SOFILEX CAPSULE 250mg

Product Information

Registration Status: Active

SOFILEX CAPSULE 250mg is approved to be sold in Singapore with effective from 1998-04-11. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN10378P.

This product contains Cephalexin 250mg in the form of CAPSULE. 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.

Cephalexin

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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank