Cefixim STADA

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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 Cefixim STADA

Quick Facts

Property Description
Active ingredient Cefixime (as Cefixime trihydrate)
Form Tablet, chewable tablet, oral suspension
Pharmacological class Third-generation cephalosporin antibiotic
Common use Systemic treatment of bacterial infections
Origin Semisynthetic

What Type of Antibiotic is Cefixim STADA?

Cefixim STADA is a prescription-only medication whose active ingredient is Cefixime. This substance is chemically classified as a third-generation cephalosporin antibiotic, belonging to the larger family of beta-lactam antibiotics. This precise classification defines the agent's role as a potent, broad-spectrum compound for combating bacterial infections.

The substance Cefixime is a semisynthetic compound, modified from a natural precursor to enhance its therapeutic properties. The distinction as a third-generation agent is clinically recognized because it exhibits high stability against beta-lactamases, enzymes produced by many resistant bacteria. This stability allows the drug to maintain its bactericidal action against a wide array of susceptible Gram-negative bacteria and Gram-positive bacteria, which is a key differentiating factor from older antibiotic classes.

Composition, Form, and General Purpose of Cefixime

The Cefixim STADA product features Cefixime as its single active ingredient and is designed for oral administration. The medication is available in multiple dosage forms, notably the solid tablet (including a chewable tablet variant) and a liquid oral suspension. The availability of the suspension is particularly important for patients who require liquid formulations.

The fundamental purpose of the medication is the elimination of the source of bacterial infections through a definitive bactericidal action. The drug's mechanism of effect works by specifically disrupting bacterial cell wall synthesis. By interfering with the construction of the protective peptidoglycan layer, the drug ensures the infectious agents lose their structural integrity and undergo cell lysis, delivering the essential therapeutic benefit of infection resolution.

Regulatory References

  1. Cefixime Drug Information
  2. Mechanism of Action
  3. Third-generation Cephalosporins (NIH)
  4. Peptidoglycan Structure (NIH)
  5. Bacterial Cell Lysis (NIH)

What side effects are possible with Cefixim STADA?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and safety characteristics of Cefixim STADA (Cefixime), categorized according to government regulatory standards (e.g., FDA and EMA).

Safety data categorizes adverse reactions primarily by frequency and the body system affected. The most frequently reported adverse events are related to Gastrointestinal Disorders.

Frequency-Classified Adverse Reactions

The following are classified based on their reported incidence in official regulatory documents:

Classification Example Reactions (Based on Regulatory Labeling)
Common Diarrhea, loose stools, nausea, abdominal pain.
Uncommon Headache, dizziness, rash, flatulence, vomiting.
Rare Angioedema, drug fever, pruritus (itching).

System-Organ Class (SOC) Groupings

Side effects are organized by the system they affect, as defined in regulatory texts:

  • Gastrointestinal Disorders: Includes the common events of diarrhea and nausea.
  • Infections and Infestations: Includes the potential for superinfection with non-susceptible organisms, such as Candidiasis, and Clostridium difficile-associated diarrhea (CDAD).
  • Immune System Disorders: Covers a range of hypersensitivity reactions.
  • Blood and Lymphatic System Disorders: Features temporary changes such as leukopenia and eosinophilia.

Serious Adverse Reactions and Safety Constraints

Official labeling documents certain rare but clinically significant reactions, including Anaphylaxis, severe cutaneous reactions like Stevens-Johnson Syndrome (SJS), and Pseudomembranous Colitis.

Cefixim STADA is contraindicated in individuals with a known allergy to Cefixime or to any other cephalosporin-class antibiotic. Caution is also advised for patients with a history of penicillin allergy due to the potential for cross-hypersensitivity. Furthermore, the label specifies that patients with severe renal impairment require monitoring and potential dose adjustment, as the drug is primarily eliminated by the kidneys.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the clinical presentation of Cefixime overdose primarily around central nervous system effects. The key documented risk is encephalopathy, which may manifest through signs such as convulsions (seizures), confusion, impairment of consciousness, and movement disorders.

Required Emergency Actions

The regulatory labels explicitly mandate that medical attention must be sought immediately at the first sign of a suspected overdose. Furthermore, emergency services (such as 911) must be contacted right away if the affected individual has collapsed, experiences a seizure, has trouble breathing, or cannot be awakened.

Management and Considerations

Management of Cefixime overdose is based on symptomatic treatment and general supportive measures, as official documents confirm that no specific antidote exists. Gastric lavage may be indicated as part of the procedure. It is officially stated that Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis, which limits the effectiveness of these procedures in overdose. The risk of serious neurological effects is officially noted to be increased, particularly in the case of overdose or renal impairment.

Therapeutic Uses of Cefixim STADA

What Cefixim STADA Treats: Main Uses and Benefits

Cefixim STADA is commonly used across conditions presenting with acute episodes of bacterial infection, primarily in the respiratory and urinary tracts. The medication is commonly used when supportive symptom management is appropriate to address the underlying bacterial cause and ease the overall symptom burden.


This agent is commonly used to help with conditions associated with acute or disruptive episodes of bacterial illness, such as otitis media (middle ear infection), pharyngitis, tonsillitis, acute bronchitis, and uncomplicated urinary tract infections (UTIs). It is considered relevant for conditions marked by increased physiological stress, such as pyelonephritis, and specific infections, including uncomplicated gonorrhea. This usage may be part of symptomatic management when pathogens demonstrate resistance to older antibiotics.

The medication is used for managing symptom clusters that may become intense or disruptive, such as sore throat, ear pain, fever, and painful urination (dysuria). This support assists with maintaining functional stability during difficult episodes and contributes to easing the overall symptom load.

“The therapeutic application supports patients during phases of increased distress or discomfort associated with acute bacterial illness.”

Quick Fact: Relief for Symptoms that Interfere with Daily Functioning
Cefixim STADA may assist with easing symptoms related to inflammatory or irritative states, such as painful urination in UTIs and localized ear pain in otitis media.

Regulatory References

  1. NIH DailyMed official prescribing information

Eligibility and Restrictions for Use

Eligibility: Who Can and Cannot Use Cefixim STADA?

This section outlines the official population-eligibility and non-eligibility rules for Cefixim STADA (Cefixime), strictly based on governmental regulatory documents.

Category Official Regulatory Statement
Populations for whom use is allowed: Adults and adolescents (ge 12 years or > 45 kg) are eligible for the adult dose. Pediatric patients starting from 6 months of age are eligible.
Populations for whom use is contraindicated: Patients with known hypersensitivity to Cefixime, any excipients, or other cephalosporin antibiotics. Those with a severe allergy to penicillin must use with caution due to cross-allergenicity.
Age-related eligibility rules: Safety and efficacy have not been established in infants younger than six months. The tablet form is not recommended for children under 10 years of age.
Condition-specific eligibility rules: Patients with impaired renal function (Creatinine Clearance < 60 mL/min) are eligible, but the label mandates a limitation or dose adjustment. Caution is required for those with a history of colitis or gastrointestinal disease.
Pregnancy and lactation eligibility status: Use during pregnancy is permitted only if clearly needed or considered essential. For nursing mothers, temporary discontinuation of breastfeeding during treatment is recommended.

Official regulatory documents define eligibility primarily by excluding populations with severe allergies and setting conditional use based on age, organ function, and reproductive status.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation defines the interaction profile of Cefixim STADA (Cefixime) through specific pharmacodynamic effects and the potential for altered plasma exposure of co-administered medicinal products.

Documented Pharmacodynamic and Exposure Interactions

Interaction Type Interacting Substance Official Regulatory Finding
Pharmacodynamic Effect Anticoagulants (e.g., Warfarin) Co-administration is officially reported to increase prothrombin time (INR), with or without clinical bleeding. This effect is associated with a fall in prothrombin activity.
Exposure Modification Carbamazepine Elevated plasma concentrations of carbamazepine have been formally reported when co-administered with Cefixime, constituting a documented alteration in the co-administered drug's exposure.

Procedural and Population Restrictions

Regulatory information places a restriction on the interpretation of certain diagnostic results: Cefixime is documented to cause false-positive reactions for ketones when the urine is tested using methods that incorporate nitroprusside reagents. No mandatory timing separation rules are specified for Cefixime with other substances.

Interaction-related cautions are officially noted for specific patient populations. The risk for coagulation effects (increased prothrombin time) is explicitly stated to be higher in patients with underlying renal impairment or hepatic impairment, as detailed in official government labeling.

Mechanism of Action

How Cefixim STADA Works

Cefixim STADA operates through a bactericidal mechanism by interfering with the structural integrity of the bacterial cell. As a beta-lactam antibiotic, its primary action is the inhibition of bacterial cell wall synthesis. The molecule achieves this by forming a stable covalent bond with key bacterial enzymes known as Penicillin-Binding Proteins (PBPs). These transpeptidases are essential for the final cross-linking of peptidoglycan strands, the core structural polymer of the cell wall. By blocking this essential enzymatic process, Cefixime prevents the formation of a rigid cell wall.

The inhibition cascade results in a rapid loss of osmotic stability across the cell membrane, leading to cell lysis (bursting) and subsequent cell death. A characteristic mechanistic feature of the molecule is its molecular structure, which confers an intrinsic stability against hydrolysis by many common beta-lactamase enzymes produced by resistant strains. This stability ensures that the PBP inhibitory action persists in the presence of these inactivating enzymes, maintaining the destructive effect on the bacterial structure.

Dosage and Administration Information

Official Administration Guidelines for Cefixim STADA

The use of Cefixim STADA, which contains the active ingredient Cefixime, is strictly governed by the official prescribing information regarding its administration route, dosing, and duration. This medication is authorized exclusively for oral administration and is available in forms including tablets, capsules, and a powder for oral suspension.

Standard Dosing and Frequency

The standard adult regimen establishes a total dose of 400 mg daily. This total dose can be administered in one of two approved schedules: either as a single 400 mg dose taken once daily or as two equal 200 mg doses taken on a divided schedule every 12 hours. For specific acute infections, a single 400 mg oral dose may be prescribed. The solid dosage forms may be taken without regard to meals.

Duration and Population Adjustments

The typical duration of treatment generally ranges from 7 to 14 days. However, for infections caused by Streptococcus pyogenes, guidelines specify a minimum treatment course of at least 10 days.

Population Dosing Principle
Pediatric Patients (6 mos+) Based on weight: 8 mg/kg of body weight per day.
Renal Impairment (CrCl leq 20 mL/min) Dose must be reduced and should not exceed 200 mg once daily.

Preparation and Handling

The oral suspension formulation requires specific preparation: the powder must be reconstituted by adding water as directed, and the final suspension must be shaken well before each use to ensure accurate dose delivery. Furthermore, the official labeling indicates that the oral suspension is the preferred dosage form for otitis media due to differing absorption characteristics.

Recent Clinical Evidence

Research evidence / Overview of studies for Cefixim STADA


Evidence for Urinary Tract and Kidney Infections

Research has explored the use of Cefixime in patients with uncomplicated urinary tract infections (UTIs), which are conditions characterized by acute or disruptive episodes of infection. Clinical studies, including randomized controlled trials (RCTs), was conducted mostly in adult female outpatients. These studies monitored outcomes related to physical discomfort, such as the complete degree of symptom resolution, and focused on microbiological eradication, monitoring outcomes related to the elimination of the bacteria from the urine. For more complex infections, such as Pyelonephritis (kidney infection), research has also been conducted, looking at bacteriological clearance and clinical response in patients with more pronounced physiological strain.


Evidence for Ear, Throat, and Lower Respiratory Infections

Research was evaluated in trials for otitis media (middle ear infection), primarily involving children (ge 6 months). These studies compared Cefixime with alternative oral antibiotics, monitoring outcomes like clinical improvement and the measured clearance of specific pathogens. For pharyngitis and tonsillitis, studies monitored outcomes related to physical discomfort and the measured clearance of Streptococcus pyogenes bacteria. Research also examined the agent's role in acute exacerbations of chronic bronchitis (AECB) in adults, monitoring outcomes related to clinical response and measured pathogen clearance from sputum samples.


Evidence for Uncomplicated Gonorrhea

Research has included systematic reviews and single-dose clinical trials in adults and adolescents. Studies was evaluated in trials measuring microbiological clearance at a short-term Test-of-Cure visit. Data show patterns related to measured pathogen clearance rates that varied depending on the anatomical site of the infection, with some evidence indicating lower measured clearance rates at the pharyngeal site.


What Remains Uncertain in the Research Landscape

Data for certain groups remain insufficient, especially regarding the long-term outcomes of treatment and the frequency of infection recurrence over extended periods. The emergence of antimicrobial resistance is a continually evolving challenge. While the agent was observed in some studies in research exploring the context of resistance, findings described measurements of bactericidal levels, and this may affect how data relate to future resistant bacterial strains. Therefore, evidence quality varies across studies, and research contributes to understanding symptom patterns, but certainty remains low regarding long-term outcomes against new, highly resistant pathogens.

Key Studies & References Label: CEFIXIME capsule - U.S. National Library of Medicine (DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Cefixim STADA (FAQ)

Q: What is Cefixim STADA and what is it used for?

A: Cefixim STADA contains the active ingredient cefixime, which is an antibiotic belonging to the group called cephalosporins. It is used to treat infections caused by bacteria, specifically:

  • Infections of the ear, nose, and throat (like otitis media, pharyngitis, or tonsillitis).
  • Infections of the lungs and lower respiratory tract (like acute bronchitis).
  • Infections of the urinary tract (like cystitis).
  • Uncomplicated gonorrhea.

Q: How should I take Cefixim STADA?

A: Always take Cefixim STADA exactly as your doctor or pharmacist has told you. Do not change your dose or stop the treatment without consulting your doctor.

  • The medicine is usually taken once or twice a day.
  • It can be taken with or without food.
  • It is important to complete the full course of treatment even if you start to feel better. Stopping early can allow the remaining bacteria to become resistant to the antibiotic.

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

A: If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten one. If you are unsure, ask your doctor or pharmacist for advice.

Q: Can Cefixim STADA cause side effects?

A: Like all medicines, Cefixim STADA can cause side effects, although not everyone gets them.

  • Common side effects often involve the digestive system, such as diarrhea, abdominal pain, and nausea.
  • Serious but rare side effects include severe allergic reactions (symptoms include rash, difficulty breathing, or swelling of the face, lips, or tongue). If you experience signs of a severe allergic reaction, seek medical attention immediately.
  • Antibiotics can sometimes cause an overgrowth of Clostridium difficile bacteria, leading to severe diarrhea (pseudomembranous colitis). Inform your doctor if you experience persistent or bloody diarrhea.

Q: Can I take Cefixim STADA with other medicines?

A: You should always inform your doctor or pharmacist about all the medicines you are currently taking, including over-the-counter medicines, supplements, and herbal remedies.

  • Cefixim STADA may interact with anticoagulants (medicines that prevent blood clotting), like warfarin, which could increase the risk of bleeding.
  • Certain diuretics, such as furosemide, may affect how cefixime works in the body.
  • Cefixime can sometimes interfere with the results of certain laboratory tests, such as urine glucose tests.

Q: Can Cefixim STADA be used during pregnancy or breastfeeding?

A: If you are pregnant, plan to become pregnant, or are breastfeeding, you should talk to your doctor before taking Cefixim STADA.

  • It is generally recommended to use this medicine during pregnancy only if clearly necessary and directed by a doctor.
  • Small amounts of the active ingredient may pass into breast milk. Your doctor will weigh the potential risks and benefits before recommending this medicine while breastfeeding.

How should Cefixim STADA be stored and disposed of?

How to Store and Dispose of Cefixim STADA

Cefixim STADA tablets must be stored at a temperature not exceeding 30°C or between 20°C and 25°C, and be protected from moisture and light. The medicine must be kept out of the sight and reach of children.


Storage of Oral Suspension

Once the oral suspension is mixed (reconstituted), it is stable for up to 14 days when kept tightly closed. It may be stored at room temperature or under refrigeration (2°C to 8°C) during this period. The suspension must be discarded after the 14-day limit.


Disposal Requirements

Unused or expired medicine should not be disposed of via wastewater or household waste. The proper procedure is to return the unused product to a pharmacist or local waste disposal service, in accordance with local requirements.

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

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