Product Information
Registration Status: ActiveSIN10419P
SOFILEX FOR ORAL SUSPENSION 125mg/5ml is approved to be sold in Singapore with effective from 1998-11-16. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN10419P.
This product contains Cephalexin 125mg/5ml in the form of POWDER, FOR SUSPENSION. It is approved for ORAL use.
This product is manufactured by XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD in MALAYSIA.
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
A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of cephaloridine or cephalothin, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.
Indication
For the treatment of respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes; otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis; skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes; bone infections caused by Staphylococcus aureus and/or Proteus mirabilis; genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
Mechanism of Action
Cephalexin, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cephalexin interferes with an autolysin inhibitor.
Pharmacokinetics
- Absorption
- Well absorbed from the gastrointestinal tract
- Distribution
- Metabolism
- No appreciable biotransformation in the liver (90% of the drug is excreted unchanged in the urine).
- Elimination
Toxicity
Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting. The oral median lethal dose of cephalexin in rats is >5000 mg/kg.
Active Ingredient/Synonyms
(6R,7R)-7-{[(2R)-2-amino-2-phenylacetyl]amino}-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 7-(D-alpha-Aminophenylacetamido)desacetoxycephalosporanic acid | 7-beta-(D-alpha-Amino-alpha-phenylacetylamino)-3-methyl-3-cephem-4-carboxylic acid | Anhydrous cefalexin | Anhydrous cephalexin | Cefalexin | Cefalexin anhydrous | Cefalexina | Céfalexine | Cefalexinum | Cephalexin anhydrous | Cephalexin |
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.