Cefaclor STADA

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Cefaclor STADA

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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 Cefaclor STADA

Quick Facts

Property Description
Active Ingredient Cefaclor
Form Capsules, Tablets, Oral Suspension
Pharmacological Class Second-generation Cephalosporin, beta-Lactam Antibiotic
General Purpose Systemic Anti-infective / Antibiotic
Origin Semi-synthetic compound

What Type of Medicine is Cefaclor STADA?

Cefaclor STADA is a prescription antibiotic and an antimicrobial agent used to eliminate susceptible bacteria in the body. Its active ingredient is Cefaclor, a compound belonging to the family of beta-Lactam antibiotics, specifically classified as a second-generation cephalosporin.


This medication is defined as a semi-synthetic compound because Cefaclor is chemically derived from the structure of Cephalosporin C, establishing its placement within the cephalosporin chemical group. The product is manufactured and distributed by STADA Arzneimittel AG, which identifies this specific brand presentation. Cefaclor is recognized as a systemic anti-infective, used in managing bacterial infections where pathogen elimination is required.

Cefaclor Composition and Available Forms

The medication is a single-ingredient product, meaning Cefaclor is the only active ingredient providing the therapeutic effect. It is designed for oral administration and is categorized as a prescription-only medicine.


Cefaclor is prepared for consumption in various dosage forms, which include capsules, tablets, and granules for oral suspension. This variety in form allows for different administration methods; for example, the liquid suspension provides a non-solid option for specific patient groups, such as children. These different forms contain the same essential component, ensuring that the anti-infective reaches the gastrointestinal system for absorption and subsequent systemic distribution throughout the body.

General Purpose of Cefaclor as an Antimicrobial Agent

The primary function of Cefaclor is to act as a bactericidal agent, meaning it achieves its purpose by killing susceptible bacteria rather than inhibiting their growth. The fundamental role of the drug is to combat proliferating bacteria and help address the underlying cause of an infection.

Regulatory References

  1. second-generation cephalosporin
  2. eta-Lactam antibiotic

What side effects are possible with Cefaclor STADA?

Possible Side Effects and Safety Information

Cefaclor's safety profile, established in regulatory documents, outlines adverse reactions categorized by frequency and the body system affected. Common effects, reported in up to 1 in 10 patients, primarily involve the Gastrointestinal System and include diarrhoea, nausea, vomiting, and headache. Skin reactions such as morbilliform eruptions are also classified as common.


Regulatory Safety Classifications

Adverse effects are formally grouped by the system-organ class involved:

  • Gastrointestinal Disorders: Include diarrhoea, colitis (including pseudomembranous colitis), nausea, and vomiting.
  • Immune System Disorders: Hypersensitivity reactions range from uncommon effects like urticaria to rare, serious reactions.
  • Blood and Lymphatic System Disorders: Rare effects may include changes in blood counts, such as leucopenia, thrombocytopenia, and eosinophilia.
  • Nervous System Disorders: Rare effects include seizures and symptoms of hyperactivity or confusion.

Serious Adverse Reactions and Risk Context

Rare but serious adverse reactions are documented, including potentially life-threatening conditions such as Anaphylaxis, Stevens-Johnson Syndrome (SJS), and severe Pseudomembranous Colitis. The official profile notes a risk of cross-hypersensitivity in patients with known penicillin sensitivity, a characteristic shared across the beta-lactam class of antibiotics.

Regarding specific populations, serum sickness-like reactions have been reported more frequently in pediatric patients. Furthermore, caution is noted for patients with severe renal impairment due to the potential for neurotoxicity. The risk of super-infection is associated with the prolonged use of this anti-infective agent.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented clinical manifestations and required emergency actions for Cefaclor overdose, strictly according to government regulatory labeling.

Documented Overdose Manifestations

Acute overdose may present with common gastrointestinal disturbances, including nausea, vomiting, diarrhea, and epigastric distress (stomach discomfort). In cases of massive ingestion, the official labeling documents the potential for more severe Central Nervous System (CNS) effects, such as reversible neurotoxicity and the occurrence of convulsions (seizures).

Required Emergency Actions

Immediate medical attention is required for anyone who has ingested more than the prescribed amount. Contact emergency services without delay if severe symptoms, such as the onset of convulsions, are observed. Management of Cefaclor overdose is symptomatic and supportive, as no specific antidote is known.

Officially described supportive measures, managed by healthcare professionals, may include gastric lavage or the administration of activated charcoal to limit absorption. Close clinical observation and laboratory monitoring, particularly of renal function, are required.

Population-Specific Consideration

Regulatory documents indicate that patients with impaired renal function are at an increased risk for more severe CNS effects due to reduced clearance of the drug, which can lead to higher circulating concentrations.

Therapeutic Uses of Cefaclor STADA

Main Uses and Benefits of Cefaclor STADA

Cefaclor STADA is commonly used across therapeutic domains where additional symptomatic support is needed to address conditions presenting with systemic or localized discomfort. These uses are relevant in clinical settings involving acute or disruptive symptom patterns, such as those caused by infections of the upper and lower respiratory tract, skin and soft tissues, and the urinary tract.

This medication is applied in scenarios where symptoms create noticeable physiological strain, which may assist with coping more steadily with fever, pain, and inflammation.

The medicine is generally used to help with conditions presenting with systemic or localized discomfort, including infections such as otitis media, pharyngitis, tonsillitis, pneumonia, bronchitis, and cystitis.

The therapeutic benefit is focused on symptomatic relief during acute episodes. It may assist with maintaining functional stability and contributes to easing the overall symptom load.

“It supports patients during difficult episodes by easing the distress caused by acute inflammation and systemic symptoms.”


Quick Fact: Supportive Relief for Acute Discomfort Cefaclor STADA is generally applied when symptoms, such as pain, fever, and localized swelling, become temporarily overwhelming; it provides supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. Cefaclor Label from DailyMed

Eligibility and Restrictions for Use

Cefaclor STADA is an antibiotic used to treat susceptible bacterial infections, and its use is strictly determined by eligibility criteria documented in official regulatory labeling.

Contraindications and Exclusion Criteria

The primary absolute exclusion for using this medicine is a known hypersensitivity or allergy to the cephalosporin class of antibiotics. Individuals with this documented allergy must not take Cefaclor STADA.

Caution is strongly advised for patients with a documented history of penicillin allergy due to a known risk of cross-hypersensitivity reactions among beta-lactam antibiotics.

Age and Condition-Based Restrictions

  • Age: The safety and effectiveness of the immediate-release forms are not established for infants under one month of age. For the extended-release formulation, safety and efficacy are not established in children younger than 16 years of age.
  • Renal Function: The drug should be administered with caution to individuals with markedly impaired renal function, as dose adjustments may be necessary to prevent toxicity.
  • Other Conditions: Caution is also recommended for patients with a history of gastrointestinal disease, particularly colitis.

Pregnancy and Lactation

Regulatory documents classify this medicine under Pregnancy Category B. It should be used during pregnancy only if clearly needed. Cefaclor is present in breast milk; caution should be exercised when administered to a nursing woman.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official Regulatory Interaction Profile

Cefaclor's interaction profile is defined by specific pharmacokinetic and pharmacodynamic outcomes, strictly as documented in official government regulatory information.

Co-administration with Probenecid increases and prolongs Cefaclor plasma concentrations. This pharmacokinetic effect is due to the inhibition of Cefaclor's renal tubular secretion, which ultimately reduces the drug's clearance from the body.

Pharmacodynamic interactions require caution with several medicine classes. Concurrent use with Oral Anticoagulants (e.g., Warfarin) may potentiate the anticoagulant effect and is associated with an increased risk of bleeding. This is generally attributed to the potential for interference with intestinal Vitamin K production. Similarly, combining Cefaclor with Aminoglycoside Antibiotics (e.g., Gentamicin) increases the risk of nephrotoxicity.

Cefaclor may decrease the effectiveness of Oral Hormonal Contraceptives by potentially altering intestinal flora. Additionally, the anti-infective activity may decrease the therapeutic efficacy of Live Bacterial Vaccines (e.g., Typhoid vaccine).

Timing and Substance Constraints

The absorption of Cefaclor Extended-Release (ER) tablets is impacted by specific substances. Aluminum- and Magnesium-Containing Antacids decrease the absorption of the ER formulation. Therefore, administration of these antacids must be separated by at least 1 hour from Cefaclor ER tablets.

Mechanism of Action

The action of Cefaclor is entirely focused on the structural integrity of susceptible bacteria, functioning as a bactericidal agent.

Irreversible Inactivation of Cell Wall Enzymes

This domain covers the primary biological target and molecular interaction. Cefaclor acts by inhibiting bacterial Penicillin-binding proteins (PBPs)—essential enzymes required for building the bacterial cell wall. By binding covalently and irreversibly to these targets, Cefaclor permanently blocks the cross-linking (transpeptidation) of the peptidoglycan layer. This action initiates the cascade that leads to the lysis of the bacterial cell.

Mechanistic Cascade and Cell Lysis

This domain addresses the resulting physiological consequence of the molecular inhibition. The failure to construct a rigid, functional wall makes the bacterial cell unable to withstand its own internal osmotic pressure. This structural compromise results in the activation of the bacterial cell's own self-degrading enzymes and ultimately causes the cell to rupture (lysis), leading directly to the bactericidal consequence.

️ Biological Constraints on Mechanistic Effectiveness

This domain defines the conditions under which the drug's mechanism is weakened. The effectiveness of Cefaclor is constrained if bacteria produce beta-lactamase enzymes that chemically destroy the drug's active structure, or if they possess modified PBPs that reduce the drug's binding affinity. These factors mechanistically constrain the drug's effectiveness at the molecular target.

Dosage and Administration Information

Administration Route and Standard Dosing

Cefaclor STADA is defined as an oral anti-infective, administered via the mouth regardless of its specific dosage form, which includes capsules, tablets, and oral suspension. The typical adult dose for immediate-release (IR) forms begins at 250 mg taken every 8 hours (three times daily), though regimens may be adjusted to 500 mg every 8 hours for certain use patterns. The established maximum daily dose for adults is 4 grams. Pediatric dosing (one month and older) is determined by weight, typically starting at 20 mg/kg/day divided into doses every 8 hours, with a maximum limit of 1 gram per day.

Administration Conditions and Handling

The required timing relative to food depends on the specific formulation. Immediate-release capsules and suspensions may be taken with or without food, as total drug absorption remains consistent. Conversely, the extended-release (ER) tablets must be consumed with a meal or within one hour of eating to ensure optimal absorption. A critical procedural restriction for the ER tablet is that it must not be cut, crushed, or chewed, as this compromises the time-release mechanism. Dosage adjustments are generally not required for older adults unless significant renal impairment is present.

Duration of Use

The treatment course must be completed for a specified duration. Administration should continue for a minimum of 48 to 72 hours after the patient becomes asymptomatic. For infections caused by Streptococcus pyogenes, the administration course must be maintained for a minimum of 10 full days.

Recent Clinical Evidence

Cefaclor STADA: Recent Clinical Evidence

This overview describes the types of clinical research and studies conducted for Cefaclor, focusing on the available evidence regarding its established uses. The information provided summarizes the research landscape and does not offer individual medical advice or treatment recommendations.


Evidence for Use in Respiratory Tract Infections

Research for infections like otitis media, tonsillitis, and pneumonia includes Randomized Controlled Trials (RCTs) and meta-analyses. These studies primarily monitored Clinical Response and Bacteriological Efficacy in both adult and pediatric patients. Reports indicate that measured outcomes were comparable to those observed with other active treatments used in clinical protocols. However, the research describes areas of uncertainty, including heterogeneity across combined trials and limited evidence documenting a clear advantage over other available treatments.


Evidence for Use in Urinary Tract Infections

The evidence for acute urinary tract infections (UTI), including cystitis, consists of regulatory clinical studies. These trials measured Clinical Success and Bacteriological Eradication in adult patients. Research indicates that certainty remains low regarding effectiveness against every specific microorganism that shows activity in laboratory tests. Long-term outcomes are not well characterized, as research primarily focused on short-term responses during the acute phase.


Evidence for Use in Skin and Soft Tissue Infections

The research base includes short-term RCTs that evaluated Cefaclor alongside other treatments for simple bacterial Skin and Soft Tissue Infections (SSSI). Studies tracked Clinical Improvement and Bacteriological Eradication in both adults and children. A limitation noted is that the results apply mainly to uncomplicated SSSIs, and comparative evidence is lacking for highly severe or complex skin infections.


Long-Term Studies and Follow-Up Data

The majority of evidence was evaluated in settings focusing on short-term or episodic symptom patterns. Research has not extensively monitored patients over long periods, meaning long-term effects are not fully established, and there is limited information regarding the extended durability of clinical outcomes.


Evidence in Special Populations

Cefaclor research describes the evaluation of the drug across different age groups, specifically Adult and Pediatric patient populations. However, data for certain groups remain insufficient when considering specific subgroups defined by high-level comorbidities.

Key Studies & References Cefaclor (DailyMed Label) - U.S. National Library of Medicine

Frequently Asked Questions (FAQ)

Common questions about Cefaclor STADA (FAQ)


Q: How quickly should a person expect Cefaclor STADA to start working?

A: Official drug information reports that the active ingredient, Cefaclor, typically achieves its highest concentrations in the bloodstream approximately 30 to 60 minutes after taking the medicine. This peak concentration reflects when the drug is circulating most actively, but the actual time it takes to notice an improvement in symptoms can vary among individuals and depends on the specific type of infection being addressed.


Q: Can Cefaclor STADA be taken by people who have high blood sugar or diabetes?

A: Regulatory information does not list high blood sugar or diabetes as a general exclusion for using this medicine. However, official sources note that taking Cefaclor may cause a false-positive result for glucose (sugar) in some types of diabetic urine tests. Regulatory information indicates that awareness of this potential effect on testing is relevant for individuals with diabetes.


Q: Are there any known interactions between Cefaclor STADA and hormonal birth control pills?

A: Yes, official sources describe that Cefaclor may potentially decrease the effectiveness of oral hormonal contraceptives, which includes birth control pills. This is thought to occur because the antibiotic may alter the natural flora within the intestines, and this information is documented in regulatory warnings regarding drug interactions.


Q: Does Cefaclor STADA interfere with or affect blood or urine lab tests?

A: The official product label indicates that Cefaclor can affect certain laboratory results. It may cause temporary changes in some blood cell counts, such as leukopenia (low white cell count). Additionally, Cefaclor is known to cause a false-positive result for glucose (sugar) in some diabetic urine tests.


Q: What kind of stomach issues can be caused by Cefaclor STADA?

A: Reported stomach and bowel issues classified as common side effects include nausea, vomiting, and diarrhea. More serious, but rare, gastrointestinal effects such as pseudomembranous colitis (inflammation of the large intestine) have also been documented in official safety information.


Q: Is Cefaclor STADA considered safe for children, and are there age restrictions?

A: The drug is indicated for use in children one month of age and older, as documented in official labeling. However, the safety and effectiveness are not established for infants younger than one month old. Furthermore, the extended-release tablet form is not established for children younger than 16 years of age.


Q: Does Cefaclor STADA pass into breast milk, and what are the general expectations for nursing mothers?

A: Official documentation confirms that the active ingredient is present in breast milk following administration. Due to this finding, official documentation states that caution should be exercised when the medicine is administered to a woman who is nursing.


Q: Is there any information about Cefaclor STADA's interaction with the blood thinner Warfarin?

A: Yes, official drug interaction information states that concurrent use with oral anticoagulants, such as Warfarin, may increase the effect of the blood thinner. This change in effect is documented in regulatory warnings for when the drug is administered with anticoagulants and is associated with an increased risk of bleeding.


Q: Why is Cefaclor STADA sometimes chosen when a patient has a penicillin allergy?

A: Cefaclor is a cephalosporin, which is a different chemical class of beta-lactam antibiotic than penicillin. While regulatory labels document a risk of cross-hypersensitivity with penicillins, the determination for its use is based on the patient's individual allergy history, as assessed by a healthcare professional.


Q: Is it necessary to take Cefaclor STADA with food to prevent an upset stomach?

A: Regulatory documents state that immediate-release forms may be taken with or without food for absorption purposes. However, some patient information indicates that if the medicine causes an upset stomach, taking it with food may help ease this side effect. Separately, the extended-release formulation is described as being taken with a meal to ensure proper absorption.


Q: What happens if Cefaclor STADA is taken for a longer period of time than was directed?

A: Official drug information states that prolonged use of Cefaclor may result in the overgrowth of non-susceptible organisms, which is known as super-infection. The medicine is intended to be used only for the duration specified in the treatment plan.


Q: What information is available regarding the safety of Cefaclor STADA in infants under one month old?

A: According to official regulatory information regarding its use in specific populations, the safety and effectiveness of the immediate-release forms of Cefaclor have not been established for infants under one month of age.


Q: What is the main difference between Cefaclor STADA and a penicillin antibiotic?

A: Cefaclor is classified as a second-generation cephalosporin, while penicillin is a separate class of beta-lactam antibiotic. Both classes share a similar way of working by targeting the bacterial cell wall, but they differ in their specific chemical structure and the range of bacteria they are effective against.


Q: Does Cefaclor STADA belong to the same drug family as Cephalexin (Keflex)?

A: Yes, Cefaclor and Cephalexin are both classified as cephalosporin antibiotics, which belong to the broader family of beta-lactam antibiotics. Cephalexin is generally a first-generation cephalosporin, while Cefaclor is a second-generation cephalosporin.


Q: Is it possible to develop a second infection, like a yeast infection, while taking Cefaclor STADA?

A: Official safety information reports that certain types of secondary infections, known as super-infections, have been reported in some patients. This includes moniliasis (a type of yeast or fungal infection) and vaginitis (vaginal inflammation).


Q: What is the connection between Cefaclor STADA and the risk of Clostridioides difficile (C. diff) diarrhea?

A: Official warnings state that Clostridium difficile associated diarrhea (CDAD), often called C. diff diarrhea, has been reported with the use of nearly all antibacterial agents, including Cefaclor. This reaction is a serious form of colitis that may range in severity.


Q: What are some common side effects of Cefaclor STADA besides rash or diarrhea?

A: Common side effects that are reported in about 1 in 100 patients or more, in addition to diarrhea and rash, include headache, nausea, and vomiting. These are listed in the drug's official adverse reactions profile.


Q: Can Cefaclor STADA affect the health of the kidneys or liver?

A: Official documentation notes that transient hepatitis and cholestatic jaundice (liver-related issues) have been reported rarely. Caution is also advised for patients with severely decreased kidney function due to the potential for nervous system effects.


Q: Can Cefaclor STADA cause unusual side effects like confusion or nervousness?

A: Yes, rare effects on the central nervous system (CNS) have been reported in official documents. These include agitation, insomnia, confusion, and nervousness, as well as reversible hyperactivity and dizziness.


Q: What should a patient know about a potential severe allergic reaction (anaphylaxis) to Cefaclor STADA?

A: Serious acute hypersensitivity reactions, including anaphylaxis, are possible but rare. Official warnings state that these severe reactions may require immediate medical interventions.


Q: What symptoms indicate a rare but serious side effect like Stevens-Johnson syndrome?

A: Stevens-Johnson Syndrome (SJS) is a rare but serious skin reaction mentioned in safety information. Symptoms may begin with fever and flu-like symptoms, followed by a spreading red or purple skin rash that leads to blistering and peeling of the skin.


Q: Can Cefaclor STADA cause headaches or dizziness?

A: According to the drug's official adverse reactions profile, headache is listed as a common side effect. Dizziness is listed as a rare central nervous system effect with an uncertain causal relationship.


Q: Is Cefaclor STADA ever prescribed for recurrent ear infections in children?

A: Official indications for use include otitis media (middle ear infection) in children. While the regulatory text does not specifically address 'recurrent' infections, its indication includes otitis media in children.


Q: What are the official clinical research themes regarding the effectiveness of Cefaclor STADA?

A: Regulatory studies generally focus on assessing clinical response and bacteriological efficacy for approved indications like infections in the respiratory tract, urinary tract, and skin. Research themes have also included examinations of its use in prophylaxis (preventative treatment) and allergy testing.


Q: Does the manufacturer recommend specific disposal instructions for unused Cefaclor STADA suspension?

A: The official label requires that the mixed suspension must be discarded after 14 days if stored under refrigeration. Regulatory documents state that disposal should follow the specific instructions on the labeling or general pharmaceutical guidelines for unused medicine.


Q: What are the symptoms of a potential blood disorder associated with Cefaclor STADA?

A: Rare changes to blood and lymphatic cell counts have been reported, such as leukopenia (low white cell count) and thrombocytopenia (low platelet count). However, the general physical symptoms that a patient would notice from these specific changes are not explicitly described in the regulatory summary.


Q: Is there any public research on Cefaclor STADA's use against drug-resistant bacteria?

A: Official labels provide information about certain strains of bacteria, such as Pseudomonas spp., that are officially identified as resistant to Cefaclor. Regulatory labels emphasize the importance of using the drug only for susceptible bacteria as a measure to reduce the development of further drug resistance.


Q: Does Cefaclor STADA come in different strengths, and what are they?

A: Yes, Cefaclor is typically available in different strengths for both solid and liquid forms. These commonly include 250 mg and 500 mg tablets and capsules, and the oral suspension is often available in 125 mg/5 mL and 250 mg/5 mL concentrations.


Q: Can Cefaclor STADA cause fever, chills, or a sore throat as a side effect?

A: Fever, chills, or a sore throat are not listed as common side effects of Cefaclor. However, official information notes that these symptoms are sometimes reported as part of a severe, rare reaction known as serum sickness-like reaction or as early symptoms of Stevens-Johnson syndrome.


Q: Are there any special considerations for older adults (65 and older) taking Cefaclor STADA?

A: Special considerations for older adults exist, particularly related to monitoring for decreased kidney function. Regulatory information states that dose adjustments are generally not required unless the patient presents with severe renal impairment.

How should Cefaclor STADA be stored and disposed of?

Official Storage and Disposal Requirements

Cefaclor storage requirements are dependent on the product form:

  • Unmixed Dry Product (Capsules/Powder): Must be stored at controlled room temperature (15 C to 30 C or 59 F to 86 F). The container must be kept tightly closed and light-resistant.
  • Reconstituted Oral Suspension: Requires storage in a refrigerator (2 C to 8 C or 36 F to 46 F). The suspension must be shaken well before use.

Stability and Disposal

The mixed suspension is stable for 14 days under refrigeration, after which any unused portion must be discarded. All medication must be stored out of sight and reach of children. Disposal should follow labeling instructions or general pharmaceutical guidelines, avoiding disposal into household trash or wastewater unless otherwise specified by a take-back program.

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

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