501 tablets. (Tramtsynolon)

release form

tablets



packaging 50 pcs

Pharmacological action

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

Has a weak mineralocorticoid effect. It inhibits the development of symptoms of inflammation. It 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 and inhibits cellular immunological reactions.

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

Enhances protein catabolism, causes an increase in blood glucose concentration, affects lipid metabolism, increases the concentration of fatty acids in blood serum. With prolonged treatment, redistribution of adipose tissue is possible.

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 adrenocortical insufficiency

Congenital adrenal hyperplasia

Subacute thyroiditis

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

Contact dermatitis spermatozoa allergic dermatitis resistant to other drugs

3. Diseases of the musculoskeletal system:

Psoriatic arthritis

Ankilozi uyuschy spondiloartirit

Acute and subacute bursitis

Epicondylitis

Acute tenosynovitis



4. Post-traumatic osteoarthritis, rheumatic disease:

Acute rheumatic fever

Rheumatoid arthritis Rheumatoid

myocarditis, juvenile rheumatoid arthritis (in cases resistant to other methods of treatment)

Rheumatic polymyalgia, Horton's disease

5. Systemic diseases of the connective tissue:

Dermatomyositis

Systemic lupus erythematosus

Mesoarteritis granulomatous hypercritical diseases:

Exfoliative dermatitis

Herpetiform bullous dermatitis

Severe seborrheic dermatitis

Severe erythema multiforme ( Stevens-Johnson syndrome)

Mushroom mycosis

Pemphigus

Severe psoriasis

Severe eczema

Pemphigoid

7. Hematologic diseases:

acquired autoimmune hemolytic anemia

congenital (erythroid) hypoplastic anemia

anemia due to bone marrow hypoplasia

secondary thrombocytopenia in adults

idiopathic thrombocytopenic purpura (thrombocytopenic purpura disease) in adults

hemolysis

8. Liver disease:

Alcoholic hepatitis with encephalopathy

Chronic active hepatitis

9. Hypercalcemia in malignant neoplasms

10. Oncological diseases:

Leukemia and lymphoma in adults

Acute leukemia in de s

11. Neurological diseases:

Tuberculous meningitis with subarachnoid block or block threat (in conjunction with appropriate antituberculosis chemotherapy)

sclerosis in acute

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

Severe sluggish anterior and posterior uveitis

Optic neuritis

Sympathetic ophthalmia

13. Respiratory diseases:

Bronchial asthma, severe srdlkrp Splendoridae Berryllosis Non-leukocytosis Berryllid syndrome Symptomatic

sarcoidosis Lightning-fast or disseminated pulmonary tuberculosis (in combination with anti-TB chemotherapy)

Aspiration pneumonitis

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

Contraindications

Systemic fungal infections.

Hypersensitivity to triamcinolone or other components of the drug.

Children's age up to 3 years (for this dosage form).

Caution:

Polcortolone is prescribed for parasitic and infectious diseases of a 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 (period of 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 abscess formation, diverticulitis, peptic ulcer of the stomach and duodenum, acute or latent peptic ulcer, recently created intestinal anastomosis

including cardiovascular diseases recently transferred myocardial infarction (in patients with acute and subacute myocardial infarction, the spread of the focus of necrosis, slowing the formation of scar tissue and, as a result, rupture heart muscle), decompensated chronic heart failure, arterial hypertension, hyperlipidemia

Endocrine diseases: diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease

Severe chronic renal and / or liver failure, nephrourolithiasis, its prevalence and acute acute psychosis, obesity (III-IV century), poliomyelitis (except for the form of bulbar encephalitis), open-angle and angle-closure glaucoma, pregnancy, lactation.

Use during pregnancy and lactation

Acceptance of glucocorticosteroids during pregnancy is permissible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. If you need to use the drug while breastfeeding, it is recommended to stop breastfeeding.

Composition

One tablet contains:

active substance: triamcinolone 4.0 mg

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

Dosing and Administration

The dose of Polcortolone is set individually, depending on the indications, the effectiveness of the therapy and the patient's condition. In accordance with the daily rhythm of secretion of endogenous glucocorticosteroids, the drug is recommended to be taken once a day, in the morning. However, in some cases, more frequent use of the drug may be necessary. 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 more doses.

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

Polcortolone should be used in minimally effective doses. If necessary, the dose should be reduced gradually.

Side effects

The frequency of development and severity of side effects depend on the duration of use, the size of the dose used and the ability to comply with the circadian rhythm of the appointment.

With short-term use of Polcortolone, like other glucocorticosteroids, side effects are rare. 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’s 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 irregularities, decreased glucose tolerance, manifestation of latent diabetes mellitus and increased need for insulin or oral hypoglycemic drugs in patients with diabetes mellitus, hirsutism.

From the digestive system:

Steroid ulcer of the stomach and duodenum with possible perforation and bleeding, pancreatitis, flatulence, erosive esophagitis, digestive disorders, nausea, vomiting, increased or decreased appetite, hiccups. In rare cases, an increase in the 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.

From the nervous system:

Delirium, disorientation, euphoria, hallucinations, manic-depressive -psychosis, depression, paranoia, increased intracranial pressure with optic nerve congestion syndrome (pseudotumor of the brain - most often in children, usually after reducing the dose too quickly symptoms - headache, impaired visual acuity or double vision) vertigo, pseudotumor of the cerebellum, cramps, dizziness, headache, nervousness or anxiety, sleep disturbances.

From the sensory organs:

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 eyes, trophic changes in the cornea.

Metabolism:

Negative nitrogen balance as a result of protein catabolism, hyperglycemia, glucosuria, increased excretion of Ca2 +, hypocalcemia, increased body weight, increased sweating, sodium and fluid retention (peripheral edema), hypernatremia, hypokalemia ( arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the musculoskeletal system:

Slowing of growth and processes of ossification in children (premature closure of the pineal gland), osteoporosis (very rarely pathological bone fractures, compression fracture of the spine, aseptic necrosis of the head of the humerus and femur, pathological fractures of the long tubular bones ), tendon rupture of muscles, muscle weakness, steroid myopathy, decreased muscle mass (atrophy).

From the skin and mucous membranes:

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

Allergic reactions: skin rash, itching, anaphylactic shock.

Other:

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

Drug Interaction

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

Barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutethimide accelerate the metabolism of glucocorticosteroids (by indicating microsomal enzymes), attenuate their action.

Antihistamines weaken the action of triamcinolone.

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

Paracetamol: hypernatremia, peripheral edema, increased calcium excretion, risk of hypocalcemia and osteoporosis. Increased risk of hepatotoxicity of paracetamol. Anabolic steroids, androgens: increased risk of developing peripheral edema, acne should be used with caution, especially in the case of liver and heart disease.

Oral contraceptives containing estrogens: increase in

concentration of globulins binding glucocorticosteroids in serum, slowing of metabolism, increase of half-life, increase of action of triamcinolone.

Cholinergic drugs, mainly atropine: increase in intraocular pressure. Anticoagulants (coumarin derivatives, indadione, heparin), streptokinase, urokinase: decrease, and in some patients the increase in efficacy should be determined on the basis of prothrombin time, increasing the risk of ulcer and bleeding from the gastrointestinal tract.

Tricyclic antidepressants can increase the mental disorders associated with triamcinolone intake. They should not be used to treat these disorders. Oral hypoglycemic drugs, insulin: weakening of hypoglycemic action, increase in blood glucose concentration may be necessary to adjust the dose of hypoglycemic drugs.

Antithyroid drugs, thyroid hormones: Changes in thyroid function may require dose adjustment or discontinuation of thyroid drug or thyroid hormone.

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

hypokalemia.

Laxatives: attenuation, hypokalemia.

Ephedrine may accelerate glucocorticosteroid metabolism, triamcinolone dose adjustment may be required.

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

Isoniazid: A decrease in the plasma isoniazid concentration, mainly in individuals with rapid acetylation, may require a dose change.

Mexiletine: accelerated metabolism of mexiletine and decreased plasma concentrations.

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

Nonsteroidal anti-inflammatory drugs, acetylsalicylic acid, alcohol: attenuation, increased risk of peptic ulcer disease and gastrointestinal bleeding.

Sodium-containing preparations and foods: peripheral edema, arterial hypertension, restriction on sodium and high-sodium diets may be necessary, the use of glucocorticosteroids may sometimes require additional sodium administration.

Vaccines containing live viruses: During the use of immunosuppressive doses of

glucocorticosteroids, replication of viruses and the development of viral diseases is possible, reducing the production of antibodies is not recommended at the same time.

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

Folic acid: increasing the need for this drug.

overdose

Even taking large doses of the drug does not cause acute intoxication, but there is a risk of overdose with prolonged use of Polkortolon, especially in large doses.

The main symptoms of an overdose are hypertension and peripheral edema. In addition, overdosage of Polkortolon may occur with the side effects described above. In the event of symptoms of overdose, the drug should be gradually discontinued and symptomatic therapy should be performed.

Storage conditions

At a temperature not exceeding 25 ° C.

Shelf suitability

3 Year

Active ingredient

Triamcinolone

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