Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4 HF, United Kingdom
Levofloxacin Tablets is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
For the above-mentioned infections Levofloxacin Tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Levofloxacin Tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Levofloxacin Tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen.
The duration of therapy varies according to the course of the disease (see table below). As with antibiotic therapy in general, administration of Levofloxacin Tablets should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.
The following dose recommendations can be given for Levofloxacin Tablets:
Dosage in patients with normal renal function (creatinine clearance >50 ml/min):
| Indication | Daily dose regimen (according to severity) | Duration of treatment (according to severity) |
|---|---|---|
| Acute bacterial sinusitis | 500 mg once daily | 10-14 days |
| Acute bacterial exacerbations of chronic bronchitis | 500 mg once daily | 7-10 days |
| Community-acquired pneumonia | 500 mg once or twice daily | 7-14 days |
| Pyelonephritis | 500 mg once daily | 7-10 days |
| Complicated urinary tract infections | 500 mg once daily | 7-14 days |
| Uncomplicated cystitis | 250 mg once daily | 3 days |
| Chronic bacterial prostatitis | 500 mg once daily | 28 days |
| Complicated Skin and soft tissue infections | 500 mg once or twice daily | 7-14 days |
| Inhalation Anthrax | 500 mg once daily | 8 weeks |
| Creatinine clearance | Dosage regimen | ||
|---|---|---|---|
| 250 mg/24 h | 500 mg/24 h | 500 mg/12 h | |
| First dose: 250 mg | First dose: 500 mg | First dose: 500 mg | |
| 50-20 ml/min | Then:125 mg/24 h | Then: 250 mg/24 h | Then: 250 mg/12 h |
| 19-10 ml/min | Then: 125 mg/48 h | Then: 125 mg/24 h | Then: 125 mg/12 h |
| <10 ml/min (including haemodialysis and CAPD)1 | Then: 125 mg/48 h | Then: 125 mg/24 h | Then: 125 mg/24 h |
1 No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
No adjustment of dosage is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function (see section 4.4 “Tendinitis and tendon rupture” and “QT interval prolongation”).
Levofloxacin is contraindicated in children and growing adolescents (see section 4.3).
Levofloxacin Tablets should be swallowed without crushing and with sufficient amount of liquid. They may be divided at the score line to adapt the dose. The tablets may be taken during meals or between meals. Levofloxacin Tablets should be taken at least two hours before or after iron salts, zinc salts, magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents), and sucralfate administration since reduction of absorption can occur (see section 4.5).
According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdosage of levofloxacin are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval as well as gastro-intestinal 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 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. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.
Shelf life: 3 years.
This medicinal product does not require any special storage conditions.
Tablets are packed in PVC/aluminium blisters.
For 250 mg, the tablets are provided in pack sizes of 1, 2, 3, 5, 7, 10, 30, 50 and 200 tablets.
Not all pack sizes may be marketed.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
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