Polcortolonum

General characteristics. Structure:

Active ingredient: 4 mg of Triamcinolonum.

Excipients: potato starch – 144,2 mg, magnesium stearate – 1,8 mg, lactose – 200 mg.

Synthetic glucocorticosteroid.

Pharmacological properties:

Pharmacodynamics. Polcortolonum is a synthetic glucocorticosteroid, to the fluorinated Prednisolonum derivatives possessing strong antiinflammatory action. Consider that 4 mg of Triamcinolonum possess antiinflammatory action, equivalent 4 mg of Methylprednisolonum, 5 mg of Prednisolonum, 0,75 mg of dexamethasone, 0,6 mg of betamethasone and 20 mg of a hydrocortisone. Possesses weak mineralokortikoidny action. Slows down development of symptoms of an inflammation. Slows down accumulation of macrophages, leukocytes and other cells in an inflammation zone. Causes reduction of permeability of capillaries. Possesses an immunodepressive effect; inhibits cellular immunological reactions.

Inhibits secretion of AKTG a hypophysis that leads to reduction of development of glucocorticosteroids and androgens bark of adrenal glands.

Strengthens a catabolism of proteins, causes increase in concentration of glucose in blood, influences lipidic exchange, increases concentration of fatty acids in blood serum. At prolonged treatment redistribution of fatty tissue is possible. The osteogenesis oppresses, reduces concentration of calcium in blood serum, can cause suppression of growth of bones in children and teenagers and development of osteoporosis in sick all age.

Indications to use:

1. Endocrinological diseases:

• Primary or secondary insufficiency of bark of adrenal glands
• Inborn adrenal struma 
• Subacute thyroiditis

2. Hard proceeding allergic diseases, resistant to other methods of therapy:

• Contact dermatitis
• Atopic dermatitis
• Serum disease
• Hypersensitivity reactions to medicines
• Year-round or seasonal allergic rhinitis, resistant to other drugs

3. Musculoskeletal system diseases:

• Psoriasis arthritis
• Ankylosing spondiloartirit
• Acute and subacute bursitis
• Epicondylitis
• Acute tendovaginitis
• Posttraumatic osteoarthritis

4.   Rheumatic diseases:

• Acute rheumatic fever
• Rheumatic myocarditis
• A pseudorheumatism, a juvenile pseudorheumatism (in cases, resistant to other methods of treatment)
• Rheumatic polimialgiya, Horton's disease

5. General diseases of connecting fabric:

• Dermatomyositis
• System lupus erythematosus
• Mesoarteritis is granulomatozny giant-cell
• System scleroderma
• Nodular periarteritis
• Recurrent polychondritis

6. Dermatological diseases:

• Exfoliative dermatitis
• Herpetiform violent dermatitis
• Heavy seborrheal dermatitis
• A heavy multiformny erythema (Stephens's syndrome - Johnson)
• Fungoid mycosis
• Pemphigus
• Heavy psoriasis
• Severe form of eczema
• Pemphigoid

7. Hematologic diseases:

• the acquired autoimmune hemolitic anemia
• inborn (erythroidal) hypoplastic anemia
• anemia owing to a marrow hypoplasia
• secondary thrombocytopenia at adults
• an idiopathic Werlhof's disease (Verlgof's disease) at adults
• hemolysis

8.  Liver diseases:

• Alcoholic hepatitis with encephalopathy
• Chronic active hepatitis

9.  A hypercalcemia at malignant new growths.

10. Oncological diseases:

• Leukoses and lymphoma at adults
• Acute leukoses at children

11. Neurologic diseases:

• Tubercular meningitis with the subarachnoidal block or at threat of the block (in combination with the corresponding antitubercular chemotherapy)
• Multiple sclerosis in the period of an aggravation

12. Diseases of eyes (heavy acute and chronic inflammatory processes):

• Heavy slow front and back uveitis
• Optic neuritis
• Sympathetic ophthalmia

13. Diseases of a respiratory organs:

• Bronchial asthma, severe form
• Berylliosis
• Leffler's syndrome which is not giving in to therapy by other means
• Symptomatic sarcoidosis
• The fulminant or disseminated pulmonary tuberculosis (in a combination with antitubercular chemotherapy)

14. Aspiration pneumonitis

15. At organ transplantation and fabrics - the prevention and treatment of graft rejection (in a combination with other immunodepressive drugs)

Route of administration and doses:

The dose of Polcortolonum is established individually, depending on indications, efficiency of therapy and a condition of the patient. According to a day-night rhythm of secretion of endogenous glucocorticosteroids drug is recommended to be accepted once a day, in the morning. However, more frequent administration of drug can be in certain cases necessary.

Adults and teenagers are more senior than 14 years: from 4 to 48 mg/days in one or several receptions.

Children: 0,1 - 0,5 mg/kg of body weight a day in one or several receptions.

In case of the admission of reception of a dose it is necessary to accept drug as soon as possible or if time of the following reception comes, to pass the forgotten dose. It is not necessary to accept a double dose at once.

Polcortolonum should be applied in minimum effective doses. If necessary the dose of drug should be reduced gradually.

Features of use:

Reception of glucocorticosteroids during pregnancy is admissible only in cases when the estimated advantage for mother exceeds potential risk for a fruit. In need of use of drug during feeding by a breast, it is recommended to stop breastfeeding.

At reception of Polcortolonum of the patient has to observe instructions of the doctor precisely.

In case of stressful situations by the patient accepting Polcortolonum parenteral administration of glucocorticosteroids is recommended.

The sudden termination of treatment can cause development of insufficiency of bark of adrenal glands therefore the dose of Polcortolonum should be reduced gradually.

Polcortolonum can mask infection symptoms, reduce resistance to an infection and ability to its localization.

Prolonged use of Polcortolonum increases risk of development of consecutive fungal or viral infections.

Prolonged use of Polcortolonum can cause development of a cataract, glaucoma with possible damage of optic nerves.

The patients accepting Polcortolonum it is not necessary to impart live virus vaccines. Introduction of the inactivated virus or bacterial vaccine can not cause the expected increase in quantity of antibodies. Besides, the patients accepting glucocorticosteroids have an increased risk of neurologic complications during vaccination.

At sudden cancellation of Polcortolonum, especially after long reception, development of the so-called withdrawal which is shown anorexia, fervescence, muscular and joint pains, the general weakness is possible. These symptoms can appear even in case insufficiency of bark of adrenal glands is noted. At patients with a hypothyroidism or cirrhosis action of Triamcinolonum amplifies.

During use of Polcortolonum there can be mental disorders what as euphoria, sleeplessness, sharp changes of mood, change of the personality, a heavy depression, psychosis symptoms. The existing earlier emotional instability or psychotic tendencies can amplify in a vremiya of treatment.

At treatment of patients with a prothrombinopenia it is necessary to appoint with care at the same time Triamcinolonum and acetylsalicylic acid.

At prolonged treatment of children it is necessary to watch their growth and development.

Influence on ability to manage vehicles, mechanisms. Polcortolonum ordinary does not influence mental reactions. However, can cause dizziness, a headache and even mental disorders.

Special precautionary measures at destruction of unused medicine. Medicines cannot be thrown out in the sewerage or in house containers for waste. How to utilize unused drug, learn from the druggist. These actions will help to protect the environment.

Side effects:

Frequency of development and expressiveness of side effects depend on duration of use, size of the used dose and a possibility of observance of a circadian rhythm of appointment.

At short-term use of Polcortolonum, as well as other glucocorticosteroids, side effects are observed seldom. At use of Polcortolonum during the long time development of the following side effects is possible.

From endocrine system. Secondary adrenal and gipotalamo-pituitary insufficiency (especially during stressful situations, such as a disease, an injury, surgery); an Icenco-Cushing syndrome (a crescent-shaped face, obesity of pituitary type, a hirsutism, increase in arterial pressure, a dysmenorrhea, an amenorrhea, a myasthenia, striya), a delay of sexual development and suppression of growth at children, disturbances of a menstrual cycle, decrease in tolerance to glucose, manifestation of a latent diabetes mellitus and increase in need for insulin or peroral hypoglycemic drugs at patients with a diabetes mellitus, a hirsutism.

From the alimentary system. "Steroid" stomach ulcer and a 12-perstny gut with a possible perforation and bleeding, pancreatitis, a meteorism, the erosive esophagitis, digestion disturbance, nausea, vomiting raised or a hyporexia, a hiccups. In rare instances – increase in activity of "hepatic" transaminases and an alkaline phosphatase.

From cardiovascular system. Arrhythmias, bradycardia (up to a cardiac standstill); development (at predisposed patients) or strengthening of expressiveness of chronic heart failure, ECG change characteristic of a hypopotassemia, arterial hypertension, hypercoagulation, fibrinferments. Patients with an acute and subacute myocardial infarction have a distribution of the center of a necrosis, delay of formation of cicatricial fabric that can lead to a rupture of a cardiac muscle.

From a nervous system. A delirium, a disorientation, euphoria, hallucinations, maniac-depressive psychosis, a depression, paranoia, increase in intracranial pressure with a syndrome of a congestive optic papilla (a brain pseudoneoplasm - most often at children, usually after too bystry reduction of a dose; symptoms - a headache, deterioration in visual acuity or doubling in eyes); вертиго, pseudoneoplasm of a cerebellum, spasm, dizziness, headache, nervousness or concern, sleep disorders.

From sense bodys. A back subkapsulyarny katarkta, increase in intraocular pressure with possible injury of an optic nerve, glaucoma, an exophthalmos, tendency to development of consecutive bacterial, fungal or viral infections of eyes, trophic changes of a cornea.

From a metabolism. Negative nitrogenous balance as a result of a protein catabolism, a hyperglycemia, a glucosuria, the increased removal of Sa2+, a hypocalcemia, increase in body weight, the increased sweating, a delay of sodium and liquid in an organism (peripheral hypostases), a hypernatremia, a gipokaliyemichesky syndrome (a hypopotassemia, arrhythmia, a mialgiya or a spasm of muscles, unusual weakness and fatigue).

From a musculoskeletal system. Delay of growth and processes of ossification at children (premature closing of epiphyseal regions of growth), osteoporosis (it is very rare – pathological fractures of bones, compression spinal fracture, an aseptic necrosis of a head humeral and a femur, pathological fractures of long tubular bones), a rupture of sinews of muscles, muscular weakness, a "steroid" myopathy, decrease in muscle bulk (atrophy).

From integuments and mucous membranes. A steroid acne, a striya, the slowed-down healing of wounds, thinning of skin, a petechia, ecchymomas, hematomas, tendency to development of a pyoderma and candidiases.

Allergic reactions: skin rash, itch, acute anaphylaxis.

Others. Development and an exacerbation of infections (emergence of this side effect is promoted jointly by the applied immunodepressants and vaccination), a leukocyturia, a syndrome of "cancellation".

Interaction with other medicines:

Cardiac glycosides: increase in risk of disturbances of a cordial rhythm and the toxicity of glycosides connected with a hypopotassemia.

Barbiturates, antiepileptic drugs (Phenytoinum, carbamazepine), rifampicin, глютетимид accelerate metabolism of glucocorticosteroids (by indication of microsomal enzymes), weaken their action.

Antihistaminic drugs weaken action of Triamcinolonum.

Amphotericinum In, karboangidraza inhibitors: hypopotassemia, hypertrophy of a myocardium of a left ventricle of heart, circulatory unefficiency.

Paracetamol: hypernatremia, peripheral hypostases, increase in removal of calcium, risk of a hypocalcemia and osteoporosis. Increase in risk of a hepatotoxic of paracetamol.

Anabolic steroids, androgens: increase in risk of development of peripheral hypostases, eels; to apply carefully, especially in case of diseases of a liver and heart.
The peroral contraceptive drugs containing estrogen: increase in concentration of the globulins connecting glucocorticosteroids in blood serum, metabolism delay, increase in an elimination half-life, strengthening of action of Triamcinolonum.

Holinoblokiruyushchy drugs, generally atropine: increase in intraocular pressure.

Anticoagulants (coumarin derivatives, индадион, heparin), Streptokinasa, urokinase: decrease, and some patients have an increase in efficiency; the dose has to be defined on the basis of a prothrombin time; increase in risk of ulceration and bleeding from digestive tract.

Tricyclic antidepressants can strengthen the mental disturbances connected with reception of Triamcinolonum. It is not necessary to apply them to treatment of these disturbances.

Peroral hypoglycemic drugs, insulin: weakening of hypoglycemic action, increase in concentration of glucose in blood; carrying out dose adjustment of hypoglycemic drugs can be necessary.

Anti-thyroid drugs, hormones of a thyroid gland: change of function of a thyroid gland, can be necessary carrying out dose adjustment or the termination of reception of anti-thyroid drug or hormone of a thyroid gland.

Diuretic drugs: weakening of effect of diuretics (kaliysberegayushchy), gipokalemiya.

Purgatives: weakening of action, gipokalemiya.

Ephedrine can accelerate metabolism of glucocorticosteroids, carrying out dose adjustment of Triamcinolonum can be necessary.

Immunodepressive drugs: increase in risk of an infection, lymphoma and other limfoproliferativny diseases.

Isoniazid: decrease in concentration of an isoniazid in a blood plasma, generally at persons with bystry acetylation; change of a dose can be necessary.

Meksiletin: the accelerated metabolism of a meksiletin and decrease in its concentration in a blood plasma.

The drugs blocking neuromuscular conductivity (the depolarizing muscle relaxants): the hypocalcemia connected using Triamcinolonum can strengthen blockade of synapses, leading to increase in duration of neuromuscular blockade.

Non-steroidal anti-inflammatory drugs, acetylsalicylic acid, alcohol: weakening of action, increase in risk of development of a peptic ulcer and bleeding from a GIT.

The drugs and food containing sodium: peripheral hypostases, arterial hypertension, restriction in a diet of sodium and medicines with the high content of sodium can be necessary; use of glucocorticosteroids sometimes demands in addition administration of sodium.

The vaccines containing live viruses: during use of immunodepressive doses
glucocorticosteroids replication of viruses and development of viral diseases, decrease in development of antibodies is possible; simultaneous use is not recommended.

Other vaccines: the increased risk of neurologic complications and decrease in development of antibodies.

Folic acid: increase in need for this drug.

Contraindications:

System fungal infections.

Hypersensitivity to Triamcinolonum or other components of drug.

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

With care. Polcortolonum is appointed at parasitic and infectious diseases of the virus, fungal or bacterial nature (now or recently postponed, including recent contact with the patient): the herpes simplex surrounding herpes (a viremichesky phase), the chicken pox, measles, the amebiasis, a strongyloidosis (established and suspected), system mycosis, active and latent tuberculosis. Use at serious infectious diseases is admissible only against the background of specific therapy.

The postvaccinal period (the period lasting 8 weeks to and 2 weeks after vaccination), lymphadenitis after BTsZh inoculation. Immunodeficiency (including AIDS, HIV infection).

Digestive tract diseases: an esophagitis, gastritis, nonspecific ulcer colitis with threat of perforation or abscessing, a diverticulitis, a peptic ulcer of a stomach and duodenum, an acute or latent round ulcer, recently created intestines anastomosis;

At diseases of cardiovascular system, including recently postponed myocardial infarction (at patients with an acute and subacute myocardial infarction distribution of the center of a necrosis, delay of formation of cicatricial fabric and thereof a rupture of a cardiac muscle is possible), dekompensirovanny, chronic, heart failure, arterial hypertension, a lipidemia;

Endocrine diseases: a diabetes mellitus (including disturbance of tolerance to carbohydrates), a thyrotoxicosis, a hypothyroidism, Itsenko-Cushing's disease;

To heavy chronic renal and/or liver failure, nefrourolitiaza;

The hypoalbuminemia and states contributing to its emergence;

System osteoporosis, gravis myasthenia, acute psychosis, obesity (the III-IV Art.), poliomyelitis (except for a form of bulbar encephalitis), open and closed-angle glaucoma, pregnancy, a lactation.

Overdose:

Even reception of high doses of drug does not cause acute intoxication, but there is a risk of overdose at prolonged use of Polcortolonum, especially in high doses. The main symptoms of overdose - arterial hypertension and peripheral hypostases. Besides, the overdose of Polcortolonum can be shown by emergence of the undesirable effects described above. In case of symptoms of overdose it is necessary to cancel gradually administration of drug, and also to carry out symptomatic therapy.

Storage conditions:

List B. To store in the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years.

Issue conditions:

According to the recipe

Packaging:

Tablets of 4 mg. On 25 tablets in the blister from PVC / It is scarlet a foil. 2 blisters with the application instruction in a cardboard pack.