Alfatil

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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 Alfatil

Quick Facts

Property Description
Active ingredient Cefaclor (Cefaclor monohydrate)
Form Capsules, tablets (extended-release), oral suspension
Pharmacological class Second-generation Cephalosporin Antibiotic
Common purpose Treatment of systemic bacterial infections
Origin Semi-synthetic compound

What Type of Medicine is Alfatil (Cefaclor)?

Alfatil is a prescription medicine identified by the active ingredient Cefaclor, a compound belonging to the cephalosporin family and categorized as a second-generation cephalosporin antibiotic. This classification, which is clinically recognized for its targeted action, indicates the medicine's designed ability to address a relatively broad spectrum of susceptible bacteria. Cefaclor is a semi-synthetic derivative, meaning it is produced in a laboratory from a naturally derived compound, and its primary role is to serve as a reliable anti-infective for patients diagnosed with various systemic bacterial infections, particularly common ear or respiratory issues. This pharmacological positioning allows it to be an important treatment option when addressing microbial threats.

Composition and Available Drug Forms

The medicine is supplied as a single-ingredient product, containing only the substance Cefaclor (often as Cefaclor monohydrate). Alfatil is formulated for oral administration and is supplied in several diverse pharmaceutical preparations, including immediate-release capsules, extended-release tablets, and formulations designed for preparation as an oral suspension. The bactericidal action of this class of antibiotics results from its mechanism of inhibiting bacterial cell-wall synthesis. This mechanism of action ensures the medicine’s effectiveness is derived from actively killing the targeted microorganisms. The availability of oral suspensions is a key differentiating feature, allowing for flexible administration in children (pediatric formulations) and other patients who have difficulty swallowing tablets or capsules.

What side effects are possible with Alfatil?

Possible Side Effects and Safety Information

Alfatil (Cefaclor), like all prescription medicines, is associated with a range of possible side effects that are documented in official regulatory labeling. These adverse reactions are classified by frequency and system-organ class according to standards established by regulatory agencies.

Common Adverse Reactions (documented in 1% to 10% of patients) primarily involve the gastrointestinal system and skin. Frequently listed effects include diarrhea, eosinophilia (an increase in a type of white blood cell), and morbilliform eruptions (measles-like rash). The regulatory profile also includes effects categorized under Nervous System Disorders, such as headache.

Serious Adverse Reactions are rare but officially documented. These include severe allergic reactions such as anaphylaxis and life-threatening skin conditions like Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. A severe intestinal complication, pseudomembranous colitis, is also listed. The potential for seizures and other neurological issues is documented, particularly in individuals with pre-existing renal impairment.

Safety Constraints and Specific Populations

The medicine is documented as contraindicated in individuals with known hypersensitivity to any cephalosporin antibiotic. Due to the potential for cross-reactivity, caution is specifically noted in patients with a history of penicillin allergy. Regulatory notes also address specific timing: some effects, such as colitis, may occur during or up to several weeks after treatment completion. For pediatric patients, the label indicates a higher documented frequency of serum-sickness-like reactions compared to adults.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation describes the overdose profile of Cefaclor (Alfatil) primarily by its documented clinical manifestations and mandated emergency response procedures.

Documented Overdose Presentations

Overdose is chiefly characterized by gastrointestinal signs as stated in regulatory sources. These include nausea, vomiting, epigastric distress, and diarrhea. The severity of certain symptoms, such as the epigastric distress and diarrhea, are explicitly noted as being dose related.

When Immediate Medical Help is Required

Seeking immediate medical attention is required upon suspicion of overdose. Regulatory guidance mandates contacting emergency services immediately if severe, life-threatening signs appear. These signs include collapse, a seizure, trouble breathing, or the inability to be awakened.

Overdose Management and Risks

Management of Cefaclor overdose is symptomatic and supportive, as no specific antidote is known according to regulatory constraints. Required supportive measures include the protection of the patient's airway and maintenance of ventilation and perfusion. Interventions such as activated charcoal are officially described, while forced diuresis and hemodialysis are documented as not having established benefit.

Regulatory documents also note a class risk: patients with renal impairment may be at an increased risk for severe central nervous system effects, particularly seizures, if the dosage is not properly adjusted.

Therapeutic Uses of Alfatil

The core therapeutic purpose of Alfatil (Cefaclor) is to provide supportive relief by addressing susceptible bacteria across several body systems. It is considered relevant for managing certain infections of the skin, ears, throat, tonsils, and urinary and lower respiratory tracts. Its application is relevant in contexts involving heightened systemic burden, as it helps address the underlying cause of infection.

This antibiotic is commonly used across conditions presenting with acute episodes, such as acute otitis media, streptococcal pharyngitis, and bacterial exacerbations of chronic bronchitis. The medicine provides support and helps address symptom clusters that may become intense or disruptive, including symptoms related to physical discomfort like earache and sore throat, and may assist with managing signs of systemic imbalance, such as fever. In these situations, Alfatil may assist with maintaining functional stability and contributes to easing the overall symptom load. It provides supportive relief when symptoms, such as the pain of dysuria (painful urination) or the distress of a productive cough, interfere with routine activities.

Quick Fact: Symptomatic Support
Symptom Category Symptoms related to physical discomfort
Typical Context Acute or disruptive episodes in the outpatient setting
Patient Benefit May support general well-being and help ease distress

Regulatory References

  1. NIH MedlinePlus overview of Cefaclor

Eligibility and Restrictions for Use

Alfatil, which contains the active ingredient cefaclor, is an antibiotic primarily used to treat certain bacterial infections. Your doctor determines if this medication is appropriate for your specific condition.

Suitable Patients

Alfatil is typically used in patients, including children over one month old and adults, for infections such as those of the ear, nose, throat, respiratory tract, and urinary tract, provided the infection is caused by bacteria sensitive to cefaclor. Individuals with mild to moderate kidney impairment generally do not require a dose adjustment, though caution and close monitoring are advised for those with marked impairment.

Contraindications (Who Cannot Use Alfatil)

Alfatil is contraindicated in patients with a known allergy or hypersensitivity to the cephalosporin class of antibiotics. Since a cross-allergy can occur, extreme caution is necessary for patients with a history of a severe or immediate allergic reaction to penicillin or other beta-lactam antibiotics.

Patients with certain rare hereditary metabolic disorders, such as fructose intolerance or glucose-galactose malabsorption (where the formulation contains saccharose), should not take this drug. Use in infants under one month of age is not established. If you have a history of gastrointestinal disease, particularly colitis, Alfatil should be used with caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Alfatil’s interaction profile focuses on altering drug concentrations through elimination interference, changes in gastrointestinal absorption, and pharmacodynamic effects with certain other products.

Category Documented Interaction Statement
Renal Elimination Interference Co-administration with Probenecid is known to increase and prolong Cefaclor serum concentrations. This effect occurs because Probenecid inhibits the renal tubular secretion of Cefaclor, leading to reduced elimination and a subsequent increase in the drug’s exposure.
Pharmacodynamic Effects The use of Cefaclor concurrently with Oral Anticoagulants (such as Warfarin) carries a documented risk for an enhanced anticoagulant effect, which may be indicated by an increase in prothrombin time.
Gastrointestinal Alteration The official label requires a time separation for certain products: the extent of absorption of Cefaclor extended-release tablets is diminished if aluminum- or magnesium-containing antacids are taken within 1 hour of administration.
Food Influence Taking Cefaclor with food does not change the total amount of drug absorbed but does reduce the peak concentration achieved ( C max) and delays the time to reach peak concentration ( T max).
Laboratory Test Interference Cefaclor is documented to cause false-positive results for glucose in urine when specific non-enzymatic tests (like Clinitest tablets) are used, and may also result in a positive direct Coombs' test.

Mechanism of Action

Targeted Inhibition of Bacterial Cell Wall Construction

Alfatil's active ingredient, Cefaclor, works by engaging in the mechanistic domain of structural biosynthesis interference. The drug binds irreversibly to essential bacterial enzymes called Penicillin-Binding Proteins (PBPs), particularly the transpeptidases, which are responsible for the final stage of building the rigid peptidoglycan layer of the bacterial cell wall. This covalent inhibition halts the cross-linking process necessary for structural integrity.


Triggering the Bactericidal Cascade

The failure to construct a stable cell wall leads to a bactericidal cascade. The weakened wall is unable to withstand the high internal pressure of the bacterial cell, and the simultaneous loss of PBP control allows the cell's own degradative enzymes, autolysins, to act unchecked. This combined effect causes a catastrophic structural failure, leading to cell rupture, or lysis, which is the physiological consequence of the bactericidal mechanism.


️ Constraints by Resistance Mechanisms

The drug's mechanism is fundamentally constrained by bacterial defense systems, primarily the production of beta-lactamase enzymes. These enzymes chemically inactivate Cefaclor by cleaving its essential beta-lactam ring, thereby preventing it from binding to the PBPs. The mechanism can also be weakened if bacteria acquire modified PBPs that exhibit reduced binding affinity to the drug, allowing the pathogen to continue cell wall synthesis.

Dosage and Administration Information

Administration Scope

Element Guideline
Route of administration Alfatil (Cefaclor) is administered exclusively through the oral route, consistent with its formulation as capsules, extended-release tablets, and an oral suspension.
Dosing schedule The standard adult dose for immediate-release (IR) forms is typically 250 mg every 8 hours, though this can be increased to 500 mg every 8 hours for severe infections. The extended-release (ER) tablets are commonly administered at 500 mg every 12 hours.
Timing in relation to meals Administration may occur with or without food. Taking the medicine with food reduces the peak plasma concentration achieved and delays the time it is reached, though the total amount of drug absorbed remains unchanged.
Preparation requirements The powder for oral suspension must be correctly prepared by adding water in two portions and shaking thoroughly to ensure proper reconstitution before being administered.
Age-group administration rules Pediatric dosing for children over one month is weight-based, typically 20 mg/kg/day divided into smaller doses every 8 hours. Dosage adjustments are not generally required for patients with moderate to severe renal impairment.
Missed-dose rules Specific instructions for missed doses are not standardized and are excluded unless explicitly detailed in the source materials.
Special procedural conditions The entire course of therapy for specific infections, such as those caused by Group A beta-hemolytic streptococci, requires a minimum duration of 10 days. Extended-release tablets must not be crushed, cut, or chewed to preserve the controlled-release mechanism.

Instruction Classifications

Classification Detail
Administration method type Oral
Frequency pattern Multiple daily doses (Every 8 hours or Every 12 hours)
Use-context constraints Administration requires adherence to form-specific rules (e.g., ER tablets cannot be crushed) and disease-specific duration rules (e.g., 10-day minimum for streptococcal infections).

Resulting Procedural Structure

Step sequence:

  • Select the appropriate dose and pharmaceutical form (capsule, tablet, or suspension) as defined by the approved adult or pediatric regimen.
  • If using the extended-release tablet, administer the dose whole, ensuring it is not cut, crushed, or chewed.
  • If using the oral suspension, ensure it is properly reconstituted with water before administration.
  • Take the prescribed dose according to the defined every 8-hour or every 12-hour schedule.
  • Continue the administration for the entire prescribed duration, which must be a minimum of 10 days for specific streptococcal infections, and at least 48 to 72 hours after resolution of general symptoms.

Connection to the overall use protocol: The established instructions define a procedural protocol centered on the oral route of administration and precise dosing frequency (e.g., every 8 or 12 hours) based on the pharmaceutical form. This protocol governs preparation steps and administration constraints, such as the minimum 10-day duration required for certain infections, ensuring the medicine is used according to recognized standards.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Alfatil (Cefaclor)

This section summarizes the types of clinical studies that have been conducted for Alfatil (Cefaclor) and the patterns those studies reported, focusing on the evidence base used by regulatory authorities. This information is a descriptive overview of the research and should not be used as clinical advice or a recommendation for use.

Evidence for Use in Acute Ear and Throat Infections

The research for Alfatil's use in common upper respiratory and ear conditions, such as acute otitis media and streptococcal pharyngitis/tonsillitis, largely relies on Randomized Controlled Trials (RCTs) and meta-analyses. These trials were designed to explore the medicine's application against other established options. The outcomes relevant in these trials included the measurement of clinical change (tracking of acute symptoms like fever or pain) and bacteriological outcomes (examining the presence or absence of the susceptible organisms).

Evidence for Use in Respiratory and Urinary Tract Infections

For infections in the lower respiratory tract and the urinary tract, the evidence base includes a mix of Early Clinical Trials and Comparative Studies. These studies were conducted during periods of increased symptom activity in patients with conditions characterized by acute or disruptive episodes. In these research scenarios, the studies monitored outcomes related to systemic or functional imbalance and tracked the bacteriological outcomes to examine the post-treatment status of susceptible bacteria. For urinary tract issues, research focused on initial or non-complex infection scenarios.

Evidence in Special Populations

The research involving Alfatil has been particularly extensive in the pediatric population (children), where many comparative RCTs were focused. Research was feasible in the pediatric population due to the characteristics of the medicine's formulation. For older adults, the available research data largely focus on the overall patterns observed in a general study population that included senior participants, rather than dedicated, large-scale studies specifically isolating this group.

The Evidence Landscape: Quality and Uncertainty

The research base for Alfatil includes studies assigned a High Evidence Level designation for the short-term outcomes they were designed to measure. However, long-term effects are not fully established because follow-up durations were limited in many initial trials. Specifically, for treating streptococcal throat infections, authoritative sources note that substantial data establishing the medicine's role in the subsequent prevention of rheumatic fever are currently not available. The evidence quality varies across studies, and the results apply only to the populations studied.

Frequently Asked Questions (FAQ)

Common questions about Alfatil (FAQ)


Q: Are certain side effects expected and not a concern?

Official product information classifies adverse reactions based on how frequently they are reported by patients. Common side effects, such as diarrhea or a minor rash, are experienced by 1% to 10% of users. This classification helps show which effects are most often observed during treatment, though any unexpected or severe effect is typically reported to a healthcare provider.


Q: What are the reports on feeling tired or dizzy while using Alfatil?

Official regulatory labeling lists both dizziness and somnolence (a technical term for drowsiness or tiredness) as adverse reactions that may occur. These effects are generally categorized as uncommon, affecting a small percentage of patients. If these effects occur, official documents advise reviewing them with a healthcare professional.


Q: Are there any reported interactions between Alfatil and common vitamins or supplements?

Official documents stress the importance of informing your healthcare provider about all substances you are taking, including vitamins and dietary supplements. Although regulatory labeling for Alfatil may not specifically document interactions with every common supplement, potential risks or alterations of drug levels are typically assessed by a healthcare professional.


Q: How does Alfatil interact with blood pressure medication?

Regulatory documentation emphasizes a careful review of all co-administered medicines. In general, certain cephalosporin antibiotics, including Alfatil, may increase the potential for kidney-related adverse effects (nephrotoxicity) when combined with some blood pressure medications, such as diuretics. A healthcare provider uses this information in the assessment of treatment options.


Q: Is it okay to take pain relievers while using Alfatil?

Regulatory documentation highlights that the co-administration of Alfatil with certain drug classes may require caution. In general, combining cephalosporin antibiotics with common pain relievers known as NSAIDs (Nonsteroidal Anti-inflammatory Drugs) is noted as potentially increasing the risk of certain adverse events. It is standard practice to review the complete medication list, including pain relievers, with a healthcare professional.


Q: What happens if I drink alcohol while taking Alfatil, according to official sources?

Official patient information generally advises informing your healthcare provider about your alcohol consumption habits while taking medication. While a severe, specific interaction with Alfatil is typically not listed in regulatory documents for cefaclor, alcohol may still influence or increase the risk of certain side effects, requiring the information to be reported for clinical review.


Q: What should be known about Alfatil and common over-the-counter cold medicines?

Regulatory documents require patients to report all medications, including over-the-counter (OTC) cold and flu products. Certain ingredients in cold medicines could potentially interact with how Alfatil or other co-administered drugs are eliminated from the body. Regulatory information emphasizes the importance of a comprehensive review of all products being used before starting treatment.


Q: How long does it usually take to notice an effect from Alfatil?

Studies and official information on the pharmacokinetics of Alfatil indicate that the active ingredient is rapidly absorbed following oral administration. Peak concentrations of the medicine in the blood are typically reached within 30 to 60 minutes after a dose. This measurement relates to the presence of the drug in the body, and the patient's feeling of symptom relief may vary.


Q: What is the general duration of effect for a dose of Alfatil?

Official information reports that the serum half-life of the active ingredient is relatively short, usually ranging from 0.5 to 1 hour. The half-life describes the time it takes for the drug concentration in the body to be reduced by half. This rapid metabolism is reflected in the requirement for standard dosing schedules, such as taking the medication every 8 or every 12 hours.


Q: If I miss a dose of Alfatil, does it significantly affect the overall treatment?

Regulatory guidance emphasizes that completing the entire prescribed course of treatment is essential to ensure the infection is fully cleared and to minimize the risk of bacterial resistance. While a missed dose requires management according to specific instructions from a healthcare provider, the full duration of therapy must be completed as directed.


Q: What does the research say about stopping Alfatil suddenly?

Official patient information explicitly states that completing the full course of therapy is required exactly as prescribed. This guidance is in place because stopping treatment too soon, even if symptoms improve, may reduce the effectiveness of the drug and increase the likelihood that the targeted bacteria will develop resistance to the medicine.


Q: What are the official guidelines regarding Alfatil use during pregnancy?

Official regulatory documents classify the active ingredient in Alfatil as a Category B drug for use during pregnancy (meaning animal studies have not shown harm to the fetus). The official guidance states that the medicine should be used only if clearly necessary. The potential benefits are weighed against any potential risks by a healthcare professional before administration.


Q: Is it possible to use Alfatil while breastfeeding, according to regulatory documents?

Regulatory documents indicate that small quantities of the active ingredient, cefaclor, are excreted into human breast milk. Official guidance advises that caution should be exercised when administering the medicine to a nursing mother. The decision to use the drug while breastfeeding is typically made in consultation with a healthcare provider.


Q: Is there any known link between Alfatil and liver issues?

Official regulatory labeling reports that rare, temporary elevations of liver enzymes may occur during treatment. More serious liver-related issues, such as hepatitis and cholestatic jaundice (a type of liver-related yellowing of the skin), have also been documented as adverse reactions.


Q: What does the patient information leaflet say about how to manage minor side effects?

Patient information materials often contain general suggestions for managing minor, common side effects. For instance, regulatory documents may suggest that taking the medicine with food can help alleviate nausea or vomiting. However, the consistent guidance in official documents points toward consulting a doctor or pharmacist for review and management of any side effect.


Q: Is it considered normal to feel different in the first few days of taking Alfatil?

Regulatory labeling acknowledges that patients may begin to feel better relatively early in the course of therapy, which is related to the drug's intended action. Any noticeable physical changes or adverse effects, however, are typically assessed against the documented list of common and serious side effects in the official product information.


Q: What is the official definition of the condition Alfatil is meant to treat?

According to the official Indications and Usage section, Alfatil is approved to treat specific bacterial infections in several body areas, including the ear, throat, respiratory tract, and urinary tract. The medicine is intended for infections that are caused by proven or strongly suspected susceptible bacteria (bacteria that the drug is known to affect).


Q: Are there any restrictions on driving or operating machinery while using Alfatil?

Official regulatory documents report nervous system side effects such as dizziness and somnolence (drowsiness). Due to the potential for these effects to impair cognitive function, regulatory patient information often advises caution regarding activities that require alertness, such as driving or operating heavy machinery, until an individual knows how the medicine affects them.


Q: Is Alfatil known to cause any issues with sleep patterns?

Official regulatory labeling reports that insomnia, which is the inability to sleep, has been documented as an adverse reaction to the medicine. This effect is generally listed as uncommon or rare in the official drug documentation.


Q: What are the official guidelines for what to do in case of a perceived overdose?

Regulatory guidance directs that in the event of a perceived overdose, patients are directed to seek immediate professional medical attention or contact a poison control center. Symptoms associated with overdose can include gastrointestinal issues such as diarrhea, nausea, and vomiting.


Q: Can Alfatil cause long-term problems or changes to the body?

Studies summarized in regulatory documents indicate that the initial clinical trials had limited follow-up durations. Because of this, official sources note that the long-term effects of Alfatil are not fully established. All information regarding treatment duration and long-term use is subject to evaluation by a healthcare professional.


Q: What are the general expectations for the results of taking Alfatil?

Research evidence supports the expectation of clinical change, meaning the tracking of acute symptoms like fever or pain, and achieving bacteriological outcomes. This means the medicine is expected to track the absence or presence of susceptible bacteria after treatment. These are the measures used in regulatory trials to assess the drug’s performance.


Q: Is Alfatil suitable for older adults?

Research data available for older adults are generally drawn from patterns observed in the overall study population that included senior participants. While dedicated, large-scale studies specifically isolating this group are limited, official documents state that the overall suitability for all patients, including older adults, is assessed on a case-by-case basis.


Q: What does 'contraindication' mean in relation to Alfatil?

In official medical documents, a contraindication is a condition or circumstance that regulatory documents state makes a particular treatment improper or inadvisable. For Alfatil, contraindications include a known allergy to the cephalosporin class of antibiotics, meaning the medicine is not permitted to be used under these specific conditions.


Q: Where can I find the official summary of the research for Alfatil?

The comprehensive summary of research and clinical trial data used to support the approval of Alfatil can be found in authoritative documents like the FDA Prescribing Information or the international Summary of Product Characteristics (SmPC). These documents contain the detailed evidence base reviewed by regulatory agencies.


Q: Are there any specific foods or drinks that regulatory documents say to avoid while taking Alfatil?

Regulatory information indicates that taking Alfatil with food may reduce the peak concentration of the drug reached in the blood. Specific regulatory instructions note that the absorption of the extended-release tablets is diminished if aluminum- or magnesium-containing antacids are taken within one hour of administration.


Q: What kind of patient monitoring is typically recommended for someone on Alfatil?

Official labeling highlights the need for close monitoring in specific patient groups, such as those with marked renal impairment, due to the potential for adverse effects. Additionally, if taken with oral anticoagulants like Warfarin, official documents require monitoring of prothrombin time to check for an enhanced anticoagulant effect.

How should Alfatil be stored and disposed of?

Alfatil (cefaclor) must be stored and handled according to specific regulatory requirements that vary by formulation.

Storage Requirements

Formulation Required Storage Condition Stability Constraint
Capsules/Tablets Controlled Room Temperature (20 C to 25 C) Store in a tight, light-resistant container.
Oral Suspension (Mixed) Refrigeration (2 C to 8 C) Must be discarded after 14 days; Do not freeze.

All forms must be kept out of the reach of children and protected from light and excessive moisture. The containers for solid forms must be kept tightly closed.

Disposal Instructions

Unused or expired medication must be safely discarded. If a medicine take-back program is unavailable, official guidelines recommend mixing the product with an undesirable substance, placing it in a sealed container, and discarding it in the household trash. The reconstituted liquid suspension must be thrown away after 14 days.

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

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