Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**DOSAGES** **Adults:** - Urinary-tract infections, 200 – 400 mg daily preferably in the morning, increased if necessary in urinary-tract infections to 400 mg twice daily. - Lower respiratory-tract infections, 400 mg daily preferably in the morning, increased if necessary to 400 mg twice daily. - Skin and soft-tissue infections, 400 mg twice daily. - Uncomplicated gonorrhoeae, 400 mg as a single dose. - Non-gonococcal urethritis and cervicitis, 400 mg daily in single or divided doses.
ORAL
Medical Information
**INDICATIONS** **AKILEN®** is indicated for severe infections in: - Urinary-tract infections. - Gonococcal and non gonococcal urethritis, gonococcal and non gonococcal cervicitis. - Lower respiratory-tract infections. - Skin and soft tissue infections.
**CONTRA-INDICATIONS** 1. Hypersensitivity to Ofloxacin and quinolone derivatives. 2. Pregnant and nursing women. 3. Prepubertal children.
J01MA01
ofloxacin
Manufacturer Information
EURO ASIA MEDICO PTE. LTD.
PT SANBE FARMA
Active Ingredients
Documents
Package Inserts
Revised package insert - AKILEN Tablet.pdf
Approved: March 4, 2021