Composition

1 g of the drug contains the following active ingredients:

lincomycin hydrochloride – 222.0 mg;

spectinomycin sulfate – 444.7 mg.

Excipients: lactose monohydrate, sodium benzoate, colloidal silicon dioxide.

Pharmacological properties

ATC vet classification code QJ01 – antibacterial veterinary drugs for systemic use. QJ01FF52 – lincomycin, combinations.

Lincomycin is a lincosamide antibiotic. It has a bacteriostatic effect against gram-positive (Staphylococcus spp., Streptococcus spp., Bacillus anthracis, Corynebacterium spp., Nocardia spp., Actinomyces spp., Clostridium perfringens) and gram-negative (Actinobacillus spp., Bordetella spp.) microorganisms. It is particularly effective against Serpulina hyodysenteriae and Mycoplasma spp. Lincomycin inhibits the synthesis of microbial cell proteins at the level of the 50S ribosomal subunit.

Spectinomycin is an aminocyclic antibiotic. It is active primarily against gram-negative microorganisms, including E. coli, Pasteurella multocida, Salmonella spp., Clostridium spp., Erysipelothrix rhusiopathiae, Haemophilus spp., Vibrio spp., and mycoplasmas (Mycoplasma spp.). The mechanism of action of spectinomycin is based on binding to the 30S ribosomal subunit of the bacterial cell, which prevents the elongation of the polypeptide chain at the translocation stage.

Lincomycin and spectinomycin work synergically in vitro against anaerobes in the pathogenesis of swine dysentery.

Lincomycin is rapidly absorbed after oral administration in pigs. A single oral dose of lincomycin at approximately 22.55 mg/kg and 100 mg/kg body weight resulted in proportional serum lincomycin concentrations being observed within 24 to 36 hours following administration. Peak plasma concentrations of lincomycin were measured four hours after administration. Similar results were observed after a single oral administration of lincomycin to pigs at doses of 4.4 and 11.0 mg/kg body weight. Lincomycin concentrations were determined over 12-16 hours, with peak concentrations achieved at 4 hours. The bioavailability of lincomycin in pigs after a single oral dose of 10 mg/kg body weight was 53% ± 19%.

Repeated oral administration of lincomycin to pigs at a dose of 22 mg/kg body weight for 3 consecutive days did not result in its accumulation. Additionally, 24 hours after drug administration, its concentration in the blood serum was not detected.

Pharmacokinetic studies in pigs indicate that lincomycin is bioavailable following intravenous, intramuscular, and oral administration. The average half-life for all routes of administration in pigs is 2.82 hours.

In chickens given this drug through drinking water at a dose of 50 mg of total activity (at a lincomycin to spectinomycin ratio of 1:2) per kilogram of body weight for 7 consecutive days, the maximum concentration (C_max) of lincomycin after the first administration of the medicated water was measured at 0.0631 μg/ml. This C_max was reached after 4 hours (t_max). Lincomycin is excreted from the body in feces.

Spectinomycin has limited absorption in the digestive tract, with only about 4-7% absorption after oral administration in chickens and pigs. Within 24 hours of taking the antibiotic, low concentrations can be detected in the kidneys, liver, lungs, muscles, and fat tissue. Spectinomycin binds to plasma proteins by no more than 10% and has low solubility in fats. Its serum concentration reaches its peak after 4 hours. Spectinomycin is practically not metabolized in the body and is excreted unchanged in feces.

Indications

Pigs: treatment of animals with dysentery caused by Brachyspira hyodysenteriae, proliferative enteropathy (ileitis) caused by Lawsonia intracellularis and enteritis caused by Escherichia coli sensitive to lincomycin and spectinomycin.

Chickens (broilers, breeding birds, and replacement chicks): treatment of birds for chronic respiratory diseases caused by Mycoplasma gallisepticum and Escherichia coli that are sensitive to lincomycin and spectinomycin.

Before starting treatment, it is necessary to determine whether the disease is present in the flock or herd.

Dosage

Orally with drinking water once daily at the following doses:

pigs – 3.33 mg of lincomycin and 6.67 mg of spectinomycin per 1 kg of body weight per day, or 15 mg of the drug per 1 kg of body weight per day (1.5 g of the drug per 100 kg of body weight) or 150 g of the drug per 1,500 liters of drinking water. The course of treatment is 5-7 days;

chickens (broilers, breeding birds, replacement chicks) – the recommended dose is 16.65 mg of lincomycin and 33.35 mg of spectinomycin per 1 kg of body weight per day for 5-7 days, or 75 mg of the drug per 1 kg of body weight per day for 5-7 days.

The required amount of SPECTOLIN is calculated using the formula:

m = 0.075 x M of bird,

where: m is the concentration of SPECTOLIN in water (g),

0.075 is the dose of SPECTOLIN (g/kg of bird weight),

M is the total live weight of the bird flock (kg).

Treatment should be started as soon as the first clinical signs appear.

For the preparation of drinking water, the rate of dissolution of the veterinary drug in water will depend on the body weight of the animals and the amount of water consumed.

Accurate determination of average body weight and daily water intake is essential for correct dosing and preventing underdosage in animals.

Medicated water should be the sole source of drinking water during treatment. Water containing the medicinal product that has not been consumed within 24 hours must be disposed of.

Withdrawal period

Pigs can be slaughtered for meat 5 days after the last administration of the drug.

Chickens can be slaughtered for meat 5 days after the last administration of the drug.

Meat obtained before the specified deadline is disposed of or fed to non-productive animals, depending on the conclusion of the veterinarian.

Release form

Polymer foil bags of 1 kg.

Storage

Shelf life: 2 years when stored in the original packaging in a dry, dark place, out of the reach of children and animals, at a temperature of 5 to 25°C.

Shelf life after first opening the primary packaging: 28 days when stored tightly closed in a dark, dry place, out of the reach of children and animals, at a temperature of 15 to 25°C.

Do not freeze!

Shelf life after dissolution in water is 24 hours.

For veterinary use only!