Description
Round, green film-coated tablets.
Composition
1 gram of the product contains active substances (mg):
- ademetionine 1,4-butanedisulfonate – 320,0;
- L-ornithine (as L-ornithine hydrochloride) – 180,0;
- milk thistle extract – 70,0.
Excipients: silicon dioxide, calcium stearate, microcrystalline cellulose, potato starch, lactose.
Pharmacological Properties
ATC vet code: QA05 Veterinary drugs used in hepatic and biliary pathology.
Ademetionine 1,4-butanedisulfonate is a salt of ademetionine, a natural amino acid present in all body tissues and fluids.
Ademetionine exhibits choleretic and cholekinetic action, and possesses detoxifying, regenerating, antioxidant, antifibrotic, and neuroprotective properties. The product replenishes the deficit of endogenous S-adenosyl-L-methionine and stimulates its synthesis in the liver and brain. It plays a key role in the body's metabolic processes and participates in important biochemical pathways, particularly in the synthesis of nucleic acids, proteins, and hormones. Ademetionine acts as a methyl group donor in biological transmethylation reactions and activates transsulfuration. The transfer of ademetionine methyl groups (transmethylation) is a crucial metabolic process in the construction of cell phospholipid membranes and plays a role in membrane fluidity. It supports the redox mechanism of cellular detoxification and coenzyme A function. It increases glutamine levels in the liver, as well as cysteine and taurine in the plasma; it reduces serum methionine levels, normalizing metabolic reactions in the liver. Ademetionine increases the level of hepatic glutathione, the most potent antioxidant in the liver, which plays an important role in hepatic detoxification in animals with liver damage.
Ademetionine stimulates cell regeneration and hepatocyte proliferation, reduces the risk of fibrosis, decreases the toxicity of bile acids in the hepatocyte, and increases the solubility and excretion of bile acids from the hepatocyte. In animals with diffuse liver diseases (cirrhosis, hepatitis) accompanied by intrahepatic cholestasis syndrome, ademetionine reduces pruritus and normalizes biochemical parameters (concentrations of direct bilirubin, alkaline phosphatase activity, aminotransferases, etc.).
Ademetionine is able to penetrate the blood-brain barrier. High concentrations of ademetionine influence transmethylation processes, which are vital in brain tissue due to their effect on the metabolism of catecholamines (dopamine, adrenaline, noradrenaline), indolamines (serotonin, melatonin), and histamine.
Following oral administration, ademetionine is well absorbed from the gastrointestinal tract in the form of parent compounds and pharmacologically active hydrolysis products, is widely distributed in the animal's body, and penetrates into the liver and other organs. Folic acid and vitamin B12 are essential cofactors for the metabolism and accumulation of ademetionine. Unmetabolized ademetionine is excreted in the urine and feces.
L-ornithine is an amino acid necessary for the synthesis of urea in the ornithine cycle (formation of urea from ammonia). Ornithine regulates the urea cycle in cats and dogs. It plays a significant role in converting ammonia, formed during the degradation of amino acids, into urea. It reduces the toxicity level of ammonia, which increases during liver diseases, promotes the synthesis of insulin and somatotropin, and activates protein metabolism.
L-ornithine is particularly essential for cats, as amino acids are heavily utilized in their energy production pathways, making deamination processes highly energy-intensive. Ornithine is recommended for cats with diagnosed or suspected hepatic encephalopathy and for animals that have endured prolonged starvation.
The combination of ademetionine and L-ornithine allows for the simultaneous regeneration of liver cells and rapid reduction of ammonia levels, which is critically important in hepatic encephalopathy.
The bioactive components of milk thistle provide hepatoprotective, cholagogic, choleretic, and membrane-stabilizing effects, neutralize free radicals in the liver, prevent the destruction of cellular structures, and specifically stabilize hepatocyte membranes. They specifically stimulate RNA polymerase and activate the synthesis of structural and functional proteins and phospholipids in damaged hepatocytes. They prevent the leakage of intracellular components (transaminases) and accelerate liver cell regeneration. They inhibit the penetration of certain toxins into hepatocytes. They significantly reduce lipid peroxidation activity in hepatocyte membranes, thereby contributing to their strengthening. Milk thistle is used to increase liver resistance to toxic influences, restore its functions, normalize liver enzyme activity, and neutralize the effects of free radicals, toxins, bacteria, and viruses.
Indications
For monotherapy or as part of combination therapy in dogs and cats with chronic hepatitis, liver cirrhosis, hepatic encephalopathy, chronic acalculous cholecystitis and cholangitis, feline triaditis (in cats), intrahepatic cholestasis, fatty dystrophy, toxic lesions of various etiologies, infectious and invasive diseases accompanied by liver damage, during periods of intensive pharmacological treatment, and for liver detoxification, accelerating hepatocyte regeneration, neutralizing and excreting ammonia, improving bile flow, preventing fatty or fibrotic liver degeneration, and normalizing the animal's metabolism.
Dosage and Administration
Administer orally, individually, strictly on an empty stomach, administer directly into the mouth once a day. The frequency of product administration may be adjusted by a veterinarian based on laboratory test results and disease severity.
Depending on the animal's body weight, the following dosing regimen is used:
|
Body weight of the animal
|
Dose of the product
|
Daily dose of active substances
|
|
From 1,0 to 5,0 kg
|
1 tablet weighing 900 mg
|
-
ademetionine
1,4-butanedisulfonate – 96 mg (50
mg of ademetionine cation);
-
L-ornithine –
54 mg;
-
milk thistle
extract – 21 mg
|
|
From 5,1 to 10 kg
|
2 tablets weighing 300 mg
|
-
ademetionine
1,4-butanedisulfonate – 192 mg
(100 mg of ademetionine cation);
-
L-ornithine –
108 mg;
-
milk thistle
extract – 42
mg
|
|
From 10,1 to 15,0 kg
|
1 tablet weighing 900 mg
|
-
ademetionine
1,4-butanedisulfonate – 288 mg
(150 mg of
ademetionine cation);
-
L-ornithine –
162 mg;
-
milk thistle
extract – 63 mg
|
|
30 kg
|
2 tablets weighing 900 mg
|
-
ademetionine
1,4-butanedisulfonate – 576 mg
(300 mg of ademetionine cation);
-
L-ornithine –
324 mg;
- milk thistle extract – 126 mg
|
Animals must be provided with continuous access to drinking water.
The course of treatment lasts 14-30 days, depending on the individual characteristics of the organism and the course of the disease. As prescribed by a veterinarian, the administration of the product can be resumed after 10 days. In chronic disease courses, the treatment is repeated several times a year.
The product may be used as part of combination therapy.
In elderly animals, treatment should be initiated at the lowest recommended dose, taking into account diminished organ and system functions, concomitant pathologies, and the use of other medicinal products.
Contraindications
Hypersensitivity to any component of the product.
Metabolic disorders or deficiency of vitamin B12 and/or folic acid in animals.
Do not use in food-producing animals.
Warnings
Adverse reactions
When the product is used according to the package leaflet, adverse events and complications are generally not observed.
In animals with hypersensitivity to the product's components, the following adverse reactions may occur: diarrhea, vomiting, depression, and pruritus. These symptoms are transient, disappear spontaneously upon discontinuation of the veterinary medicinal product, and do not require the use of other medicinal products.
Special precautions for use
Use the product in accordance with the package leaflet.
Recommended doses must be observed.
Due to the presence of lactose in the veterinary medicinal product, its use in animals with hyperglycemia, diabetes mellitus, and milk allergy is permitted only after consulting a veterinarian.
Use during pregnancy, lactation, lay
The possibility of using the veterinary medicinal product in females during pregnancy and lactation is determined by the attending veterinarian based on a benefit-risk assessment.
Interaction with other medicinal products and other forms of interaction
Interactions of the product with other groups of medicinal products have not been identified. The product may be used as part of combination therapy.
Special precautions for persons pdministering the veterinary medicinal product
When handling the product, adhere to general personal hygiene and safety rules for working with veterinary medicinal products. People with hypersensitivity to the components of DETOXOL® TABS should avoid direct contact with the tablets. In case of allergic reactions and/or accidental ingestion of DETOXOL® TABS, seek medical advice immediately and show the package leaflet or the label to the physician.
Presentation
Tablets weighing 300 and 900 mg in blisters of 10 pieces, with 1, 2, 3, or 5 blisters per package. Polymer containers of 10, 20, 30, or 50 tablets. Secondary packaging - cardboard box.
Storage Conditions
Store in a dry place, protected from light, out of the reach of children, separately from food and feed, at a temperature from 5 to 25 °C.
Failure to comply with temperature storage requirements may reduce the product's efficacy or lead to complete degradation of ademetionine 1,4-butanedisulfonate.
Shelf Life
3 years.
For veterinary use only!