Expiration date: 04/2025

The composition and form of issue:

Tablets 1. tablet contains:

triamcinolone 4 mg

auxiliary substances: lactose, potato starch magnesium stearate 

blistere in 25 PCs the paper cartons 2 blister.

Description pharmaceutical form:

Tablets white or almost white, round, flat, chamfered. On one side of the tablet embossed "O" on the other "".

Description pharmacological action:

Is a synthetic GCS, a fluorinated derivative of prednisone, has strong anti-inflammatory action (action 4 mg triamcinolone similar to the effect of 4 mg of methylprednisolone, 5 mg of prednisone, 0.75 mg of dexamethasone, 0.6 mg of betamethasone, and 20 mg hydrocortisone). It has a weak mineralocorticoid effect. Inhibits the development of symptoms of inflammation. Inhibits the accumulation of macrophages, leukocytes and other cells in the area of inflammation. Causes a decrease in capillary permeability. Has immunosuppressive effect inhibit cellular immune responses.

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

Increases protein catabolism, increases the concentration of glucose in the blood, affects the lipid metabolism, increases the concentration of fatty acids in serum. Long-term treatment possible redistribution of adipose tissue. Inhibits the formation of bone tissue, reduces the concentration of calcium in blood serum, can cause suppression of bone growth in children and adolescents and osteoporosis in patients of all ages.

Indications:

• endocrine diseases: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia, subacute thyroiditis
  
• severe allergic disease resistant to other therapies: contact and atopic dermatitis, serum sickness, hypersensitivity reactions to drugs, seasonal or year-round allergic rhinitis
  
• diseases of the musculoskeletal system: psoriatic arthritis, ankylosing spondylitis, acute and subacute bursitis, epicondylitis, acute tenosynovitis, posttraumatic osteoarthritis
  
• rheumatic diseases: acute rheumatic fever, rheumatic myocarditis, rheumatoid arthritis, juvenile rheumatoid arthritis (with resistance to other therapies), polymyalgia rheumatic disease Horton
  
• systemic connective tissue disease: dermatomyositis, systemic lupus erythematosus, giant cell granulomatous mesenteric, systemic sclerosis, polyarteritis nodosa, relapsing polyhedric
  
• dermatological diseases: exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe erythema multiforme (Stevens-Johnson syndrome), mycosis fungoides, pemphigus, severe psoriasis, severe eczema, pemphigoid
  
• hematological diseases: acquired autoimmune hemolytic anemia, congenital (erythroid) hypoplastic anemia, anemia due to hypoplasia of the bone marrow, secondary thrombocytopenia in adults, idiopathic thrombocytopenic purpura (illness Verlgofa) in adults, hemolysis
  
• liver disease: alcoholic hepatitis with encephalopathy, chronic active hepatitis
  
• hypercalcemia of malignancy
  
• cancer: leukemias and lymphomas in adults, acute leukemias in children
  
• neurological disease: tuberculous meningitis with subarachnoid block or impending block (in conjunction with appropriate antituberculous chemotherapy), multiple sclerosis in acute
  
• eye diseases (severe acute and chronic inflammatory processes): heavy sluggish front and rear uveitis, optic neuritis, sympathetic ophthalmia
  
• diseases of the respiratory system: bronchial asthma (severe form), beryllium, Leffler syndrome (not amenable to therapy other drugs), symptomatic sarcoidosis, fulminant or disseminated pulmonary tuberculosis (in combination with antituberculous chemotherapy), aspiration pneumonitis
  
• in the transplantation of organs and tissues for the prevention and treatment of graft rejection (in combination with other immunosuppressive drugs).
  

Contraindications:

• systemic fungal infection
  
• hypersensitivity to triamcinolone and other components of the drug
  
• children up to age 3 years (for this dosage form).
  

Caution: parasitic and infectious diseases virus, fungal or bacterial origin (currently or recently migrated, including the recent contact with the patient): herpes simplex, herpes zoster (vermicella phase), chickenpox, measles, amoebiasis, strongyloidiasis (established and suspected), systemic mycosis, active and latent tuberculosis application for serious infectious diseases is admissible only against the background of specific therapy post-vaccination period (duration 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination immunodeficiency States (including AIDS, HIV-infection) disease of the gastrointestinal tract: esophagitis, gastritis, ulcerative colitis with the threat of perforation or abecedarian, diverticulitis, ulcer disease stomach and duodenal ulcers, acute or latent peptic ulcer, recently created anastomosis of intestine diseases of the cardiovascular system: including recent myocardial infarction (in patients with acute and subacute myocardial infarction may spread of necrosis, slowing the formation of scar tissue and, consequently, rupture of the heart muscle), decompensated chronic heart failure, arterial hypertension, hyperlipidemia, endocrine diseases: diabetes mellitus (incl. violation of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, disease Itsenko-Kushinga severe chronic renal and/or liver failure, nefrourolitiaz hypoalbuminemia and status, predisposing to its occurrence systemic osteoporosis, polio (excluding the tabloid form of encephalitis), myasthenia gravis, acute psychosis, obesity (III–IV degree) open - and closed-angle glaucoma pregnancy lactation.

Application of pregnancy and breast-feeding:

Receiving corticosteroids during pregnancy only valid in cases where the expected benefit to the mother outweighs the potential risk to the fetus. If necessary, use of the drug during lactation is recommended to stop breastfeeding.

Side effects:

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

Short-term use of triamcinolone, like other corticosteroids, side effects are rare. When you use triamcinolone for a long time may develop the following side effects.

From the endocrine system: secondary adrenal and hypothalamic-pituitary failure (especially during stressful situations such as illness, injury, surgery), the syndrome Itsenko-Kushinga (Crescent-shaped face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delayed sexual development and growth suppression in children, menstrual irregularities, reduced tolerance to carbohydrates, manifestation of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic medications in patients with diabetes mellitus, hirsutism.

From the digestive system, steroid ulcer of stomach and duodenum ulcer with possible perforation and hemorrhage, pancreatitis, flatulence, erosive esophagitis, indigestion, nausea, vomiting, increased or decreased appetite, hiccups in rare cases — increase in liver transaminases and alkaline phosphatase.

From the CCC: arrhythmia, aetiology (until the heart failure), development (in predisposed patients) or increased severity of chronic heart failure, changes in the ECG, characteristic of hypokalemia, hypertension, hypercoagulability, thrombosis in patients with acute and subacute myocardial infarction — distribution 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 the syndrome of stagnant optic nerve nipple (pseudotumor of the brain — most often in children, usually after too rapid dose reduction, the symptoms — headache, deterioration of visual acuity or diplopia), vertigo, pseudotumor of the cerebellum, seizures, dizziness, headache, nervousness or anxiety, and sleep disorders.

From the sensory organs: the rear subcapsular cataracts, increased intraocular pressure with possible damage to the optic nerve, glaucoma, exophthalmos, propensity to develop secondary bacterial, fungal or viral eye infections, trophic changes of the cornea.

From the metabolic: negative nitrogen balance as a result of protein catabolism, hyperglycemia, glycosuria, increased excretion of Ca2+, hypocalcemia, increase in body weight, increased sweating, retention of sodium and fluid in the body (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the side of musculoskeletal system: slowing growth and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely — pathological fractures, spinal compression fracture, aseptic necrosis of a head humeral and a femur, pathological fractures of long tubular bones), rupture of tendons of muscles, muscle weakness, steroid myopathy, reduction of muscle mass (atrophy).

With the skin and mucous membranes: steroid acne, striae, delayed wound healing, thinning of skin, petechiae, ekhimozy, bruising, tendency to the development of pyoderma and candidiasis.

Allergic reactions: skin rash, itching, anaphylactic shock.

Other: development and exacerbation of infections (the emergence of this side effect contribute jointly used immunosuppressants and vaccination), pyuria, the syndrome.

Drug interactions:

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

Barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutethimide — accelerates metabolism of corticosteroids (by induction of microsomal enzymes), weaken their action.

Antihistamines weaken the effect of triamcinolone.

Amphotericin b, carbonic anhydrase inhibitors: hypokalemia, myocardial hypertrophy of the left ventricle, insufficiency of blood circulation.

Paracetamol: hypernatremia, peripheral edema, increased excretion of calcium, the risk of hypocalcemia and osteoporosis. Increase the risk of hepatotoxicity of paracetamol.

Anabolic steroids, androgens: increase the risk of peripheral edema, acne applied carefully, especially in diseases of the liver and heart.

Oral contraceptives containing estrogen: increase in the concentration of globulin that binds glucocorticoids in the blood serum, decreased metabolism, increase in T1/2, enhancing the effect of triamcinolone.

Holinoblokirutuyu drug (mainly atropine) — increase in intraocular pressure.

Anticoagulants (coumarin derivatives, indandiona, heparin), streptokinase, urokinase: the decline and in some patients, improving the efficiency of the dose should be determined on the basis of PV increased risk of ulceration and bleeding from the gastrointestinal tract.

Tricyclic antidepressants may increase mental disorders, associated with the reception of triamcinolone. Should not be prescribed for the treatment of these disorders.

Oral hypoglycemic drugs, insulin: the weakening of the hypoglycemic action, an increase in the concentration of blood glucose, a correction dose protivodiabeticakih drugs.

Antithyroid drugs, thyroid hormones change the function of the thyroid gland (possible dose adjustment of these drugs or the termination of their admission).

Diuretics: reduce the action of diuretics (potassium-sparing), hypokalemia.

Laxatives: the weakening action hypokalemia.

Ephedrine can accelerate metabolism of corticosteroids (possible adjustment of the dose of triamcinolone).

Immunosuppressive drugs: increased risk of developing infections, lymphomas and other lymphoproliferative diseases.

Isoniazid: decreased isoniazid concentrations in the blood plasma, mostly in persons with rapid acetylation (maybe changing dose).

Meksiletin: accelerated metabolism mexiletine and reducing its concentration in the blood serum.

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

NSAIDs (including acetylsalicylic acid), alcohol: reducing the actions increase the risk of ulcers and bleeding from the gastrointestinal tract.

Drugs and food containing sodium: peripheral oedema, hypertension (it may be necessary to limit sodium diet and taking medications with a high content of sodium but sometimes the use of GCS requires the additional introduction of sodium).

Vaccines that contain live viruses during the use of immunosuppressive doses of corticosteroids possible replication of viruses (development of viral diseases) and reduced antibody production (concurrent use is not recommended).

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

Folic acid: increased needs for this drug.

Method of application and dose:

Inside, it is recommended to take 1 time a day, in the morning (in accordance with circadian rhythm of secretion of endogenous corticosteroids) if necessary, more frequent intake. Dose set individually, depending on indications, effectiveness of treatment and condition of the patient.

Adults and adolescents over 14 years — from 4 to 48 mg/day in one or more steps.

Children — 0.1–0.5 mg/kg/day in one or more steps.

In case of missed dose should take the drug as soon as possible, but if it is approaching time for your next dose, missing dose not take. Do not take a double dose.

Polcortolon should be used in minimum effective doses. If necessary, the dose should be reduced gradually.

Overdose:

Symptoms: hypertension and peripheral edema, appearance of undesirable side effects described above.

Treatment: gradually stop taking the drug or reduce the dose, and to spend symptomatic therapy.

The risk of overdose increases with prolonged use of triamcinolone, especially in large doses. There is practically no danger of acute poisoning.

Special instructions:

Upon receipt of Polcortolone should precisely adhere to the instructions of the doctor.

In case of stressful situations to patients receiving the drug, recommended parenteral administration of corticosteroids.

Sudden discontinuation of treatment can cause the development of insufficiency of the adrenal cortex, therefore, dose should be reduced gradually.

Polcortolon may mask the symptoms of infection, to reduce resistance to infection and ability to its localization. Prolonged use of Polcortolone increases the risk of secondary fungal or viral infections.

Prolonged use of Polcortolone can cause the development of cataracts, glaucoma with possible optic nerve damage.

Patients receiving Polcortolon should not be vaccinated live viral vaccines. The introduction of inactivated viral or bacterial vaccines may not cause the expected increase in the number of antibodies. In addition, in patients taking corticosteroids, there is an increased risk of neurologic complications during vaccination.

With the sudden cancellation of Polcortolone, especially after long-term use may develop the so-called withdrawal syndrome, manifested by anorexia, fever, muscle and joint pain, General weakness. These symptoms may appear even in the case when not marked insufficiency of the adrenal cortex.

In patients with hypothyroidism or cirrhosis of the liver triamcinolone effect is enhanced.

During the application of Polcortolone can appear mental disorders, such as euphoria, insomnia, abrupt mood changes, personality changes, severe depression, psychotic symptoms. Preexisting emotional instability or psychotic tendencies may intensify during treatment.

In the treatment of patients with hypoprothrombinemia should be used with caution at the same time Polcortolon and acetylsalicylic acid.

Long-term treatment of children should observe their growth and development.