Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
The following indications are restricted to adults.
Ofloxacin is suitable for treatment of the following bacterial infections if these are caused by pathogens sensitive to ofloxacin (see section 5.1):
Consideration should be given to official guidance on the appropriate use of anti-bacterial agents.
The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily.
Up to 400 mg may be given as a single dose, preferably in the morning. Generally, individual doses should be given at approximately equal intervals.
In individual cases it may be necessary to increase the dose to a maximum total dose of 800 mg daily, which should be given as 400 mg twice daily, at approximately equal intervals. This may be appropriate in infections due to pathogens known to have reduced or variable susceptibility to ofloxacin, in severe and/or complicated infections (e.g. of the respiratory or urinary tracts) or if the patient does not respond adequately.
The following doses are recommended:
| Indications | Single and Daily Doses |
|---|---|
| Uncomplicated urethral/ cervical gonorrhoea | 400 mg |
| Uncomplicated lower urinary tract infections | 200 mg-400 mg daily |
| Complicated infections of the upper urinary tract | 400 mg daily, increasing if necessary, to 400 mg twice a day |
| Lower respiratory tract infections | 400 mg daily, increasing, if necessary, to 400 mg twice a day |
| Non-gonococcal urethritis and cervicitis | 400 mg daily |
A single dose of 400 mg of ofloxacin is sufficient for the treatment of uncomplicated gonorrhoea.
Following a normal initial dose, dosage should be reduced in patients with impairment of renal function as determined by creatinine clearance or plasma creatinine level.
| Creatinine Clearance | Plasma Creatinine | Maintenance Dose* |
|---|---|---|
| 20 to 50 ml/min* | 1.5 to 5 mg/dl | 100 mg – 200 mg ofloxacin per day) |
| <20ml/min** | >5 mg/dl | 100 mg ofloxacin per day |
* According to indication or dose interval
** The serum concentration of ofloxacin should be monitored in patients with severe renal impairment and dialysis patients.
Patients undergoing haemodialysis or peritoneal dialysis should be given 100 mg ofloxacin per day.
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:
The excretion of ofloxacin may be reduced in patients with severe hepatic dysfunction.
(e.g. cirrhosis of the liver with ascites). In such cases, it is recommended that the dose should not exceed 400 mg ofloxacin daily, because of possible reduction of excretion.
Ofloxacin is contraindicated for use in children or growing adolescents (see section 4.3).
No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal or hepatic function. (See section 4.4 QT interval prolongation).
Treatment should not exceed 2 months duration.
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.
For oral use.
Ofloxacin tablets should be swallowed whole with sufficient liquid before or during meal times. They should not be taken within two hours of mineral antacids, sucralfate or metal ion preparations (aluminium, iron, magnesium or zinc), didanosine chewable or buffered tablets (for HIV), since reduction of absorption of ofloxacin can occur (see section 4.5).
The most important signs to be expected following acute overdose are CNS symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures increases in 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.
In the case of overdose steps to remove any unabsorbed ofloxacin e.g. gastric lavage, administration of adsorbants and sodium sulphate, if possible during the first 30 minutes, are recommended; antacids are recommended for protection of the gastric mucosa.
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.
Elimination of ofloxacin may be increased by forced diuresis.
2 years.
This medicinal product does not require any special storage conditions.
Aluminium PVC/PVDC blisters and polypropylene bottles with polyethylene tamper evident closure (with optional polyethylene ullage filler).
Obtainable in the following pack sizes: 3, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 30, 50, 100, 250 tablets.
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.
