Product Information
Registration Status: ActiveSIN14723P
CEFEPIME SANDOZ POWDER FOR SOLUTION FOR INJECTION/INFUSION 1G/VIAL is approved to be sold in Singapore with effective from 2015-01-22. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN14723P.
This product contains Cefepime 1g/vial in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS, INTRAMUSCULAR use.
This product is manufactured by Sandoz Industrial Products GmbH (Sterile Bulk) in GERMANY, andSandoz GmbH (Finished Dosage Form) in AUSTRIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Cefepime is a fourth-generation cephalosporin antibiotic developed in 1994. Cefepime has an extended spectrum of activity against Gram-positive and Gram-negative bacteria, with greater activity against both Gram-negative and Gram-positive organisms than third-generation agents. Cefepime is usually reserved to treat severe nosocomial pneumonia, infections caused by multi-resistant microorganisms (e.g. Pseudomonas aeruginosa) and empirical treatment of febrile neutropenia.
Indication
For the treatment of pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species. Also for empiric treatment of febrile neutropenic patients and uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms. Also for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes and complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
Mechanism of Action
Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).
Pharmacokinetics
- Absorption
- The absolute bioavailability of cefepime after an IM dose of 50 mg/kg was 82.3 (±15)% in eight patients.
- Distribution
- * 18.0 ±2.0 L * 0.3 ±0.1 L/kg [Pediatric]
- Metabolism
- Hepatic. Cefepime is metabolized to N-methylpyrrolidine (NMP) which is rapidly converted to the N-oxide (NMP-N-oxide).
- Elimination
Clearance
* 120 mL/min [Healthy adult male receiving a single 30-minute IV infusions of cefepime] * 3.3 +/-1.0 mL/min/kg [Petriatic patients (2 months – 11 years of age) receiving a single IV dose]
Toxicity
Symptoms of overdose include seizures, encephalopathy, and neuromuscular excitability.
Active Ingredient/Synonyms
(6R,7R)-7-{[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-[(1-methylpyrrolidinium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate | Cefepima | Cefepime | Cefepimum | Cefepime |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.