Product Description

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. A daily dose of up to 400 mg ofloxacin may be given as a single dose. In this case, it is preferable to administer ofloxacin in the morning.

Daily doses of more than 400 mg must be divided into two separate doses and be given at approximately equal intervals.

Adults: The usual intravenous dosages in adults are:

Acute exacerbation of chronic bronchitis, community acquired pneumonia: 200 mg twice daily.

Complicated skin and soft tissue infections: 400 mg twice daily.

The dose may be increased to 400 mg twice daily in severe or complicated infections.

* for prostatitis longer duration of treatment may be considered after careful re- examination of the patient.

Ofloxacin tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous ofloxacin.

Ofloxacin solution is only intended for SLOW intravenous infusion; it is administered once or twice daily. The infusion time for Ofloxacin IV should not be less than 30 minutes for 200 mg. This is of particular importance when ofloxacin is administered concomitantly with drugs that can lead to a reduction in blood pressure or with barbiturate-containing anaesthetics. Generally, individual doses are to be given at approximately equal intervals.

Posology in patients with renal insufficiency

In patients with impaired renal function, the following oral or I.V. dosages are recommended:

* According to indication or dose interval.

** The serum concentration of ofloxacin should be monitored in patients with severe renal impairment and dialysis patients.

When creatinine clearance cannot be measured, it can be estimated with reference to the serum creatinine level using the following Cockcroft's formula for adults:
 

Posology in hepatic insufficiency (e.g. cirrhosis with ascites)

It is recommended that a maximum daily dose of 400 mg of ofloxacin be not exceeded, because of possible reduction of excretion.

Children: Ofloxacin is not indicated for use in children or growing adolescents.

Elderly

Age in itself does not impose to adapt the dosage of ofloxacin. However, special attention to renal function should be paid in elderly patients, and the dosage should be adapted accordingly. (See section 4.4 QT interval prolongation)

Duration of treatment: The duration of treatment is determined according to the response of the causative organisms and the clinical picture. As with all antibacterial agents, treatment with Ofloxacin should be continued for at least 3 days after the body temperature has returned to normal and the symptoms have subsided.

In most cases of acute infection, a course of treatment lasting 7 to 10 days is sufficient. Once the patient's condition has improved, the mode of administration should be changed from parenteral to oral, normally at the same total daily dose.

Treatment should not exceed 2 months duration.