Levofloxacin-O 150

Therapeutic indications:

The drug is used for therapeutic purposes in pigs and poultry (broiler chickens, laying hens, and replacement pullets of chickens) for bacterial infections caused by pathogens sensitive to levofloxacin. It is prescribed to pigs for the treatment of diseases of bacterial etiology of the respiratory tract, gastrointestinal tract, urogenital system, skin and soft tissue infections, as well as spirochetosis and mycoplasmal infections; in poultry - for colibacillosis, dysentery, necrotic enteritis, pseudomoniasis, campylobacteriosis, staphylococcosis, pasteurellosis.

Pharmacotherapeutic group:

Naphthyridine derivatives, quinolones, fluoroquinolones.

Dosage form description

Solution for oral administration. In appearance, the drug is a transparent solution ranging from light yellow to dark yellow, with greenish and brownish shades permissible.

Polymer bottles of 1 l and canisters of 5 l.

Composition of the veterinary drug:

1 ml of the drug contains 150 mg of levofloxacin (in the form of levofloxacin hemihydrate) as the active substance.

Pharmacological activity:

Levofloxacin, the active substance of the drug, has a bactericidal effect on gram-positive and gram-negative microorganisms, which leads to the disruption of bacterial growth and division: Enterococcus spp., Listeria monocytogenes, Staphylococcus spp., Streptococcus spp., Acinetobacter spp., Borrelia spp., Campylobacter spp., Enterobacter spp., Escherichia coli, Haemophilus spp., Klebsiella spp., Moraxella catarrhalis β+/β-, Morganella morganii, Pasteurella spp., Proteus spp., Providencia spp., Pseudomonas spp., Salmonella spp., Serratia spp., Bacteroides fragilis, Clostridium perfringens, Fusobacterium necrophorum, Peptostreptococcus spp., as well as Chlamydia spp., Mycobacterium spp., Mycoplasma pneumoniae, Rickettsia spp.

The mechanism of action of levofloxacin is associated with the blockade of DNA gyrase (topoisomerase II) and topoisomerase IV, disruption of superspiralization and cross-linking of deoxyribonucleic acid breaks, inhibition of deoxyribonucleic acid synthesis, and profound metabolic changes in the cytoplasm, cell wall, and membranes. Upon oral administration of the drug, levofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract. Feed intake has little effect on the rate and completeness of absorption. The bioavailability of levofloxacin after oral administration is 99%, the concentration in blood serum reaches a maximum 2 hours after administration, and the half-life is about 7 hours. Levofloxacin penetrates well into organs and tissues, including the lungs, bronchial mucosa, urogenital organs, polymorphonuclear leukocytes, and alveolar macrophages. It is excreted from the body predominantly by the kidneys via glomerular filtration or tubular secretion. It is mainly excreted in the urine unchanged within 48 hours, and in minor amounts with feces within 72 hours.

Dosage:

The drug is administered to pigs and poultry orally individually or in a group method with drinking water at a daily dose of 1 ml of the drug per 20 kg of body weight (which corresponds to 7.5 mg of levofloxacin per 1 kg of body weight) for 3-5 days.

The aqueous solution of the drug is prepared daily in a volume calculated for consumption during the day. During the treatment period, animals and poultry must receive only water containing the drug.

Contraindications:

Contraindicated for use in animals and poultry with increased individual sensitivity to the components of the drug, as well as in case of severe hepatic and/or renal insufficiency.

Overdose:

In case of overdose in animals and poultry, restlessness, disorientation, loss of appetite, nausea, diarrhea, and sometimes tendon damage (including tendinitis), joint and muscle pain may be observed. In these cases, it is necessary to discontinue the use of the drug and prescribe symptomatic therapy.

Pregnancy and lactation:

The drug is not recommended for use in pregnant and lactating sows, as well as newborn piglets, due to the lack of data from studies on its effect on the organism.

Special indications:

No specific features of the action upon the first use of the drug and upon its discontinuation have been identified. Skipping a regular administration of the drug to animals and poultry should be avoided, as this may lead to a decrease in therapeutic efficacy. If a dose is missed, the treatment course must be resumed as soon as possible in accordance with the prescribed dose and treatment regimen. The missed dose of the drug should not be compensated by increasing the dose.

Side effects and individual intolerance:

Side effects and complications when using the drug in accordance with this instruction are generally not observed. In animals and poultry with increased individual sensitivity to the components of the drug, allergic reactions may occur. In this case, the use of the drug is discontinued, antihistamines are prescribed if necessary, and symptomatic treatment is performed.

Interaction with other veterinary medicinal products:

The drug should not be used concurrently with antacids containing magnesium or aluminum, or with preparations containing iron salts, as these may reduce the absorption of levofloxacin in the animal's gastrointestinal tract. A minimum interval of two hours should be observed between the administration of levofloxacin and the aforementioned substances. Concurrent use with glucocorticoids is prohibited due to an increased risk of tendinitis and/or tendon rupture; likewise, the product should not be used with non-steroidal anti-inflammatory drugs (NSAIDs), tetracyclines, or macrolides, as these combinations may enhance the toxic effects of levofloxacin. Concomitant use with vitamin K antagonists, such as warfarin, increases the risk of bleeding.

Withdrawal period:

Slaughter of pigs for meat is permitted no earlier than 9 days, poultry - no earlier than 7 days, and the use of eggs for food purposes - no earlier than 10 days after the last administration of the drug. Meat in case of forced slaughter of animals/poultry earlier than the specified period, as well as eggs obtained before the expiration of the specified period, can be used as feed for carnivorous animals.

Shelf-life:

2 years from the date of manufacture. Use of the drug after the expiration date is prohibited.

Storage conditions:

In a place protected from light at a temperature from 2 °C to 25 °C. The drug should be stored in a place inaccessible to children. After the first opening of the bottle/canister – 28 days subject to storage conditions. The prepared aqueous solution is valid for 24 hours.