Cladex

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Cladex

Medically reviewed

Marina Burgos

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 Cladex

Property Description
Active Ingredient Cefotaxime (as Cefotaxime sodium)
Form Sterile powder for solution for injection
Pharmacological Class Third-generation Cephalosporin, Beta-lactam antibiotic
General Purpose Systemic bacterial infection control
Origin Synthetic compound

What is Cladex and What Class of Medicine is it?

Cladex is a synthetic pharmaceutical preparation whose active ingredient is Cefotaxime, often formulated as Cefotaxime sodium, which is classified as an antibiotic agent. This medication’s primary function is to eliminate or inhibit the growth of bacteria within the body. Cefotaxime is specifically categorized as a third-generation cephalosporin, placing it within the broader beta-lactam family of medicines. This distinction is important because the molecular structure is clinically recognized for its broad-spectrum capability against a diverse range of pathogens, including many Gram-negative species.


Cladex Composition and Pharmaceutical Form

Cladex is supplied as a sterile powder for solution for injection, a pharmaceutical form that requires reconstitution with a suitable sterile solvent immediately prior to patient administration. This preparation method is necessary because Cefotaxime is inherently unstable in a ready-to-use liquid form. The required route of delivery is parenteral administration—delivered via injection—as its chemical structure is not suited for effective oral absorption. This injectable format ensures the necessary concentration of the drug reaches the bloodstream quickly and efficiently for infections where reliable plasma levels are critical.


What is the General Purpose of Cladex?

The general purpose of Cladex is to provide systemic support and control for bacterial infections, acting as a powerful bactericidal agent. A typical, neutral use scenario involves managing infections where the patient requires an injectable, broad-spectrum agent for reliable microbial eradication. The medicine achieves this by irreversibly destroying the susceptible bacteria's outer defense layer, the cell wall. Its effectiveness is rooted in its inherent broad-spectrum capability, offering a definitive and reliable therapeutic pathway toward clearing systemic bacterial challenges by targeting and eliminating the pathogen population directly.

Regulatory References

  1. Cefotaxime - StatPearls - NCBI Bookshelf

What side effects are possible with Cladex?

Possible Side Effects and Safety Information

The safety profile of Cladex (cefotaxime) is officially documented by regulatory authorities, classifying potential adverse reactions by both frequency and the physiological system affected. This provides a structured understanding of the medicine's risk profile.


Frequency and System-Organ Classified Adverse Reactions

Adverse reactions are formally grouped into categories reflecting their typical occurrence rates:

  • Common Reactions (1/100 to < 1/10): Frequently listed effects include diarrhoea, nausea, and vomiting (Gastrointestinal Disorders), along with reactions at the administration site, such as pain or inflammation.
  • Uncommon Reactions (1/1,000 to < 1/100): These include changes in blood cell counts, such as leukopenia or eosinophilia, as well as transient increases in liver enzymes and serum creatinine. Seizures are also noted in this category.

Serious Adverse Reactions and Key Safety Constraints

Certain reactions, though typically rare, are considered clinically significant and are highlighted in official documents:

  • Serious Hypersensitivity: Severe, immediate allergic reactions, including anaphylaxis, are documented. The medicine is formally contraindicated in individuals with a known history of severe allergy to cefotaxime, other cephalosporins, or any other beta-lactam antibiotic.
  • Gastrointestinal: Persistent and severe diarrhoea may signal pseudomembranous colitis (Clostridium difficile-associated diarrhoea).
  • Neurological Risk: Official labeling notes an increased risk of encephalopathy (confusion, seizures) particularly with high doses in patients with renal impairment. This population requires specific regulatory consideration due to the potential for drug accumulation.
  • Duration-Related Safety: For treatment courses extending beyond seven days, haematological monitoring is specified in regulatory texts to observe for blood count changes.

Overdose and Emergency Response

Cladex Overdose and When to Seek Help

The official regulatory profile for Cefotaxime overdose is defined by the risk of acute Central Nervous System (CNS) toxicity. Documented manifestations may include signs corresponding to the known side effect profile, specifically CNS excitation conditions, myoclonia (muscle twitching), reversible encephalopathy (impaired consciousness), and gastrointestinal distress. Convulsions and death are risks noted with very high dosages, and potentially life-threatening arrhythmia has been noted with rapid intravenous administration.

Immediate Emergency Actions

The medication must be discontinued immediately if an overdose is suspected. Regulators mandate seeking immediate medical attention at the first sign of an acute adverse reaction. Emergency services must be contacted if the individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened.

Management and Specific Risks

No specific antidote is known to exist. Management relies on supportive treatment and procedures designed to accelerate drug elimination. Plasma levels can be reduced by hemodialysis or peritoneal dialysis. A specific risk note states that the susceptibility to undesirable CNS effects is increased in patients with severely restricted kidney function, epilepsy, or meningitis. Symptomatic treatment for overdose-induced cramps requires diazepam or phenobarbital.

Therapeutic Uses of Cladex

What Cladex Treats: Main Uses and Benefits

Cladex (cefotaxime) is generally used to treat serious bacterial infections and is applied across domains where additional symptomatic support is needed. The medication assists in managing conditions that present with severe, full-body symptoms like high fever and profound fatigue, as well as localized discomfort such as pain and swelling in areas like the lungs, joints, or abdomen. It is commonly used for indications like lower respiratory tract infections, pelvic inflammatory disease, and serious bone and joint infections.

The primary focus is on helping to ease the overall symptom load and provides supportive relief when symptoms interfere with routine activities during these acute episodes. It is relevant in clinical settings that involve acute or unstable symptom patterns.

Targeting Severe Systemic Sickness

Cladex is primarily used to address the severe, full-body symptoms that signal a serious bacterial infection. It is applied across domains where additional symptomatic support is needed and may assist with managing the intensity of these overwhelming systemic manifestations.

Quick Fact: Symptomatic Support Cladex is considered relevant in clinical settings that involve acute or unstable symptom patterns associated with major infections.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Cladex?

Eligibility Scope

Populations for whom use is allowed: Adults and children across all age groups, including neonates. Use is established for individuals requiring treatment for susceptible systemic bacterial infections.

Populations for whom use is contraindicated: Individuals with a documented immediate-type hypersensitivity to Cefotaxime, any other cephalosporin antibiotic, or a severe allergy to penicillins due to cross-sensitivity risk. The solution for intramuscular (IM) injection prepared with a Lidocaine diluent is strictly prohibited in infants under 30 months and patients with certain severe cardiac conditions.

Age-related eligibility rules: The medicine is approved across the lifespan. However, use in older adults or patients with renal impairment requires special consideration and monitoring due to potential reduced organ function.

Condition-specific eligibility rules: Use is restricted in patients with severe renal dysfunction and requires careful monitoring in patients with hepatic dysfunction. Caution is advised for those with a history of colitis or other severe gastrointestinal diseases.

Pregnancy and lactation eligibility status: Cefotaxime is classified as Pregnancy Category B. It is generally not recommended unless the treating clinician determines the potential benefits outweigh any risks. The drug is excreted in low amounts in breast milk, and use during lactation requires caution and monitoring.

Eligibility Classifications (High-Level)

Eligibility severity classification: Strictly Contraindicated (Hypersensitivity) and Contraindicated Conditionally (Lidocaine diluent in specific groups). Regulatory basis: FDA / EMA / National Health Authorities. Eligibility-context constraints: Non-eligibility is primarily defined by immunological response and formulation-specific age prohibitions.

Resulting Eligibility Structure

Official eligibility statements:

  • Use is strictly prohibited if a history of immediate-type hypersensitivity to cephalosporins exists.
  • Use is established in children and neonates, but the Lidocaine-containing IM formulation is contraindicated in infants under 30 months.
  • Patients with impaired renal or hepatic function must be carefully monitored.

Connection to the overall eligibility profile: Official regulatory documents define who can and cannot use the medicine by establishing absolute contraindications based on prior hypersensitivity to cephalosporins and related antibiotics. Eligibility is also constrained by specific age-related prohibitions tied to the drug's formulation, as well as mandatory caution and monitoring for populations with impaired organ function such as renal or hepatic insufficiency.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation defines the interaction profile of Cefotaxime through several specific constraints, focusing primarily on administration restrictions and effects on drug exposure or toxicity.

Administration Prohibitions and Timing Rules

Cefotaxime solution reconstituted with Lidocaine is strictly contraindicated for the intravenous (IV) route of administration, as stated in prescribing information. Cefotaxime must not be mixed in the same syringe or intravenous line with Aminoglycosides or alkaline solutions (such as Sodium Bicarbonate) due to physical and chemical incompatibilities.

Pharmacokinetic and Pharmacodynamic Interactions

The uricosuric agent Probenecid is documented to interfere with Cefotaxime’s renal tubular transfer, resulting in an increase in plasma concentration and a reduction in renal clearance. Co-administration with potentially nephrotoxic drugs, including Aminoglycosides and Potent Diuretics (e.g., Furosemide), carries a documented risk of potentiated nephrotoxic effects. Cefotaxime may also decrease the level or effect of oral contraceptives by altering intestinal flora.

Population-Specific Notes

The potential for nephrotoxic potentiation in combination with other agents is noted as heightened in the elderly and in patients with pre-existing renal impairment, requiring specific clinical consideration.

Mechanism of Action

Cladex (Cefotaxime) is a bactericidal agent that operates by interfering with the structural integrity of susceptible bacteria, a mechanism characterized by its irreversible and specific action on bacterial enzymes.

Irreversible Disruption of the Bacterial Cell Wall

Cefotaxime acts as a covalent inhibitor by permanently binding to Penicillin-Binding Proteins (PBPs), which are bacterial transpeptidases essential for building the cell wall. This binding action prevents the final peptidoglycan cross-linking required for structural rigidity, thereby disrupting the bacterial cell wall synthesis pathway. The resulting cellular failure is characterized by a destabilized cell wall that cannot withstand turgor pressure, culminating in bacterial lysis (rupture).

Constraints on Bactericidal Effectiveness

This bactericidal process is constrained by bacterial counter-mechanisms, primarily the production of beta-lactamase enzymes. These enzymes chemically destroy the Cefotaxime molecule before it can inhibit the PBP target, preventing the necessary covalent bond formation required to complete the molecular cascade and resulting in loss of PBP inhibition.

Dosage and Administration Information

How to Use Cladex — Administration Guidelines

Cladex (Cefotaxime) is a synthetic antibiotic administered solely through the parenteral route (injection or infusion), a requirement dictated by its chemical structure which prevents effective oral absorption. It is supplied as a sterile powder for solution that must be reconstituted with a suitable sterile solvent immediately before use.

Administration Routes and Scheduling

The route and frequency of administration are specified based on the required dose and the severity of the infection. For less severe cases, the intramuscular (IM) route may be used; for this method, the powder may be dissolved in a 1% Lidocaine solution. Solutions prepared with Lidocaine must not be administered intravenously. For severe infections, or when the total daily dose exceeds 2 g, the intravenous (IV) route is the standard. IV administration is performed either as a slow bolus injection over 3 to 5 minutes or as a controlled infusion over 20 to 60 minutes.

Standard adult dosing ranges from 1 g to 2 g given every 8 to 12 hours, with a total daily dose that must not exceed 12 g. The frequency may be increased to every 4 hours for critical, life-threatening conditions. Treatment duration typically continues for 3 to 4 days after clinical symptoms have improved.

Population-Specific Dosing

Dosing for pediatric patients is weight-based, generally falling within the range of 50 to 180 mg/kg/day divided into multiple doses. Dose modification is utilized for adults with severely impaired kidney function (creatinine clearance le 5 mL/min); the daily maintenance dose is typically halved in such instances.

Recent Clinical Evidence

Research evidence / Overview of studies for Cladex


Research Evidence for Serious Respiratory and Systemic Infections

Research examined Cladex (cefotaxime) in studies involving serious infections of the lungs, such as pneumonia, and infections that spread throughout the body, known as septicemia or bloodstream infection. Researchers conducted Randomized Controlled Trials (RCTs) and comparative trials to look at how the medicine was evaluated in hospitalized adults and children. The research focused on outcomes such as the clinical success rate (where symptoms were measured for resolution) and the bacteriological success rate (which tracked the eradication of the harmful bacteria).

Studies monitored these short-term outcomes shortly after the patient completed the course of treatment used in the trials. These trials describe the patterns of clinical outcome measurements that were observed in the studied groups, contributing to the broader evidence landscape.

Evidence for Abdominal and Urinary Tract Infections

Research has explored the use of Cladex in complicated infections affecting the digestive system, such as Spontaneous Bacterial Peritonitis (SBP), and complex urinary tract infections (UTIs). Trials monitored clinical and bacteriological outcomes following the defined course of acute treatment. Studies also monitored the drug's concentration in relevant body fluids to ensure adequate levels were reached at the infection site.

Studies Evaluating Central Nervous System Infections (Meningitis)

Cladex was evaluated in specific research contexts for infections like meningitis in neonates, children, and adults. Studies specifically monitored the drug's levels in the Cerebrospinal Fluid (CSF) and looked at outcomes such as pathogen eradication in the CSF. The evidence provides insight into short-term changes and forms the basis for established practices for evaluating this medication in younger populations. The primary uncertainty here relates to dosing; research is ongoing to establish the most effective dose for critically ill patients, where certainty remains low regarding a single, universally optimal dose.

Areas of Uncertainty and Research Gaps

Several areas remain uncertain. Comparative evidence is lacking from recent, large-scale trials against the newest antibiotics specifically developed to address highly resistant bacterial strains. Furthermore, the follow-up durations were limited in most primary trials, meaning there is limited information for long-term outcomes regarding the durability of the treatment effect. For some older trials, the evidence quality varies across studies, and sample sizes were modest, meaning the results apply only to the populations studied under those specific conditions.

Frequently Asked Questions (FAQ)

Common questions about Cladex (FAQ)

Q: What is the most common side effect listed for Cladex?

Regulatory documents classify side effects by how often they occur. Common reactions, which may affect up to 1 in 10 people treated, include diarrhoea, nausea, vomiting, and localized reactions such as pain or inflammation at the administration site.


Q: Are there any long-term side effects associated with Cladex use?

Clinical trial follow-up periods are typically limited, indicating that information regarding long-term outcomes after treatment ends is limited. For treatment courses extending beyond seven days, official regulatory information states that haematological monitoring may be considered to check for changes in blood cell counts.


Q: How long does it typically take for a person to notice the effects of Cladex?

Since Cladex is administered by injection, it is rapidly absorbed into the bloodstream. Pharmacokinetic data indicates that the drug reaches high concentrations in the bloodstream within five to thirty minutes of administration, which is a requirement for reliable control of systemic bacterial challenges.


Q: Are there different strengths of Cladex tablets?

Cladex is supplied only as a sterile powder for solution for injection (not as tablets) because the active ingredient is not effectively absorbed when taken orally. The powder is available in multiple strengths, such as 500 mg, 1 g, and 2 g vials, which are reconstituted before administration.


Q: Can Cladex be taken with food, or does it need to be taken on an empty stomach?

Since the medicine must be administered exclusively by injection or infusion (the parenteral route), the concept of taking it with or without food does not apply. This is due to its chemical structure, which is not suited for absorption in the digestive system.


Q: What are the signs of a serious allergic reaction to Cladex?

Signs of a serious allergic reaction, known as anaphylaxis, may include rash, hives, swelling of the mouth, face, lips, tongue, or throat, or difficulty breathing. These signs are associated with severe hypersensitivity, which is a condition warranting immediate medical attention.


Q: How often do people need to have check-ups while taking Cladex?

Official regulatory texts indicate that haematological monitoring (blood count checks) is necessary to consider for treatment courses extending beyond seven days. The frequency of other check-ups is generally determined by the patient’s infection and overall clinical condition.


Q: What is the chance of experiencing a rare side effect of Cladex?

Regulatory documents use standardized definitions to classify adverse reaction rates. A 'rare' reaction is defined as one that may affect less than 1 in 1,000 people but more than 1 in 10,000 people.


Q: Do official sources describe Cladex as having a quick onset of action?

Official sources describe that because the medicine is delivered by injection, it achieves high concentrations in the bloodstream quickly. This rapid distribution is a characteristic consistent with the goal of controlling systemic bacterial challenges.


Q: Does Cladex change the way other medications are absorbed?

Regulatory documentation notes one specific mechanism: Cladex may decrease the level or effect of oral contraceptives by altering the intestinal flora. It is recognized that patients must consider discussing the use of all other medications with a health professional during treatment.


Q: Can Cladex cause mood changes or mental health side effects?

Official labeling notes risks related to the nervous system, including uncommon reactions such as seizures and, particularly in patients with kidney problems, encephalopathy (confusion). Other general mood changes are not typically listed as common effects in official product information.


Q: What are the main ingredients in Cladex besides the active drug?

The active ingredient is Cefotaxime, typically formulated as Cefotaxime sodium. Official labeling highlights the presence of sodium (approximately 48 mg per 1 g vial) as an excipient that must be considered for patients who are on a sodium-restricted diet.


Q: Has there been any research comparing Cladex to placebo?

Studies supporting the use of Cladex include Randomized Controlled Trials (RCTs) and comparative trials. These types of studies represent the standard methodology used by researchers to determine a drug's efficacy.


Q: Can I use Cladex if I have a history of seizures?

Caution is officially advised for patients with a history of seizure disorders. Regulatory documents note that the drug itself has the potential to cause seizures, especially when high doses are used in patients with impaired kidney function.


Q: Does Cladex interact with common over-the-counter pain relievers?

No clinically significant interaction is typically documented in regulatory information with common over-the-counter pain relievers such as acetaminophen (Paracetamol) or ibuprofen. The consideration of all co-administered medications with a health professional remains necessary.


Q: Can Cladex be taken with multivitamins or supplements?

Official regulatory labels do not generally list specific interactions with common multivitamins. However, in patients with severe liver impairment, close monitoring of the blood for signs of Vitamin K deficiency may be necessary to consider.


Q: Is there a generic version of Cladex available?

Yes, the active pharmaceutical ingredient, Cefotaxime, is the official generic name. It is marketed and available from various manufacturers as 'Cefotaxime sodium for injection'.


Q: Is there a risk of dependence or addiction with Cladex?

Cladex is not classified as a controlled substance under federal law. Regulatory information does not associate this antibiotic with risks of dependence or addiction.


Q: Do certain foods need to be avoided while taking Cladex?

While general food restrictions are not typically required, the injection contains a high concentration of sodium. This must be considered for patients who are required to follow a strict sodium-restricted diet, such as those with certain heart conditions.


Q: Can Cladex interfere with laboratory test results?

Yes, official documentation states that Cladex can interfere with certain laboratory tests. For example, it may cause a false positive reaction during the Coombs’ test.


Q: Is Cladex a controlled substance?

No, Cladex is not classified as a controlled substance under federal law by authorities such as the DEA (Drug Enforcement Administration).


Q: Are there warnings about taking Cladex with alcohol?

Official regulatory warnings regarding a specific severe reaction (known as a disulfiram-like effect) with alcohol are not documented for this medicine.


Q: Is the benefit of Cladex considered to outweigh the risks in general?

Regulatory approval of Cladex by authorities such as the FDA and EMA is granted based on the official determination that the benefits of the medicine are considered to outweigh its known risks for its approved therapeutic uses.


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

Pharmacokinetic data shows the elimination half-life of the active substance is approximately 50 to 80 minutes in most adults with normal kidney function. This measure indicates the time required for half of the drug to be cleared from the system.


Q: Does Cladex affect the ability to drive or operate machinery?

Official documentation advises caution regarding driving or operating machinery. This is because the potential for neurological disturbances, such as seizures or encephalopathy (confusion), may impair a person's ability to perform these tasks safely.

How should Cladex be stored and disposed of?

Official Storage and Disposal Requirements

Cladex (Cefotaxime sterile powder) must be stored and handled according to specific regulatory instructions to maintain product stability and safety.

Condition Category Required Regulatory Statement
Temperature Store the dry powder below 25 C. Do not refrigerate or freeze the dry powder.
Protection Keep the product in the original container to protect from light and moisture.
Child Safety Keep out of the sight and reach of children.

The reconstituted solution should ideally be used immediately as it has limited stability. The solution is typically stable for up to 24 hours under refrigeration (2 C to 8 C). The product is for single use only, and any unused solution remaining in the vial must be discarded.

For disposal, the medicine must not be thrown away via wastewater or household trash. Unused or expired Cladex must be disposed of according to local regulatory procedures, which often involves returning it to a pharmacist or using an approved drug take-back program.

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

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