cefotaxime Powder for solution for injection 500 mg, 1 g, 2 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
PICS
Manufacturer #554

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Cefotaxime

Cefotaxime is an antibiotic used in the treatment of a number of bacterial infections. Specifically in the treatment of joint infections, pelvic inflammatory diseases, meningitis, pneumonia, urinary tract infections, sepsis, gonorrhea, and cellulitis. It is specifically prescribed in the treatment of Lower respiratory tract infections like pneumonia, which is most commonly caused, by S. pneumonia or genitourinary system infections - urinary tract infections like E. coli, S. epidermidis, and P. mirabilis and cervical or urethral gonorrhea. It is also used in the treatment of Gynecologic infections like pelvic inflammatory disease, endometritis, and pelvic cellulitis and sepsis-like secondary to Streptococcus spp, S. aureus, E. coli, and Klebsiella spp. It is also used in the treatment of Intra-abdominal infections like peritonitis, in the treatment of bone and joint infections caused by S. aureus, Streptococcus spp and CNS infections like meningitis or ventriculitis secondary to N. meningitides, H. influenzae, S. pneumonia. Cefotaxime is traded under the brand name Claforan among others. Takeda chemical industries ltd discovered it in 1976, and Cefotaxime came into commercial use in 1980. It record on efficacy has earned it a place on the World Health Organization's List of Essential Medicines. It is sold as a generic medication.

Dosage Forms & Strengths

Cefotaxime is given either by injection into a vein or muscle. Its injectable solution is sold in 20mg/mL, 40mg/mL and the powder for injection is for 500mg is sold in 1g, 2g, 10g concentrations. In the treatment of Gonococcal Urethritis or Cervicitis, the standard recommended dose is 0.5 g IM once, and in the treatment of Rectal Gonorrhea, the men are recommended a dose of 1 g IM once and women are prescribed a dose 0.5 g IM once. In the treatment of Infections Caused by Susceptible Organisms of the Uncomplicated types, the standard recommended dose is 1 g IV or IM administered every 12 hours and in the treatment of moderate to severe cases, the dose is 1-2 g IV or IM every 8 hours. In the treatment of More serious bloodstream infections like septicemia the prescribed dose is 2 g IV given every 6-8 hours and in the Life-threatening case, 2 g IV every 4 hours but the maximum daily dose cannot exceed 12 g per day. While preparing Preparation for Surgery, in the treatment of Prophylaxis of surgical infection, the recommended dose is 1 g IM/IV once 30-90 minutes before the start of the procedure.

The price of Cefotaxime

In the USA, consumers pay $56 for a Cefotaxime injectable powder for injection 1 g is around for a supply of 25 powder for injection and Cefotaxime Sodium Injection of 4ml, cost around $1.05 in India.

How does it work?

Cefotaxime is a β-lactam antibiotic, meaning it is related to structural components of the drug molecule itself. β-lactams work by inhibiting bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins. The inhibition leads to the final trans-peptidation of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria lyse due to ongoing activity eventually in the cell wall autolytic enzymes in the absence of cell wall assembly. β-lactams are considered to be bactericidal.

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