Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Ibigen S.r.l., Via Fossignano, 2, 04011 Aprilia (LT), Italy
Levofloxacin Ibigen solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
For the above-mentioned infections Levofloxacin Ibigen 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.
The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin Ibigen after initial use of the intravenous preparation may be completed with an appropriate oral presentation according to the SPC of an appropriate oral presentation and as considered appropriate for the individual patient. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
The following dose recommendations can be given for Levofloxacin Ibigen.
Dose in patients with normal renal function (creatinine clearance >50 ml/min):
| Indication | Daily dose regimen (according to severity) | Duration of treatment1 (according to severity) |
|---|---|---|
| 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 |
| Chronic bacterial prostatitis | 500mg 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 |
1 Treatment duration includes intravenous plus oral treatment. The time to switch from intravenous to oral treatment depends on the clinical situation but is normally 2 to 4 days
| Dose regimen | |||
|---|---|---|---|
| 250 mg/24 h | 500 mg/24 h | 500 mg/12 h | |
| Creatinine clearance | 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 Ibigen is contraindicated in children and growing adolescents (see section 4.3).
Levofloxacin Ibigen solution for infusion is administered by slow intravenous infusion once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg Levofloxacin Ibigen solution for infusion (see section 4.4).
For incompatibilities see section 6.2 and compatibility with other infusion solutions see section 6.6.
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 Ibigen solution for infusion are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval.
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. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.
Shelf life: 3 years.
Shelf life after perforation of the rubber stopper: immediate use (see section 6.6).
From a microbiological point of view, the solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Keep the vial in the outer carton in order to protect from light. Inspect visually prior to use. Only clear solutions without particles should be used.
50ml, type 1 glass vial with flanged aluminium cap and bromobutyl rubber stopper.
Each vial contains 50 ml solution for infusion. Pack sizes of 1 and 10 vials.
100ml, type 1 glass vial with flanged aluminium cap and bromobutyl rubber stopper.
Each vial contains 100 ml solution for infusion. Pack sizes of 1 and 10 vials.
Not all pack sizes may be marketed.
Levofloxacin Ibigen solution for infusion should be used immediately (within 3 hours) after perforation of the rubber stopper in order to prevent any bacterial contamination. No protection from light is necessary during infusion.
This medicinal product is for single use only.
The solution should be visually inspected prior to use. It must only be used if the solution is clear, greenish-yellow solution, practically free from particles.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Levofloxacin Ibigen solution for infusion is compatible with the following solutions for infusion:
Combination solutions for parenteral nutrition (amino acids, glucose, electrolytes).
See section 6.2 for incompatibilities.
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