Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Amesol is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
In the above-mentioned infections Amesol should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Amesol 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.
Amesol tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen.
Amesol tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin; given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
The following dose recommendations can be given for levofloxacin:
Dosage in patients with normal renal function (creatinine clearance >50 ml/min):
| Indication | Daily dose regimen (according to severity) | Duration of treatment |
|---|---|---|
| Acute bacterial sinusitis | 500 mg once daily | 10-14 days |
| Acute exacerbation of chronic obstructive pulmonary disease including bronchitis. | 500 mg once daily | 7-10 days |
| Community-acquired pneumonia | 500 mg once or twice daily | 7-14 days |
| Acute 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 daily | 8 weeks |
| Creatinine clearance | Dose 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 dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.
No adjustment of dose 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”).
Amesol is contraindicated in children and growing adolescents (see section 4.3).
Amesol tablets should be swallowed without crushing and with sufficient amount of liquid. They may be divided at the score line to adapt the dosage. The tablets may be taken during meals or between meals. Amesol 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 overdose 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.
60 months.
Store below 30°C.
Amesol 250 mg film-coated tablets are packed in blisters of PVC/Alu of: 3, 5, 7, 10, 50, 90, 100, 200 and 300 tablets.
Amesol 500 mg film-coated tablets are packed in blisters of PVC/Alu of: 3, 5, 7, 10, 50, 80, 90, 200 and 300 tablets.
Not all pack sizes may be marketed.
None.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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