3 months to expiry Ghana · FDA Ghana

GEBETAX 500MG INJECTION

CETOTAXIME

FDA/SD.233-030269 500mg

What it does

Cetotaxime is an antibiotic used to treat various bacterial infections.

Commonly used for: bacterial infections, infections of the lungs (pneumonia), infections of the skin, urinary tract infections (UTIs) …

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Registration & product details

Registration no.
FDA/SD.233-030269
Registration date
2023-03-14
Expiry date
2026-11-01
Status
3 months to expiry
Active ingredient
CETOTAXIME
Dosage form
-
Strength
500mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Nectar Lifesciences
Applicant / LTR
GB PHARMA (GH) LIMITED
Country of origin
INDIA
Manufacturer location
WRMQ+5MJ, Barotiwala, Himachal Pradesh 174103, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:42:14 · updated 2026-09-18 04:00:10

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Cetotaxime is an antibiotic used to treat various bacterial infections.

What it treats

  • bacterial infections
  • infections of the lungs (pneumonia)
  • infections of the skin
  • urinary tract infections (UTIs)
  • infections in the blood (sepsis)

How it works

Cetotaxime works by stopping the growth of bacteria, helping to eliminate the infection.

Who it's for

Cetotaxime is for individuals of all ages who have bacterial infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: cetotaxime

Cefotaxime is a third-generation cephalosporin antibiotic that offers broad-spectrum activity against gram-positive and gram-negative bacteria. It is commonly used to treat various infections due to its efficacy, safety profile, and ability to penetrate well into body tissues and fluids, including the central nervous system.

Indications

  • Bacterial meningitis
  • Severe pneumonia
  • Urinary tract infections
  • Sepsis
  • Skin and soft tissue infections
  • Intra-abdominal infections

Dosage

Children: Refer to the BNF for Children for appropriate paediatric dosing guidelines based on age, weight, and clinical condition.

Adults: Refer to the BNF for specific dosage recommendations, which may vary based on the type and severity of the infection.

Mechanism of action

Cefotaxime exerts its antibacterial effect by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, disrupting the transpeptidation process, which is crucial for cell wall structural integrity. This inhibition leads to the lysis and death of the bacteria.

Pharmacodynamics

Cefotaxime demonstrates time-dependent antibacterial activity, meaning that the duration for which the drug concentration remains above the minimum inhibitory concentration (MIC) is critical for its effectiveness. It has a broad spectrum of activity, particularly against Enterobacteriaceae, Streptococcus pneumoniae, and Haemophilus influenzae.

Pharmacokinetics

Cefotaxime is administered parenterally and is rapidly distributed throughout the body, achieving high concentrations in tissues and body fluids. It is primarily eliminated by renal excretion, with about 50-70% of the drug being excreted unchanged in the urine. The half-life is approximately 1 hour in individuals with normal renal function, but it may be prolonged in those with renal impairment.

Contra-indications

  • Hypersensitivity to cefotaxime or any cephalosporin antibiotics
  • History of severe allergic reactions to penicillins
  • Severe renal impairment (without dose adjustment)

Adverse effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Rash
  • Allergic reactions (e.g., anaphylaxis)
  • Neutropenia
  • Thrombocytopenia
  • Elevated liver enzymes
  • Seizures (in cases of overdose or renal impairment)

Interactions

  • Probenecid may increase serum concentrations of cefotaxime
  • Aminoglycosides may have additive nephrotoxicity
  • Oral anticoagulants may have altered effects due to changes in gut flora
  • Cephalosporins may interfere with the effectiveness of live bacterial vaccines

Precautions

  • Use with caution in patients with a history of gastrointestinal disease, particularly colitis
  • Monitor renal function in patients with pre-existing renal impairment
  • Caution in patients with a history of penicillin allergy
  • May cause false-positive results in urinary glucose tests

Pregnancy

Cefotaxime is categorized as pregnancy category B. It should only be used if clearly needed and the benefits outweigh the risks.

Breast-feeding

Cefotaxime is excreted in breast milk in small amounts. Caution is advised when administering to nursing mothers.

Storage

Store at 2-8 degrees Celsius. Protect from light. Reconstituted solutions should be used promptly or stored at 2-8 degrees Celsius for no more than 24 hours.

Formulations

  • Injection: Cefotaxime sodium for injection in various strengths (e.g., 500 mg, 1 g, 2 g)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.