Levosinalon
International non-proprietary name:
Levofloxacin
Ingredients:
100 ml of solution contains 512.4 mg of levofloxacin hemihydrate, equivalent to 500 mg of levofloxacin.
Pharmacotherapeutic group: Quinolone group antibacterial agents, fluoroquinolones.
Pharmacological properties:
Pharmacodynamics:
Mechanism of action
Levosinalone, like other antibacterial agents from the fluoroquinolone group, acts on the DNA-gyrase complex and topoisomerase IV.
Resistance mechanism
Resistance to levofloxacin can be acquired through a process that occurs in leaps and bounds through targeted site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Other mechanisms of resistance, such as permeability barriers (as observed in Pseudomonas aeruginosa ) and efflux mechanisms, may contribute to levofloxacin susceptibility.
Cross-resistance between levofloxacin and other fluoroquinolones has been observed. Due to the mechanism of action, there is generally no cross-resistance between other antibacterial drugs and levofloxacin.
Pharmacokinetics:
Absorption
Orally administered levofloxacin is rapidly and almost completely absorbed, reaching peak plasma concentrations within 1-2 hours. Absolute bioavailability is 99-100%.
Food intake has minimal effect on the absorption of levofloxacin.
When taken at a dose of 500 mg once or twice a day, steady-state plasma concentrations are reached within 48 hours.
Distribution
Levofloxacin is approximately 30-40% bound to plasma proteins. The mean volume of distribution of levofloxacin is approximately 100 l after a single dose and repeated administration of a 500 mg dose, indicating extensive distribution into body tissues.
Distribution in tissues and body fluids
Levofloxacin penetrates the bronchial mucosa, epithelial fluid, alveolar macrophages, lung tissue, skin (blister fluid), prostate tissue, and urine. However, levofloxacin penetrates poorly into the cerebrospinal fluid.
Biotransformation
Levofloxacin is metabolized to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide. These metabolites account for less than 5% of the dose excreted in the urine. Levofloxacin is stereochemically stable and does not undergo chiral inversion.
Instructions for use:
Community-acquired pneumonia, complicated skin and soft tissue infections
The use of the drug for the treatment of the above-mentioned infections is possible when the use of antibacterial agents recommended primarily for the treatment of these infections is not appropriate.
Pyelonephritis and complicated urinary tract infections
Chronic bacterial prostatitis
Prevention and treatment after infection with inhalation anthrax (which damages the lungs)
Contraindications:
In patients with hypersensitivity to levofloxacin or any quinolone or to any of the excipients of this medicine; in patients with epilepsy; in patients with tendon problems related to fluoroquinolone treatment; in children and adolescents; pregnancy; lactation period.
Directions for use and dosage:
The dosage of the drug is determined depending on the type of infection, the severity of the infection and the sensitivity of the likely causative pathogen. During treatment with levofloxacin, after the initial intravenous administration, the treatment can be completed with appropriate oral administration. Given the bioequivalence of parenteral and oral forms, the same dosage can be used. Duration of treatment includes intravenous administration followed by oral administration. The transition from intravenous administration to oral treatment depends on the clinical situation, but is usually 2-4 days. Usually levosinalone is given 500 mg once daily 7-14 days depending on the severity of the condition. Levofloxacin infusion solution is administered by slow intravenous infusion once or twice daily. The duration of infusion should be at least 30 minutes for 250 mg and 60 minutes for 500 mg. Levosinalone is compatible with the following infusion solutions: 0.9% sodium chloride solution, 5% glucose injection, 2.5% glucose in Ringer's solution.
Release form:
100 ml of solution in a clear glass vial. 1 vial is packed in a cardboard box with an insert leaflet.
Storage conditions:
Store below 25°C, protected from light. Do not freeze.
Pharmacy discharge condition:
It is available on prescription.
Manufactured for:
OPES HEALTHCARE UK LIMITED 71-75 Shelton Street, London, England, United Kingdom, WC2H 9JQ at OPES HEALTHCARE PRIVATE LIMITED Ahmedabad, Gujarat, India.