Composition

Each film-coated tablet contains:
Norfloxacin ........................
400 mg
Inactive ingredients: Lactose DC anhydrous, croscarmellose sodium, starch 1500, magnesium stearate, sodium lauryl sulphate, talc purified, colloidal silicon dioxide.


Therapeutic Indications

EPINOR is a broad-spectrum, quinolone bactericidal agent indicated for the treatment of:
Upper and lower, complicated and uncomplicated, acute and chronic urinary tract infections.
These infections include cystitis, pyelitis, chronic prostatitis and those urinary infections associated with urological surgery, neurogenic bladder or nephrolithiasis caused by bacteria susceptible to EPINOR.

Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.


Dosage and Administration

EPINOR should be taken with a glass of water at least one hour before or two hours after a meal or milk ingestion.

Multivitamins, products containing iron or zinc, antacids containing magnesium and aluminium, sucralfate or products containing didanosine should not be taken within 2 hours of administration of EPINOR.

Susceptibility of the causative organism to EPINOR should be tested.

However, therapy may be initiated before obtaining the results of these tests.


Diagnosis Dosage Therapy duration
Uncomplicated lower urinary tract infections (e.g.
cystitis) 400 mg twice daily 3 days
Urinary tract infections 400 mg twice daily 7-10 days
Chronic relapsing urinary tract infection 400 mg twice daily Up to 12 weeks

If adequate suppression is obtained within the first 4 weeks of therapy, the dose may be reduced to 400 mg daily.

Patients with renal impairment:
EPINOR is suitable for the treatment of patients with renal impairment.
Clinical studies showed there was no difference in the mean half-life of norfloxacin in patients with a creatinine clearance of less than 10 ml/min/
1.73 m², compared to patients with creatinine clearance of 10-30 ml/min/
1.73 m².
Hence, for these patients, the recommended dose is one 400 mg tablet once daily.
At this dosage, concentrations in appropriate body tissues or fluids exceed the MICs for most pathogens sensitive to norfloxacin.

Use in the elderly:
In the absence of renal impairment, no adjustment of dosage is necessary.
Limited clinical studies have shown norfloxacin to be well-tolerated.