Zolev-500 (levofloxacin) coated tablets 500 mg. №5

Description

Zolev-500 (levofloxacin) coated tablets 500 mg. №5

Composition

active substance: levofloxacin;

1 tablet of Levofloxacin-Teva 500 mg contains 512.46 mg of levofloxacin hemihydrate, which is equivalent to 500 mg of levofloxacin;

excipients:

core: sodium stearyl fumarate, crospovidone, colloidal anhydrous silica, copovidone, microcrystalline cellulose;

film coating: lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide red (E172), iron oxide yellow (E172).

Dosage form

Film-coated tablets.

Main physical and chemical properties: pink, oval, biconvex tablets, size 6 x 13 mm or 8 x 16 mm, film-coated, with a line on one side and on the sides; with engraving “L” on the side without a dash.

Pharmacotherapeutic group

Quinolone antibacterials. Fluoroquinolones.

ATX code J01M A12.

Pharmacological properties

Levofloxacin is characterized by a broad spectrum of antibacterial activity. The bactericidal effect is provided by the inhibition of levofloxacin bacterial enzyme DNA gyrase, which belongs to type II topoisomerases. The result of such suppression is the impossibility of the transition of bacterial DNA from a state of relaxation to a super-twisted state, which, in turn, makes it impossible to further divide (multiply) bacterial cells. The spectrum of activity of levofloxacin includes gram-positive, gram-negative bacteria together with non-fermenting bacteria.

Usually sensitive species:

• Gram-positive aerobes: Bacillus anthracis, Staphylococcus aureus methicillin-sensitive, Staphylococcus saprophyticus, Streptococci, group C and G, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes;
• Gram-negative aerobes: Eikenella corrodens, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella oxytoca, Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri;
• Anaerobes: Peptostreptococcus;
• Others: Chlamydophila pneumonia, Chlamydophila psittaci, Chlamydia trachomatis, Legionella pneumophila, Mycoplasma pneumonia, Mycoplasma hominis, Ureaplasma urealyticum.

Indication

Zolev-500 is indicated for the treatment in adults of the following infections caused by levofloxacin-sensitive microorganisms:

• acute bacterial sinusitis;
• exacerbation of chronic obstructive pulmonary disease, including bronchitis;
• community-acquired pneumonia;
• complicated skin and soft tissue infections;
• uncomplicated cystitis.

In the case of treatment of the above infections, the drug is used only when the use of other antibacterial agents, which are usually prescribed for the initial treatment of these infections, is not possible.

• complicated urinary tract infections and acute pyelonephritis;
• chronic bacterial prostatitis;
• pulmonary form of anthrax: post-exposure prevention and treatment.

Zolev-500 in this dosage form (tablets) can be used to complete the course of therapy in patients who have shown improvement during the initial treatment of Zolev-500 with solution for infusion.

Official guidelines for the proper use of antibacterial agents should be considered.

Contraindication:

• hypersensitivity to levofloxacin, other fluoroquinolones or to any component of the drug;
• epilepsy;
• tendon fluoroquinolone-related tendon injuries;
• children’s age;
• pregnancy and breastfeeding.

Method of application and dosage

Zolev-500 tablets are taken 1 or 2 times a day. The dose depends on the type, severity of the infection and the susceptibility of the probable pathogen.

Zolev-500 in this dosage form (tablets) can be used to complete the course of therapy in patients who have shown improvement during initial treatment with Zolev-500 , solution for infusion, using the same dosage.

The duration of treatment depends on the course of the disease and is not more than 14 days. It is recommended to continue treatment with Zolev-500 for at least 48-72 hours after normalization of body temperature or destruction of pathogens confirmed by microbiological tests.

Zolev-500 tablets should be swallowed without chewing, with plenty of fluids. For ease of dosing, the tablet can be divided by a dividing line. You can take pills with food or at other times.

• acute bacterial sinusitis – 1 time 10-14 days;
• exacerbation of chronic bronchitis of bacterial etiology – 1 time 7-10 days;
• nosocomial pneumonia – 1-2 times 7-14 days;
• pyelonephritis – 1 time 7-10 days;
• complicated urinary tract infections – 1 time 7-14 days;
• uncomplicated cystitis – 1 time 3 days;
• chronic bacterial prostatitis – 1 time 28 days;
• complicated skin and soft tissue infections – 1-2 times 7-14 days;
• pulmonary anthrax – 1 time 8 weeks.

Overdose

• Symptoms. According to animal toxicity studies and clinical pharmacology studies for doses in excess of therapeutic, the most important signs that can be expected after an acute overdose of levofloxacin are central nervous system symptoms (confusion, dizziness, loss of consciousness and seizures). ; reactions from the digestive system, such as nausea and erosion of mucous membranes; possible prolongation of the QT interval.
• Treatment. Treatment is symptomatic. ECG monitoring should be considered as QT interval prolongation is possible. Antacids are used to protect the gastric mucosa. Hemodialysis, including peritoneal dialysis or HAPD, is not effective in removing levofloxacin from the body. There are no specific antidotes.

Side effects

• from the psyche: insomnia;
• from the nervous system: headache, dizziness;
• from the digestive system: diarrhea, vomiting, nausea;
• from the hepatobiliary system: increase in liver enzymes.