Levofloxacin-O 150

Therapeutic indications:

The drug is used to treat bacterial infections caused by pathogens sensitive to levofloxacin in pigs and poultry (broiler chickens, laying hens and young chickens). Pigs are prescribed for treatment of bacterial diseases of respiratory organs, gastrointestinal tract, urogenital system, skin and soft tissue infections, as well as spirochetosis and mycoplasma infections; poultry in colibacillosis, dysentery, necrotizing enteritis, pseudomonosis, campylobacteriosis, staphylococcosis, pasteurellosis.

Composition of the veterinary drug:

1 ml of the drug contains as active ingredients:

• 150 mg levofloxacin (in the form of levofloxacin hemihydrate)

Pharmacological activity:

The drug belongs to antibacterial agents of fluoroquinolones group.

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

The mechanism of action of levofloxacin is associated with blockade of DNA-gyrase (topoisomerase II) and topoisomerase IV, disruption of superspiralization and cross-linking of deoxyribonucleic acid breaks, inhibition of deoxyribonucleic acid synthesis, deep metabolic changes in cytoplasm, cell wall and membranes.

Upon oral administration, levofloxacin is rapidly and almost completely absorbed from the gastrointestinal tract. Feed intake has little effect on the rate and completeness of absorption. Bioavailability of levofloxacin after oral administration is 99%, concentration in blood serum reaches maximum in 2 hours after administration, half-life is about 7 hours. Levofloxacin penetrates well into organs and tissues, including lungs, bronchial mucosa, urogenital organs, polymorphonuclear leukocytes, alveolar macrophages. It is excreted from the body mainly by the kidneys through tubular filtration or tubule secretionwith urine within 48 hours in unchanged form. Minor amounts are found in the feces over a period of 72 hours.

Dosage:

The drug is administered orally to pigs and poultry individually or in groups with water for drinking 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) during 3-5 days.

Aqueous solution of the drug shall be prepared daily in the volume calculated for daily consumption.

During the treatment period animals and poultry should receive only water containing the drug.

Precautions and adverse reactions:

Adverse reactions are usually not observed. In animals and poultry with increased individual sensitivity to the components of the drug, allergic reactions are possible. In this case, the use of the drug is discontinued and antihistamines are prescribed; symptomatic treatment is given.

Do not use in animals and poultry with severe hepatic and/or renal insufficiency, as well as with increased individual sensitivity to the components of the drug.

In overdose of the drug in animals and poultry there may be restlessness, disorientation, loss of appetite, nausea, diarrhea, sometimes - tendon damage (including tendonitis), joint and muscle pain. In this cases discontinue use of the drug and prescribe means of symptomatic therapy.

Do not use the drug at the same time with antacids containing magnesium and aluminum, as well as with preparations containing iron salts due to possible decrease in absorption of levofloxacin in the gastrointestinal tract of the animal. The recommended time interval between the administration of levofloxacin and the above-mentioned drugs should be at least two hours. Do not use the drug concominantly with glucocorticoids due to increased risk of tendonitis and/or tendon rupture, as well as non-steroidal anti-inflammatory drugs, tetracyclines and macrolides due to increased toxic effect of levofloxacin. Simultaneous use with vitamin K antagonists, e.g. warfarin, increases the risk of bleeding.

After the first administration and cancellation, no peculiarities of the drug use have been revealed.

Avoid missing the next administration of the drug to animals and poultry, as it may lead to decrease of therapeutic efficacy. If administration of the veterinary drug is missed, resume it in the same dosage according to the same treatment scheme as soon as possible. Do not use higher doses to offset a missed one.

The drug is not recommended for use in farrowing and lactating sows, as well as newborn piglets, due to the lack of data on the study of the drug effect on their organism.

Withdrawal period:

Pigs should not be slaughtered for human consumption within 9 days after the last treatment, poultry - 7 days after the last treatment. Eggs should not be used for food purposes withn 10 days after the last drug administration. Meat and eggs obtained before expiration of the specified period, may be used for feeding carnivorous animals.

Storage conditions:

Store in a dark place at a temperature between 2 °C to 25 °C. The drug should be kept out of the reach of children.

Shelf-life:

Shelf-life of the veterinary drug is 2 years from the date of manufacture. Shelf-life after the first opening of the bottle is 28 days under appropriate storage conditions. The prepared working solution should be used within a day.