Keflin

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Keflin

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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 Keflin

What is Keflin? A Foundational Overview

Property Description
Active ingredient Cefalotin sodium
Form Powder for solution for injection
Pharmacological class beta-Lactam antibiotic, First-generation cephalosporin
Common use Anti-infective agent (Bactericidal)
Origin Semisynthetic

What Type of Medicine is Keflin (Cefalotin)?

Keflin is the original trade name associated with the active ingredient Cefalotin sodium, a prescription-only semisynthetic antibiotic substance. This compound belongs to the pharmacological group of beta-Lactam antibiotics and is specifically classified as a first-generation cephalosporin. Cefalotin sodium is recognized by international nomenclature bodies, with Cefalotin being its International Nonproprietary Name (INN). This class of antibiotics is utilized for its efficacy against susceptible pathogens.


Composition and General Purpose of Cefalotin

Cefalotin is formulated as a single-agent product supplied as a powder for solution for injection intended for parenteral administration. Unlike common oral antibiotics, this injectable form is positioned for situations requiring rapid and consistent systemic availability of the compound. The high-level composition consists of the active ingredient, Cefalotin sodium, which must be reconstituted into an aqueous vehicle prior to use for injection. The general purpose of Cefalotin is to provide bactericidal activity, meaning it directly kills bacterial pathogens. It achieves this by interfering with their cell wall synthesis, thereby supporting the body's clearance of the bacterial presence.

What side effects are possible with Keflin?

Possible Side Effects and Safety Information

Keflin (cefaloțin) is associated with adverse reactions typical of cephalosporin antibiotics, spanning various organ systems. The profile is characterized by the potential for hypersensitivity reactions and gastrointestinal disturbances.

Key Adverse Reaction Categories

System-Organ Class Common/Notable Reactions
Immune System Hypersensitivity reactions (e.g., rash, fever, anaphylaxis)
Gastrointestinal Diarrhea, nausea, vomiting, abdominal pain; rare pseudomembranous colitis
Hematologic Eosinophilia, leukopenia; rare hemolytic anemia, thrombocytopenia
Hepatic Transient increases in liver transaminases (AST, ALT)
General/Local Pain, redness, or swelling at the injection site (intravenous/intramuscular)
Renal Rare interstitial nephritis (often hypersensitivity-mediated); nephrotoxicity, particularly with concomitant use of aminoglycosides or in pre-existing renal impairment
Nervous System Rare reports of delirium or confusion, particularly in patients with kidney impairment

Serious Safety Information and Restrictions

Contraindications: Keflin is contraindicated in individuals with a known allergy to cefaloțin, sodium bicarbonate, or any serious allergy to other cephalosporin or penicillin antibiotics due to the risk of life-threatening cross-sensitivity (anaphylaxis).

Clinically Significant Risks:

  • Clostridium difficile-associated Diarrhea (CDAD): This condition can range from mild diarrhea to fatal colitis and has been reported with cefaloțin. Onset may occur even several weeks after treatment cessation.
  • Nephrotoxicity: Caution is advised in patients with pre-existing renal impairment, as the drug's effects may be increased due to slower elimination. Dosage adjustments are typically required for renal insufficiency to reduce the risk of neurotoxicity and seizures.

Other Safety Notes: The administration of cephalosporins may result in a false-positive reaction for glucose in the urine using certain testing methods (e.g., copper reduction tests) and may also cause a positive direct Coombs' test.

Overdose and Emergency Response

Overdose and when to seek help

Overdosage with Cefalotin sodium, particularly involving the administration of inappropriately large doses, is officially associated with the risk of Central Nervous System (CNS) toxicity.

The principal manifestations documented in regulatory sources are severe neurological effects, including seizures (convulsions). Other severe CNS signs associated with overdosage of this antibiotic class may include encephalopathy, confusional state, myoclonia, and altered mental status.

When to Seek Urgent Help

The critical factor in this overdose profile is the necessity to seek immediate medical attention upon the onset of any neurological symptoms. Official regulatory guidance mandates that if seizures occur, the drug must be promptly discontinued.

A major population-specific consideration stated in regulatory documents is that patients with renal impairment are at a significantly increased risk for developing these severe CNS manifestations due to drug accumulation. Dosage reduction is officially required when renal function is impaired to mitigate this risk.

Management Profile

Management for Cefalotin overdosage is strictly symptomatic and supportive. No specific antidote is known or documented in the official prescribing information. Supportive measures may include the use of anticonvulsant therapy if clinically indicated to control seizures. For instances of overwhelming overdosage, procedures such as hemodialysis may be considered.

Therapeutic Uses of Keflin

What Keflin Treats: Main Uses and Benefits

Cefalotin (Keflin) is commonly used for the management of conditions presenting with acute episodes related to severe bacterial infections, reflecting its role as an injectable antibiotic. The medication is applied in addressing conditions like septicemia, bacterial pneumonia, infections of the bone, joints, and deep soft tissues, and is relevant in managing extensive cellulitis.

The primary therapeutic benefit is applied in addressing the bacterial cause, which supports the easing of severe systemic symptoms like high fever and profound malaise, contributing to easing the overall symptom burden.

“The use of Cefalotin may assist with managing intense localized pain and swelling, thereby improving comfort during periods of heightened symptoms.”

Beyond treating established infections, Cefalotin is commonly used to help manage the risk of postoperative infection (surgical prophylaxis) before certain high-risk procedures, like cardiac and orthopedic surgeries, supporting the recovery phase and helping to maintain functional stability.


Quick Fact: Relief for Systemic Discomfort

Quick Fact: Relief for Systemic Discomfort
Symptom Focus Symptoms related to systemic imbalance, such as high fever and malaise.
Condition Context Applied in clinical settings that involve acute or unstable symptom patterns, such as septicemia.
Patient Benefit Provides support that helps ease the overall symptom burden, particularly in acute states.

Eligibility and Restrictions for Use

The eligibility for using Cefalotin (Keflin) is strictly governed by regulatory documentation, primarily concerning known allergies and the patient's existing health conditions.


Populations for Whom Use is Restricted or Contraindicated

Classification Population/Condition
Absolute Contraindication Patients with a known hypersensitivity (allergy) to Cefalotin or any other antibiotic in the cephalosporin class [Source 1.1].
Conditional/Restricted Use Patients with impaired renal function (kidney disease). Use requires caution and dose adjustment due to the risk of toxicity from high serum concentrations [Source 2.1].
Caution Required Patients with a history of penicillin allergy, due to the potential for cross-hypersensitivity among beta-Lactam antibiotics [Source 1.1].
Caution Required Patients with a history of severe bowel conditions or colitis [Source 2.1].

Age and Physiological Status Eligibility

  • Older Adults (Geriatric Use): Eligible, but caution is required because this population is more likely to have decreased renal function, which may necessitate careful dose selection [Source 3.2].
  • Pediatric Use: Generally established, but specific restrictions may apply, as safety and efficacy are often not established in very young infants (e.g., under a specific minimum age) [Source 3.4].
  • Pregnancy and Lactation: Use during pregnancy is generally categorized as B (not associated with fetal harm in animal studies, but human data is inadequate). It is permitted only when the therapeutic need has been clearly established [Source 3.1]. Cefalotin is excreted into breast milk in small amounts, and regulatory labeling advises caution for nursing mothers [Source 3.1].

What should I know about interactions with other medicines?

The interaction profile for Cefalotin (Keflin) is defined by pharmacokinetic changes, additive toxicological risk, and interference with certain diagnostic tests, as documented in government regulatory labeling.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Interacting Substance Category Official Interaction Outcome Regulatory Basis
Probenecid Inhibits renal tubular secretion, resulting in higher and more prolonged serum concentrations of Cefalotin. Pharmacokinetic
Oral Anticoagulants (e.g., Warfarin) Possesses an additive effect that increases the risk of bleeding (Hypothrombinaemia). Pharmacodynamic
Nephrotoxic Drugs (e.g., Aminoglycosides, Loop Diuretics) Associated with an increased incidence of nephrotoxicity when co-administered. Toxicological

The interaction with nephrotoxic drugs is a population-specific consideration noted to be of greater clinical significance in patients with pre-existing renal function impairment. No explicit, formal contraindicated combinations are uniformly documented in regulatory summaries, and there are no stated timing-based separation requirements for administration.

Interference with Diagnostic Products

Cefalotin administration is documented to interact with certain laboratory products, potentially yielding false-positive results for the Antiglobulin (Coombs') Test and specific urinary glucose tests that rely on copper reduction methods (e.g., Clinitest).


This structure reflects how regulatory bodies classify the product's interaction patterns, detailing substances that alter systemic exposure, increase specific toxicity risks, or constrain procedural testing.

Mechanism of Action

How Keflin Works: Mechanism of Action

The activity of Cefalotin (Keflin) is strictly defined by its direct, destructive interference with the structures essential for bacterial survival, resulting in rapid pathogen elimination.


Targeting the Bacterial Cell Wall Construction System

This mechanism acts within the domain of structural enzyme inhibition, engaging the Penicillin-Binding Proteins (PBPs) embedded in the bacterial cell membrane. Cefalotin irreversibly binds to and inactivates these enzymes, which halts the final cross-linking step of peptidoglycan synthesis, the essential structural polymer. This molecular action initiates a cascade that leads to a fundamentally defective bacterial cell wall and the subsequent physiological outcome of pathogen clearance.


The Cascade of Osmotic Integrity Failure

The failure of the cell wall construction system leads immediately to the loss of osmotic integrity. Because the weakened wall cannot withstand the internal fluid pressure (turgor), the bacterial cell rapidly swells and ruptures (lysis). This destructive process produces the resulting physiological effect of acute bacterial population reduction within the affected system.


Constraints Imposed by Bacterial Defense Systems

The scope of this mechanism is constrained by specific defense processes, primarily the bacterial production of beta-Lactamase enzymes, which chemically destroy the drug before it reaches its PBP target. The mechanism is also limited when bacteria possess altered PBPs with reduced binding affinity. These constraints are relevant as they influence the overall scope of the pathogen eradication mechanism.

Dosage and Administration Information

How Cefalotin (Keflin) is Used in Practice

Cefalotin sodium (Keflin) is administered via parenteral routes to ensure consistent systemic exposure, primarily through intravenous (IV) injection or infusion, and less commonly through intramuscular (IM) deep injection. The medication is supplied as a powder for solution for injection and requires reconstitution prior to use, such as combining the 1 g vial with 4 mL of sterile water for the IM route.


Dosing and Schedule Patterns

The standard adult regimen for established infections involves doses ranging from 500 mg to 2 g administered at fixed intervals, typically every 4 to 6 hours. For severe or life-threatening infections, the total daily dose may reach up to 12 g via the IV route, requiring adherence to strict infusion protocols, including alternating infusion sites for prolonged, high-dose therapy.

In the context of surgical prophylaxis, a dose of 2 g is given intravenously 0.5 to 1 hour prior to the surgical incision. This is followed by doses of 2 g every 6 hours, usually continued for up to 24 hours postoperatively, with certain high-risk procedures extending the course to 72 hours.


Population-Specific Administration

Dose modifications are typically utilized for specific patient groups. Patients with renal impairment require a reduced maintenance dose following an initial loading dose, with the schedule determined by the degree of kidney function loss. For pediatric patients, dosing is calculated based on body weight, using a regimen of 80 to 160 mg/kg per day in divided doses, with a specialized schedule of 20 mg/kg every 12 hours for infants weighing less than 2 kg.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Keflin

Cefalotin (Keflin) is an antibiotic that has been a focus of research for several specific infectious conditions since its introduction. The available evidence, which primarily stems from older Randomized Controlled Trials (RCTs), comparative studies, and subsequent systematic reviews, provides context for its clinical research history. This summary describes the research landscape and the focus of the studies conducted, consistent with regulatory overview standards.


Evidence for Use in Serious Established Infections

Research has examined Cefalotin's role in the management of conditions associated with acute or disruptive episodes, such as severe bloodstream infections (septicemia), serious bacterial pneumonia, and deep infections of the bone, joints, and soft tissues. The initial evidence base consists of short-term RCTs and comparative clinical trials that studied hospitalized adults with these severe infections, often utilizing other antibiotics as comparators in the trials. Findings from these studies describe patterns observed in the short-term clinical course, which contribute to the broader evidence landscape related to its use against specific bacterial targets.

Evidence for Use in Surgical Antimicrobial Prophylaxis

Cefalotin was studied for its role in surgical antimicrobial prophylaxis (SAP), which involves preventing infections after certain high-risk surgical procedures. The evidence base for this use includes systematic reviews and meta-analyses that pooled data from numerous RCTs across the first-generation cephalosporin class. The key endpoint research examined was the measured incidence of Surgical Site Infection (SSI), categorized by depth and location. Findings from this aggregated evidence describe patterns observed in the measured SSI incidence in the studied surgical populations.

What is Still Uncertain About the Research Landscape

For most research on Cefalotin, the focus was concentrated on the acute treatment phase. Comparative evidence is lacking from large-scale, recent RCTs that rigorously compare Cefalotin against newer, current-generation treatments for its indications. Additionally, there is limited information for long-term outcomes across all indications, with most follow-up concentrating on the acute recovery period. Subgroup findings remain uncertain in specific populations, such as older adults or those with complex underlying health conditions, where evidence quality varies across studies.

Key Studies & References

  1. Cephalosporins: Indications, Uses, Dosage, Drugs Interactions, Side effects - General Drug Information and Clinical Context
  2. Summary of a systematic review on surgical antibiotic prophylaxis prolongation - Evidence for single-dose vs prolonged regimen (Relevant to Prophylaxis Section)
  3. Cephalosporin-class Activity against Skin and Soft Tissue Infections (SSTIs) - Review of First-Generation use

Frequently Asked Questions (FAQ)

Common questions about Keflin (FAQ)


Q: Why is Keflin typically given by injection instead of as an oral pill?

A: Keflin (Cefalotin) is designed for parenteral administration, meaning it is given by injection or infusion. Official documents state that this route is necessary to achieve the consistent systemic exposure required to effectively treat serious infections. This approach ensures the medication is available in the body rapidly and predictably.


Q: What are the most common reported side effects associated with Keflin?

A: According to official labeling, common reported side effects often involve the gastrointestinal system, such as diarrhea, nausea, and vomiting. Allergic reactions, including skin rash and fever, are also frequently noted in the safety profile. This information contributes to the overall safety profile described in the official documents.


Q: Are allergic reactions to Keflin a major concern, and what are the signs?

A: Yes, allergic reactions are a major concern and a reason why the medication is contraindicated for some individuals. Regulatory information lists signs such as rash, fever, and swelling (angioedema). In rare, severe cases, a life-threatening reaction called anaphylaxis (which affects breathing and blood pressure) may occur.


Q: Does Keflin interfere with or affect other antibiotics if taken together?

A: Official documents indicate that combining Keflin with certain other medicines, particularly some other types of antibiotics called aminoglycosides, can create an increased risk of kidney toxicity (nephrotoxicity). The potential for this increased risk is part of the drug interaction profile described in official documents.


Q: Is Keflin considered safe for use during pregnancy, based on regulatory information?

A: Regulatory classification places Cefalotin in a category where animal studies have shown no fetal harm, although human data is not fully adequate. Official labeling states that the medication should be used during pregnancy only when the therapeutic need is clearly established, meaning the benefit is determined to be clearly necessary in light of the potential risk to the fetus.


Q: Is Keflin’s use in children supported by appropriate studies and clinical data?

A: The use of Cefalotin in most pediatric patients is generally established through clinical experience. However, official information notes that the safety and effectiveness have not been established in very young infants, particularly those under a certain minimum weight (such as less than 2 kilograms) or specific minimum age limits.


Q: Why do official warnings mention a risk of seizures with cephalosporin antibiotics like Keflin?

A: Warnings about seizures are related to a condition called neurotoxicity that can occur if the medication accumulates in the body. This accumulation is most likely to happen in patients with impaired kidney function. For this reason, dosage adjustments are required when kidney issues are present to reduce this risk.


Q: Is Keflin known to cause central nervous system side effects like dizziness or headache?

A: Regulatory safety data mentions that rare nervous system side effects can occur, particularly delirium or confusion, especially in patients with existing kidney impairment. The official documentation does not consistently list common symptoms such as dizziness or headache.


Q: Are there any long-term effects associated with repeated or prolonged use of Keflin?

A: Research evidence often focuses on short-term clinical outcomes during the acute treatment phase. Official summaries note that there is a lack of detailed information for long-term outcomes across all indications. Official prescribing information describes the need for monitoring during prolonged use.


Q: What is a 'Positive direct Coombs' test' and how does it relate to Keflin use?

A: Official labeling states that Keflin can cause interference with laboratory testing. It may lead to a false-positive result for the Direct Coombs' Test, which is a blood test looking for antibodies on red blood cells. This finding does not necessarily indicate a true medical problem caused by the drug.


Q: Are there documented cases of Keflin causing liver-related side effects, such as jaundice?

A: Safety data includes reports of transient increases in liver enzymes (AST/ALT), which is an effect on the liver. More severe liver issues, such as jaundice (yellowing of the skin or eyes) or hepatitis, have been reported rarely with antibiotics in the cephalosporin class.


Q: Does the risk of side effects change depending on the administration method (IV vs. IM)?

A: Official documentation confirms that the risk of local side effects is related to the administration route. This includes common issues like pain, swelling, or redness that can occur specifically at the site of injection, whether it is given intravenously (IV) or intramuscularly (IM).


Q: Is Keflin considered a broad-spectrum antibiotic?

A: Official information defines Cefalotin's antimicrobial activity by stating that it covers a range of susceptible pathogens. Its spectrum of activity is generally described as covering certain types of Gram-positive bacteria (like Staphylococcus and Streptococcus) as well as a selection of Gram-negative bacteria.


Q: What specific types of bacteria is Keflin primarily designed to target?

A: Regulatory documents state that Cefalotin is indicated for infections caused by susceptible organisms. It primarily targets Gram-positive bacteria such as certain Staphylococcus and Streptococcus species, along with specific, common Gram-negative bacteria.


Q: Can Keflin be used for general respiratory tract infections?

A: Yes, Cefalotin is officially indicated for the treatment of various respiratory tract infections caused by susceptible bacteria. This includes conditions like bacterial pneumonia, among others, as stated in the authoritative product information.


Q: What types of skin and soft tissue infections is Keflin indicated for?

A: Official indications state that Cefalotin is used to treat skin and skin structure infections. These are caused by susceptible strains of bacteria, including certain species of Staphylococcus and Streptococcus, as described in the official labeling.


Q: How quickly is Keflin expected to start working after administration?

A: Due to its injection route, Cefalotin has a rapid onset of action. Pharmacokinetic studies in official documents show that drug concentrations typically reach therapeutic levels in the bloodstream quickly, often within minutes to hours following administration.


Q: What is the general duration of treatment for infections requiring Keflin?

A: The length of therapy is determined by the healthcare provider based on the type and severity of the infection being treated. However, for most established bacterial infections, the general treatment course described in official documentation typically ranges from 5 to 14 days.


Q: Is there a known link between Keflin and yeast or fungal infections, such as thrush?

A: Yes, a known potential effect of antibiotics like Cefalotin is the possibility for the overgrowth of non-susceptible organisms, such as fungi. This can lead to secondary infections like oral thrush (sore, white mouth/tongue) or vaginal fungal infections.


Q: What is the recommended approach if I develop signs of a secondary infection while on Keflin?

A: Patient information from regulatory sources strongly advises that if you notice signs of a secondary infection, the regulatory advice is to contact a healthcare provider immediately.


Q: What should be done if I experience persistent or worsening symptoms a few days into treatment with Keflin?

A: Official patient guidance states that if the symptoms of your original infection do not improve within a few days of starting Cefalotin, or if the symptoms appear to be getting worse, the authoritative guidance is to inform a healthcare provider immediately.


Q: Are there specific criteria for what constitutes a susceptible strain of bacteria for Keflin treatment?

A: Yes, the official labeling and microbiology sections refer to specific susceptibility testing criteria and recognized standards. These standards are used by clinical laboratories to determine whether an isolated strain of bacteria is considered susceptible to the effects of Keflin.


Q: Can poor nutrition or low levels of Vitamin K increase the risk of side effects with Keflin?

A: Regulatory warnings note that some antibiotics in this class are associated with a decrease in prothrombin activity, which is key for blood clotting. For patients who are at risk of bleeding complications, official information indicates that Vitamin K may be administered.


Q: What is the general history of Keflin's development and use in medicine?

A: Cefalotin, sold under the original trade name Keflin, holds a significant place in the history of antibiotics. Official and historical sources describe it as being the first cephalosporin antibiotic to be marketed, initially introduced for clinical use in the 1960s.

How should Keflin be stored and disposed of?

Storage and Protection Requirements

Condition Type Required Parameter
Dry Powder Temperature Must be stored at Controlled Room Temperature (CRT), typically 20 C to 25 C (68 F to 77 F).
Light / Moisture The vial must be protected from light and guarded against moisture and excessive heat.
Freezing Restriction Do not freeze the dry powder form of the medication.
Container Rule Keep the product in its original container and maintain it tightly closed.
Post-Reconstitution Reconstituted solution has limited stability and must be stored under refrigeration (2 C to 8 C) for the period specified by the label (e.g., typically 24 hours).

Official Disposal Rules

Unused, expired, or unwanted Keflin and related waste material must be disposed of according to local, regional, and national regulations. To protect the environment, the product should not be disposed of via household wastewater or drains. Additionally, as a mandatory safety rule for all prescription medicines, Keflin must be stored out of the sight and reach of children.

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

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