NEOCEF 100MG/5ML

Specifications

Manufacturer

Laboratórios Atral, S.A., Portugal

Applicant company

TV TPI CO. LTD.

Active ingredient

Cefixime (dưới dạng Cefixime trihydrate 112mg/5ml)

Content

100mg/5ml

Shelf life

24 months

Dosage Form

Powder for oral suspension

Package

Box of 1 bottle x 60ml, with a 5ml measuring spoon. Box of 1 bottle x 120ml, with a 5ml measuring spoon

Visa Number

560110331025

Issuing Date

17/07/2025

Therapeutic area

Antibiotics

Indication

Treatment of infections caused by susceptible bacteria as follows:
- Acute exacerbation of chronic bronchitis.
- Community-acquired pneumonia.
- Lower urinary tract infections.
- Pyelonephritis.
Treatment of otitis media, sinusitis, and pharyngitis.
The use of cefixime should be reserved for cases where the causative pathogen is known or suspected to be resistant to commonly used antibiotics, or when treatment failure could pose a significant risk.
Official guidance on the appropriate use of antibacterial agents should be taken into consideration.

Dosage

Adults and children over 10 years of age (weighing more than 50 kg)
The recommended dose is 200 - 400 mg/day depending on the severity of the infection, administered as a single daily dose or in two divided doses.
Elderly patients
Elderly patients should use the same recommended dose as adults. Renal function should be monitored, and dose adjustment is required for patients with severe renal impairment.
Children under 10 years of age (weighing less than 50 kg) - Oral suspension
The recommended dose for children is 8 mg/kg/day administered as a single daily dose or in two divided doses. The recommended daily dose for children by strength and volume is as follows:

Weight (kg) / Age	Daily dose (mg)	Daily dose (ml)
6 months to 1 year	75 mg	3.75 ml
Children from 1 - 4 years	100 mg	5 ml
Children from 5 - 10 years	200 mg	10 ml

Children weighing more than 50 kg or older than 10 years should be treated with the recommended adult dose (200 - 400 mg/day), depending on the severity of the infection.
Children under 6 months of age
The safety and efficacy of cefixime have not been established in children under 6 months of age.
Renal impairment
Cefixime may be administered in the presence of impaired renal function. Patients with creatinine clearance (CrCl) ≥ 20 ml/min may be given the normal dose. In patients with CrCl < 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients maintained on chronic ambulatory peritoneal dialysis or hemodialysis should follow the same recommendation as for patients with CrCl < 20 ml/min.