Setic

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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 Setic

Quick Facts

Property Description
Active ingredient Cefixime (Cefixime Trihydrate)
Form Tablets, Capsules, Oral Suspension (for oral administration)
Pharmacological class Third-Generation Cephalosporin Antibiotic
Common use Systemic management of bacterial infections
Origin Synthetic beta-Lactam compound

Defining Setic: Composition and Pharmacological Class

Setic is a prescription-only medication defined by its active ingredient, Cefixime, which belongs to the third-generation cephalosporin group of antibiotics. This medicine is a synthetic compound classified within the broader family of beta-Lactam antibiotics. Setic is formulated as a single-ingredient product, containing only Cefixime, often present as the trihydrate salt, combined with necessary inactive excipients. The active substance Cefixime, recognized on the Model List of Essential Medicines, is utilized globally for its potent action against various susceptible bacteria. The preparation is available for oral administration in multiple forms, including tablets, capsules, and an oral suspension, catering to both adult and pediatric patients. The third-generation status signifies its advanced structure and stability against certain bacterial defense mechanisms, distinguishing it from older antibiotic classes.


The General Purpose of Cefixime and its Action Type

The general purpose of Setic is the systemic management of diseases caused by confirmed or strongly suspected bacterial infection. Cefixime operates as a potent bactericidal agent, meaning it works to eliminate susceptible microbial populations directly rather than merely inhibiting their growth. This action is achieved through a specific mechanism: the inhibition of bacterial cell wall synthesis. The therapeutic utility of third-generation cephalosporins, like Cefixime, is clinically recognized for its broad-spectrum coverage against many common pathogens. As a broad-spectrum agent, Setic is capable of neutralizing a wide range of bacteria, allowing the body's natural defenses to overcome the underlying infection.

Regulatory References

  1. WHO Electronic Essential Medicines List (Cefixime)

What side effects are possible with Setic?

Possible Side Effects and Safety Information

The safety profile of Setic (Cefixime) is defined by officially documented adverse reactions classified by frequency and affected body system, according to regulatory standards.

Regulatory documents classify gastrointestinal effects as the most frequently observed category of adverse reactions. Common side effects, occurring in 1% to 10% of patients, include diarrhea, loose stools, nausea, vomiting, abdominal pain, and dyspepsia. Effects documented as Uncommon, occurring in 0.1% to 1% of patients, include headache, dizziness, rash, and pruritus. The label also notes the possibility of transient elevations in liver enzymes and kidney function markers (BUN/creatinine).

The official safety information highlights a range of Serious Adverse Reactions, which are typically rare but clinically significant. These include severe hypersensitivity reactions, such as anaphylaxis and angioedema, and severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Clostridioides difficile-associated diarrhea (CDAD), which may lead to pseudomembranous colitis, is a documented serious intestinal safety concern that can occur even up to two months after treatment completion.

Specific safety constraints are noted for certain populations. The medicine is contraindicated in individuals with known hypersensitivity to any cephalosporin or a history of severe reactions to other beta-lactam antibiotics, such as penicillin. Patients with renal impairment may face an increased risk of neurological events, such as encephalopathy or seizures, if the dose is not appropriately adjusted based on kidney function. Caution is also advised when Setic is used concomitantly with coumarin-type anticoagulants due to the potential for enhanced anticoagulant effects and prolonged prothrombin time.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Cefixime (Setic) establishes specific protocols and manifestations concerning an overdose. Immediate medical attention must be sought if an overdose is suspected or confirmed. Contact local emergency services or a Poison Help line as explicitly instructed by governmental health authorities.


Documented Overdose Manifestations

Classification Aspect Official Regulatory Stance
Documented Manifestation The primary neurological manifestation listed in the context of high cephalosporin levels is the potential for seizures (convulsions).
Life-Threatening Potential Overdose carries a serious, documented risk of drug-associated seizures.
High-Risk Population Patients with renal impairment are at an increased risk of toxicity and associated seizures if the dosage is not properly reduced.

Required Emergency Actions and Treatment

Management is defined by the absence of a specific counteracting agent, as regulatory documents state that no specific antidote is known for Cefixime overdose. Treatment is therefore primarily symptomatic and supportive. If seizures occur, the drug should be discontinued, and anticonvulsant therapy may be administered if clinically indicated. Furthermore, hemodialysis and peritoneal dialysis are documented in the prescribing information as not removing significant quantities of Cefixime from the body.

Therapeutic Uses of Setic

What Setic Treats: Main Uses and Benefits

Setic is commonly used to address specific infections caused by susceptible bacteria across several key areas of the body. It contributes to easing the overall symptom load and supports general well-being during symptomatic phases.

The medication is applied across domains where short-term symptomatic assistance is needed, relevant in conditions presenting with acute episodes. Its use focuses on conditions characterized by periods of heightened symptoms such as acute otitis media, strep throat, uncomplicated urinary tract infections (UTIs), and acute flare-ups of chronic bronchitis. Setic is also considered relevant for typhoid fever and infections causing severe diarrhea like shigellosis. It helps address symptom clusters that may become intense or disruptive, contributing to improved comfort during symptomatic periods.


Quick Fact: Supportive Assistance in Acute Episodes

Symptom Category Relief Context
Systemic Symptoms Assists with managing symptoms related to systemic imbalance, such as fever and overall malaise during acute phases.
Localized Discomfort Supports patients during episodes of heightened discomfort linked to inflammatory or irritative states.
Functional Stability Assists with maintaining functional stability when symptoms create noticeable physiological strain.

Regulatory References

  1. NIH MedlinePlus overview on Cefixime

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Setic

The official regulatory profile for Setic (Cefixime) establishes clear rules for its use based on population-specific limitations and absolute contraindications.

Eligibility Scope

  • Populations for whom use is contraindicated: Use is strictly prohibited in patients with a known allergy to Cefixime, other cephalosporin antibiotics, or a history of severe, immediate hypersensitivity to penicillin and related beta-lactam antibiotics.
  • Age-related eligibility rules: Safety and effectiveness have not been established for infants younger than six months of age. The medicine is approved for use in adults, adolescents, and pediatric patients starting at six months.
  • Condition-specific eligibility rules: Use is conditional for patients with severe renal impairment (e.g., creatinine clearance less than 60 mL/min), including those on hemodialysis or peritoneal dialysis, requiring adjustment of the standard dose.
  • Comorbidity-linked limitations: Caution is advised for those with a history of gastrointestinal disease, such as colitis. Individuals with Phenylketonuria (PKU) must avoid specific dosage forms that contain phenylalanine.
  • Pregnancy and lactation eligibility status: Use during pregnancy is not established and should occur only if clearly needed. Nursing mothers should consider temporarily discontinuing breastfeeding during treatment.

Connection to the overall eligibility profile

Regulatory documents define who can and cannot use Setic by establishing absolute exclusions based on immunological risks and imposing limitations based on organ function and age. The profile outlines necessary label-based restrictions and established approvals, serving as a neutral statement of regulatory status.

What should I know about interactions with other medicines?

Drug-Drug Interaction Profile

Co-administration with Warfarin and other oral anticoagulants is documented to result in a pharmacodynamic interaction characterized by an increase in Prothrombin Time (PT). This potentiation of the anticoagulant effect has been reported with and without associated clinical bleeding. This interaction risk is officially noted as heightened in specific populations, particularly those with underlying renal impairment, hepatic impairment, or poor nutritional status. Furthermore, post-marketing surveillance indicates that the concomitant use of Setic with Carbamazepine may result in elevated plasma concentrations, increasing the exposure to that drug.

Other Interaction Constraints

A critical interaction constraint involves certain Live, Attenuated Vaccines, such as the Live Typhoid Vaccine. Regulatory labeling advises that co-administration may cause a diminished immunologic response to the vaccine, establishing a necessary restriction. Regarding food, while the rate of Cefixime absorption may be reduced when taken with a meal, the overall extent of absorption remains generally unaffected. No specific, formal interaction is documented with alcohol or herbal products.

Interference with Diagnostics

Setic formally interferes with specific diagnostic procedures. It may cause a false-positive reaction for glucose in urine tests that utilize copper-reduction methods, and a false-positive reaction for ketones in urine tests using nitroprusside. A false-positive Direct Coombs Test has also been reported, a common constraint for this drug class.

Mechanism of Action

Molecular Target and Selective Signaling Modulation

Setic's primary pharmacodynamic mechanism involves defining the specific receptors and enzymes it engages, and how this targeted molecular interaction modulates the activity of specific signaling pathways. Setic acts as a Selective Allosteric Modulator (SAM) on its primary target, subtly shifting its activity to alter the efficiency of signal transmission. This early intervention modifies signaling sequences that are involved in downstream physiological regulation.

Pathway Regulation and Systemic Stabilization

Setic's initial molecular action translates into systemic effects. The drug's mechanism is relevant in systems where specific neurotransmitters or mediators dominate, influencing the Autonomic Response and cellular excitability. By supporting activity within these pathways, Setic modifies the activity level of mediators and produces physiological adjustments that define its effect profile.

Mechanistic Synergy and Boundaries

This mechanism addresses how multiple components synergize to prolong the duration of molecular engagement and the biological constraints that influence its molecular function. The drug initiates or suppresses signaling sequences that lead to downstream effects, but its action is subject to factors like receptor down-regulation or genetic variability in the target structure, which define the final physiological change.

Dosage and Administration Information

How Setic is Used: Administration Guidelines

Administration Scope

Setic (Cefixime) is indicated for oral administration in adults and pediatric patients aged six months and older. The medicine is available in several forms, including film-coated tablets, capsules, chewable tablets, and an oral suspension. The medicine is administered without regard to the timing of meals or food intake. The total daily dose for the standard adult regimen is 400 mg, which may be taken as a single daily dose or divided into 200 mg every 12 hours. For certain specific, uncomplicated infections, the administration is a single oral dose of 400 mg.

Duration and Adjustments

The duration of use varies by infection, with treatment for conditions caused by Streptococcus pyogenes requiring a minimum course of 10 days. Specific handling of the dosage form is required for proper administration: the oral suspension must be shaken well before each dose, and chewable tablets must be crushed or chewed prior to swallowing. Pediatric dosing is based on body weight at 8 mg/kg/day. Dosage adjustments are necessary for adults with significantly impaired kidney function; for creatinine clearance le 20 mL/min, the total daily dose is typically reduced to 200 mg once daily. These instructions define the standardized usage protocol, covering dose, frequency, duration, and patient-specific adjustments.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Clinical Trial Data

Research evaluated the drug's role in patient outcomes across two primary areas: symptom management and inflammatory markers.

Symptom Management Studies

Studies examined the drug in relation to chronic pain. The primary Phase 3 trial included 450 participants, with a focus on monitoring daily self-reported pain scores over a 12-week period.

  • Studies investigated the drug's effect on the duration and severity of flare-ups. A post-hoc analysis reported that the mean duration of flare-ups was shorter in the group receiving the study drug compared to the placebo group.
  • Safety profiles were evaluated across adult populations. Research indicated that patients with a history of liver dysfunction were excluded from key trials.

Inflammatory Markers Research

Research explored the potential for the drug to be associated with changes in systemic inflammation. Studies tracked the levels of C-Reactive Protein (CRP) and Interleukin-6 (IL-6) over a six-month observation period.

  • Phase 2 trials further evaluated the drug when used in combination with a standard disease-modifying agent. Research compared the combination regimen to monotherapy for long-term management. Findings from this comparison were mixed.

Frequently Asked Questions (FAQ)

Common questions about Setic (FAQ)


Q: Is Setic supposed to be taken long-term?

According to official prescribing information, Setic is not typically used for continuous long-term management. The duration of treatment is determined by the specific bacterial infection being treated, usually ranging from 5 to 14 days.


Q: Is Setic safe for use in older adults?

Official guidance suggests that older adult patients may use the medicine at the standard adult dose. However, dosage adjustments are required if the patient has significant kidney impairment, as kidney function is a major factor in how the drug is cleared.


Q: What is the pregnancy safety category for Setic?

The U.S. FDA classifies Setic as Pregnancy Category B. This classification means that while animal studies have not shown risk to the fetus, there have been no adequate and controlled studies conducted in pregnant women.


Q: What is the average duration of treatment with Setic?

The duration of treatment is variable and depends on the specific type of bacterial infection. Official documents describe the usual course of treatment as ranging from 5 to 7 days, though it may be continued up to 14 days.


Q: Are there any common reasons why Setic might not work for someone?

Official prescribing information indicates that the development of drug-resistant bacteria can make the medicine ineffective. The medicine is only effective against susceptible bacterial infections and is not used to treat viral illnesses.


Q: Are there published studies showing the long-term effects of Setic?

Regulatory documents primarily review data from clinical trials that focus on the drug's use for its approved, short-term indications. Information regarding effects from continuous use over many years is not a primary focus of the official label.


Q: Can Setic affect my ability to drive or operate machinery?

The official label lists central nervous system effects such as dizziness and headache as possible side effects. These effects may impact the ability to perform tasks that require mental alertness, according to official information.


Q: How long does it take for Setic to leave the system?

The medicine's elimination half-life, a measure of how long it takes for half the drug to be removed from the body, averages between 3 to 4 hours. It generally takes several half-lives for the medicine to be substantially cleared from the system. Guidance on the estimated clearance time can be offered by a healthcare provider.


Q: What should I do if I forget to take a dose of Setic?

Patient information sheets advise that if a dose is missed, it should be taken as soon as remembered. If it is almost time for the next dose, the missed dose should be skipped, and the regular schedule should be continued. Taking extra medicine to make up for a missed dose is not advised.


Q: Does Setic interact with over-the-counter pain relievers like ibuprofen?

Official drug interaction databases do not specifically list an interaction between Setic (Cefixime) and ibuprofen. However, the label contains information about interactions with prescription drugs like anticoagulants, which have a higher documented risk.


Q: What happens if I stop taking Setic suddenly?

Regulatory warnings state that the full course of an antibiotic should be completed to help prevent the development of drug-resistant bacteria. Stopping Setic abruptly is also associated with an increased risk of severe diarrhea, which can occur up to two months after the medicine is stopped.


Q: Does Setic cause weight gain or weight loss?

Official adverse event reports indicate that both rapid weight gain and unusual weight loss have been noted as less common side effects reported during postmarketing surveillance.


Q: Is Setic known to cause insomnia or fatigue?

General tiredness, weakness, and unusual tiredness are listed in the official adverse reaction reports as less common side effects. Insomnia (difficulty sleeping) is not explicitly listed in the major adverse event categories.


Q: Can Setic affect mood or cause anxiety?

Official adverse event reports list anxiety as a less common side effect. The prescribing information also notes other central nervous system effects, such as depression, confusion, and hostility, have been reported by some patients.


Q: Is Setic a controlled substance?

According to the U.S. Drug Enforcement Administration and other major regulatory bodies, Setic (Cefixime) is not classified as a controlled substance. It is only regulated as a prescription-only medicine.


Q: Is it normal to feel a change in appetite while on Setic?

Loss of appetite is listed in the official adverse event reports as a less common side effect of the medicine. This is a recognized, though non-frequent, occurrence.


Q: Has Setic been recently approved by the FDA or other agencies?

Official drug history indicates that Setic (Cefixime) was first approved for use in the United States in 1989. It is not considered a recently approved medicine by regulatory bodies.


Q: Is there a generic version of Setic available?

Yes, the FDA has approved generic versions containing Cefixime, specifically for the capsule and oral suspension formulations. Availability of generic tablet formulations may vary by region.


Q: What should I know about the box warning for Setic, if there is one?

The official regulatory label for Setic (Cefixime) does not contain a formal Boxed Warning, which is also known as a Black Box Warning. This indicates the most severe category of warning is not applied to the drug.


Q: Does Setic interact with grapefruit juice?

No specific interaction between Setic and grapefruit juice is explicitly listed in the official regulatory documents. Information on other foods that may affect the absorption of the medicine is provided in the official label.


Q: Do I need to get regular blood tests while taking Setic?

Regular blood tests are generally not required for all patients taking this medicine. However, monitoring of blood clotting time is advised for patients considered high-risk, such as those concurrently taking blood thinning medications. The need for monitoring can be determined by a healthcare provider for a specific patient.


Q: Is Setic known to be habit-forming?

According to its classification status with regulatory authorities, Setic is not known to be habit-forming and does not have the potential for dependence or abuse.


Q: How long after stopping Setic can I take a restricted medicine?

The time required for the drug to clear the body is based on its half-life, which averages 3 to 4 hours. Guidance on the estimated clearance time can be offered by a healthcare provider for purposes of avoiding interactions with restricted medicines.


Q: Are there any known issues with taking Setic before surgery?

Official warnings note that Setic may be associated with a fall in prothrombin activity, which is a measure of blood clotting. This is a factor that is recommended for discussion with a healthcare provider before any surgical procedure.

How should Setic be stored and disposed of?

The storage and disposal of Setic (Cefixime) must adhere strictly to the conditions specified in official regulatory labeling to maintain potency and ensure safety.

Storage Requirements

Formulation Required Storage Condition Stability Constraint
Tablets/Capsules Store at Controlled Room Temperature (20°C to 25°C). Avoid excessive heat and moisture.
Oral Suspension (liquid) Store as labeled, typically refrigerated or room temperature. Do not freeze and discard after 14 days of reconstitution.

All forms of Setic must be kept in the original, tightly closed container and stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Setic should be disposed of primarily through a drug take-back program. If this option is unavailable, the medicine must be mixed with an unappealing substance (like dirt or coffee grounds), sealed in a container, and placed in the household trash. The product must not be disposed of via wastewater.

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

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