Polcortolonum

Polcortolonum – the synthetic glucocorticosteroid drug having the expressed antiinflammatory and weak mineralokortikoidny effect, and also having antiedematous, antiallergic and antipruritic effect.

Form of release and structure

• Tablets: a round form, flat, almost white or white color, with a facet, on one party an engraving – "4/mg", on another – "About" (in blisters on 25 pieces, 2 blisters in a cardboard pack);
• Ointment for external use of 0,1%: almost white or white translucent weight with a smell of an ointment basis (in aluminum tubas on 15 g, 1 tuba in a pack cardboard).

Active agent of drug – Triamcinolonum (in the form of acetonide):

• 1 tablet – 4 mg;
• 1 g of ointment – 1 mg.

Excipients of tablets: potato starch, lactose, magnesium stearate.

Additional components of ointment: lanolin, vaseline white, propylene glycol, citric acid.

Indications to use

For tablets:

• Hard proceeding allergic diseases steady against other therapeutic methods: atopic dermatitis, contact dermatitis, seasonal and year-round allergic rhinitis, hypersensitivity reactions to medicines, a serum disease;
• Dermatological diseases: severe forms of eczema, fungoid mycosis, herpetiform violent dermatitis, pemphigus, exfoliative dermatitis, pemphigoid, heavy seborrheal dermatitis, psoriasis of heavy degree, Stephens-Johnson's syndrome (heavy mnogoformny erythema);
• General diseases of connecting fabric: a system lupus erythematosus, a nodular periarteritis, granulematozny giant-cell mesoarteritis, the dermatomyositis recuring a polychondritis, a system scleroderma;
• Rheumatic diseases: Horton's disease, a pseudorheumatism, a rheumatic polimialgiya, rheumatic myocarditis, acute rheumatic fever, a juvenile pseudorheumatism (at resistance to other methods of treatment);
• Endocrine diseases: subacute thyroiditis, primary and secondary insufficiency of bark of adrenal glands, inborn adrenal struma;
• Hematologic diseases: secondary thrombocytopenia at adults, Verlgof's disease (an idiopathic Werlhof's disease) at adults, the acquired autoimmune hemolitic anemia, hemolysis, anemia owing to a marrow hypoplasia, erythroidal (inborn) hypoplastic anemia;
• Neurologic diseases: multiple sclerosis in the period of an aggravation, tubercular meningitis with the subarachnoidal block or risk of its development (in a combination with antitubercular therapy);
• Musculoskeletal system diseases: an acute tendovaginitis, an acute and subacute bursitis, the posttraumatic osteoarthritis ankylosing a spondylarthritis, psoriasis arthritis, an epicondylitis;
• Diseases of a respiratory organs: Leffler's syndrome, an aspiration pneumonitis, a symptomatic sarcoidosis, a berylliosis, a severe form of bronchial asthma disseminated or a fulminant pulmonary tuberculosis (in a combination with antitubercular therapy);
• Serious acute and chronic illness of eyes of inflammatory character: sympathetic ophthalmia, optic neuritis, heavy slow uveitis (front and back);
• Liver diseases: chronic active hepatitis, alcoholic hepatitis with encephalopathy;
• Oncological diseases: acute leukoses at children, lymphoma and leukoses at adults;
• Hypercalcemia at malignant new growths.

Besides, Polcortolonum in tablets is applied to treatment and the prevention of graft rejection at change of fabrics or bodies (in a combination with other immunodepressive means).

For ointment:

• Dermatitis (including allergic, contact and seborrheal);
• Prurigo;
• Eczema;
• Multiformny erythema;
• Strophulus;
• Stings of insects.

Contraindications

For tablets:

• System mycoses;
• Children's age up to 3 years;
• Lactation (or feeding should be interrupted);
• Hypersensitivity to drug components.

For ointment:

• Chicken pox;
• Fungus and viral diseases of skin;
• Tuberculosis cutis;
• Perioral dermatitis;
• Pink and vulgar eels;
• Trophic ulcers of shins owing to a varicosity;
• Precancerous conditions of skin;
• Skin new growths;
• Children's age up to 2 years;
• Hypersensitivity to any component of drug.

In the tablets Polcortolonum with care apply in the following cases:

• Parasitic and infectious diseases of the fungal, bacterial and virus nature (including recently postponed, including recent contact with the patient): chicken pox, a viremichesky phase of the surrounding herpes, a herpes simplex, measles, active and latent tuberculosis, an amebiasis, system mycosis, a strongyloidosis and suspicion on it (at serious infectious diseases drug can be used along with performing specific therapy);
• Immunodeficiency (including syndrome of the acquired immune deficit (SAID) and human immunodeficiency virus (HIV));
• The vaccinal period (8 weeks to and 2 weeks after vaccination);
• Lymphadenitis after BTsZh inoculation;
• Digestive tract diseases: nonspecific ulcer colitis with threat of perforation or abscessing, gastritis, an esophagitis, an acute and latent round ulcer, a diverticulitis, recently created intestines anastomosis, a peptic ulcer of a stomach and a 12-perstny gut;
• Diseases of cardiovascular system, including dekompensirovanny chronic heart failure, lipidemia, arterial hypertension, recently postponed myocardial infarction;
• Endocrine diseases: a diabetes mellitus (including disturbance of tolerance to carbohydrates), a hypothyroidism, a thyrotoxicosis, Itsenko-Cushing's disease;
• Open and closed-angle glaucoma;
• Obesity of the III-IV degree;
• Chronic renal and/or liver failure of heavy degree;
• System osteoporosis;
• Myasthenia;
• The hypoalbuminemia and states contributing to its emergence;
• Nefrourolitiaz;
• Poliomyelitis (except for a form of bulbar encephalitis);
• Acute psychosis;
• Pregnancy.

Ointment Polcortolonum should be applied with care to patients (especially advanced age) with poorly expressed hypodermic fatty tissue, and also during pregnancy and a lactation.

Route of administration and dosage

Tablets
In this dosage form Polcortolonum is accepted inside during meal usually 1 time a day, in the morning (according to a day-night rhythm of secretion of endogenous glucocorticoids), but in certain cases the doctor can recommend division of a daily dose into several receptions.

The dose for each patient is established individually depending on indications, the general state and efficiency of the carried-out therapy.

The daily dose for adults and teenagers is more senior than 14 years can fluctuate ranging from 4 to 48 mg, for children up to 14 years – 0,1-0,5 mg/kg.

Regardless of a disease it is recommended to appoint Polcortolonum in a minimal effective dose. In the course of treatment if there is a need, the dose is gradually reduced.

In case of the admission of the next dose it is necessary to accept drug as soon as possible, but if already time of the following reception comes, then the passed dose does not need to be accepted. It is also impossible to accept a double dose at once.

Ointment for external use
In this dosage form Polcortolonum it is necessary to inflict a thin layer on area defeats and to rub.

In an initiation of treatment frequency rate of use makes 2-3 times a day, then it is reduced to 1-2 times.

At an excessive likhenization or a hyperkeratosis drug can be applied under an occlusive bandage, but it is no more than 1 time within 24-48 hours.

Treatment duration depending on a clinical situation – 1-2 weeks if drug is applied on face skin – no more than 7 days.

To children 2 years are more senior it is possible to apply ointment only 1 time a day on bodies, small on surface area, without affecting face skin.

Side effects

Possible side effects at use of Polcortolonum in tablets:

• From endocrine system: an Icenco-Cushing syndrome (including a hirsutism, obesity of pituitary type, a crescent-shaped face, a myasthenia, an amenorrhea, a dysmenorrhea, striya, increase in arterial pressure), secondary gipotalamo-pituitary and adrenal insufficiency (especially at stressful situations – diseases, injuries, surgical interventions), a hirsutism, decrease in tolerance to glucose, disturbances of a menstrual cycle, manifestation of a latent diabetes mellitus and increase in need for insulin or peroral hypoglycemic means at patients with a diabetes mellitus, a delay of sexual development and suppression of growth at children;
• From the alimentary system: digestion disturbances, a hiccups, raised or a hyporexia, nausea, vomiting, a meteorism, an erosive esophagitis, pancreatitis, steroid stomach ulcer and a 12-perstny gut with a possible perforation and bleeding; seldom – increase in activity of hepatic transaminases and an alkaline phosphatase;
• From cardiovascular system: changes, characteristic of a hypopotassemia, on the electrocardiogram, hypercoagulation, arterial hypertension, arrhythmias, fibrinferments, strengthening of expressiveness or development of chronic heart failure (at predisposed patients), bradycardia (up to a cardiac standstill); patients with an acute and subacute myocardial infarction have a delay of formation of cicatricial fabric and distribution of the center of a necrosis owing to what the rupture of a cardiac muscle is possible;
• From the central and peripheral nervous system: вертиго, hallucinations, a disorientation, a headache, a cerebellum pseudoneoplasm, a sleep disorder, nervousness or concern, spasms, euphoria, a depression, maniac-depressive psychosis, paranoia, a delirium, the brain pseudoneoplasm which is shown a headache, deterioration in visual acuity or doubling in eyes (increase in intracranial pressure with a syndrome of a congestive optic papilla; most often at children, usually after too bystry dose decline);
• From a musculoskeletal system: delay of growth and processes of ossification at children (premature closing of epiphyseal regions of growth), a steroid myopathy, muscular weakness, decrease in muscle bulk (atrophy), a rupture of sinews of muscles, osteoporosis (it is very rare – pathological fractures of bones, an aseptic necrosis of a head humeral and a femur, pathological fractures of long tubular bones, compression spinal fracture);
• From a metabolism: a hypocalcemia, the increased calcium removal, a hypernatremia, peripheral hypostases (a delay of sodium and liquid in an organism), increase in body weight, a hyperglycemia, a gipokaliyemichesky syndrome (a hypopotassemia, a spasm of muscles or a mialgiya, arrhythmia, unusual weakness, fatigue), the strengthened sweating, a glucosuria, negative nitrogenous balance as a result of a protein catabolism;
• From an organ of sight: tendency to development of consecutive fungal, viral or bacterial infections of eyes, an exophthalmos, glaucoma, increase in intraocular pressure with possible injury of an optic nerve, a back subkapsulyarny cataract, trophic changes of a cornea;
• Dermatological reactions: thinning of skin, delay of healing of wounds, petechias, striya, ecchymomas, tendency to development of a pyoderma and candidiasis, hematoma, steroid eels;
• Allergic reactions: itch, skin rash, acute anaphylaxis;
• Others: withdrawal, leukocyturia; in case of simultaneous use of immunodepressants or vaccination – development and an exacerbation of infections.

Expressiveness and frequency of development of side effects depend on a dose of drug, duration of its use and a possibility of observance of a circadian rhythm of appointment. At short-term courses of treatment undesirable reactions are observed seldom.

Ointment Polcortolonum at prolonged use can cause the following local reactions in the field of putting drug: bruises, skin hemorrhages, irritation and erubescence, atrophy of a hypodermic fatty tissue, hyperkeratosis, striya, epidermis overgrowth, healing process delay.

Special instructions

Tablets
In case of stressful situations parenteral administration of glucocorticosteroids (GKS) is recommended to patients who accept Polcortolonum orally.

At the sudden termination of treatment development of insufficiency of bark of adrenal glands and a withdrawal therefore the dose of drug should be reduced gradually is possible.

Polcortolonum can mask symptoms of infectious process, reduce resistance of an organism to an infection and ability to restriction of its distribution.

During treatment by this drug it is not necessary to carry out immunization by live virus vaccines. At introduction of the inactivated bacterial or virus vaccine can not occur the expected increase in quantity of antibodies. Besides, GKS increase risk of development of neurologic complications during vaccination.

Action of Triamcinolonum amplifies at patients with cirrhosis and a hypothyroidism.

Patients should appoint Polcortolonum with care with a prothrombinopenia who receive acetylsalicylic acid.

At long therapy of children it is necessary to control their growth and development carefully.

Ointment for external use
Due to the increased risk of development of side effects ointment is not recommended to be rubbed in face skin.

Not to apply on skin around eyes.

During pregnancy and a lactation medicine can be appointed only in exceptional cases, it is necessary to apply it on limited sites of skin and is short-term. The feeding women cannot apply on skin of mammary glands.

Medicinal interaction

Possible reactions of interaction at simultaneous use of Polcortolonum in the form of tablets along with other medicines:

• Cardiac glycosides: the risk of development of disturbances of a cordial rhythm and other toxic effects connected with a hypopotassemia increases;
• Anticonvulsants, barbiturates, глютетимид, rifampicin: metabolism decreases and action of Triamcinolonum is weakened;
• Blockers histamine _{H1 receptors}: the effect of Triamcinolonum decreases;
• Karboangidraza inhibitors, Amphotericinum In: the risk of development of a hypopotassemia, circulatory unefficiency, hypertrophy of a myocardium of a left ventricle increases;
• The hormonal contraceptives containing estrogen: action of Triamcinolonum amplifies;
• Anabolic steroids, androgens: the risk of development of peripheral hypostases, appearance of eels increases (such combination demands care, especially in the presence of diseases of a liver and heart);
• Paracetamol: the probability of developing of peripheral hypostases, hypocalcemias, hypernatremias, osteoporosis, increase in removal of calcium and a hepatotoxic of paracetamol increases;
• Holinoblokatora (atropine): the risk of increase in intraocular pressure increases;
• Anticoagulants (heparin, индандион, coumarin derivatives), urokinase, Streptokinasa: efficiency of Polcortolonum changes (at some patients – decreases, at others – raises; in this case it is necessary to define a dose depending on a prothrombin time, risk of a canker and bleeding from digestive tract);
• Tricyclic antidepressants: the mental disturbances caused by reception of Polcortolonum amplify (such combination is not recommended);
• Insulin and peroral hypoglycemic drugs: their action because of what concentration of glucose in blood increases is weakened (correction of doses is required);
• Anti-thyroid drugs, hormones of a thyroid gland: function of a thyroid gland can change (in this case dose adjustment or cancellation of these medicines is required);
• Kaliysberegayushchy diuretics, laxative drugs: their action is weakened, the risk of development of a hypopotassemia appears;
• Ephedrine: Triamcinolonum biotransformation accelerates (dose adjustment of Polcortolonum can be required);
• Immunodepressants: the probability of development of infections, lymphoma and other limfoproliferativny diseases increases;
• Isoniazid: its concentration in a blood plasma decreases (generally at patients with bystry acetylation; change of a dose of drug is required);
• Meksiletin: his metabolism accelerates and concentration in a blood plasma decreases;
• The depolarizing muscle relaxants: duration of neuromuscular blockade at patients with the hypocalcemia connected using Polcortolonum can increase;
• Non-steroidal anti-inflammatory drugs (including acetylsalicylic acid), alcohol: the risk of a canker and bleeding from digestive tract increases;
• Folic acid: its effect decreases (increase in its dose can be required);
• Live virus vaccines: development of viral diseases, replication of viruses and decrease in development of antibodies is possible (these combinations are not recommended);
• Other vaccines: development of antibodies decreases, the probability of development of neurologic complications increases;
• Drugs of sodium and the food containing sodium: the risk of emergence of peripheral hypostases and development of arterial hypertension increases (in this case cancellation of drugs of sodium and introduction of restrictions to a diet is required).

During treatment Polcortolonum it is not necessary to carry out by ointment for external use vaccination.

Terms and storage conditions

To store in the place, dry, dark, unavailable to children, at a temperature up to 25 ºС.

Period of validity of tablets – 3 years, ointments – 2 years.