AMESOL Film-coated tablet Ref.[28104] Active ingredients: Levofloxacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Amesol is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):

  • Acute bacterial sinusitis.
  • Acute exacerbation of chronic obstructive pulmonary disease including bronchitis.
  • Community-acquired pneumonia.
  • Complicated skin and soft tissue infections.
  • Uncomplicated cystitis (see section 4.4).

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.

  • Acute pyelonephritis and complicated urinary tract infections (see section 4.4).
  • Chronic bacterial prostatitis.
  • Inhalation Anthrax: post exposure prophylaxis and curative treatment (see section 4.4).

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.

4.2. Posology and method of administration

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.

Posology

The following dose recommendations can be given for levofloxacin:

Dosage in patients with normal renal function (creatinine clearance >50 ml/min):

IndicationDaily dose regimen (according to severity) Duration of treatment
Acute bacterial sinusitis500 mg once daily10-14 days
Acute exacerbation of chronic obstructive pulmonary disease including bronchitis.500 mg once daily7-10 days
Community-acquired pneumonia500 mg once or twice daily7-14 days
Acute pyelonephritis500 mg once daily7-10 days
Complicated urinary tract infections500 mg once daily7-14 days
Uncomplicated cystitis250 mg once daily3 days
Chronic bacterial prostatitis500 mg once daily28 days
Complicated skin and soft tissue infections500 mg once or twice daily7-14 days
Inhalation Anthrax500 mg daily8 weeks

Special populations

Impaired renal function (creatinine clearance ≤50ml/min)

Creatinine clearanceDose regimen
250 mg/24 h500 mg/24 h500 mg/12 h
 first dose: 250 mgfirst dose: 500 mgfirst dose: 500 mg
50-20 ml/minthen: 125 mg/24 hthen: 250 mg/24 hthen: 250 mg/12 h
19-10 ml/minthen: 125 mg/48 hthen: 125 mg/24 hthen: 125 mg/12 h
<10 ml/min (including haemodialysis and CAPD)1 then: 125 mg/48 hthen: 125 mg/24 hthen: 125 mg/24 h

1 No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Impaired liver function

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.

Elderly population

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”).

Paediatric population

Amesol is contraindicated in children and growing adolescents (see section 4.3).

Method of administration

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).

4.9. Overdose

Symptoms

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.

Management

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.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store below 30°C.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

None.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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