Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION** **General dosage recommendations:** The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200mg to 800mg daily. Up to 400mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Generally, individual doses are to be given at approximately equal intervals. Flovid tablets should be swallowed with liquid; they should not be taken within two hours of magnesium/aluminium containing antacids, sucralfate or iron preparations since reduction of absorption of ofloxacin can occur. **Lower urinary tract infection:** 200 to 400mg daily. **Upper urinary tract infection:** 200 to 400mg daily increasing, if necessary, to 400mg twice a day. **Lower respiratory tract infection:** 400mg daily increasing, if necessary, to 400mg twice daily. **Uncomplicated urethral and cervical gonorrhoea:** A single dose of 400mg. **Non-gonococcal urethritis and cervicitis:** 400mg daily in single or divided doses. **Skin and soft tissue infections:** 400mg twice daily. **Impaired renal function:** Following a normal initial dose, dosage should be reduced in patients with impairment of renal function. When creatinine clearance is 20 – 50ml / minute (serum creatinine 1.5 – 5.0mg/dl) the dosage should be reduced by half (100 – 200mg daily). If creatinine clearance is less than 20ml/minute (serum creatinine greater than 5mg/dl) 100mg should be given every 24 hours. In patients undergoing haemodialysis or peritoneal dialysis, 100mg should be given every 24 hours. **Impaired liver function:** The excretion of ofloxacin may be reduced in patients with severe hepatic dysfunction. **Elderly:** No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal or hepatic function. **Children:** Ofloxacin is not indicated for use in children or growing adolescents. **Duration of treatment:** Duration of treatment is dependent on the severity of the infection and the response to treatment. The usual treatment period is 5 – 10 days except in uncomplicated gonorrhoea, where a single dose is recommended. Treatment should not exceed 2 months duration. Note: The information given here is limited. For further information consult your doctor or pharmacist.
ORAL
Medical Information
**INDICATIONS** Ofloxacin is indicated for the treatment of the following infections when caused by susceptible organisms: upper and lower urinary tract infections; lower respiratory tract infections; uncomplicated urethral and cervical gonorrhoea; non-gonococcal urethritis and cervicitis, skin and soft tissue infections.
**CONTRAINDICATIONS** - This drug is contraindicated in patients who are allergic to ofloxacin or other quinolones and in patients with renal function impairment. - Risk-benefit should be considered in patients with severe hepatic function impairment. - Ofloxacin should not be used in patients with a past history of tendinitis. - Ofloxacin is contraindicated in patients with history of epilepsy or with a lowered seizure threshold. - Ofloxacin is contraindicated in children or growing adolescents, since animal experiments do not entirely exclude the risk of damage to the cartilage of joints in the growing subjects.
J01MA01
ofloxacin
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
HOVID Bhd.
Active Ingredients
Documents
Package Inserts
Flovid 200 PI.pdf
Approved: April 20, 2023