administered with food or shortly after a meal. No formal interaction with alcohol or common herbal products is explicitly documented in the official prescribing information.

Mechanism of Action

How Soficlor Works

Targeting Essential Bacterial Cell Wall Assembly

The primary action of Soficlor (Cefaclor) is purely bactericidal, meaning its mechanism is dedicated to actively killing susceptible bacteria rather than simply stopping their growth. This is achieved by targeting a specific set of enzymes called Penicillin-Binding Proteins (PBPs), which are vital for the assembly of the bacterial cell wall. The drug forms a covalent bond with these enzymes, resulting in the irreversible inhibition of the final step in the cross-linking of the protective peptidoglycan layer. This molecular interference leads to the structural collapse of the bacterial cell.

Initiating the Bactericidal Lysis Cascade

The consequence of blocking cell wall construction is the failure of the bacterial cell to maintain its structural support against internal pressure. This defect triggers a lysis cascade: the intense internal osmotic pressure cannot be contained, leading to the activation of the cell’s own autolytic enzymes. This cascade culminates in the rupture and death (lysis) of the bacterial cell, which is the key physiological effect resulting in microbial clearance. The combined effects of inhibiting structural synthesis and forcing cell lysis lead to a bactericidal consequence.

Mechanistic Constraints by PBP Modification

The mechanism's effectiveness is constrained by the bacteria's biological defenses, such as the production of beta-lactamase enzymes, which can chemically neutralize the Cefaclor molecule before it reaches its target. Furthermore, bacteria can resist the drug by modifying the structure of their PBPs, making the molecular target less receptive to Cefaclor's binding, functionally preventing the initiation of the bactericidal effect.

Dosage and Administration Information

How Soficlor is Administered

Soficlor, which contains Cefaclor, is approved exclusively for oral administration. The medicine is supplied in various forms, including immediate-release capsules, tablets, and a powder for oral suspension. To ensure the proper delivery of the active ingredient, all solid forms, including standard and extended-release tablets, must be swallowed whole and must not be crushed, cut, or chewed. The oral suspension requires reconstitution and must be shaken well prior to measuring each dose.


Official Dosing and Regimen Principles

Standard adult regimens for immediate-release formulations typically involve a dose of 250 mg taken every 8 hours (three times daily). For more severe infections, the dose may be increased, though the maximum recommended total daily intake is 4 grams. For specific uses, the total daily amount may be divided into a twice-daily schedule (every 12 hours).

Contextual Use Patterns:

Instruction Detail
Duration of Course Treatment for infections caused by beta-haemolytic streptococci requires a minimum of 10 days.
Timing with Food Immediate-release forms are taken with or without food, but extended-release tablets should be administered with a meal.
Pediatric Dosing Pediatric dosage is calculated based on body weight, typically ranging from 20 mg/kg/day to 40 mg/kg/day, divided over the day.

If a dose is missed, the standard approach is to take it as soon as possible, unless it is nearly time for the next scheduled dose, in which case the missed dose should be skipped to maintain the schedule.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Soficlor

This summary details the clinical research supporting Soficlor (Cefaclor), focusing on the types of studies conducted, the outcomes measured, and areas where evidence remains uncertain.


Evidence for Approved Indications

Research exploring Soficlor's use for common infections—including otitis media, pharyngitis, tonsillitis, uncomplicated urinary tract infections (UTIs), and Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB)—is primarily based on Randomized Controlled Trials (RCTs) and multicenter clinical data submitted to health authorities. Studies in these areas typically focus on adult and pediatric patients.

Investigators examine outcomes related to the overall clinical status of the infection and the microbiologic status (documented presence or absence of specific bacteria) at the infection site. Findings describe patterns observed during short-term study periods, where clinical response was measured against the documented resolution of symptoms such as pain or fever.


Research on Specialized Uses and Limitations

Soficlor was studied for certain highly specialized uses, such as in research exploring prophylaxis to affect the incidence of cholangitis in pediatric patients who have undergone specific liver surgery. The evidence base for prophylactic research in this scenario remains heterogeneous, with findings mixed across different studies.

A key research limitation is that the majority of studies have limited follow-up durations, focusing on short-term outcomes immediately after treatment. Furthermore, data remain insufficient for research exploring certain specialized outcomes, such as rheumatic fever. Research is ongoing regarding the documented status against increasingly resistant bacterial strains, and comparative evidence against some newer antibiotic agents is still emerging.

Frequently Asked Questions (FAQ)

Common questions about Soficlor (FAQ)

Q: Are there any major side effects I should know about before taking Soficlor?

Official product information describes adverse reactions by frequency and organ system. The most common reactions are typically related to the digestive system, such as diarrhea, and certain skin effects like a rash.

Regulatory documents also note the potential for rare, but serious, reactions, including severe allergic responses like anaphylaxis and major skin conditions.

Q: Is it normal to feel tired when starting Soficlor?

Tiredness or somnolence (sleepiness) is mentioned in official documentation as a potential effect.

For the immediate-release form, it is classified as a rare event, and for the extended-release tablet, it is listed as an uncommon effect.

Q: Does Soficlor interact with alcohol?

According to the official prescribing information, there is no formal drug-alcohol interaction explicitly documented for Soficlor.

Q: Can Soficlor cause headaches?

Yes, official regulatory data lists headache as a common side effect associated with certain formulations of the medicine, such as the extended-release and modified-release tablets.

Q: Is Soficlor generally safe for older adults?

Official documents state that the adult population, including older adults, is included in the established use. However, official information notes that use is conditional on the patient having normal kidney function.

Caution is advised if there is markedly impaired renal (kidney) function.

Q: Has Soficlor been studied in children or teenagers?

Clinical research has included both adult and pediatric patients. Official documentation confirms that the safety and effectiveness are not established for infants younger than one month of age.

Furthermore, the extended-release tablet formulation is not established for use in children under 16 years old.

Q: What happens if you stop taking Soficlor suddenly?

Regulatory guidelines specify that the duration of treatment should follow the regimen prescribed by a healthcare professional.

For example, treatment for infections caused by beta-haemolytic streptococci includes a minimum recommended course of 10 days.

Q: What specific drugs are listed as interacting with Soficlor?

Official prescribing information highlights interactions with two main types of drugs. When taken with Probenecid, Soficlor's concentration in the blood may increase.

There is also a documented interaction with oral anticoagulants, such as Warfarin, which may result in an increase in prothrombin time.

Q: What makes Soficlor different from other drugs in its class?

Soficlor contains Cefaclor, which is chemically classified as a second-generation cephalosporin antibiotic.

This classification is generally associated with having a broader spectrum of activity against certain types of susceptible bacteria when compared to some first-generation agents in the same class.

Q: Is Soficlor safe for individuals with heart conditions?

Regulatory information for the extended-release formulation notes uncommon effects that include cardiovascular events, such as chest pain, palpitation, or congestive heart failure. These are documented in the list of possible effects.

Q: Are there any specific safety classification details for Soficlor?

Soficlor is classified as Pregnancy Category B. The official label outlines key safety warnings, including a contraindication for individuals with hypersensitivity to cephalosporins and a documented risk of cross-hypersensitivity with penicillin.

It also notes the potential risk of Clostridioides difficile-associated diarrhea (CDAD).

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

Official pharmacokinetic data indicates how quickly the drug reaches its highest concentration in the bloodstream. Average peak concentrations of Soficlor are generally achieved within 30 to 60 minutes after administration to fasting individuals.

Q: Does Soficlor affect birth control pills?

Official regulatory themes related to antibiotic-oral contraceptive interactions note that Cefaclor may reduce the effectiveness of oral contraceptives containing ethinyl estradiol in some individuals.

Q: What is the risk of having an allergic reaction to Soficlor?

Regulatory documentation highlights that the most significant risk factor for an allergic reaction is a known history of penicillin allergy.

This is due to the documented potential for cross-hypersensitivity reactions within the beta-lactam antibiotic class.

Q: Is Soficlor a controlled substance?

Soficlor contains Cefaclor, which is classified as a prescription antibiotic. It is not scheduled as a controlled substance by government authorities.

Q: How long do people usually stay on Soficlor treatment?

The total duration of treatment is guided by the type and severity of the infection being addressed.

General courses often range from 7 to 10 days, but treatment for infections caused by certain bacteria, like beta-haemolytic streptococci, requires a minimum of 10 days.

Q: Does taking Soficlor change anything about my lab test results?

Official information indicates that Soficlor can interfere with certain laboratory tests. It may cause a false-positive result in tests for glucose in the urine that use specific solutions (Benedict's or Fehling's).

The medicine can also cause a positive direct Coombs' test.

Q: Are there any long-term effects associated with Soficlor use?

The official label notes that prolonged use of the medicine is associated with a risk of superinfection, meaning the overgrowth of bacteria or fungi that are not susceptible to the drug.

This is a condition that requires careful clinical observation.

Q: Are generic versions of Soficlor available?

Yes, the active ingredient in Soficlor, Cefaclor, is available in generic form.

Q: Is it safe to drive while taking Soficlor?

According to official regulatory information, Cefaclor is generally not expected to affect a person's ability to drive or operate machinery.

Q: How quickly does Soficlor leave the body?

Official pharmacokinetic data describes how quickly the drug is processed by the body. The serum half-life of the drug in healthy individuals is documented as being approximately 0.6 to 0.9 hours.

Q: What happens if a user takes too much Soficlor?

Regulatory documents describe the documented symptoms associated with overdose as typically non-specific. These generally include digestive issues such as nausea, vomiting, diarrhea, and general gastric upsets.

Q: Are there any requirements for taking Soficlor, like getting regular blood tests?

Regulatory documents state that during prolonged treatment or if an individual has markedly impaired renal (kidney) function, careful clinical observation and laboratory studies may be required.

This can include monitoring hematological status (blood tests).

Q: Is Soficlor available over the counter?

Soficlor contains Cefaclor, which is classified as a prescription-only medication. It is not available for purchase without a prescription.

Q: Why do official documents restrict Soficlor use for certain groups?

Official regulatory documents establish restrictions based on factors like known contraindications, such as a major allergy to cephalosporins.

They also mandate caution for certain conditions, including significantly impaired kidney function or a history of colitis, to help ensure appropriate use.

Q: Does Soficlor interact with herbal remedies?

The official prescribing information does not explicitly document a formal interaction between Soficlor and common herbal products.

Q: How is Soficlor typically supplied (e.g., tablet, liquid)?

Soficlor is commercially available in several standard dosage forms for oral use. These typically include capsules, standard or extended-release tablets, and a powder that is mixed to create an oral suspension (liquid form).

Q: What should I do if I experience a rare but serious side effect from Soficlor?

Regulatory information advises that, in the event of a severe allergic reaction, discontinuation of the drug is recommended.

Serious acute hypersensitivity reactions may require emergency medical treatment, such as the administration of intravenous fluids, oxygen, and other measures.

Q: Is Soficlor an FDA-approved drug?

Yes, the active ingredient in Soficlor, Cefaclor, has been approved by major regulatory bodies, including the U.S. Food and Drug Administration (FDA), for the conditions it is intended to treat.

How should Soficlor be stored and disposed of?

How to Store and Dispose of Soficlor?

The official storage requirements for Soficlor (Cefaclor) vary based on the medication's form, and strict adherence is required to maintain stability and effectiveness.

Product Form Storage Requirement Stability Period
Capsules/Tablets Store at Controlled Room Temperature (15 C to 30 C), protected from moisture and excessive heat. Until Expiration Date
Oral Suspension (Reconstituted) Store immediately in a refrigerator (2 C to 8 C) and avoid freezing. Must be discarded after 14 days

All forms of the medicine must be kept in the original container, tightly closed, and secured out of the sight and reach of children. When disposing of Soficlor, do not flush it down a toilet or pour it down a drain unless specifically instructed to do so. Unused or expired medication should be disposed of through a medicine take-back program or by mixing it with an undesirable substance, sealing it in a bag, and placing it in the trash.

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

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