Polcortolone tablets 4mg, No. 50

• Endocrine diseases: insufficiency of the adrenal cortex (primary or secondary), congenital adrenal hyperplasia, subacute thyroiditis;

• severe allergic diseases resistant to other methods of treatment: contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis;

• diseases of the musculoskeletal system: psoriatic arthritis, ankylosing spondylitis, acute and subacute bursitis, epicondylitis, acute tendovaginitis, post-traumatic osteoarthritis; rheumatic diseases: acute rheumatic fever, rheumatic myocarditis, rheumatoid arthritis, juvenile rheumatoid arthritis (in cases resistant to other treatments), polymyalgia rheumatica, Horton's disease;

• systemic connective tissue diseases: dermatomyositis, SLE, granulomatous giant cell mesoarteritis, systemic scleroderma, periarteritis nodosa, recurrent polychondritis; dermatological diseases: exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe erythema multiforme (Stevens-Johnson syndrome), fungal mycosis, pemphigus, severe psoriasis, severe eczema, pemphigoid;

• hematological diseases: acquired autoimmune hemolytic anemia, congenital (erythroid) hypoplastic anemia, anemia due to bone marrow hypoplasia, secondary thrombocytopenia in adults, idiopathic thrombocytopenic purpura (Verlhof's disease) in adults, hemolysis;

• liver diseases: alcoholic hepatitis with encephalopathy, chronic active hepatitis; hypercalcemia in malignant neoplasms; oncological diseases: leukemia and lymphoma in adults, acute leukemia in children;

• neurological diseases: tuberculous meningitis with subarachnoid block or with the threat of its occurrence (in combination with anti-tuberculosis therapy), multiple sclerosis during an exacerbation; severe acute and chronic inflammatory eye diseases: severe sluggish anterior and posterior uveitis, optic neuritis, sympathetic ophthalmia;

• respiratory diseases: bronchial asthma (severe form), beryllium disease, Leffler's syndrome, symptomatic sarcoidosis, fulminant or disseminated pulmonary tuberculosis (in combination with anti-tuberculosis therapy), aspiration pneumonitis; for the prevention and treatment of transplant rejection during organ and tissue transplantation (in combination with other immunosuppressive agents).

Set individually, depending on the indications, the effectiveness of therapy and the patient's condition.

It is recommended to take the entire daily dose 1 time / day in the morning with meals (in accordance with the daily rhythm of endogenous glucocorticoid secretion), however, in some cases, more frequent administration of the drug may be necessary. Adults and adolescents over 14 years of age are prescribed at a dose of 4-48 mg / day in 1 or more doses. Children are prescribed the drug at a dose of 100-500 ?g / kg of body weight / day in 1 or more doses. If a dose is missed, the drug should be taken as soon as possible. If the time for the next dose is approaching, do not take the missed dose. Do not take a double dose at once. Polcortolone should be administered at the lowest effective dose. If necessary, the dose of the drug can be gradually reduced.

The tablets are white or off-white, round, flat, beveled, engraved with 'O' on one side and '4 / mg' on the other.

1 tab.

triamcinolone 4 mg

Excipients: potato starch, magnesium stearate, lactose.

• Systemic mycoses;

• children under 3 years old;

• hypersensitivity to the drug.

Polcortolone is prescribed with caution for parasitic and infectious diseases of a viral, fungal or bacterial nature (ongoing or recently transferred, including recent contact with a patient): herpes simplex, herpes zoster (viremic phase), chickenpox, measles, amebiasis, strongyloidosis ( established and suspected), systemic mycosis, active and latent tuberculosis. Application for severe infectious diseases is permissible only against the background of specific therapy. With caution, the drug should be prescribed in the post-vaccination period (a period lasting 8 weeks before and 2 weeks after vaccination), with lymphadenitis after BCG vaccination, with immunodeficiency conditions (including AIDS, HIV infection). Care should be taken when treating persons with gastrointestinal diseases such as esophagitis, gastritis,UC with the threat of perforation or abscess formation, diverticulitis, gastric ulcer and duodenal ulcer, acute or latent peptic ulcer, newly created intestinal anastomosis.

The drug is prescribed with caution to patients with diseases of the cardiovascular system, incl. with a recent myocardial infarction (in patients with acute and subacute myocardial infarction, it is possible to spread the focus of necrosis, slow down the formation of scar tissue and, as a result, rupture of the heart muscle), with chronic heart failure in the stage of decompensation, with arterial hypertension and hyperlipidemia. Caution is needed when prescribing Polcortolone to persons with endocrine diseases (diabetes mellitus / including in violation of carbohydrate tolerance /, thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease), in chronic renal and / or hepatic failure of severe degree, nephrourolithiasis, in hypoalbuminemia and conditions predisposing to its occurrence, systemic osteoporosis, myasthenia gravis, acute psychosis,obesity of III-IV degree, poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma, during pregnancy and lactation.

pharmachologic effect

Synthetic glucocorticoid drug, is a fluorinated derivative of prednisolone. It has a strong anti-inflammatory effect and has a weak mineralocorticoid effect. It inhibits the development of symptoms of inflammation by reducing capillary permeability and reducing the accumulation of macrophages, leukocytes and other cells in the area of ??inflammation. It has an immunosuppressive effect, incl. by suppressing the cellular immune response. Suppresses the secretion of ACTH by the pituitary gland, which leads to a decrease in the production of GCS and androgens by the adrenal cortex. It enhances protein catabolism, causes an increase in the concentration of glucose in the blood, affects lipid metabolism, and increases the concentration of fatty acids in the blood serum. With prolonged treatment, the redistribution of adipose tissue is possible.Triamcinolone inhibits the formation of bone tissue and reduces the concentration of calcium in the blood serum, and therefore, while taking the drug, it is possible to suppress bone growth in children and adolescents and the development of osteoporosis in patients of all age groups. Triamcinolone 4 mg is believed to have anti-inflammatory effects equivalent to methylprednisolone 4 mg, prednisolone 5 mg, dexamethasone 0.75 mg, betamethasone 0.6 mg and hydrocortisone 20 mg.

Pharmacokinetics

Absorption After oral administration, it is easily absorbed from the gastrointestinal tract. Bioavailability is 20-30%. Taking the drug with food slows down the absorption of triamcinolone in the initial phase, but does not affect the overall bioavailability of the drug. Distribution Plasma protein binding (mainly globulins) is 40%. Penetrates through the placental barrier and is excreted in breast milk. Metabolism and excretion Biotransformed mainly in the liver. The biological half-life is approximately 5 hours. It is excreted mainly by the kidneys in the form of inactive metabolites.

Side effect

From the endocrine system: secondary adrenal and hypothalamic-pituitary insufficiency (especially in stressful situations such as illness, injury, surgery), Itsenko-Cushing's syndrome (including moon face, pituitary 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, erosive esophagitis, flatulence, indigestion, nausea, vomiting, increased or decreased appetite, hiccups; in rare cases - an increase in the activity of hepatic transaminases and alkaline phosphatase.

From the side of 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 and the slowing down of the formation of scar tissue, which can lead to rupture of the heart muscle.

From the side of the central nervous system and peripheral nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure with congestive optic papilla syndrome (pseudotumor of the brain - most often in children, usually after a too rapid dose reduction; symptoms - headache, deterioration in visual acuity or double vision); vertigo, pseudotumor of the cerebellum, convulsions, dizziness, headache, nervousness or anxiety, sleep disturbance.

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

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

On the part of the musculoskeletal system: growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, compression fracture of the spine, aseptic necrosis of the head of the humerus and femur, pathological fractures of long tubular bones), muscle tendon rupture, muscle weakness, steroid myopathy, decreased muscle mass (atrophy).

Dermatological reactions: steroid acne, striae, delayed wound healing, thinning of the skin, petechiae, ecchymosis, hematomas, a tendency to develop pyoderma and candidiasis. Allergic reactions: skin rash, itching, anaphylactic shock.

Others: the development and exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccinations), leukocyturia, withdrawal syndrome. The frequency of development and the severity of side effects depend on the duration of their use, the size of the dose used and the possibility of observing the circadian rhythm of the appointment. With short-term use of triamcinolone, like other GCS, side effects are rare.

Side effects usually occur with prolonged use of the drug. Use during pregnancy and lactation Use of the drug during pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, the issue of stopping breastfeeding should be resolved.

Application for violations of liver function

Polcortolone is prescribed with caution in case of liver dysfunction.

Application for impaired renal function

Polcortolone is prescribed with caution for renal failure.

Application in children

Long-term use of Polcortolone in pediatric practice requires careful monitoring of the growth and development of children.

Contraindication:

children up to age 3 years.

special instructions

In case of stressful situations, patients taking Polcortolone are recommended parenteral administration of GCS. Sudden discontinuation of treatment can cause the development of adrenal cortex insufficiency, therefore, the dose of Polcortolone should be reduced gradually. Polcortolone can mask the symptoms of infection, reduce resistance to infection and the ability to limit its spread. Long-term use of Polcortolone increases the risk of developing 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. Administration of an inactivated viral or bacterial vaccine may not produce the expected increase in antibody levels. In addition, in patientstaking corticosteroids, there is an increased risk of neurological complications during vaccination. It should be remembered that a sudden cessation of treatment can cause the development of adrenal cortex insufficiency, therefore, the dose of Polcortolone should be reduced gradually. With the sudden cancellation of Polcortolone, especially after prolonged use, the development of the so-called withdrawal syndrome is possible, manifested by anorexia, fever, muscle and joint pain, and general weakness. These symptoms may appear even when adrenal insufficiency is not noted. In patients with hypothyroidism or cirrhosis of the liver, the effect of triamcinolone is enhanced. During the use of Polcortolone, mental disorders such as euphoria, insomnia, mood swings, personality changes, severe depression, symptoms of psychosis may appear.Preexisting emotional instability or psychotic tendencies may be exacerbated during treatment. In the treatment of patients with hypoprothrombinemia, caution should be exercised when simultaneously prescribing triamcinolone and acetylsalicylic acid.

Use in pediatrics

Long-term use of Polcortolone in pediatric practice requires careful monitoring of the growth and development of children.

Overdose

Symptoms: increased blood pressure, peripheral edema; it is possible to increase the side effects described above.

Treatment: gradual dose reduction and drug withdrawal; if necessary, symptomatic therapy is carried out. Taking large doses of the drug does not cause acute intoxication. But with prolonged use of Polcortolone, especially in large doses, there is a risk of overdose.

Drug interactions

With the simultaneous use of Polcortolone and cardiac glycosides, the risk of developing cardiac arrhythmias and other toxic effects of glycosides associated with hypokalemia increases. When used simultaneously with Polcortolone, barbiturates, anticonvulsants (phenytoin, carbamazepine), rifampicin, glutethimide accelerate the metabolism of triamcinolone (due to the induction of microsomal enzymes) and weaken its effect. With the simultaneous use of histamine H1 receptor blockers weaken the effect of Polcortolone. With the combined use of Polcortolone with amphotericin B, carbonic anhydrase inhibitors, the risk of hypokalemia, left ventricular myocardial hypertrophy and circulatory failure increases. With the simultaneous use of Polcortolone with paracetamol, the likelihood of hypernatremia, peripheral edema,increase in calcium excretion, the risk of hypocalcemia, osteoporosis, paracetamol hepatotoxicity increases. When Polcortolone is used together with anabolic steroids or androgens, the risk of developing peripheral edema, acne increases (this combination requires caution, especially in the case of liver and heart diseases). When used in combination, hormonal contraceptives containing estrogens enhance the effect of Polcortolone by increasing the concentration of globulins that bind GCS in the blood serum, slowing down their metabolism and increasing T1 / 2. With the simultaneous use of Polcortolone with anticholinergics (atropine), an increase in intraocular pressure is possible. Anticoagulants (coumarin derivatives, indandione, heparin), streptokinase, urokinase reduce (in some patients increase) the effectiveness of Polcortolone.The dose should be determined on the basis of prothrombin time and take into account the increased risk of ulceration and bleeding from the gastrointestinal tract. The combined use of tricyclic antidepressants can exacerbate mental disorders associated with taking Polcortolone (this combination is not recommended). With the simultaneous use of Polcortolone weakens the effect of oral hypoglycemic drugs, insulin, increases the concentration of glucose in the blood (dose adjustment of hypoglycemic drugs may be required). With the combined use of Polcortolone and antithyroid drugs and thyroid hormones, it is possible to change the function of the thyroid gland (dose adjustment or cancellation of the antithyroid drug or thyroid hormones may be required). Polcortolone weakens the effect of potassium-sparing diuretics.Concomitant use can cause hypokalemia. Polcortolone reduces the effectiveness of laxatives, while increasing the risk of hypokalemia. With the simultaneous use of ephedrine, it accelerates the biotransformation of triamcinolone, which may require a dose adjustment of Polcortolone. With the combined use of Polcortolone and immunosuppressants, the risk of developing infections, lymphomas and other lymphoproliferative diseases increases. When used in conjunction with isoniazid, a decrease in the concentration of isoniazid in the blood plasma (mainly in persons with rapid acetylation) may occur, in which case a dose change is necessary. When used together, the metabolism of mexiletine is accelerated and its concentration in the blood plasma decreases. With simultaneous use with depolarizing muscle relaxants, hypocalcemia associated with the use of Polcortolone,may increase the duration of neuromuscular blockade. Polcortolone reduces the effect of NSAIDs (including acetylsalicylic acid), alcohol, while increasing the risk of ulcerative lesions and the development of bleeding from the gastrointestinal tract. With the simultaneous use of Polcortolone with drugs or food containing sodium, peripheral edema and arterial hypertension may appear. In such a situation, it is necessary to restrict sodium in the diet and eliminate drugs with a high sodium content. When using vaccines containing live viruses, against the background of the use of immunosuppressive doses of GCS, replication of viruses and the development of viral diseases, a decrease in the production of antibodies are possible (the combination is not recommended). When used simultaneously with other vaccines, the risk of neurological complications increases and the production of antibodies decreases.When combined with folic acid, an increase in the need for this drug is possible.