Zolev (levofloxacin) solution for infusions 5 mg/ml. 100 ml. vial №1

Description

Zolev (levofloxacin) solution for infusions 5 mg/ml. 100 ml. vial №1

Composition

active substance: levofloxacin;

1 ml of solution for infusion contains: levofloxacin hemihydrate equivalent to levofloxacin – 5 mg;

Excipients

sodium chloride, disodium edetate, hydrochloric acid, water for injections.

Dosage form

Solution for infusion.

Basic physical and chemical properties: transparent solution of greenish-yellow color.

Pharmacotherapeutic group

Antibacterial agents of the quinolone group. Fluoroquinolones.

ATC code J01M A12.

Pharmacological properties:

• Pharmacodynamics
  Levofloxacin is a synthetic antibacterial agent from the group of fluoroquinolones, S – enantiomer of a racemic mixture of the drug ofloxacin;
• Mechanism of action
  As an antibacterial drug from the group of fluoroquinolones, levofloxacin acts on the complex of DNA-DNA gyrase and topoisomerase IV;
• Pharmacokinetic / pharmacodynamic ratio
  The degree of bacterial activity of levofloxacin depends on the ratio of the maximum serum concentration (Cmax) or the area under the pharmacokinetic curve (AUC) and the minimum inhibitory (inhibitory) concentration (MIC).
• Mechanism of resistance
  The main mechanism of resistance is due to mutations in the gyr-A genes. In vitro, there is cross-resistance between levofloxacin and other fluoroquinolones.
  Due to the mechanism of action, there is usually no cross-resistance between levofloxacin and other classes of antibacterial agents.

Antibacterial spectrum

The prevalence of resistance may vary geographically and over time for selected species. It is desirable to obtain local information on resistance, especially in the treatment of severe infections. If necessary, you should seek the advice of a specialist, when the local prevalence of resistance is such that the usefulness of the drug, at least in some types of infections, is questionable.

Usually sensitive species

• Aerobic gram-positive bacteria: Staphylococcus aureusmeticillin-sensitive, Staphylococcus saprophyticus, Streptococci, group C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.
• Aerobic gram-negative bacteria: Burkholderia cepacia, Eikenella corrodens, Haemophilus influenzae, Haemophilu sparainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia.
• Anaerobic bacteria: Peptostreptococcus.
• Others: Chlamydophila pneumoniae, Chlamydophila psittaci, Chlamidia trachomatis, Legionella pneumophila, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum.

Species for which acquired (secondary) resistance can be problematic

• Aerobic gram-positive bacteria: Enterococcus faecalis, Staphylococcus aureusmethicillin-resistant, Staphylococcuscoagulasespp.
• Aerobic gram-negative bacteria: Acinetobacter baumannii, Citrobacter freundii, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Morganella morganii, Proteus mirabilis, Providencia stuartii, Pseudomons Seratiga aerugin.
• Anaerobic bacteria: Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgatus, Clostridium difficile.

Other data

Nosocomial infections caused by P.Aeruginosa, may require combination therapy.

Indication

Infections caused by drug-sensitive microorganisms:

• community-acquired pneumonia;
•  complicated skin and soft tissue infections;
•  complicated urinary tract infections (including pyelonephritis);
•  chronic bacterial prostatitis;
•  pulmonary form of anthrax: prevention after contact and treatment.

Contraindication

Hypersensitivity to any component of the drug, to levofloxacin or to other quinolones. Epilepsy, side effects from tendons after previous use of quinolones. Pregnancy and breastfeeding. Children’s age (up to 18 years).

Method of application and dosage

Levofloxacin should be used immediately (within 3 hours) after perforation of the rubber stopper. Protection from light during infusion is not required.

Under room lighting, the solution for intravenous administration can be stored for up to 3 days without protection from light.

Taking into account the biological equivalence of oral and parenteral forms, the same dosage is possible.

The dosage depends on the type and severity of the infection

The recommended dosage is for adults with normal renal function in whom creatinine clearance is greater than 50 ml / minute.

Mixing with other solutions for infusions

Levofloxacin is compatible with the following infusion solutions:

0.9% sodium chloride solution, 5% glucose monohydrate, 2.5% glucose in Ringer’s solution, multicomponent solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

Children

The use of the drug is contraindicated in children and adolescents, as it is possible damage to articular cartilage.

Overdose

Symptoms: dizziness, hallucinations, disturbance of consciousness, confusion, convulsions, tremor, prolongation of the QT interval, increased manifestations of other adverse reactions.

Treatment: symptomatic and supportive. ECG monitoring should be considered as QT interval prolongation is possible. Levofloxacin is not removed by hemodialysis or peritoneal dialysis; there is no specific antidote.

Adverse reactions:

allergic reactions: anaphylactoid shock, urticaria, bronchospasm / dyspnea, allergic pneumonitis, dyspnea, anaphylactic shock;

such reactions can sometimes be observed even after the first dose within minutes or hours after application;

from the skin and subcutaneous tissues: rash, itching, redness of the skin, urticaria, hypersensitivity to sunlight and ultraviolet radiation, severe bullous rashes such as toxic epidermal necrolysis (Lyell’s syndrome), Stevensnapper’s syndrome – John Steps , leukocytoplastic vasculitis;

from the digestive tract and metabolism: nausea, diarrhea;

from the central nervous system: headache, dizziness / vertigo, drowsiness, insomnia, nervousness;

from the cardiovascular system: tachycardia, hypotension;

from the musculoskeletal system: arthralgia, myalgia, tendon lesions, including tendinitis (eg Achilles tendon);

from the liver: increased liver enzymes (ALT / AST, alkaline phosphatase, GGTP);

from the kidneys: increased serum creatinine;

from the blood system: eosinophilia, leukopenia;

from the senses: visual and auditory disorders, ringing in the ears, impaired taste and perception of odors, blurred vision, temporary vision loss, hearing loss, taste and smell, vertigo.

local reactions: changes at the injection site, including redness, pain, phlebitis.

others: phlebitis, asthenia, candidiasis, development of secondary infections;

infections and invasions: mycoses (and proliferation of other resistant microorganisms).