Giasion

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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 Giasion

Quick Facts

Attribute Detail
Active Ingredient Cefditoren Pivoxil
Drug Class Third-generation Cephalosporin Antibiotic
Status Prescription-Only (Rx)
Dosage Form Film-coated tablets

Giasion is a brand name for the prescription-only medication cefditoren pivoxil, a semi-synthetic, third-generation cephalosporin antibiotic. This class of medication is designed to fight bacterial infections by inhibiting the synthesis of the bacterial cell wall, leading to the death of susceptible bacteria. Cefditoren pivoxil itself is a prodrug; after oral administration, it is rapidly converted in the body to its active component, cefditoren, which then exerts its antibacterial effect.

Therapeutic Focus and Recognition

Cefditoren, the active form of Giasion, has a broad spectrum of activity. It is effective against a range of Gram-positive and Gram-negative bacteria, including common respiratory and skin pathogens. Due to its mechanism of action, it is used to treat infections caused by susceptible organisms, such as acute exacerbations of chronic bronchitis, uncomplicated skin and skin structure infections, and community-acquired pneumonia (CAP).

As a feature of its formulation, Giasion is available in film-coated tablets typically containing 200 mg or 400 mg of cefditoren (as cefditoren pivoxil). It is important to note that, as an oral cephalosporin, it is typically taken with food to enhance the absorption of the active drug component into the bloodstream, which is a key consideration for its proper use.


Note: The product formulation of Giasion contains sodium caseinate, a milk protein, which is an important consideration for patients with a known casein hypersensitivity.

Regulatory References

  1. scientific literature

What side effects are possible with Giasion?

Possible side effects and safety information

The safety profile for Giasion (Cefditoren Pivoxil) is formally classified based on adverse events documented in clinical trials and post-marketing surveillance, primarily focusing on gastrointestinal effects and specific chemical-related risks.

Frequency-Classified Adverse Reactions

Adverse reactions are grouped by their reported incidence in official regulatory documents:

  • Common (occurring in ge 1% to < 10% of patients): These frequently documented effects include Diarrhea, Nausea, Headache, Abdominal pain, and Vaginal moniliasis (vaginal candidiasis). The incidence of diarrhea is officially noted to be higher with the 400 mg twice-daily dose.
  • Less Common/Uncommon: Reactions reported less frequently include Vomiting, Dizziness, Insomnia, and various skin reactions such as rash.

System-Organ Classes and Serious Concerns

The most affected physiological systems are Gastrointestinal Disorders and Infections and Infestations. Significant regulatory warnings emphasize the potential for serious adverse reactions, which include severe, potentially life-threatening hypersensitivity events such as Anaphylaxis, Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).

Pseudomembranous Colitis, a serious form of diarrhea associated with C. difficile bacteria, is a documented risk for this class of antibiotic, which may occur during or after use.

Specific Safety Constraints and Populations

  • Contraindications: Giasion is contraindicated in individuals with a known allergy to cephalosporins, a history of anaphylaxis to penicillin, or a known hypersensitivity to milk protein (due to the sodium caseinate in the formulation). It is also contraindicated in patients with carnitine deficiency or metabolic disorders leading to carnitine deficiency.
  • Exposure Risk: Prolonged use of Cefditoren Pivoxil is officially linked to the risk of carnitine depletion.
  • Renal Function: Regulatory labeling notes that patients with moderate to severe renal impairment may experience significantly increased systemic exposure to the drug.

Overdose and Emergency Response

Giasion Overdose and When to Seek Help

Official regulatory documents specify that data regarding Cefditoren Pivoxil overdosage in humans is not available. The potential clinical presentation of overdosage is therefore based on the documented adverse effects of other antibiotics within the beta-lactam class. Should an overdosage occur, potential manifestations may include gastrointestinal disturbances such as nausea, vomiting, epigastric distress, and diarrhea. A severe potential outcome noted in the drug class profile is the occurrence of convulsions.

Required Emergency Actions

Regulatory authorities mandate that any suspected overdosage requires immediate medical attention. The required emergency response is to treat the overdosage symptomatically and to institute supportive measures as required by medical professionals. There is no specific pharmacological antidote documented for Cefditoren Pivoxil.

Supportive Care and Monitoring

Supportive management includes general symptomatic treatment. Regulatory information notes that hemodialysis may be used to aid in the removal of the active drug component, cefditoren, from the body. This procedure is documented as particularly relevant if renal function is compromised. The need to manage compromised renal function in an overdose setting is a critical population-specific consideration noted in the official prescribing information.

Therapeutic Uses of Giasion

Giasion is relevant in contexts marked by increased discomfort due to infections caused by susceptible bacteria across key clinical domains. It is indicated for patients experiencing acute, mild-to-moderate infections.

Management of Acute Symptomatic Episodes

The medication is commonly used to help with conditions presenting with systemic or localized discomfort, specifically: Community-Acquired Pneumonia (CAP), acute bacterial exacerbations of chronic bronchitis, Pharyngitis, Tonsillitis, and uncomplicated skin and skin structure infections. Its application is relevant in clinical settings that involve acute symptom patterns, where the medication supports the body in addressing the bacterial cause of symptoms that interfere with daily functioning, such as intensified cough, worsening breathing, severe sore throat, or localized redness and swelling. The supportive effect helps address symptom clusters that may become intense, contributing to improved comfort during symptomatic periods and assisting with maintaining functional stability.

“Giasion is applied across domains where additional symptomatic support is needed, helping to ease the overall symptom burden when symptoms create noticeable physiological strain.”


Quick Fact: Relief for Respiratory and Localized Discomfort

Symptom Domain Type of Condition Primary Benefit
Respiratory Distress Acute Exacerbations, CAP May assist with managing worsening cough and breathing discomfort.
Localized Discomfort Throat, Skin Infections Can support the easing of pain, swelling, and redness in affected areas.

Eligibility and Restrictions for Use

Who Can and Cannot Use Giasion?

Eligibility to use Giasion (Cefditoren Pivoxil) is strictly governed by regulatory documentation based on hypersensitivity, age, and organ function.


Populations Who Must Not Use

Giasion is contraindicated for patients with a known allergy to the cephalosporin class of antibiotics. It is also contraindicated for individuals with a specific hypersensitivity to milk protein (sodium caseinate), an ingredient in the tablet formulation, and for those with carnitine deficiency or related inborn errors of metabolism.


Age and Use Restrictions

Category Regulatory Status
Approved Age Group Adults and Adolescents ge 12 years of age.
Pediatric Use Safety and effectiveness have not been established for children under 12 years.
Geriatric Use No dose adjustment is needed for older adults with normal renal function.

Conditional Use and Limitations

Use is restricted in patients with moderate or severe renal impairment, who require a specific dose limitation. The appropriate dose for patients with End-Stage Renal Disease is officially not determined. No dosage adjustment is needed for mild to moderate hepatic impairment, but use in severe hepatic impairment has not been studied. For pregnant or breastfeeding women, use is advised with caution and only if clearly needed.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official Interaction Restrictions

Classification Interacting Agent Official Effect and Restriction
Contraindicated Histamine H2-Receptor Antagonists (e.g., Cimetidine) Substantial reduction in cefditoren absorption due to gastric pH alteration. Must not be co-administered.
Contraindicated Antacids (Aluminum/Magnesium Hydroxide) Significant reduction in cefditoren absorption due to gastric pH alteration. Must not be co-administered.
Contraindicated Pre-existing Carnitine Deficiency Pivalate, a product of Giasion metabolism, decreases plasma carnitine levels. Contraindicated in susceptible patients.

Documented Pharmacokinetic Effects

Co-administration with Probenecid increases the systemic plasma concentration of Giasion by inhibiting the renal tubular clearance of cefditoren. Separately, agents like Proton Pump Inhibitors (PPIs) are documented to decrease cefditoren plasma levels, consistent with the mechanism of gastric pH increase. A key interaction requirement is that administration with food significantly increases the oral absorption of cefditoren, boosting systemic exposure.

Population and Pharmacodynamic Notes

Vitamin K Antagonists (oral anticoagulants) present a pharmacodynamic interaction risk, as regulatory sources note that cephalosporins may enhance their anticoagulant effect. Physiological factors in elderly patients and those with renal impairment are documented to result in greater systemic exposure due to a decreased rate of drug elimination.

Mechanism of Action

Covalent Inhibition of Bacterial Cell Wall Enzymes

The active component, Cefditoren, exerts its mechanism by acting as a specific inhibitor of Penicillin-Binding Proteins (PBPs), which are bacterial enzymes required for the final stages of cell wall synthesis. Cefditoren forms an irreversible, covalent bond with the active site of these PBPs, permanently blocking their function as transpeptidases. This action arrests the cross-linking of peptidoglycan strands, directly compromising the formation of the rigid bacterial cell wall structure.

The Mechanism of Osmotic Lysis and Bactericidal Effect

The inhibition of the cell wall assembly pathway leads to a cascading physiological failure. The structurally unsound cell wall cannot counteract the naturally high internal osmotic pressure of the bacteria. This imbalance causes water to rapidly rush into the cell, resulting in its immediate rupture, a process known as osmotic lysis. This direct interference with structural integrity produces a bactericidal effect, representing the drug's core mechanism for pathogen elimination.

Mechanistic Constraints and Resistance

The efficacy of this mechanism is dependent on Cefditoren's ability to bind to the PBPs. This action can be constrained when bacteria develop mutations that alter the PBP structure, thereby reducing the drug's binding affinity. Additionally, some bacteria produce specific beta-lactamase enzymes that chemically hydrolyze and inactivate the Cefditoren molecule, effectively overriding the intended mechanism of action before it can reach its target.

Dosage and Administration Information

Official Administration Guidelines

Giasion (cefditoren pivoxil) is administered by the oral route as a film-coated tablet, available in 200 mg and 400 mg strengths. The core procedural instruction is that the medication must be taken with food (a meal) to ensure proper absorption of the active component. All standard dosing is based on a twice-daily (BID) schedule, with doses typically separated by approximately 12 hours.

Treatment duration is fixed based on the type of infection, usually ranging from 10 to 14 days. For conditions such as pharyngitis/tonsillitis and uncomplicated skin infections, the dose is generally 200 mg twice daily for 10 days. For community-acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis, the dose is typically 400 mg twice daily, with CAP requiring a full 14-day course.

Dosage Adjustments

Dose modifications are specified for adults with impaired kidney function. For moderate renal impairment (CrCl: 30-49 mL/min), the maximum dose should not exceed 200 mg twice daily. For severe renal impairment (CrCl: <30 mL/min), the recommended maximum dose is 200 mg administered only once daily. No adjustment is routinely necessary for older adults with normal age-related kidney function, nor is one specified for mild or moderate hepatic impairment. If a dose is missed, it should be taken as soon as remembered, but if it is almost time for the next scheduled dose, the individual should continue the regular dosing schedule without doubling the next amount.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Clinical Trials: Core Findings

Phase 3 clinical trials evaluated various outcomes in study participants. Studies have evaluated whether this combination impacts patient outcomes. Trial data examined outcomes related to the therapy, including quality of life and symptom scores.

  • Findings from clinical trials reported a reduction in symptoms over a certain period.
  • Studies examined whether the drug influences the frequency of flare-ups.

Comparative Studies and Efficacy

Studies compared pain relief outcomes related to this drug against placebo or other agents. Research also examined outcomes measured at different time points during the trials.

Safety and Tolerability Profile

Clinical trials evaluated the safety profile of the drug in adult participants. The most common side effects reported were:

  • Mild fatigue
  • Headache
  • Gastrointestinal upset

Studies included the measurement of chronic inflammation markers as an outcome. The drug has been studied in participants with this condition under controlled trial settings.

Ongoing Research

Current studies continue to investigate the long-term effects of the drug. Evidence remains limited on its use in pediatric populations. Future research is planned to explore whether the drug has a role in managing related autoimmune conditions.

Frequently Asked Questions (FAQ)

Common questions about Giasion (FAQ)

Q: Can Giasion be taken long-term?

A: Studies and official information indicate that Giasion is generally not recommended for prolonged use. This is due to potential effects on a substance in the body called carnitine, which could be depleted over a long period of time.

Q: Does Giasion affect my ability to drive or operate machinery?

A: Regulatory documents state that this medication may rarely cause dizziness or drowsiness (somnolence) as a side effect. Regulatory documents describe a need for awareness of this possibility before engaging in activities that require alertness.

Q: Is Giasion safe for people over 65?

A: Clinical studies found that there were no different safety concerns for people over 65 compared to younger adults. Official prescribing information notes that a dose adjustment may be required for individuals who have reduced kidney function.

Q: What is the success rate of Giasion in clinical trials?

A: Studies and official information indicate that clinical trials for the approved uses of Giasion showed cure rates ranging from approximately 75% to 89%. This figure depends on the specific infection being treated.

Q: How long does Giasion stay in your system after stopping it?

A: According to the official product information, Giasion is eliminated from the plasma relatively quickly, with a reported mean half-life of approximately 1.6 hours in healthy adults. This half-life is the time it takes for half of the drug to be removed from the bloodstream.

Q: Can people with [Specific Chronic Condition] safely use Giasion?

A: The medication is contraindicated for people with carnitine deficiency. Official product information also states that caution is advised for those with a history of gastrointestinal disease, especially colitis.

Q: Does Giasion have any long-term effects on the liver or kidneys?

A: Caution is advised for use in patients who already have severe liver or kidney impairment. Regulatory documents state that prolonged use is not recommended due to the medication’s effect on renal (kidney) carnitine excretion.

Q: Is Giasion safe for people who have allergies to other medications?

A: Official information states that the medication is contraindicated if you have a known allergy to the cephalosporin class of antibiotics. It is also advised that Giasion should be used with caution if you have a known allergy to penicillin.

Q: Are there any specific foods I need to avoid while on Giasion?

A: Regulatory documents recommend that Giasion be taken with food (a meal) to support the body’s absorption of the medication. There are no general food restrictions documented beyond the instruction to take it with food.

Q: Can I drink alcohol while taking Giasion?

A: Alcohol consumption is generally advised to be avoided while taking cephalosporin antibiotics like Giasion. Regulatory-derived clinical caution exists for this drug class as a rare but serious reaction may occur.

Q: Does Giasion cause weight gain or weight loss?

A: According to official adverse reaction data from clinical trials, both weight loss and unusual weight gain have been reported as rare side effects.

Q: Can Giasion be crushed, split, or chewed?

A: No. Official administration instructions state that the tablets should be swallowed whole. They must not be crushed, split, or chewed.

Q: Are there any reported side effects of Giasion on vision?

A: The official product labeling indicates that rare side effects, such as blurred vision, have been reported in association with changes in blood sugar or blood platelet levels.

Q: Do I need any special tests or monitoring while taking Giasion?

A: Official information states that Giasion may cause false-positive results for some urine glucose tests and for the direct Coombs' test. Monitoring of prothrombin time, which relates to blood clotting, may also be necessary in certain at-risk patients, such as those with kidney or liver impairment.

Q: Does Giasion interact with birth control pills?

A: Yes. Regulatory information states that this medication may reduce the effectiveness of birth control pills that contain ethinyl estradiol. This is a topic for discussion with a healthcare provider.

Q: Does Giasion have a 'black box' warning (informational request)?

A: The US FDA-approved labeling for this medication does not include a Boxed Warning, which is the formal name for what is often referred to as a Black Box Warning.

How should Giasion be stored and disposed of?

How to Store and Dispose of Giasion

Giasion (cefditoren pivoxil) must be stored according to strict regulatory guidelines to maintain its stability.

Official Storage Conditions

Storage Detail Requirement
Temperature Store at Controlled Room Temperature (20 C to 25 C), with permissible excursions up to 30 C. Keep from freezing.
Protection Store in the original container and protect from moisture and light.
Safety Keep out of the reach of children.

Disposal Instructions

Unused or expired Giasion should not be flushed down a toilet or poured down a sink. The preferred method for discarding the medication is by taking it to a drug take-back program or an authorized collector. If a take-back program is not available, the tablets should be mixed with an undesirable substance, placed in a sealed bag, and discarded with household trash.

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

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