Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Dosage and Administration:** 1. Urinary tract infections: 200 to 400mg daily, preferably in the morning, increased if necessary in upper urinary tract infections to 400mg twice daily. 2. Lower respiratory tract infections: 400mg daily, preferably in the morning, increased if necessary to 400mg twice daily. 3. Skin and soft tissue infections: 200 to 400mg twice daily. 4. Uncomplicated gonorrhoea: 400mg as a single dose. 5. Non-gonococcal urethritis and cervicitis: 400mg daily in single or divided doses. 6. Renal impairment: When creatinine clearance is 20–50mL/minute, the dosage should be reduced by half (100–200mg). If creatinine clearance is less than 20mL/minute, 100mg should be given every 24 hours. In patients undergoing haemodialysis or peritoneal dialysis, 100mg should be given every 24 hours. 7. Liver impairment: Dose of ofloxacin should be reduced accordingly in patients with impaired liver function.
ORAL
Medical Information
**Indication(s):** For the treatment of infections caused by susceptible strains of microorganism in infections of the urinary tract, lower respiratory tract, skin and soft tissue, gonorrhoea and non-gonococcal urethritis and cervicitis.
**Contraindication(s):** 1. Patient who has shown previous hypersensitivity to this drug or to other quinolone antibiotics. 2. Ofloxacin is contraindicated in patients with a history of epilepsy or with a lowered seizure threshold. 3. Ofloxacin is contraindicated in children or growing adolescents and in pregnant or breast-feeding women.
J01MA01
ofloxacin
Manufacturer Information
YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Y.S.P. INDUSTRIES (M) SDN BHD
Active Ingredients
Documents
Package Inserts
OFCIN FILM COATED TABLET 400MG PI.pdf
Approved: January 13, 2021