Polcortolone, pills 4mg, 50pcs

Composition

One tablet contains:

Active ingredient: triamcinolone 4.0 mg

excipients: potato starch-144.2 mg, magnesium stearate-1.8 mg, lactose-200.0 mg

Pharmacological action

Polcortolone is a synthetic glucocorticosteroid, a fluorinated prednisone derivative, which has a strong anti-inflammatory effect. 4 mg triamcinolone is considered to have an anti-inflammatory effect equivalent to 4 mg methylprednisolone,5 mg prednisolone,0.75 mg dexamethasone,0.6 mg betamethasone and 20 mg hydrocortisone.

It has a weak mineralocorticoid effect. Inhibits the development of inflammatory symptoms. Inhibits the accumulation of macrophages, white blood cells and other cells in the area of inflammation. Causes a decrease in capillary permeability. It has an immunosuppressive effect; it inhibits cellular immunological reactions.

Inhibits the secretion of ACTH by the pituitary gland, which leads to a decrease in the production of glucocorticosteroids and androgens by the adrenal cortex.

Increases the catabolism of proteins, causes an increase in the concentration of glucose in the blood, affects lipid metabolism, increases the concentration of fatty acids in the blood serum. With long-term treatment, it is possible to redistribute adipose tissue.

Inhibits the formation of bone tissue, reduces the concentration of calcium in the blood serum, can cause suppression of bone growth in children and adolescents and the development of osteoporosis in patients of all ages.

Indications

1. Endocrinological diseases:

Primary or secondary insufficiency of the adrenal cortex

Congenital adrenal hyperplasia

Subacute thyroiditis

2. Severe allergic diseases that are resistant to other therapies:

Contact dermatitis

Atopic dermatitis

Serum sickness

Hypersensitivity reactions to medicinal products

Year-round or seasonal allergic rhinitis that is resistant to other medications

3. Diseases of the musculoskeletal system:

Psoriatic arthritis

Ankylosing spondylitis

Acute and subacute bursitis

Epicondylitis

Acute tendovaginitis

Post-traumatic osteoarthritis

4. Rheumatic diseases:

Acute rheumatic fever

Rheumatic myocarditis

Rheumatoid arthritis, juvenile rheumatoid arthritis (in cases that are resistant to other treatments)

Polymyalgia rheumatica, Horton’s disease

5. Systemic connective tissue diseases:

Dermatomyositis

Systemic lupus erythematosus

Mesoarteritis granulomatous giant cell

Systemic scleroderma

Nodular periarteritis

Recurrent polychondritis

6. Dermatological diseases:

Exfoliative dermatitis

Bullous dermatitis herpetiformis

Severe seborrheic dermatitis

Severe erythema multiforme (Stevens-Johnson syndrome)

Fungal mycosis

Pemphigus

Severe psoriasis

Severe form of eczema

Pemphigoid

7. Hematological diseases:

acquired autoimmune hemolytic anemia

congenital (erythroid) hypoplastic anemia

anemia due to bone marrow hypoplasia

secondary thrombocytopenia in adults

idiopathic thrombocytopenic purpura (Werlhof’s disease) in adults

hemolysis

8. Liver diseases:

Alcoholic hepatitis with encephalopathy

Chronic active hepatitis

9. Hypercalcemia in malignant neoplasms

10. Oncological diseases:

Leukemias and lymphomas in adults

Acute leukemias in children

11. Neurological diseases:

Tuberculosis meningitis with subarachnoid block or at risk of block (in combination with appropriate antitubercular chemotherapy)

Multiple sclerosis in the acute period

12. Eye diseases (severe acute and chronic inflammatory processes):

Severe sluggish anterior and posterior uveitis

Optic neuritis

Sympathetic ophthalmia

13. Respiratory diseases:

Severe bronchial asthma

Beryllioz

Leffler’s syndrome that cannot be treated by other means

Symptomatic sarcoidosis

Lightning-fast or disseminated pulmonary tuberculosis (in combination with antitubercular chemotherapy)

Aspiration pneumonitis

14. When transplanting organs and tissues-prevention and treatment of graft rejection (in combination with other immunosuppressive drugs).

Use during pregnancy and lactation

Use of glucocorticosteroids during pregnancy is permissible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during breast-feeding, it is recommended to stop breastfeeding.

Contraindications

Systemic fungal infections.

Hypersensitivity to triamcinolone or other components of the drug.

Children under 3 years of age (for this dosage form).

With caution: Polkortolon is prescribed for parasitic and infectious diseases of viral, fungal or bacterial nature (currently or recently transferred, including recent contact with the patient): herpes simplex, herpes zoster (viremic phase), chickenpox, measles, amoebiasis, strongyloidosis (established and suspected), systemic mycosis, active and latent tuberculosis. Use in severe infectious diseases is permissible only against the background of specific therapy. Post-vaccination period (a period lasting 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency conditions (including AIDS, HIV infection).

Diseases of the gastrointestinal tract: esophagitis, gastritis, ulcerative colitis with the threat of perforation or abscessing, diverticulitis, peptic ulcer of the stomach and duodenum, acute or latent peptic ulcer, newly created intestinal anastomosis;

In diseases of the cardiovascular system, including recent myocardial infarction (in patients with acute and subacute myocardial infarction, the spread of necrosis may occur, the formation of scar tissue may slow down and the resulting rupture of the heart muscle), decompensated chronic heart failure, arterial hypertension, hyperlipidemia;

Endocrine diseases: diabetes mellitus (including impaired tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itsenko-Cushing’s disease;

Severe chronic renal and/or hepatic insufficiency, nephrourolithiasis; Hypoalbuminemia and conditions predisposing to its occurrence;

Systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (grade III-IV), polio (except for the form of bulbar encephalitis), open – and angle-closure glaucoma, pregnancy, lactation.

Side effects

The frequency of development and severity of side effects depend on the duration of use, the amount of dose used and the possibility of observing the circadian rhythm of use.

With short-term use of Polcortolone, as well as other glucocorticosteroids, side effects are rarely observed. When using Polcortolone for a long time, the following side effects may develop: :

From the endocrine system:

Secondary adrenal and hypothalamic-pituitary insufficiency (especially during stressful situations, such as illness, trauma, surgery); Itsenko-Cushing syndrome (moon-shaped face, pituitary-type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delayed sexual development and growth suppression in children, menstrual disorders, decreased glucose tolerance, manifestation of latent diabetes mellitus. diabetes mellitus and increased need for insulin or oral hypoglycemic drugs in patients with diabetes mellitus, hirsutism.

From the digestive system:

“Steroid ” stomach and duodenal ulcer with possible perforation and bleeding, pancreatitis, flatulence, erosive esophagitis, digestive disorders, nausea, vomiting, increased or decreased appetite, hiccups. In rare cases-increased activity of “hepatic” transaminases and alkaline phosphatase.

From the cardiovascular system:

Arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of chronic heart failure, ECG-changes characteristic of hypokalemia, arterial hypertension, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction-the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.

Nervous system disorders:

Delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure syndrome congestive nipple of the optic nerve (pseudotumor of the brain – most commonly in children, usually after too rapid dose reduction; symptoms – headache, blurred vision or double vision); vertigo, pseudotumor cerebellum, convulsions, dizziness, headache, nervousness or anxiety, and sleep disorders.

From the side of the senses:

Posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, glaucoma, exophthalmos, a tendency to develop secondary bacterial, fungal or viral infections of the eye, trophic changes in the cornea.

From the side of metabolism:

Negative nitrogen balance due to protein catabolism, hyperglycemia, glucosuria, increased Ca2+ excretion, hypocalcemia, weight gain, increased sweating, sodium and fluid retention in the body (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the musculoskeletal system:

Slowing growth and ossification processes in children (premature closure of epiphyseal growth zones), osteoporosis (very rare – a pathological bone fractures, spinal compression fracture, aseptic necrosis of head of humerus and femur, pathological fracture of long bones), rupture of tendons of muscles, muscle weakness, “steroid” myopathy, reduced muscle mass (atrophy).

From the skin and mucous membranes:

Steroid acne, striae, delayed wound healing, thinning of the skin, petechiae, ecchymosis, hematomas, a tendency to develop pyoderma and candidiasis.

Allergic reactions: skin rash, pruritus, anaphylactic shock.

Other services:

The development and exacerbation of infections (the appearance of this side effect is promoted by jointly used immunosuppressants and vaccination), leukocyturia, withdrawal syndrome.

Interaction

Cardiac glycosides: increased risk of cardiac arrhythmias and glycoside toxicity associated with hypokalemia.

Barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutetimide accelerate the metabolism of glucocorticosteroids (by indicating microsomal enzymes), weaken their effect.

Antihistamines weaken the effect of triamcinolone.

Amphotericin B, carbonic anhydrase inhibitors: hypokalemia, left ventricular myocardial hypertrophy, circulatory failure.

Paracetamol: hypernatremia, peripheral edema, increased calcium excretion, risk of hypocalcemia and osteoporosis. Increased risk of paracetamol hepatotoxicity. Anabolic steroids, androgens: increased risk of developing peripheral edema, acne; use cautiously, especially in the case of liver and heart diseases.

Oral contraceptives containing estrogens: increased

concentration of globulins binding glucocorticosteroids in the blood serum, slower metabolism, increased half-life, increased effect of triamcinolone.

Anticholinergic drugs, mainly atropine: increased intraocular pressure. Anticoagulants (coumarin derivatives, indadione, heparin), streptokinase, urokinase: reduced and in some patients increased efficacy; dose should be determined based on prothrombin time; increased risk of ulceration and bleeding from the gastrointestinal tract.

Tricyclic antidepressants may increase the psychiatric disorders associated with taking triamcinolone. They should not be used to treat these disorders. Oral hypoglycemic drugs, insulin: weakening of the hypoglycemic effect, an increase in the concentration of glucose in the blood; it may be necessary to adjust the dose of hypoglycemic drugs.

Antithyroid drugs, thyroid hormones: changes in the function of the thyroid gland, it may be necessary to adjust the dose or stop taking the antithyroid drug or thyroid hormone.

Diuretics: weakening of the action of diuretics (potassium-sparing),

hypocalemia.

Laxatives: weakening of the effect, hypocalemia.

Ephedrine may accelerate the metabolism of glucocorticosteroids, and it may be necessary to adjust the dose of triamcinolone.

Immunosuppressive drugs: increased risk of infection, lymphoma, and other lymphoproliferative diseases.

Isoniazid: reduced plasma concentrations of isoniazid, mainly in individuals with rapid acetylation; dose adjustment may be necessary.

Mexiletine: increased metabolism of mexiletine and decreased plasma concentrations.

Drugs that block neuromuscular conduction (depolarizing muscle relaxants): hypocalcemia associated with the use of triamcinolone may increase synapse blockade, leading to an increase in the duration of neuromuscular blockade.

Nonsteroidal anti-inflammatory drugs, acetylsalicylic acid, alcohol: weakening the effect, increasing the risk of peptic ulcer disease and bleeding from the gastrointestinal tract.

Medications and foods containing sodium: peripheral edema, arterial hypertension, it may be necessary to limit the diet of sodium and medications with a high sodium content; the use of glucocorticosteroids sometimes requires additional sodium use.

Vaccines containing live viruses: during the use of immunosuppressive doses

of glucocorticosteroids, viral replication and the development of viral diseases, a decrease in antibody production are possible; simultaneous use is not recommended.

Other vaccines: increased risk of neurological complications and reduced antibody production.

Folic acid: increased need for this medication.

How to take, course of use and dosage

The dose of Polcortolone is set individually, depending on the indications, the effectiveness of therapy and the patient’s condition. In accordance with the daily rhythm of endogenous glucocorticoid secretion, the drug is recommended to be taken 1 time a day, in the morning. However, in some cases, it may be necessary to take the drug more frequently. Adults and adolescents over 14 years of age: from 4 to 48 mg / day in one or more doses.

Children: 0.1-0.5 mg / kg of body weight per day in one or several doses.

If you miss a dose, you should take the drug as soon as possible or, if the time for the next dose is approaching, skip the forgotten dose. Do not take a double dose at once.

Polcortolone should be used in the lowest effective doses. If necessary, the dose of the drug should be reduced gradually.

Overdose

Even taking large doses of the drug does not cause acute intoxication, but there is a risk of overdose with prolonged use of Polcortolone, especially in large doses. The main symptoms of overdose are arterial hypertension and peripheral edema. In addition, an overdose of Polcortolone may result in the undesirable effects described above. If symptoms of overdose occur, you should gradually stop taking the drug, as well as conduct symptomatic therapy.

Special instructions

When taking Polcortolone, the patient must strictly follow the doctor’s instructions.

Parenteral use of glucocorticosteroids is recommended for patients taking Polcortolone in case of stressful situations.

Sudden discontinuation of treatment may cause the development of adrenal insufficiency, so the dose of Polcortolone should be reduced gradually.

Polcortolone can mask the symptoms of infection, reduce resistance to infection and the ability to localize it.

Long-term use of Polcortolone increases the risk of secondary fungal or viral infections.

Long-term use of Polcortolone can cause the development of cataracts, glaucoma with possible damage to the optic nerves.

Patients taking Polcortolone should not be vaccinated with live viral vaccines. use of an inactivated viral or bacterial vaccine may not cause the expected increase in the number of antibodies. In addition, patients taking glucocorticosteroids have an increased risk of neurological complications during vaccination.

If Polcortolone is suddenly discontinued, especially after prolonged use, the so-called withdrawal syndrome may develop, which is manifested by anorexia, fever, muscle and joint pain, and general weakness. These symptoms may appear even if there is no insufficiency of the adrenal cortex. In patients with hypothyroidism or cirrhosis of the liver, the effect of triamcinolone is enhanced.

During the use of Polcortolone, mental disorders may occur, such as euphoria, insomnia, sudden mood changes, personality changes, severe depression, and symptoms of psychosis. Pre-existing emotional instability or psychotic tendencies may increase during treatment.

When treating patients with hypoprothrombinemia, triamcinolone and acetylsalicylic acid should be administered with caution simultaneously.

With long-term treatment of children, their growth and development should be monitored.

Special precautions when disposing of an unused medicinal product

Medicines should not be disposed of in sewers or household waste containers. Ask your pharmacist for instructions on how to dispose of unused medication. These activities will help protect the environment.

Influence on the ability to drive vehicles and fur. :

Polcortolone usually does not affect mental reactions. However, it can cause dizziness, headaches, and even mental disorders.

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Triamcinolone

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults by doctor’s prescription, Children by doctor’s prescription, Children over 14 years of age

Indications

Rheumatoid Arthritis, Dermatitis