Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Ofloxacin is indicated in adults for the treatment of the following bacterial infections (see sections 4.4 and 5.1):
For the below-mentioned infections ofloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections:
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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.
| Indication | Daily dose regimen (according to severity) | Duration of treatment (according to severity) |
|---|---|---|
| Complicated UTI | 200 mg twice daily (can be increased to 400 mg twice daily) | 7-21 days |
| Pyelonephritis | 200 mg twice daily (can be increased to 400 mg twice daily) | 7-10 days (can be extended to 14 days) |
| Acute prostatitis | 200 mg twice daily (can be increased to 400 mg twice daily) | 2-4 weeks* |
| Chronic prostatitis | 4-8 weeks* | |
| Epididymo-orchitis | 200 mg twice daily (can be increased to 400 mg twice daily) | 14 days |
| Pelvic inflammatory disease | 400mg twice daily | 14 days |
* 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 Tarivid 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.
In patients with impaired renal function, the following oral or I.V. dosages are recommended:
| CREATININE CLEARANCE | UNIT DOSE mg* | NUMBER / 24h | INTERVALS h |
|---|---|---|---|
| 50–20 ml/min | 100–200 | 1 | 24 |
| <20 ml/min** | 100 | 1 | 24 |
| or haemodialysis | or | ||
| or peritoneal dialysis | 200 | 1 | 48 |
* 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:
It is recommended that a maximum daily dose of 400 mg of ofloxacin be not exceeded, because of possible reduction of excretion.
Ofloxacin is not indicated for use in children or growing adolescents.
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)
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 Tarivid 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.
The most important signs to be expected following acute overdosage are CNS symptoms such as confusion, dizziness, impairment of consciousness and seizures, increases QT interval as well as gastrointestinal reactions such as nausea and mucosal erosions.
CNS effects including confusional state, convulsion, hallucination, and tremor have been observed in post marketing experience.
Elimination of ofloxacin may be increased by forced diuresis.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Antacids may be used for protection of gastric mucosa.
A fraction of ofloxacin may be removed from the body with haemodialysis. Peritoneal dialysis and CAPD are not effective in removing ofloxacin from the body. No specific antidote exists.
3 years.
Tarivid IV presented in glass infusion bottles should be protected from light.
Clear, colourless Type I glass vials with grey chlorobutyl rubber closures and aluminium caps containing either 50 ml, 100ml or 200 ml infusion solution.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
