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
YUNG SHIN PHARMACEUTICAL IND CO LTD
YSP Industries (M) Sdn Bhd
Active Ingredients
Documents
Package Inserts
OFCIN FILM COATED TABLET 200MG PI.pdf
Approved: January 13, 2021