Extacef

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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 Extacef

Extacef is a prescription-only medicine (POM) that serves as a systemic anti-infective agent with the active ingredient Cefixime. It is primarily used to address illnesses caused by susceptible bacterial pathogens, operating as a bactericidal agent throughout the body.

Quick Facts
Active ingredient Cefixime
Form Tablet, capsule, oral suspension
Pharmacological class Third-generation cephalosporin
Common use Systemic bacterial infections
Origin Semisynthetic

Defining Extacef: What Type of Medicine is It?

Extacef is classified as a semisynthetic beta-lactam antibiotic, specifically belonging to the third-generation cephalosporin class. This classification establishes the drug’s core function as a potent antimicrobial agent designed to eliminate bacteria. Cefixime is recognized as a third-generation cephalosporin effective against a wide range of bacteria. The active compound, Cefixime (with the chemical formula C16H15N5O7S2), is noted for its broad spectrum of activity against many common microbial threats.


Composition, Origin, and Available Forms

The composition of Extacef is based on Cefixime as a single-ingredient product, and it is manufactured as a semisynthetic compound. This medication is available as an oral preparation in multiple dosage forms: tablets, capsules, and a liquid oral suspension. The availability of both solid and liquid forms ensures that the medication can be administered effectively to different patient groups, including both adult patients and pediatric groups.


The General Purpose of This Antibiotic

The general purpose of Extacef is to stop the progression of a bacterial infection by actively killing the causative susceptible bacterial pathogens. This is why it is defined as a bactericidal agent. Cefixime functions as an oral treatment for common bacterial infections. By directly eliminating the microbes, Extacef helps resolve the infection at its source, facilitating the body’s recovery, though it is explicitly ineffective against illnesses caused by viruses.

What side effects are possible with Extacef?

Possible Side Effects and Safety Information

The safety profile of Extacef (Cefixime) is documented in regulatory sources by classifying adverse reactions based on frequency and affected physiological system. The most common effects reported generally involve the gastrointestinal system.

Frequency-Classified Adverse Reactions

The most frequently reported adverse reactions, according to official labeling, are Gastrointestinal Disorders.

Classification Common Adverse Reactions (Examples)
Most Common (Incidence ge 3%) Diarrhea, Loose Stools, Abdominal Pain, Nausea, Flatulence
Less Common (Incidence < 2%) Headache, Dizziness, Pruritus, Skin Rash, Vaginitis

Serious Adverse Reactions and System-Organ Effects

Official documents highlight the potential for serious adverse reactions, which are classified as rare or infrequent. These are grouped into specific System-Organ Classes (SOCs):

  • Immune System Disorders: Severe hypersensitivity reactions, including Anaphylactic Reactions and angioedema.
  • Skin and Subcutaneous Tissue Disorders: Severe cutaneous reactions, such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
  • Gastrointestinal Disorders: Severe gastrointestinal events, including Pseudomembranous Colitis (or Clostridium difficile-associated diarrhea).
  • Renal and Nervous Systems: Documented post-marketing events include Acute Renal Failure and Seizures (convulsions), particularly noted in cases of unadjusted dosage in patients with renal impairment.

Safety Considerations for Specific Populations

Specific constraints are noted in regulatory labels for certain patient groups. Caution is advised for individuals with a history of penicillin allergy due to the potential for cross-allergenicity. Dose adjustment is explicitly required for patients with renal impairment to mitigate the increased risk of systemic accumulation and subsequent neurological effects. Furthermore, the safety and effectiveness of Extacef have not been established in infants under six months of age. Prolonged therapy may lead to the overgrowth of non-susceptible organisms, potentially resulting in superinfection.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory information regarding an overdose of Extacef (Cefixime) indicates that there is limited experience with acute overdosage. Studies involving healthy subjects who received high doses, specifically up to 2 grams, showed that the resulting adverse reactions were not significantly different from the side effect profile observed at standard, recommended doses.

Clinical Management and Emergency Response

Since there is no established, specific clinical picture for an Extacef overdose, general supportive measures are recommended for management. It is crucial to seek immediate emergency medical attention if an overdose is suspected or confirmed, or if the individual exhibits severe symptoms.

Key Regulatory Facts for Overdose Management:

Management Fact Regulatory Statement
Specific Antidote No specific antidote exists for Extacef.
Dialysis Effectiveness Cefixime is not removed from the circulation in significant quantities by hemodialysis or peritoneal dialysis.
Recommended Action General supportive measures are recommended for the treatment of an overdose.

Because the drug is not effectively cleared by dialysis and lacks a specific antidote, any suspected overdose requires the prompt attention of healthcare professionals for necessary supportive care and monitoring.

Therapeutic Uses of Extacef

What Extacef Treats: Main Uses and Benefits

Extacef (Cefixime) is an antibiotic applied to help address susceptible bacterial pathogens that may be the cause of acute infections in multiple areas of the body, providing support that helps ease the overall symptom burden. It is applicable within clinical settings that involve acute or disruptive symptom patterns across key therapeutic domains.


This medication is generally used for conditions characterized by periods of heightened symptoms in the respiratory tract (including acute bronchitis, pharyngitis, and sinusitis), the genitourinary tract (such as uncomplicated UTIs and cystitis), and the middle ear (otitis media). It helps address symptom clusters that may become intense or disruptive, such as fever, sore throat, cough, and burning pain during urination.

“Extacef is commonly used to help manage symptoms associated with bacterial illness in both pediatric and adult populations.”

Therapeutic Focus: Symptom Management

Domain Focus Condition Category Primary Symptom Relief
Respiratory Acute bacterial flares Easing cough and inflammation
Genitourinary Uncomplicated infections Reducing dysuria and urgency
Pediatric/ENT Otitis media Supporting pain and fever management

By helping to address the infection, Extacef assists with maintaining functional stability and offers symptomatic relief that helps patients cope more steadily with difficult episodes. It is commonly used when short-term symptomatic assistance is needed for these acute, community-acquired illnesses.

Regulatory References

  1. NIH DailyMed Prescribing Information

Eligibility and Restrictions for Use

Official Eligibility for Extacef (Cefixime)

The use of Extacef is strictly determined by regulatory rules defining who is officially eligible for the medicine and who must not use it.

Absolute Contraindications The medicine is contraindicated for all patients with a known hypersensitivity to the active ingredient Cefixime, to any other cephalosporins, or a history of a severe immediate allergic reaction to penicillin or related beta-lactam antibiotics.

Age and Developmental Status

  • Established Use: Approved for adults and pediatric patients six months of age and older.
  • Use Not Established: Safety and efficacy have not been established for infants under six months of age. Tablets are generally not recommended for children under 10 years.

Conditional and Restricted Use

  • Renal Function: Patients with severe renal impairment (creatinine clearance below a defined threshold) are eligible but require conditional management as mandated by the official prescribing information.
  • Pregnancy and Lactation: Use during pregnancy is permitted only if clearly needed. For nursing mothers, consideration should be given to temporarily discontinuing nursing throughout the course of treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Extacef (Cefixime) interactions are officially documented in regulatory information, primarily affecting plasma concentrations of certain co-administered drugs and impacting coagulation parameters.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Interacting Substance Interaction Classification Official Outcome Reported
Oral Anticoagulants (e.g., Warfarin) Pharmacodynamic Increased prothrombin time has been reported, with or without clinical bleeding.
Probenecid Pharmacokinetic (Transporter) Increases Cefixime peak serum concentration (C max) and Area Under the Curve (AUC) by decreasing renal clearance.
Carbamazepine Pharmacokinetic (Exposure) Elevated levels of Carbamazepine have been reported.
Salicylates (650 mg oral dose) Pharmacokinetic (Exposure) May result in a 20-25% decrease in Cefixime peak serum concentration (C max) and AUC.

Administration and Population Notes

Co-administration with Carbamazepine officially requires drug monitoring of Carbamazepine levels due to the documented risk of elevated plasma concentrations. An important note from official labeling identifies that patients with underlying renal or hepatic impairment are at increased risk for a fall in prothrombin activity when receiving concomitant anticoagulant therapy.

Regarding food, administration with a meal does not affect the total absorbed amount of Cefixime (AUC). However, food is documented to increase the time to maximal absorption (T max). No contraindicated drug-drug combinations are explicitly documented.

Mechanism of Action

Targeting the Bacterial Cell Wall Pathway

The molecular action of Extacef (Cefixime) is the irreversible inhibition of bacterial Penicillin-Binding Proteins (PBPs), the enzymes responsible for cell wall construction. The drug's active moiety permanently binds to these targets, blocking the final transpeptidation step needed to create the rigid peptidoglycan structure.


Triggering the Bactericidal Lysis Cascade

Blocking cell wall construction causes the immediate loss of bacterial structural integrity, initiating a destructive cellular event. This mechanism activates internal bacterial autolytic enzymes, leading to the rapid physical rupture and death (lysis) of the microbe due to overwhelming osmotic pressure. This pathway results in the drug's classification as a bactericidal agent.


Limits of Mechanistic Specificity

Extacef's action is confined to organisms possessing a peptidoglycan cell wall; its mechanism is irrelevant to viruses or other non-bacterial pathogens. Furthermore, the drug's action is structurally constrained by bacterial defense mechanisms, such as the genetic alteration of PBPs or the enzymatic degradation by Extended-Spectrum beta-lactamases (ESBLs), which chemically neutralize the drug before it can engage its target.

Dosage and Administration Information

How Extacef is used

Extacef (Cefixime) is administered exclusively by the oral route across its available dosage forms, which include tablets, capsules, and oral suspension. Its use is guided by established parameters concerning dose, frequency, and treatment duration.

Standard Dosage and Frequency

For most adult patients, the standard recommended dose is 400 mg daily. This dose may be administered either as a single daily dose or divided into two equal doses of 200 mg every 12 hours.

  • Uncomplicated Gonorrhea: The regimen is a single oral dose of 400 mg.

Duration and Administration Conditions

Usage Condition Instruction
Food Intake May be taken with or without food.
Typical Duration Generally 7 to 14 days.
S. pyogenes Infections Must be administered for at least 10 days.
Oral Suspension Shake well before each use. Must be reconstituted with water.
Form Substitution Tablets should not be substituted for the oral suspension for the treatment of otitis media.

Population-Specific Adjustments

Pediatric Patients: For children six months and older, the dose is weight-based, typically 8 mg/kg of body weight per day, administered once daily or in two divided doses.

Renal Impairment: Dose modification is required for adult patients with reduced kidney function (CrCl < 60 mL/min). A dose of 200 mg once daily should not be exceeded for patients with severe renal impairment (CrCl le 20 mL/min).

Recent Clinical Evidence

Research Evidence / Overview of Studies for Extacef (Cefixime)

This section provides an overview of the types of scientific research and clinical evaluations that have been conducted on Extacef (Cefixime), drawing from regulatory and peer-reviewed sources. It describes what the studies investigated and what was observed without offering clinical advice or interpretations of drug performance.


Evidence for Use in Urinary Tract Infections (UTIs) and Cystitis

The evidence base for this condition involves Randomized Controlled Trials (RCTs) and systematic reviews. Extacef was evaluated in studies exploring the management of uncomplicated UTIs and cystitis, primarily focusing on non-pregnant adult women. The research examined outcomes related to physical discomfort, such as the burning pain and urgency associated with these infections, as well as the bacteriological eradication of the susceptible organisms causing the infection.

Findings describe patterns observed in the studies where pathogen clearance and the patterns of change in acute symptoms were observed in the study populations. However, the follow-up durations were limited, typically lasting only a few weeks after treatment completion. This means there is limited information for long-term outcomes regarding the risk of future, recurrent UTIs.


Evidence for Use in Otitis Media (Middle Ear Infection)

Research on the use of Extacef for middle ear infection (otitis media) consists of large, multicenter RCTs primarily focused on the pediatric population. These studies research examined outcomes related to systemic or functional imbalance, such as the measured changes in signs and symptoms related to the ear infection, and the bacteriological eradication of key pathogens in children.

Reports from the clinical trials describe patterns observed in the studies where the measured clearance of the target bacteria was reported in the children receiving treatment. While these trials contribute to the broader evidence landscape, evidence is limited on the drug's performance against certain bacterial strains, such as specific types of S. pneumoniae. Also, long-term effects are not fully established, particularly concerning auditory outcomes or patterns of re-infection following treatment.


What is Still Uncertain in the Research Landscape

Several areas in the research landscape evidence is limited or requires ongoing study. In some cases, comparative evidence is lacking to definitively position Extacef against all newer or established first-line treatments. The findings described in research may be influenced by the constant evolution of bacterial resistance, and the evidence quality varies across studies based on design and sample size. Overall, research does not determine whether an individual will respond similarly, as study results reflect the specific conditions and group patterns under which they were conducted, and certainty remains low for outcomes beyond the short-term follow-up periods.

Key Studies & References

  1. Cefixime Oral Suspension - NIH DailyMed Prescribing Information
  2. Infectious Diseases Society of America (IDSA) Clinical Practice Guideline for the Diagnosis and Management of Asymptomatic Bacteriuria

Frequently Asked Questions (FAQ)

Common questions about Extacef (FAQ)

Q: How quickly does Extacef start working?

Extacef is absorbed relatively slowly after it is taken. According to official product information, the concentration of the drug reaches its highest level in the bloodstream, known as peak serum concentrations, typically between 2 to 6 hours after an oral dose. The drug starts working to inhibit bacterial growth as soon as it is absorbed.

Q: Does Extacef interact with pain relievers like Tylenol or Advil?

Regulatory documents indicate a potential interaction with Salicylates, a class of medications that includes aspirin, which may decrease the amount of Extacef absorbed. Official labels do not typically list every single non-Salicylate pain reliever, such as Acetaminophen (Tylenol) or Ibuprofen (Advil). Concerns regarding specific pain relievers that are not Salicylates should be directed toward a healthcare professional for guidance.

Q: Is it common to feel tired while taking Extacef?

The official side effects profile lists headache and dizziness as less common adverse reactions associated with the medication. While general fatigue or tiredness is not typically listed in the most common categories, any drug that causes dizziness has the potential to affect alertness. Rarely, feeling weak may be associated with more serious adverse events related to blood counts.

Q: What should I do if I miss a dose of Extacef?

Regulatory-funded resources describe that if a dose is missed, it is generally recommended to take it as soon as it is remembered. If it is close to the next scheduled dose, the missed dose may be skipped to continue the regular schedule. Official guidance cautions against taking extra medicine to make up for the missed dose.

Q: Does alcohol affect Extacef?

Many official summaries do not report a major interaction specifically between Cefixime, the active ingredient in Extacef, and alcohol. However, alcohol can interfere with recovery from an infection and may sometimes increase the risk of certain side effects. Questions regarding alcohol consumption during a course of Extacef should be directed toward a healthcare professional.

Q: Does Extacef affect birth control pills?

Official information indicates that antibiotics like Extacef may reduce the effectiveness of oral contraceptives (birth control pills) in some individuals. This reduction could potentially increase the risk of an unintended pregnancy or cause breakthrough bleeding. The potential need for additional birth control methods during and immediately following treatment is a common topic to discuss with a healthcare professional.

Q: Will Extacef make me drowsy?

Dizziness is listed in the official adverse effect profile as a less common reaction. Although explicit drowsiness is not typically listed among the most frequent side effects, any sensation of dizziness can temporarily impact your alertness or ability to concentrate.

Q: How long does Extacef stay in my system after the last dose?

Official pharmacological data indicates how long the drug remains active in the body. For most patients with normal kidney function, the drug's plasma half-life—the time it takes for the concentration to reduce by half—is typically about 3 to 4 hours. Extacef is primarily cleared from the body unchanged through the urine.

Q: Can Extacef be taken with vitamins or supplements?

Interactions are possible with a wide range of products, including prescription medications, nonprescription (OTC) drugs, and various herbal or vitamin supplements. A comprehensive list of all products, including vitamins and supplements, is typically reviewed by a healthcare professional before starting treatment due to the potential for interactions.

Q: Is there a generic version of Extacef?

Yes, the active ingredient in Extacef, Cefixime, is widely available as a generic drug. This means there are multiple generic preparations available in addition to the brand-name products.

Q: Can Extacef be crushed or split?

Regulatory information states that certain solid forms, such as some 400 mg tablets that have a score line, may be split to achieve required divided doses. Other forms, like chewable tablets, should be chewed. Modification of the dosage form should only be performed if it is specifically permitted or instructed for the prescribed product.

Q: How does Extacef affect the liver?

Abnormal liver tests, specifically elevated liver enzymes (transaminases), have been reported in the adverse effects profile. Regulatory information also warns that signs of potential liver problems may include dark urine, yellowing of the skin or eyes (jaundice), or abdominal pain. Concerns regarding these effects are typically reviewed by a healthcare professional immediately.

Q: Does Extacef interact with herbal supplements like St. John's Wort?

Official sources describe that the use of all herbal supplements is generally reviewed with a healthcare professional before starting any antibiotic. This caution is based on the general potential for certain antibiotics to interfere with the metabolism or effectiveness of other products.

Q: What does official documentation say about Extacef and sunlight sensitivity?

Official drug labels for Cefixime do not typically list photosensitivity or increased sunlight sensitivity among the common or serious adverse reactions. While this is a common risk with some other classes of antibiotics, it is not consistently noted as a primary risk for this medication.

How should Extacef be stored and disposed of?

How to Store and Dispose of Extacef (Cefixime)

The storage and disposal of Extacef must strictly follow regulatory instructions to maintain product integrity and ensure safety.

Storage Requirements

Extacef solid forms (tablets/powder) must be stored at controlled room temperature (e.g., 20 C to 25 C) and protected from light and moisture. The product must not be frozen and should be kept in its tightly closed container. It is mandatory to store the medicine out of the reach and sight of children.

Stability and Disposal

The liquid suspension, once prepared (reconstituted), is stable for 14 days. Any unused portion of the reconstituted suspension must be discarded after 14 days. For disposal of unused or expired medicine, regulatory guidelines advise not flushing it down the toilet and recommend mixing it with an unappealing substance before sealing and placing it in household trash if a take-back program is unavailable.

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

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