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Клафоран

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Клафоран

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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.

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Overview of Клафоран

Quick Facts

Property Description
Active ingredient Cefotaxime (as sodium salt)
Form Powder for solution for injection
Pharmacological class beta-Lactam, Third-generation Cephalosporin Antibiotic
Common use Systemic treatment of bacterial infections
Origin Semi-synthetic compound

Клафоран: Classification and Composition of the Medicine

Клафоран is the original trade name for the semi-synthetic medicinal compound Cefotaxime, classified as a prescription-only (Rx) antibiotic belonging to the beta-lactam family. Specifically, it is designated as a third-generation cephalosporin. This status confirms its chemical structure offers enhanced stability against bacterial defense enzymes, such as beta-lactamases, a key differentiating factor from earlier antibiotics.

The active component is Cefotaxime, typically supplied as the sodium salt. The generic substance is recognized globally as an Essential Medicine, underscoring its foundational importance in treating serious infections worldwide. Cefotaxime is a single-ingredient product, relying solely on the validated action of the compound.

Form and General Purpose of Клафоран

Клафоран is supplied exclusively as a sterile lyophilized powder intended for the preparation of an injectable solution. This particular formulation mandates parenteral delivery—meaning administration via intravenous or intramuscular injection—which is a critical feature that ensures rapid, high therapeutic concentrations are achieved within the body.

The fundamental purpose of this medicine is the systemic treatment of serious bacterial infections. Its primary action is bactericidal, actively destroying susceptible bacteria by interfering with the synthesis of their protective cell walls. This mechanism is clinically recognized for its broad-spectrum utility against many Gram-negative and Gram-positive pathogens, offering a robust tool for resolving the underlying microbial cause of disease.

Regulatory References

  1. World Health Organization (WHO)
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What side effects are possible with Клафоран?

Possible Side Effects and Safety Information

The safety profile for Клафоран (Cefotaxime) is characterized by official classifications that detail the nature and frequency of documented adverse reactions, according to regulatory sources.

Adverse Reaction Scope

Adverse events are formally grouped into categories based on the physiological systems affected, such as Blood and Lymphatic System Disorders, Gastrointestinal Disorders, Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders. These groupings structure the comprehensive safety data.

Frequency-Classified Adverse Reactions

Classification Examples of Documented Effects
Very Common Pain at the injection site (Intramuscular)
Common Diarrhea, rash, injection site inflammation, transient elevation of hepatic enzymes, positive Coombs’ test
Uncommon Convulsions (Seizures), leukopenia, eosinophilia, thrombocytopenia
Frequency Not Known Serious bullous skin reactions (e.g., Stevens-Johnson syndrome), acute renal failure, agranulocytosis, encephalopathy, Clostridium difficile-associated diarrhea (CDAD)

Serious Safety Considerations

The official prescribing information designates certain reactions as serious due to their clinical importance. These include severe anaphylactic reactions (shock), neurotoxicity (such as convulsions or encephalopathy), and severe colitis (CDAD).

Exposure and Population Safety Notes

Specific regulatory notes relate to treatment context and patient status. For patients with renal impairment, dose reduction is required due to the increased risk of neurotoxicity. Furthermore, hematologic monitoring is advised for courses of therapy that exceed ten days, as effects like neutropenia and agranulocytosis are associated with prolonged exposure. Co-administration with potentially nephrotoxic agents, such as aminoglycosides, is a safety limitation explicitly documented in regulatory labeling.

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Overdose and Emergency Response

Overdose with Cefotaxime has been officially documented to result in manifestations of neurotoxicity, including encephalopathy, which involves the impairment of consciousness and confusion. High doses, particularly in susceptible individuals, may also lead to convulsions or seizures. Systemic signs such as dyspnea, cyanosis, and hypothermia are also reported in regulatory documentation.

Severe outcomes may involve life-threatening arrhythmia associated with rapid intravenous administration and, in extremely high-dose scenarios, mortality. The risk of neurotoxicity is significantly increased in patients with severe renal insufficiency due to impaired drug clearance, which should be monitored.

Regulatory guidance dictates immediate contact with emergency services if severe symptoms occur, such as collapse, seizure, profound trouble breathing, or the inability to awaken. The official protocol also requires contacting the poison control helpline upon suspected overexposure. The officially described management for overexposure is supportive care, and regulatory documents note that Cefotaxime is largely eliminated by haemodialysis, a documented procedural measure for drug removal in severe cases.

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Therapeutic Uses of Клафоран

What Клафоран Treats: Main Uses and Benefits

Клафоран is commonly used across domains where additional symptomatic support is needed to manage conditions presenting with systemic or localized discomfort. The medication is relevant for easing symptoms linked to organ-specific functional stress in conditions like bloodstream infection (sepsis), meningitis, severe pneumonia, and complicated infections of the urinary tract, bones, and joints. It is also applied when short-term symptomatic assistance is needed in general clinical scenarios, such as its application as prophylaxis relevant to the risk of infection during certain surgical procedures, including Cesarean section.

“The treatment provides support that helps ease the overall symptom burden and may assist with maintaining functional stability during difficult episodes.”

This treatment provides support that generally helps ease the overall symptom burden, particularly by addressing symptom clusters related to systemic imbalance and increased neurological activity.


Quick Fact: Relief for Acute Infection
Primary Use Context Applied in clinical settings that involve acute or unstable symptom patterns.
Symptom Focus Helps manage symptoms of heightened physiological activity and systemic imbalance.
Patient Benefit Supports the patient during difficult episodes by easing distress.

Regulatory References

  1. NIH MedlinePlus overview of Cefotaxime
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Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Клафоран — official regulatory information

Eligibility scope

Populations for whom use is allowed Populations for whom use is contraindicated
Patients of all ages (neonates, infants, children, adults) who do not have a documented contraindication. Individuals with a documented hypersensitivity to Cefotaxime or any other Cephalosporin antibiotic.
Individuals with a known history of severe allergic reaction to Penicillins due to cross-sensitivity risk.
For products containing lidocaine (IM administration): Known allergy to lidocaine, non-paced heart block, severe heart failure, intravenous route, or infants under 30 months of age.

Condition- and Age-Related Eligibility

  • Age-Related Eligibility: Use is established across the entire age spectrum, from neonates to geriatric patients. Specific dosage recommendations apply to premature infants and newborns.
  • Condition-Specific Eligibility: Use is restricted and requires careful dosage adjustment for patients with impaired renal function (e.g., creatinine clearance le 10 mL/min). Caution is also advised for individuals with a history of colitis.

Pregnancy and Lactation Eligibility Status

  • Pregnancy (FDA Category B/AU TGA B1): The medicine should be used during pregnancy only if the anticipated benefit is clearly justified and outweighs the potential risks, as adequate human studies are lacking.
  • Lactation (Breastfeeding): Cefotaxime is excreted into human milk. Use requires caution and a decision to be made, weighing the benefits against the risk of potential effects on the infant.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Клафоран (Cefotaxime) is defined by its effects on renal clearance, risks of compounded toxicity, and specific procedural constraints documented in regulatory labeling.

Documented Interaction Patterns

Interaction Type Interacting Substance(s) Regulatory Outcome / Restriction
Exposure Modification Probenecid (Uricosuric) Inhibits renal tubular transfer, resulting in a documented 2-fold increase in Cefotaxime plasma concentration and reduced clearance.
Additive Toxicity Aminoglycosides (e.g., Gentamicin) and Potent Diuretics (e.g., Furosemide) Risk of potentiated nephrotoxic effects; requires monitoring of renal function in elderly or renally impaired patients.
Formulation Restriction Lidocaine Injection BP Contraindicated for intravenous use when Cefotaxime is reconstituted with Lidocaine.
Timing Constraint Aminoglycoside Solutions Must not be mixed in the same syringe or infusion fluid; requires separate administration.
Lab Test Interference Coombs Test, Urinary Glucose Tests May cause a false positive Coombs test and false positive urinary glucose results with copper reduction methods.

Other Interactions

Co-administration with certain bacteriostatic antibiotics may result in a formal pharmacodynamic antagonism. Furthermore, Cefotaxime may potentially reduce the efficacy of Oral Contraceptives containing estrogen by altering intestinal flora.

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Mechanism of Action

Targeted Destruction of the Bacterial Cell Wall

The primary mechanism of Cefotaxime involves the direct and irreversible covalent inhibition of bacterial Penicillin-Binding Proteins (PBPs), which are essential enzymes for constructing the protective peptidoglycan layer. By blocking the final transpeptidation step, the drug structurally compromises the bacterial cell wall. This failure triggers bacterial autolytic enzymes, leading to the rapid rupture and cell destruction (lysis). This mechanism results in a bactericidal effect, actively destroying susceptible microorganisms.

Structural Evasion of Microbial Defenses

Cefotaxime possesses specific chemical stability that allows it to resist hydrolysis by many common bacterial beta-lactamase enzymes. This key structural feature ensures that the active drug molecule remains intact and available to interact with the PBP target sites. However, the mechanism's action is constrained by highly evolved enzymes, such as Extended-Spectrum beta-Lactamases (ESBLs), which can efficiently cleave the drug's beta-lactam ring, thereby functionally neutralizing its destructive action.

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Dosage and Administration Information

Official Administration Guidelines for Клафоран (Cefotaxime)

The administration of Клафоран (cefotaxime sodium) is strictly by the parenteral route: either Intravenous (IV) injection or infusion, or Intramuscular (IM) injection. It is supplied as a powder for solution that must be reconstituted and, in many cases, further diluted prior to use.

Procedural Steps

  1. Preparation and Inspection: The lyophilized powder must be reconstituted with an appropriate sterile diluent, such as Sterile Water for Injection. The resulting solution should be visually inspected; it typically ranges from very pale yellow to light amber and must be clear of particulate matter. For IM use, 1% Lidocaine solution may be used for reconstitution in adults to reduce pain, but must never be used for IV administration.
  2. Route and Timing:
    • IV Injection: The reconstituted dose should be injected slowly directly into a vein or the tubing of a freely-flowing IV line over a period of 3 to 5 minutes. Rapid IV injection, especially via a central venous catheter, is not recommended.
    • IV Infusion: The reconstituted dose may be diluted further in a compatible IV fluid (e.g., 0.9% Sodium Chloride) and administered as an infusion over 20 to 60 minutes.
    • IM Injection: The dose must be injected deeply into a large muscle mass (e.g., gluteal muscle). Doses larger than 2 g should be divided between two separate injection sites.

Official Dosing Frequency and Rules

Dosage and frequency are determined by the patient's age and condition, and the overall daily dose must not exceed 12 g. The drug is administered at fixed time intervals to maintain therapeutic levels:

  • Adults (and Children ge 50 kg): Doses are typically given every 8 to 12 hours (q8hr to q12hr). In severe or life-threatening cases, the dose may be increased up to 2 g every 4 to 8 hours (q4hr to q8hr).
  • Neonates and Infants: Specific dosing schedules are required due to reduced renal clearance. For example, neonates 0–7 days old typically receive 50 mg/kg every 12 hours, while infants 7 days–1 month old receive 50 mg/kg every 8 hours.
  • Missed Doses: If a scheduled dose is missed, it should be administered as soon as remembered. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped, and the regular dosing schedule resumed; a double dose must not be given.

For surgical infection prophylaxis, a single dose is administered 30 to 90 minutes prior to the procedure.

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Recent Clinical Evidence

Research Evidence: Cefotaxime (Claforan)

Cefotaxime, a third-generation cephalosporin, continues to be evaluated in clinical settings for the treatment of various bacterial infections. Current research focuses on its use in severe infections, its comparative outcomes against other antibiotics, and its safety profile in specific patient populations.


Efficacy in Severe Infections

Studies have documented the use of cefotaxime in treating serious bacterial infections, including meningitis, septicemia, and spontaneous bacterial peritonitis (SBP). Clinical trials of hospitalized patients with serious infections such as pneumonia and complicated urinary tract infections have reported successful clinical and bacteriological responses. For SBP, clinical trials often position cefotaxime as a first-line treatment, though ongoing research compares its outcomes with those of other antibiotics like ceftriaxone or ciprofloxacin.

Comparative Trial Outcomes

Comparative clinical trials have investigated the use of cefotaxime against other antibiotics, particularly other third-generation cephalosporins. Studies comparing cefotaxime and ceftriaxone in the treatment of serious infections in intensive care unit (ICU) patients have indicated similar clinical efficacy and rates of adverse effects between the two agents.

Infection Type Primary Clinical Focus in Research
Sepsis Optimal dosing regimens in neonates and young infants
Meningitis Efficacy against various susceptible bacterial strains
Peritonitis (SBP) Comparative outcomes versus alternative antibiotics

Safety Profile and Tolerability

Safety reviews and large retrospective studies involving thousands of hospitalized children receiving cefotaxime have generally documented a low rate of adverse reactions. The most commonly reported side effects across various clinical trials are local reactions (e.g., pain at the injection site) and mild systemic effects, such as rash or diarrhea. Research continues to monitor for potential hematologic changes, such as neutropenia or leukopenia, which have been reported infrequently with prolonged use.

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Frequently Asked Questions (FAQ)

Common questions about Клафоран (FAQ)

Q: Can Cefotaxime be taken orally in pill form?

According to official product labeling, Cefotaxime is supplied as a lyophilized powder for solution and is approved only for parenteral (Intravenous or Intramuscular) administration. It is not approved or labeled for administration in a pill or oral form.

Q: Does Claforan interact with Tylenol (Acetaminophen)?

Official drug interaction resources generally indicate no known interaction between Cefotaxime and Acetaminophen. This is based on specific interaction studies and regulatory review. Patients are generally advised to discuss all medications they are taking with a healthcare provider.

Q: Why can't Lidocaine be used for IV injections?

Regulatory safety information strictly contraindicates the intravenous (IV) use of Cefotaxime when it has been reconstituted with Lidocaine. This restriction is because the intravascular administration of Lidocaine may lead to serious adverse effects, such as disturbances of cardiac conduction and potentially seizures.

Q: How long does it take for Cefotaxime to start working after the first dose?

Studies and official information indicate that Cefotaxime is designed to enter the bloodstream rapidly. Pharmacokinetic data show that the mean peak concentrations of the drug in the blood are generally achieved within 30 minutes following an intramuscular (IM) injection.

Q: What are the signs of an allergic reaction to Cefotaxime?

Regulatory documents state that signs of a serious allergic reaction may include hives, difficulty breathing, swelling of the face or throat, or a red or purple skin rash that spreads and causes blistering (severe skin reaction). The medication must be discontinued immediately if any signs of a severe allergic reaction occur.

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How should Клафоран be stored and disposed of?

How to Store and Dispose of Claforan (Cefotaxime Sodium)

To ensure product stability, the unopened dry powder must be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), and must be protected from excessive light by being kept in its original outer carton.

Stability and Handling

Once the solution is prepared, it should preferably be used immediately. If necessary, the reconstituted solution may be stored for a maximum of 24 hours under refrigeration (2 C to 8 C). The product must be stored out of the sight and reach of children.

Disposal

Claforan is for single use only. Any unused solution must be discarded after the required storage time has passed. Disposal of the unused product or waste material should be performed in accordance with local requirements for pharmaceutical waste.

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

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