Composition

Each film coated tablet contains:
Ofloxacin ....………...........……….. 200 mg
Excipients: Pre-gelatininized starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, hydroxypropyl methylcellulose, propylene glycol 6000, titanium dioxide.

Therapeutic Indications

EPICOFLOCIN is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms.
EPICOFLOCIN is indicated for the treatment of the following infections when caused by sensitive 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.

Dosage and Administration

General dosage recommendations:
The dose of EPICOFLOCIN is determined by the type and severity of the infection.
The dosage range for adults is: 200-800 mg daily. Up to 400 mg 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.
EPICOFLOCIN tablets should be swallowed with liquid; they should not be taken within two hours of magnesium/aluminium containing antacids, sucralfate, zinc or iron preparations since reduction of absorption of ofloxacin can occur.
Lower urinary tract infection: 200-400 mg daily.
Upper urinary tract infection: 200-400 mg daily increasing, if necessary, to 400 mg twice a day.
Lower respiratory tract infection: 400 mg daily increasing, if necessary, to 400 mg twice daily.
Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
Non-gonococcal urethritis and cervicitis: 400 mg daily in single or divided doses.
Skin and soft tissue infections: 400 mg 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 20-50 ml/minute (serum creatinine: 1.5-5 mg/dl) the dosage should be reduced by half (100-200 mg daily).
If creatinine clearance is less than 20 ml/minute (serum creatinine greater than 5 mg/dl) 100 mg should be given every 24 hours.
In patients undergoing haemodialysis or peritoneal dialysis, 100 mg 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:
EPICOFLOCIN 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.