Bactigram

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Medically reviewed

Laura Arias

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 Bactigram

Bactigram is a prescription-only medication primarily used as a potent Broad-spectrum Antibacterial agent. Its foundational identity is defined by its active ingredient, Cefaclor, a synthetic compound that belongs to the anti-infective family known as cephalosporins.


Quick Facts

Property Description
Active ingredient Cefaclor (as monohydrate)
Form Capsules and Oral Suspension (for reconstitution)
Pharmacological class Second-generation Cephalosporin (a type of beta-lactam antibiotic)
General purpose Treats bacterial infections
Origin Synthetic

What Type of Antibiotic is Bactigram (Cefaclor)?

Bactigram is formally classified as a second-generation cephalosporin, which is a type of beta-lactam antibiotic. This classification places it within a core group of synthetic drugs recognized for their ability to combat a wide array of bacterial infections. The expanded scope of activity of Cefaclor, providing coverage against various Gram-positive and specific Gram-negative bacteria, is a key feature of its second-generation status, making it a valuable option in typical use scenarios such as the treatment of respiratory tract or skin structure infections.


Composition, Forms, and General Purpose

The medication is a single active ingredient product, containing only Cefaclor, often prepared as the monohydrate salt, along with necessary pharmaceutical excipients. Bactigram is designed for oral intake and is typically supplied in two common pharmaceutical preparations: as Capsules or as a powder to be reconstituted into an Oral suspension. The availability of the suspension form is particularly relevant for the pediatric patient group. Cephalosporins like Cefaclor are used for systemic antibacterial action, as the compound is absorbed systemically to reach the site of infection.


How Cefaclor's Action Differs from Other Agents

Cefaclor functions by executing a bactericidal effect, which means it actively kills susceptible bacteria rather than merely inhibiting their growth. This action is achieved through cell wall synthesis inhibition, where the compound interferes with the bacteria’s ability to correctly build and maintain its protective structural layer. This mechanism is utilized for microbial eradication, establishing its direct role in addressing the infection.

Regulatory References

  1. NIH Cefaclor Overview

What side effects are possible with Bactigram?

Possible Side Effects and Safety Information

The safety profile for Bactigram (Cefaclor) is defined by adverse reactions documented in official regulatory sources, with effects generally classified by frequency and the body system affected. Diarrhea and headache are the most frequently reported adverse reactions and are classified as Common.

Documented Adverse Reactions by System

Adverse effects are reported across several System-Organ Classes. Gastrointestinal disorders are common, also including nausea and vomiting. Skin and Subcutaneous Tissue disorders encompass various hypersensitivity reactions, such as rash (morbilliform eruptions) and urticaria. Effects on the Nervous System include dizziness and somnolence (drowsiness), while changes to the Blood and Lymphatic System may include transient eosinophilia or thrombocytopenia.

Classification Examples of Documented Effects
Common Diarrhea, Headache
Rare / Frequency Not Known Pseudomembranous colitis, Interstitial nephritis, Transient hepatitis, Seizures, Confusion

Serious Safety Events and Specific Considerations

The labeling documents several serious adverse reactions, including anaphylaxis and rare but severe cutaneous events like Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Rare cases of a distinct hypersensitivity pattern known as serum-sickness-like reactions have also been reported, noted to occur more frequently in pediatric patients than in adults. For patients with renal impairment, there is a documented risk of neurotoxicity, including seizures, which necessitates careful safety monitoring.

Restrictions and Test Interference

A high-level safety constraint involves documented cross-sensitivity risk for individuals with a history of penicillin allergy. The medication is also known to interfere with certain laboratory tests, potentially causing a false-positive reaction for glucose in the urine when tested using copper-reduction methods, and may result in a positive direct Coombs' test.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented overdose manifestations and mandated actions for Bactigram (Cefaclor), as described in government regulatory documents.

Documented Overdose Manifestations

Acute overdose presentations are primarily related to the gastrointestinal system. Manifestations listed in regulatory labeling include:

  • Nausea
  • Vomiting
  • Epigastric Distress
  • Diarrhea

Serious Outcomes and Urgent Action

Overdoses of cephalosporins, the class to which Cefaclor belongs, carry a risk of severe Central Nervous System (CNS) effects. Regulators document the potential for Seizures and Neurotoxicity, especially in patients with existing renal impairment or CNS disorders, and among the elderly.

Mandated Action: Individuals must seek medical attention immediately upon known or suspected overdose. The medication should be discontinued if drug-associated seizures occur.

Supportive Management and Monitoring

There is no specific antidote documented for Cefaclor overdose. Officially described supportive measures include:

  • Activated Charcoal administration to reduce absorption.
  • Gastric Lavage if a large amount (e.g., more than five times the normal total daily dose) was ingested.
  • Monitoring: Vital signs, blood gases, and serum electrolytes must be meticulously monitored and maintained.

The official guidance notes that procedures such as hemodialysis or forced diuresis have not been established as beneficial for managing this overdose.

Therapeutic Uses of Bactigram

Bactigram (Cefaclor) is generally used to help manage a range of bacterial infections across several key systems, providing supportive symptom management that assists with easing distressing symptoms. The medication is applied across several therapeutic domains where symptoms are driven by susceptible bacterial pathogens.

Managing Acute Respiratory and Systemic Bacterial Symptoms

This medication is commonly used to help manage conditions presenting with acute episodes that involve symptomatic discomfort, such as Lower Respiratory Tract Infections (LRTIs), sinusitis, and Upper Respiratory Tract Infections (URTIs). This therapeutic use is considered relevant for managing infections characterized by symptoms related to systemic imbalance (like high fever) and heightened physiological activity (like persistent cough). It is relevant for easing the impact of the infection, and supports the patient during difficult episodes by easing distress and helps improve day-to-day comfort.

Addressing Localized and Functional Bacterial Infections

Bactigram is considered relevant for easing symptoms related to infections such as otitis media (middle ear infection), pharyngitis (sore throat), uncomplicated urinary tract infections (UTIs), and various skin and soft tissue infections. It is applied across domains where additional symptomatic support is needed to address symptom clusters that may become intense or disruptive, such as ear pain, painful urination, or localized redness and swelling. Its use assists with maintaining functional stability and supports general well-being during symptomatic phases.

Quick Fact: Relief for Localized Pain Bactigram is used to help manage symptoms related to inflammatory or irritative states caused by bacteria in the ear, throat, or skin, contributing to improved comfort.

Eligibility and Restrictions for Use

Who Can and Cannot Use Bactigram?

Eligibility for Bactigram (Cefaclor) is strictly defined by regulatory documents, focusing on patient history, age, and pre-existing conditions.

Absolute Contraindications

Bactigram must not be used in populations with documented hypersensitivity or allergy to Cefaclor, any other cephalosporin antibiotic, or a history of severe allergic reaction to penicillins. Use is also contraindicated in infants under the age of one month, as safety and efficacy have not been established in this group.

Conditional and Restricted Use

Population Group Regulatory Restriction
Markedly Impaired Renal Function Must be used with caution; careful observation is required.
History of Colitis/GI Disease Must be used with caution due to potential complications.
Pregnant Women Use is limited to scenarios 'only if clearly needed' (FDA Category B).
Nursing Women Caution is advised, as small amounts pass into breast milk.
Pediatric (under 16) Safety and effectiveness of the extended-release tablet formulation are not established.

For adults and children one month of age and older, use is permitted provided none of the documented contraindications are present.

What should I know about interactions with other medicines?

The official regulatory profile for Bactigram (Cefaclor) documents several clinically significant interaction patterns, primarily centered on pharmacokinetic interference and pharmacodynamic effects, as described by government health authorities.

Interacting Medicines and Substances

Category Documented Interaction Statement
Exposure-Altering Agents Probenecid is officially documented to inhibit the renal excretion of Cefaclor, leading to increased and prolonged serum concentrations (systemic exposure) of Cefaclor.
Pharmacodynamic Impact Use with Oral Anticoagulants (such as Warfarin) is associated with a prolongation of prothrombin time, officially documenting a heightened risk of bleeding.
Administration Timing Aluminum- or Magnesium-containing Antacids must be separated by time from the administration of extended-release Cefaclor tablets to prevent interference with Cefaclor absorption.

Other Official Interaction Notes

Category Regulatory Constraint
Laboratory Test Interference Cefaclor may cause a false-positive reaction for glucose in the urine when tests using copper reduction methods (e.g., Clinitest) are used.
Population Note The clearance of Cefaclor is reduced in patients with renal impairment, which prolongs the elimination half-life and increases the potential for drug accumulation.

The official labeling defines the interaction structure around these pharmacokinetic and pharmacodynamic constraints. No substances are listed as formally contraindicated combinations based solely on the drug interaction risk. The profile also includes a specific administration timing rule for the extended-release formulation to ensure optimal drug levels are achieved.

Mechanism of Action

Irreversible Inhibition of Bacterial Cell Wall Construction

Bactigram (Cefaclor) functions by acting as an irreversible covalent inhibitor of Penicillin-Binding Proteins (PBPs), which are bacterial transpeptidase enzymes essential for building the cell wall. The drug's beta-lactam ring opens upon binding to the PBP active site, permanently stopping the process of peptidoglycan cross-linking. This molecular action immediately halts the formation of the rigid structural layer necessary for bacterial survival.

This structural failure triggers a downstream causal cascade that leads to osmotic instability. The resulting loss of cellular integrity, often amplified by the activation of bacterial autolytic enzymes, causes the cell to rupture. This physiological effect is definitive bactericidal activity, marked by the death and destruction of the susceptible microbe.

The effectiveness of this mechanism is constrained by bacterial adaptation, including the production of beta-lactamase enzymes that chemically destroy Cefaclor before it reaches its target, or the evolution of modified PBPs with reduced binding affinity.

Dosage and Administration Information

General Principles of Bactigram Usage

The usage of Bactigram (Cefaclor) is characterized by specific administration parameters focusing on the route, dosage, frequency, and duration. As an antibiotic, the medicine is administered via the oral route across all its available forms, which include immediate-release capsules, powder for oral suspension, and extended-release (ER) tablets.


Dosing and Schedule

Instruction Entity Adult Standard Regimen Population Specifics
Dosing Frequency Typically every 8 hours (three times daily). ER tablets use an every 12 hour schedule. Pediatric dosing is weight-based: standard 20 mg/kg/day (max 1 g/day).
Standard Dosage 250 mg or 500 mg immediate-release. Maximum daily dose for severe cases is 4 g. Dose adjustment is generally not required for renal impairment, though specific protocols are utilized during hemodialysis.
Course Duration Ranges from 7 to 10 days. Treatment for beta-haemolytic streptococcal infections is typically maintained for a minimum of 10 days.

Administration Conditions

Administration is subject to the specific formulation. Immediate-release capsules and suspensions are compatible with or without food. However, extended-release tablets are taken with meals to enhance absorption. ER tablets are designed to be swallowed whole and are not to be cut, crushed, or chewed. In the event of a missed dose, the standard procedure is to take it as soon as possible, unless it is nearly time for the next scheduled dose, at which point the missed dose is skipped to avoid a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Bactigram

This overview describes the research landscape for Bactigram (Cefaclor), detailing the types of studies that have been conducted, the outcomes monitored, and the areas where research remains limited or uncertain, according to official and peer-reviewed scientific sources. The text below summarizes the structure of the evidence and provides no medical advice or guidance.


Evidence for Use in Respiratory Tract Infections (LRTIs and URTIs)

The clinical evaluation of Bactigram for respiratory infections like bronchitis, pneumonia, otitis media, and pharyngitis research examined both adults and pediatric patients (≥ 1 month old) through Randomized Controlled Trials (RCTs). These studies monitored clinical cure (used in research exploring how signs change over time) and bacteriologic eradication (used in studies examining the reduction of the causative pathogen). Findings describe patterns observed in the studies over short-term periods (7 to 14 days), relevant to conditions presenting with cycles of stability and flare-ups. What remains uncertain is the activity against certain resistant bacterial strains, and the correlation between laboratory findings and clinical response can sometimes vary.

Evidence for Use in Urinary Tract and Skin Infections

Studies explored the use of Bactigram for uncomplicated urinary tract infections (UTIs) and skin and soft tissue infections (SSTIs). For UTIs, Randomized Clinical Studies examined adult female outpatients, monitoring bacteriologic eradication and clinical cure over short courses. For SSTIs, research was part of the original clinical trial program for uncomplicated disease. Evidence quality varies across studies, and research data are still emerging for long-term outcomes related to recurrence in UTIs, and the drug's activity is limited against certain organisms often involved in complex infections, such as Enterococcus and Serratia species.

Research in Pediatric and Other Special Populations

Clinical studies examined pediatric patients (children ≥ 1 month) for otitis media, and some trials was studied for pregnant women with certain drug hypersensitivities. While research has been conducted in specific cohorts, the results apply only to the populations studied, and data for certain groups remain insufficient when considering long-term outcomes for pediatric use.

Follow-up Duration, Long-Term Outcomes, and Uncertainty

The overall evidence stems from studies designed to assess research exploring short-term symptom changes; these follow-up durations were limited to the period immediately after the 5-to-14-day treatment course. Long-term effects are not fully established. Evidence highlights what is known — and what is still uncertain — including that subgroup findings are uncertain for complex or severe infections, as research focuses predominantly on uncomplicated episodes. The research provides context but not individual predictions regarding sustained health outcomes.

Key Studies & References

  1. MedlinePlus Drug Information: Cefaclor (Oral Route)
  2. Clinical efficacy and pharmacokinetic profile of cefaclor
  3. WHO ATC/DDD Index: Cefaclor (J01DC04) - Systemic Antibacterials

Frequently Asked Questions (FAQ)

Common questions about Bactigram (FAQ)

Q: How quickly should I expect to feel better after starting Bactigram?

Official research and clinical studies for Bactigram typically monitor progress over short-term periods, often between 7 to 14 days, with attention to signs of clinical cure. While the mechanism of action involves the rapid destruction of susceptible bacteria, official product information does not provide a specific timeline for when an individual patient should first notice an improvement in symptoms.


Q: What happens if I accidentally miss a dose of Bactigram?

The administration rules for Bactigram describe that a missed dose may be taken as soon as possible. However, if it is nearly time for your next scheduled dose, it is described that the missed dose should be skipped entirely. Official guidance notes that double doses should be avoided to make up for a missed one.


Q: What conditions would make someone ineligible to use Bactigram?

Bactigram is contraindicated (must not be used) if a person has a documented allergy to Cefaclor, any other cephalosporin antibiotic, or a history of a severe allergic reaction to penicillins. Additionally, the drug is not approved for use in infants under one month of age. Official documents define conditional use during pregnancy and nursing, which requires careful assessment.


Q: Is it necessary to finish all the Bactigram, even if I feel better sooner?

Regulatory documents define the typical course duration for Bactigram as ranging from 7 to 10 days, and treatment for certain bacterial infections, such as those caused by Streptococcus, must last a minimum of 10 days. Official product information emphasizes that the course duration defined for the drug is necessary for the full therapeutic effect, particularly in infections like those caused by Streptococcus.


Q: Can Bactigram make an existing medical condition worse?

The official product labeling requires caution when Bactigram is used in people with certain pre-existing conditions. Specifically, careful observation is needed for those with markedly impaired renal (kidney) function or a history of gastrointestinal diseases, particularly colitis, due to the potential for complications. Regulatory documents indicate that patients taking Oral Anticoagulants may also require careful monitoring.


Q: Does Bactigram treat viral infections, or only bacterial ones?

Bactigram is formally classified as an antibacterial drug. Its mechanism is designed to kill susceptible bacteria, and regulatory documents confirm it is indicated only for the treatment of infections proven or strongly suspected to be caused by bacteria. Consistent with its classification, it is not effective against infections caused by viruses.


Q: Are there any major food restrictions I need to know about while on Bactigram?

Official warnings primarily focus on the timing of certain non-food items. The administration of extended-release tablets must be separated in time from aluminum- or magnesium-containing antacids to prevent interference with drug absorption. No other major food or beverage restrictions are typically documented in the official labeling.


Q: Does Bactigram interact with common pain relievers like ibuprofen or aspirin?

While specific interactions may vary, official product information sometimes advises caution when Bactigram is taken with drugs that can affect the kidneys. This includes certain Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or aspirin. Regulatory information indicates that caution and monitoring may be necessary.


Q: I'm taking a blood thinner; is Bactigram safe to take with it?

The official product information documents an interaction with Oral Anticoagulants (often called blood thinners), such as Warfarin. This combination is associated with a prolongation of prothrombin time, documenting a heightened risk of bleeding. Regulatory documents indicate that patients taking Oral Anticoagulants may require careful monitoring.


Q: Can older adults use Bactigram, or are there special concerns?

Bactigram may be used in older adults. However, official labeling advises caution in the presence of reduced kidney function, which is more common in the elderly population. Neurotoxicity, including confusion or seizures, has been reported in patients with reduced kidney function who are taking cephalosporin antibiotics.


Q: What is the difference between Bactigram and similar '-mycin' antibiotics?

Bactigram is classified as a cephalosporin antibiotic, which means it works by inhibiting the formation of the bacterial cell wall. This specific method of action is chemically distinct from many '–mycin' antibiotics (like macrolides or aminoglycosides), which typically work by interfering with the bacteria’s ability to build proteins.


Q: Does Bactigram need to be taken with food, or can I take it on an empty stomach?

The required administration condition depends on the specific formulation. Immediate-release capsules and the liquid suspension can be taken with or without food. However, extended-release tablets must be taken with meals to ensure the medicine is properly absorbed by the body.


Q: Are there any long-term health concerns associated with repeated use of Bactigram?

Official labeling notes that using Bactigram for prolonged periods may lead to the overgrowth of non-susceptible organisms, which is referred to as superinfection. Additionally, clinical studies were designed to assess short-term symptom changes, meaning long-term effects beyond the typical course duration are not fully established in the research.


Q: Can Bactigram be used during pregnancy, or is it typically avoided?

Official product information states that Bactigram is classified as FDA Category B for pregnancy. Use in pregnant women is generally limited to scenarios where it is clearly needed. The decision to use this medication during pregnancy is typically based on an assessment of need by a qualified prescriber.


Q: Are headaches a common complaint when taking Bactigram?

Yes, headaches are listed as a 'Common' side effect in the official safety profile for Bactigram, meaning they are among the most frequently reported adverse reactions.


Q: Why does my doctor need to know all the vitamins and supplements I take when prescribing Bactigram?

Doctors are required to know this information because Bactigram may interact with other medications, and in rare cases, prolonged use can cause a reduction in Vitamin K synthesis, which is important for blood clotting. The required submission of a complete list of all medications and supplements is a standard measure to identify all potential interactions.


Q: Does Bactigram stay in the system long after the last dose?

In patients with normal kidney function, the half-life of Bactigram (Cefaclor) is short, typically less than one hour. This means the drug is generally eliminated from the body quite rapidly. This elimination time can be prolonged in patients who have reduced kidney function.


Q: Is Bactigram known to cause confusion or changes in mood?

Yes, the official profile documents some rare effects on the Central Nervous System. These reported effects include confusion, nervousness, and insomnia (difficulty sleeping). This risk is increased in patients with impaired kidney function.


Q: What should I do if I get diarrhea while taking Bactigram?

Diarrhea is a common side effect of Bactigram, and mild cases often improve upon stopping the medicine. However, official warnings state that if you experience severe diarrhea or diarrhea that persists, this situation may require consultation, as it could be a sign of a more serious issue.


Q: If I am allergic to penicillin, can I still take Bactigram?

Bactigram is contraindicated if you have a history of a severe allergic reaction to penicillins or any other cephalosporin. This is due to a documented risk of cross-sensitivity between the drug classes, meaning a person allergic to penicillin may also be allergic to Bactigram.


Q: Is the use of Bactigram linked to antibiotic resistance issues?

Official product information emphasizes that Bactigram, like other antibiotics, should only be used to treat infections caused by susceptible bacteria. This measure is important to help limit the development of drug-resistant bacteria. Prolonged use of the drug may also result in superinfection by non-susceptible organisms.


Q: Why do official documents sometimes mention 'special populations' for Bactigram use?

Official documents discuss 'special populations' because these groups, such as those with impaired kidney function, pregnant or nursing women, or children of certain ages, may require specific dosage adjustments, careful monitoring, or are excluded from using certain formulations.


Q: Is it normal to feel tired or weak while on Bactigram?

The official product profile lists somnolence (drowsiness) and asthenia (a feeling of lack of energy or weakness) as reported effects. These effects are typically reported rarely or in the context of other reactions described in the official safety documents.


Q: Why is the drug described as a 'bacteriostatic' or 'bactericidal' agent?

Bactigram is formally described as a bactericidal agent. This means its mechanism, which involves permanently stopping the construction of the bacterial cell wall, actively causes the death and destruction of susceptible bacteria, rather than just inhibiting their growth.

How should Bactigram be stored and disposed of?

How to Store and Dispose of Bactigram (Cefaclor)

Bactigram requires specific storage conditions that vary by formulation to maintain stability.

Capsules and Dry Powder must be stored at controlled room temperature, 15 C to 30 C (59 F to 86 F). The product must be protected from moisture and excessive heat, and must not be frozen.

Reconstituted Oral Suspension must be stored in a refrigerator (2 C to 8 C). The liquid is stable for only 14 days when refrigerated, and any remaining portion must be discarded after this period.

All forms of this medication must be kept out of the sight and reach of children.

For disposal, unused or expired medicine must be discarded and should not be flushed down the toilet or poured down the sink. Dispose of the product according to local guidelines, which often recommend mixing it with an undesirable substance for placement in household trash.

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

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