TRIMECOL

powder for oral administration

Description

Water-soluble white powder.

Composition

1 g of the drug contains:

active ingredients: colistin sulfate - 120.000.000 UI

trimethoprim- 50 mg;

Excipients: glucose.

Pharmacological properties

ATCvet: QJ01- antibacterials for systemic use. (QJ01RA95 polymyxins, combinations with other antibacterials)

A combination of trimethoprim 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 destroying 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.

Trimethoprim is a broad-spectrum antimicrobial product of diaminopyrimidine group. It is effective against gram-positive (Staphylococcus spp.; Streptococcus spp.); and negative microorganisms (Escherichia coli, Klebsiella spp., Salmonella spp.; Pasteurella spp.; Enterobacter spp., Proteus spp.; Shigella spp.; Haemophilus spp.; Chlamidia spp.), as well as toxoplasma and coccidia. Its mode of action is associated with inhibition of bacterial reductase of dihydrofolic acid.

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. 60% of colistin binds to phospholipids and liposaccharides of gram-negative bacteria. It is primarily excreted in feces.

Trimethoprim is quickly absorbed from digestive tract and well distributed in body tissues and fluids. Trimethoprim concentrations in tissues are generally higher than in the blood. High levels of Trimethoprim are noted in lungs, kidneys and liver. Trimethoprim concentration in serum reaches its maximum in 1.5 after administration. Average half-life makes about 2.5 hours. Trimethoprim is primarily excreted renally.

Administration

Treatment of diseases of respiratory organs, urinary system and digestive tract caused by trimethoprim- and colistin-sensitive microorganisms in 3-month old calves, goats and lambs, swine, rabbits, chickens and broiler chickens.

Dosage

Orally with drinking water or liquid feed in the following doses:

3-month old calves, goats and lambs, swine, rabbits:  2 - 2.5 g of the drug (colistin - 2,400,000 - 3,000,000 IU, trimethoprim - 100 - 125 mg.) per 10 kg of body weight in two doses (not more than 30 g per day per animal), for 3 days;

chickens: 1-2.5 g of the drug (colistin - 1,200,000 - 3,000,000 IU, trimethoprim - 50 - 125 mg) per 1 l of drinking water (young birds - no more than 1 g per 1 l of drinking water at the beginning of treatment) for 3 days.

Medicated solution shall be the only source of drinking water throughout the whole treatment period.

Contraindications

Do not administer for prevention!

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

Do not administer in combination with aminoglycosides (gentamicin, neomycin), muscle relaxants and anesthetics. Resistance of strains of pathogenic bacteria to colistin and/or trimethoprim belongs to contraindications.

Do not administer to hens, laying eggs for human consumption, as well as ruminants with functionally developed fore stomachs.

Precautions

Side effect

Hypersensitivity is very rare.

At high doses, colistin can cause renal failure.

Special precautions for administration

During treatment, animals are given only water with the drug. The dissolved drug shall be used within 24 hours. Do not prescribe the drug in sub-therapeutic doses and animals with hypersensitivity to the drug components.

As colistin is used in human medicine to treat infections caused by multidrug-resistant bacteria, it shall only be used based on the results of susceptibility testing of microorganisms.

Administration in pregnancy and lactation

The drug in pregnant animals is recommended only when drug benefits outweigh the possible risks at the veterinarian's discretion.  

Do not administer in laying hens, if their eggs are used for human consumption, during the laying period or for up to 4 weeks before egg laying.

Excretion (withdrawal) period

Slaughter of animals and poultry for meat is allowed 10 (calves, lambs, swine, rabbits) and 7 (poultry) days after the last application of the drug. 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, 50, 100, 500 and 1000 g.

Paper bags of 5 and 25 kg.

Storage

Store in a dry, dark place out of the reach of children at 5-25 °С.

Shelf life - 2 years.

24 hours after dissolution in drinking water.

For veterinary use only!