ICON  Overview
ICON  Mission and Vision
ICON  NoroBio Standard
ICON  Our Culture/Values
ICON  Drug Registration
ICON  Marketing & promotion
ICON  GO & NGO Tender
ICON Finished Medicine
ICON Food supplement
ICON API
ICON  Meet us in CPHI
Betterway
English |  Français  |   Email
Welcome to norobio.com
Home > Products > Finished Medicine > Powder for injection
   - Finished Medicine
  - Tablets & Capsules
  - Powder for injection
  - Others
  - Injections
  - Bio Products
  - SVP
   + Food supplement
   + API
 
 
 Cefuroxime Sodium for Injection (RERAWAY)  
 

QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each vial contains, as the active ingredient, cefuroxime sodium for injection equivalent to 250mg, 750mg or 1.5g of cefuroxime.

 



PHARMACEUTICAL FORM

 

Vials containing an off-white to slightly yellow sterile powder for solution for injection or infusion.

 



Therapeutic indications

 

Cefuroxime sodium for injection is indicated for the treatment of infections caused by susceptible strains of the designated micro-organisms, or before the infecting organism has been identified, in the diseases listed below.

Respiratory tract infections, for example, acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess and postoperative chest infections.

Ear, nose and throat infections, for example, sinusitis, tonsillitis and pharyngitis.

Urinary tract infections, for example, acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria.

Soft tissue infections, for example, cellulitis, erysipelas, peritonitis and wound infections.

Bone and joint infections, for example, osteomyelitis and septic arthritis.

Obstetric and gynaecological infections, pelvic inflammatory disease.

Gonorrhoea, particularly if penicillin is unsuitable.

Other infections, including septicaemia and meningitis.

Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.

Consideration should be given to official local guidance (eg, national recommendations) on the appropriate use of antibacterial agents.

Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.

 

 

Posology and method of administration

 

Usually cefuroxime is effective when administered alone, but when appropriate it may be used in combination with metronidazole or an aminoglycoside.

General Dosage

Adults: Many infections will respond to 750mg three times daily by intramuscular or intravenous injection. For more severe infections this dose should be increased to 1.5g three times daily intravenously. The frequency of dosage may be increased to six-hourly injections, intramuscular or intravenous, giving total daily doses of 3g to 6g.

Infants and children: Doses of 30 to 100mg/kg/day given in three or four divided doses. A dose of 60mg/kg/day will be appropriate for most infections.

Neonates: Doses of 30 to 100mg/kg/day given in two or three divided doses. In the first weeks of life the serum half-life of cefuroxime can be three to five times that in adults.

Gonorrhoea

1.5g should be given as a single dose or as two 750mg injections into different sites, eg, each buttock.

Meningitis

Cefuroxime therapy is suitable for sole therapy of bacterial meningitis due to sensitive strains.

Infants and children: 200 to 240mg/kg/day intravenously in three or four divided doses. This dosage may be reduced to 100mg/kg/day after three days or when clinical improvement occurs.

Neonates: The initial dosage should be 100mg/kg/day intravenously. This dosage may be reduced to 50mg/kg/day after three days or when clinical improvement occurs.

Adults: 3g intravenously every eight hours. No data is currently available to recommend a dose for intrathecal administration.

Prophylaxis

The usual dose is 1.5g intravenously with induction of anaesthesia. For orthopaedic, pelvic and abdominal operations this may be followed with two 750mg doses 8 and 16 hours later. For vascular, cardiac, oesophageal and pulmonary operations this may be supplemented with 750mg intramuscularly three times a day for a further 24 to 48 hours.

In total joint replacement, 1.5g cefuroxime powder may be mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer.

Dosage in Impaired Renal Function

As cefuroxime is excreted by the kidneys, the dosage should be reduced to allow for slower excretion in patients with impaired renal function, once creatinine clearance falls below 20ml/min, as follows:

Marked impairment (creatinine clearance 10 to 20ml/min)

750mg twice daily

Severe impairment (creatinine clearance of less than 10ml/min)*

750mg once daily

Continuous peritoneal dialysis

750mg twice daily

Renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units

750mg twice daily

Low-flux haemofiltration

As for impaired renal function

 

*For patients on haemodialysis, a further 750mg should be given at the end of each dialysis session.

 

© 2010 Noro Bio-Pharmaceutical Co., Ltd. all rights reservedExport Company