PRESOL 20 mg 20 tablets

PRESOL 20 mg 20 tablets

Description

Flat-cylindrical tablets with a score and a bevel, 0.5 g, white to white with a cream tint.

Composition

1 tablet (0.5 g) contains the active ingredient: prednisolone – 20.0 mg. Excipients: microcrystalline cellulose, corn starch, lactose monohydrate, colloidal silicon dioxide, calcium stearate.

Pharmacological properties

ATC vet classification code: QH02 – Corticosteroids for systemic use. QH02AB04 – Prednisolone.

Prednisolone is a synthetic short-acting glucocorticosteroid. It has anti-inflammatory, antiallergic, antishock, desensitizing, gluconeogenic, immunosuppressive and antiproliferative effects. Interacting with specific cytoplasmic receptors, it forms a complex that penetrates the nucleus and induces the formation of proteins, in particular enzymes, that regulate various processes in cells.

The pharmacological action of prednisolone is carried out through the stabilization of cell membranes, inhibition of macrophage accumulation, reduction of leukocyte migration, reduction of capillary permeability, which prevents the formation of edema. Prednisolone inhibits phagocytosis, affects the metabolism of arachidonic acid, as well as the synthesis and release of inflammatory mediators. The immunosuppressive effect of prednisolone is due to the inhibition of the activity of T- and B-lymphocytes, a decrease in the content of complement in the blood, as well as inhibition of the production and effects of interleukin-2. It has a catabolic effect in lymphoid and connective tissues, muscles, adipose tissue, skin and bone tissue, increases the level of glucose in the blood. It exhibits some mineralocorticoid activity, increases the reabsorption of sodium ions and water in the renal tubules, increases the excretion of potassium and calcium ions from the body, especially when their level in the blood plasma increases. Prednisolone inhibits the synthesis and secretion of adrenocorticotropic hormones by the pituitary gland and secondarily glucocorticosteroids by the adrenal glands.

Compared to hydrocortisone, the anti-inflammatory activity of prednisolone is 4 times greater, and the mineralocorticoid activity is 0.6 times less.

Prednisolone is rapidly absorbed from the gastrointestinal tract. It has high bioavailability. The time to reach maximum concentration in blood plasma is 1-2 hours. A significant part of prednisolone (90%) binds to cortisone-binding globulin – transcortin and albumin. It is metabolized in the liver, kidneys, small intestine, bronchi. Oxidized forms of prednisolone are glucuronized or sulfated. The half-life (T1/2) is 2-4 hours. It is excreted by the kidneys mainly in the form of metabolites, up to 20% in unchanged form.

Application

For symptomatic treatment or as an adjunct to the treatment of dogs and cats with inflammatory and immune-mediated diseases: pathologies of the musculoskeletal system; acute infectious and invasive diseases; allergic skin lesions; injuries and surgical operations.

Dosage

The drug is administered orally once a day 15-30 minutes after feeding. The dose and total duration of treatment are determined by the veterinarian individually in each individual case, depending on the severity of the symptoms. The lowest effective dose should be used.

Initial dose 0.5-2 mg prednisolone (active ingredient) per kg body weight per day. For long-term treatment: when the desired effect is achieved after a period of daily dosing, the dose should be reduced to the lowest effective dose. The dose should be reduced by administration every other day and/or by halving the dose at intervals of 5-7 days until the lowest effective dose is reached.

Dogs should be treated in the morning and cats in the evening due to the difference in the rhythm of the day.

Contraindication

Do not use in cases of known hypersensitivity to the components of the drug. Do not use in animals suffering from viral or fungal infections that are not controlled by appropriate treatment. It is not recommended to use the drug in animals with diabetes, liver, kidney or heart failure, gastric and duodenal ulcers, bone fractures and osteoporosis, degenerative eye diseases and/or corneal ulcers, hyperadrenocorticalism; in the presence of arterial hypertension, acute disorders of higher nervous activity, Itsenko-Cushing’s syndrome; during pregnancy.

Overdose

Overdose does not cause any side effects other than those listed below (in the section Warnings. Side effects). Antidote is unknown. Signs of overdose should be treated symptomatically.

Reservation

Side effect

Anti-inflammatory corticosteroids, such as prednisone, are known to have a wide range of side effects. Although single high doses are generally well tolerated, they can cause serious side effects with prolonged use. Dosage for medium- and long-term use should generally be the minimum necessary to control symptoms.

Cushingoid symptoms may occur very frequently, including significant changes in fat, carbohydrate, protein, and mineral metabolism, such as redistribution of body fat, muscle weakness, and osteoporosis.

Based on post-marketing experience and additional data, lethargy, diarrhea and vomiting have been observed very rarely.

During therapy, effective doses often suppress the hypothalamic-pituitary-adrenal axis. After discontinuation of treatment, symptoms of adrenal insufficiency may occur, extending to atrophy of the adrenal cortex, which may result in the animal being unable to cope adequately with stressful situations.

Systemic corticosteroids may rarely cause polyuria, polydipsia, and polyphagia, especially early in therapy. Some corticosteroids may cause sodium and water retention and hypokalemia with prolonged use. Systemic corticosteroids may cause calcium deposits in the skin (cutaneous calcinosis).

Corticosteroids can rarely slow wound healing, and the immunosuppressive effect can weaken resistance to existing infections or exacerbate them.

Gastrointestinal ulceration has been reported very rarely in animals treated with corticosteroids, usually in conjunction with nonsteroidal anti-inflammatory drugs.

Steroids can very rarely cause an enlarged liver (hepatomegaly) with elevated serum liver enzyme levels.

Special precautions for use

In cases where bacterial infection is present, the product should be used in conjunction with appropriate antibacterial therapy.

Due to the pharmacological properties of prednisolone, special caution should be exercised when administering the veterinary drug to animals with weakened immune systems.

Corticosteroids such as prednisone increase protein catabolism and should therefore be administered with caution to old or malnourished animals.

Pharmacologically active doses may cause atrophy of the adrenal cortex, leading to adrenal insufficiency. This may be particularly evident after discontinuation of corticosteroid therapy. Adrenal insufficiency may be minimized by administering therapy every other day, if possible. The dose should be reduced and withdrawn gradually to avoid the development of adrenal insufficiency.

Corticosteroids such as prednisolone should be used with caution in patients with hypertension, epilepsy, previous steroid myopathy, immunocompromised animals, and young animals, as corticosteroids may cause growth retardation.

Use during pregnancy, lactation

Do not use in pregnant animals. Studies in laboratory animals have shown that use in early pregnancy may cause fetal abnormalities. Use in late pregnancy may cause abortion or early delivery.

Glucocorticoids are excreted in milk and may cause growth retardation in young animals. Use during lactation only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other means and other forms of interaction

Phenytoin, barbiturates, ephedrine, and rifampicin may accelerate the metabolic clearance of corticosteroids, leading to decreased blood levels and reduced physiological effect.

Concomitant use of this veterinary medicinal product with non-steroidal anti-inflammatory drugs may lead to exacerbation of gastrointestinal ulcers. Since corticosteroids may impair the immune response to vaccination, prednisolone should not be used concomitantly with vaccines or within two weeks of vaccination.

Prednisolone may cause hypokalemia and therefore increase the risk of cardiac glycoside toxicity. The risk of hypokalemia may be increased if prednisolone is used with potassium-depleting diuretics.

Special precautions

An animal that is being treated with a corticosteroid should not be vaccinated.

Special precautions for persons and service personnel administering the product to animals

Personnel handling the product should follow basic hygiene and safety rules adopted when handling veterinary medicinal products. Wash hands thoroughly immediately after handling the product.

Prednisolone or other corticosteroids may cause hypersensitivity (allergic reactions).

People with known hypersensitivity to prednisolone or other corticosteroids or to any of the excipients should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, especially by a child, seek medical advice immediately and show the package leaflet or label to the physician.

Corticosteroids may cause foetal malformations; therefore it is recommended that pregnant women avoid contact with the veterinary medicinal product.

Forms of incompatibility (main)

It is an insulin antagonist. Should not be used in combination with vaccines due to its immunosuppressive effects.

Release form

20 tablets in a blister, 1 blister in a pack.

Storage

In a dry, dark place inaccessible to children at a temperature of 5 to 25 ° C. Shelf life – 2 years.

For use in veterinary medicine!