AMPICOL®

Description

Water-soluble white powder.

Composition

1 g of the drug contains:

active ingredient: colistin sulfate - 1 200 000 IU;

amoxicillin trihydrate – 200 mg;

Excipient: glucose.

Pharmacological properties

ATCvet: QJ01– antibacterials for systemic use. QJ01RA95 polymyxins, combinations with other antibacterials.

A combination of amoxicillin and colistin with synergistic action.

Colistin is a polymyxins antibiotic with bactericidal effect on gram-negative microorganism (E.сolі, Salmonella spp., Pasteurella spp., Haemophіlus spp., Bordetella spp.). The mechanism of action of colistin consists in violation of integrity of cytoplasmic membrane in bacteria. Colistin interacts with phospholipids and penetrates inside, thus, it destroys the cell membrane structure. The bacterial membrane permeability changes right after contact with the drug. Apart from antibacterial effect, colistin binds phospholipid A and neutralizes toxic effect of bacterial endotoxin.

Amoxicillin is a broad-spectrum semi-synthetic antibiotic of the penicillin group.  It has bactericidal effect against gram-positive (Corynebacterіum spp., Erysіpelothrіx spp., Clostrіdіum spp., Streptococcus spp., Staphylococcus spp.) and gram-negative (E.сolі, Campylobacter spp., Actіnobacіllus spp., Haemophіlus spp., Pasteurella spp., Proteus mіrabіlіs, Salmonella spp.) microorganisms. It prevents synthesis of bacteria cell walls, inhibiting the activity of enzymes of transpeptidase and carboxypeptidase, which causes osmotic balance disorders, resulting in death of microorganisms at their growth stage.

Colistin is poorly absorbed from intestine in minor quantities, so it is effective in treatment of diseases of digestive organs. In contrast to low concentrations of colistin in blood serum and tissues, its concentration in various segments of digestive tract is constantly high.   There is a higher concentration of colistin in the colon and cecum than in the oral cavity. Colistin is almost non-systemic absorbed after oral administration. 40% of colistin is unchanged in feces. 60% of colistin binds to phospholipids and liposaccharides of gram-negative bacteria. It is primarily excreted in feces.

Amoxicillin when taken orally is absorbed from the digestive tract in greater amounts than ampicillin. The bioavailability of amoxicillin is 60 - 70%. It is rapidly distributed in body fluids, especially synovial fluid. Plasma protein binding is 37 to 38%. Half-life period makes 0.7-1.4 hours. It is excreted primarily in bile.

Administration

Treatment of calves, goatlings and lambs of up to 3 months of age, in swine and broiler chickens of gastrointestinal diseases caused by amoxicillin- and colistin-sensitive microorganisms.

Dosage

Orally with drinking water in the following doses:

calves, goats and lambs under 3 months old - 5 g of the drug (6,000,000 IU of colistin sulfate and 1 g of amoxicillin trihydrate) per 100 kg of body weight, twice a day for 3-5 days;

broiler chickens, swine - 1 kg of the drug (1,200,000,000 IU of colistin sulfate and 200 g of amoxicillin trihydrate) per 1000 liters of drinking water for 3-5 days.

The drug solution shall be the only source of drinking water throughout the whole treatment period!

Contraindications

Do not administer to animals with hypersensitivity to colistin and amoxicillin as well as to animals with liver and kidney disorders.

Do not administer in combination with ampicillin, chloramphenicol, tetracyclines, sulfonamides, cephalosporin antibiotics, macrolides and aminoglycoside antibiotics.

Do not prescribe in combination with other antibacterials.

Do not administer for prevention.

Do not administer in ruminants with functionally developed fore stomachs, as well as laying hens, whose eggs are used for human consumption.

Do not administer in rabbits, ants, hamsters or other small herbivores.

Precautions

Side effect

In case of the drug in the recommended doses, no side effects are observed.

Possible allergic reactions. In case of allergic reactions, the drug is discontinued and antihistamines are prescribed to the animal; if necessary, carry out symptomatic treatment.

Special precautions for administration

Do not administer to animals with hypersensitivity to drug components.

After preparation of the mother solution using water with high hardness, the formation of turbidity or sediment is possible, which does not affect the therapeutic efficacy of the drug.

Interaction with other drugs or other forms of interaction

Do not prescribe in combination with other antibacterials.

The action of colistin is inhibited by bivalent cations Ba2 +, Ca2 + and Mg2 +; unsaturated fatty acids and ammonium compounds.

Excretion (withdrawal) period

Slaughter of animals and poultry for meat is allowed 11 days (calves, lambs, goats), 8 days (swine) and 3 days (broiler chickens) after the last drug application. Meat, obtained before the mentioned term, shall be utilized or fed to non-productive animals depending on the statement of a veterinary physician.

Packaging

Packages made of film or foil materials of 10 g, 50 g, 100 g, 500 g and 1 kg.

Paper bags of 5 kg, 10 kg, 25 kg and 50 kg.

Storage

Store in a dry dark place out of the reach of children at 5-30 °С.

Shelf life

 2 years.

Use the drug within 30 days following the initial sampling from the package provided it is stored in a dry, dark place at 5-30  С.

Shelf life is 24 hours after dissolution in drinking water.

For veterinary use only!