Levospey


Prescription

Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S(-) enatiomer of
the racemic drug substance ofloxacin.As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA-DNA-gyrase complex and topoisomerase IV.

The degree of the bactericidal activity of levofloxacin depends on the ratio of the maximum
concentration in serum (Cmax) or the area under the curve (AUC) and the minimal inhibitory
concentration (MIC).

The main mechanism of resistance is due to a gyr-A mutation. In vitro there is a cross-resistance
between levofloxacin and other fluoroquinolones. Due to the mechanism of action, there is generally no
cross-resistance between levofloxacin and other classes of antibacterial agents.
It has in vitro activity against a wide range of gram-negative and gram-positive microorganisms.

Composition

Each 100 ml contains:
Levofloxacin Hemihydrate USPeq. to Levofloxacin 500 mg;
Excipients q.s.

Indications for use

should be used with the following indications:
In adults with infections of mild to moderate severity, Levospey infusion are indicated for the treatment
of the following infections when due to levofloxacin-susceptible microorganisms:
– Acute bacterial exacerbations of chronic bronchitis;
– Community-acquired pneumonia;
– Uncomplicated urinary tract infections;
– Complicated urinary tract infections (including pyelonephritis);
– Chronic bacterial prostatitis;
– Inhalation Anthrax: postexposure prophylaxis and curative treatment.

Mode of administration

Levospey solution for infusion is administered by slow intravenous infusion once or twice daily. The
dosage depends on the type and severity of the infection and the susceptibility of the presumed
causative pathogen. Treatment with Levospey after initial use of the intravenous preparation may be
completed with an Levospey the film-coated tablets and as considered appropriate for the individual
patient. Given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
The duration of therapy varies according to the course of the disease. Administration of Levospey
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.
Levospey is only intended for slow intravenous infusion. The infusion time must be at least 30 minutes
for 250 mg or 60 minutes for 500 mg Levospey.
Acute bacterial exacerbations of chronic bronchitis: 250 to 500 mg once daily. Duration of the treatment- 7 – 10 days
Community-acquired pneumonia: 500 mg once or twice daily. Duration of the treatment – 7 – 14 days.
Respiratory, thoracic and mediastinal disorders: bronchspasm, dyspnoea, pneumonitis allergic.
Nervous system disorders: dizziness, headache, somnolence, convulsion, tremor, paraesthesia,
sensory or sensorimotor peripheral neuropathy, dysgeusia including ageusia, parosmia including
anosmia.
Uncomplicated urinary tract infections: 250 mg once daily. Duration of the treatment – 3 days.
Complicated urinary tract infections including pyelonephritis: 250 mg once daily. Duration of the
treatment – 7 – 10 days.
Chronic bacterial prostatitis: 500 mg once daily. Duration of the treatment – 28 days.
Complicated skin and soft tissue infections: 500 mg once or twice daily. Duration of the treatment – 7 –14 days.
Inhalation Anthrax: 500mg once daily. Duration of the treatment – 8 weeks.
Impaired renal function (creatinine clearance < 50 ml/min).