Polcortolone, tablets 4 mg 50 pcs

Polcortolone is a synthetic glucocorticosteroid, a fluorinated derivative of prednisolone, with strong anti-inflammatory effects. It is thought 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.

It has a weak mineralocorticoid action. Inhibits the development of inflammatory symptoms. Inhibits the accumulation of macrophages, leukocytes and other cells in the inflammatory area. Causes a decrease in capillary permeability. It has immunosuppressive effect; it inhibits cellular immunological reactions.

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

It increases protein catabolism, causes an increase in blood glucose concentrations, affects lipid metabolism, increases the concentration of fatty acids in the blood serum. With long-term treatment it is possible to redistribute adipose tissue.

Inhibits bone formation, decreases serum calcium concentration, may cause suppression of bone growth in children and adolescents and development of osteoporosis in patients of all ages.

Indications

Primary or secondary insufficiency of the adrenal cortex

Congenital adrenal hyperplasia

Subacute thyroiditis

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

Contact dermatitis

Atopic dermatitis

Serum disease

Drug hypersensitivity reactions

Year-round or seasonal allergic rhinitis resistant to other medications

3. Diseases of the musculoskeletal system:

Psoriatic arthritis

Ankylosing spondylitis

Acute and subacute bursitis

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Epicondylitis

Acute tendovaginitis

Posttraumatic osteoarthritis

4. Rheumatic diseases:

Acute rheumatic fever

Rheumatic myocarditis

Rheumatoid arthritis, juvenile rheumatoid arthritis (in cases resistant to other treatments)

Rheumatic polymyalgia, Horton’s disease

5. Systemic connective tissue diseases:

Dermatomyositis

Systemic lupus erythematosus

Mesoarteritis granulomatous gigantocellularis

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Systemic scleroderma

Nodular periarteritis

Recurrent polychondritis

6. Dermatologic diseases:

Exfoliative dermatitis

Herpetiform bullous dermatitis

Severe seborrheic dermatitis

Severe erythema multiforme (Stevens-Johnson syndrome)

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Fungal mycosis

Puberculosis

Severe psoriasis

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Severe eczema

Pemphigoid

7. Hematologic diseases:

acquired autoimmune hemolytic anemia

congenital (erythroid) hypoplastic anemia

anemia due to bone marrow hypoplasia

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secondary thrombocytopenia in adults

idiopathic thrombocytopenic purpura (Verlhof disease) in adults

haemolysis

8. Liver disease:

Alcoholic hepatitis with encephalopathy

Chronic active hepatitis

9. Hypercalcemia in malignancies

10. Cancers:

Leukemia and lymphoma in adults

Acute leukemia in children

11. Neurological diseases:

Tuberculous meningitis with subarachnoid block or at risk of block (in combination with appropriate anti-tuberculosis chemotherapy)

Multiple sclerosis during exacerbation

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

Severe flaccid anterior and posterior uveitis

Optic neuritis

Sympathetic ophthalmia

13. Respiratory diseases:

Bronchial asthma, severe form

Berylliosis

Leffler syndrome, not amenable to therapy by other means

Symptomatic sarcoidosis

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Molten or disseminated pulmonary tuberculosis (in combination with anti-tuberculosis chemotherapy)

Aspiration pneumonitis

14. In organ and tissue transplants – prevention and treatment of graft rejection (in combination with other immunosuppressive drugs).

Active ingredient

Composition

One tablet contains:

active ingredient: triamcinolone 4.0 mg

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

How to take, the dosage

The dose of Polcortolone is set individually, depending on the indications, the effectiveness of therapy and the patient’s condition. According to the daily rhythm of endogenous glucocorticosteroid secretion, it is recommended to take the drug once a day, in the morning. However, in some cases, more frequent administration of the drug may be necessary. Adults and adolescents over 14 years of age: from 4 to 48 mg/day in one or several doses.

Children: 0.1-0.5 mg/kg body weight per day in one or more doses.

If a dose is missed, take the drug as soon as possible or, if the next dose is approaching, skip the forgotten dose. Do not take a double dose at once.

Polcortolone should be used in the lowest effective dose. If necessary, the dose of the drug should be reduced gradually.

Interaction

Heart glycosides: increased risk of cardiac rhythm disturbances and glycoside toxicity associated with hypokalemia.

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

The antihistamines weaken the effect of triamcinolone.

Amphotericin B, carbohydrase inhibitors: hypokalemia, left ventricular myocardial hypertrophy, circulatory failure.

Paracetamol: hypernatremia, peripheral edema, increased calcium excretion, risk of hypocalcemia and osteoporosis. Increased risk of hepatotoxicity of paracetamol. Anabolic steroids, androgens: increased risk of peripheral edema, acne; use with caution, especially in liver and heart disease.

Estrogen-containing oral contraceptive agents: increase

the concentration of glucocorticosteroid-binding globulins in blood serum, slowed metabolism, increased elimination half-life, increased action of triamcinolone.

Choline-blocking drugs, mainly atropine: increase in intraocular pressure. Anticoagulants (coumarin derivatives, indadione, heparin), streptokinase, urokinase: decreased, and in some patients increased effectiveness; dose should be determined based on prothrombin time; increased risk of ulceration and gastrointestinal bleeding.

Tricyclic antidepressants may exacerbate psychiatric disorders associated with triamcinolone administration. They should not be used to treat these disorders. Oral hypoglycemic drugs, insulin: weakening of hypoglycemic effect, increased blood glucose concentrations; it may be necessary to perform dose adjustment of hypoglycemic drugs.

Antithyroid drugs, thyroid hormones: change in thyroid function; dosage adjustment or discontinuation of antithyroid drug or thyroid hormone may be necessary.

Diuretics: weakening the effect of diuretics (potassium-saving),

hypokalemia.

Laxatives: weakening of action, hypokalemia.

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

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

Isoniazid: decreased plasma concentrations of isoniazid, mostly in persons with rapid acetylation; dose modification may be necessary.

Mexiletine: accelerated metabolism of mexiletine and decreased plasma concentrations.

Medications that block neuromuscular conduction (depolarizing myorelaxants): hypocalcemia associated with triamcinolone use may increase synaptic blockade, resulting in increased duration of neuromuscular blockade.

Non-steroidal anti-inflammatory drugs, acetylsalicylic acid, alcohol: weakening of action, increased risk of peptic ulcer disease and bleeding from the gastrointestinal tract.

Drugs and food containing sodium: peripheral edema, arterial hypertension, it may be necessary to limit sodium in the diet and sodium-rich medications; use of glucocorticosteroids sometimes requires additional sodium administration.

Vaccines containing live viruses: while using immunosuppressive doses

glucocorticosteroids may cause viral replication and development of viral disease and decrease antibody production; concomitant use is not recommended.

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

Folic acid: increased need for this drug.

Special Instructions

The patient must follow the doctor’s instructions exactly when taking Polcortolone.

Partneral administration of glucocorticosteroids is recommended for patients taking Polcortolone in stressful situations.

Sudden discontinuation of treatment may cause adrenal insufficiency, so the dose of Polcortolone should be reduced gradually.

Polcortolone may mask symptoms of infection and reduce resistance to infection and the ability to localize it.

Long-term use of Polcortolone increases the risk of secondary fungal or viral infections.

Long-term use of Polcortolone may cause the development of cataracts, glaucoma with possible damage to the optic nerves.

Patients taking Polcortolone should not be vaccinated with live virus vaccines. Injection of inactivated viral or bacterial vaccine may not produce the expected increase in antibodies. In addition, patients taking glucocorticosteroids have an increased risk of neurological complications during vaccination.

If Polcortolone is suddenly withdrawn, especially after long-term use, a so-called withdrawal syndrome may develop, manifested by anorexia, elevated body temperature, muscle and joint pain, and general weakness. These symptoms may appear even when there is no insufficiency of the adrenal cortex. In patients with hypothyroidism or liver cirrhosis the effect of triamcinolone is increased.

Mental disorders such as euphoria, insomnia, rapid mood changes, personality changes, severe depression, symptoms of psychosis may appear during the use of Polcortolone. Pre-existing emotional instability or psychotic tendencies may intensify during treatment.

When treating patients with hypoprothrombinemia, triamcinolone and acetylsalicylic acid should be used with caution.

In long-term treatment of children, their growth and development should be monitored.

Special precautions when disposing of unused medication

Medications should not be thrown down drains or into household waste containers. Ask your pharmacist about how to dispose of unused medication. These measures will help protect the environment.

Polcortolone does not normally affect mental responses. However, it can cause dizziness, headache and even mental disorders.

Contraindications

Hypersensitivity to triamcinolone or other components of the drug.

Children under 3 years of age (for this dosage form).

Diseases of the gastrointestinal tract: Esophagitis, gastritis, non-specific ulcerative colitis with threat of perforation or abscessing, diverticulitis, gastric and duodenal ulcer, acute or latent peptic ulcer, newly created intestinal anastomosis;

In diseases of the cardiovascular system, including recent myocardial infarction (patients with acute and subacute myocardial infarction may spread the focus of necrosis, delay the formation of scar tissue and thereby rupture the heart muscle), decompensated chronic heart failure, hypertension, hyperlipidemia;

Endocrine diseases: Diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Icenko-Cushing’s disease;

Severe chronic renal and/or hepatic failure, nephrourolithiasis; Hypoalbuminemia and conditions predisposing to its occurrence;

Systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (III-IV stage.), poliomyelitis (except for bulbar encephalitis), open- and closed-angle glaucoma, pregnancy, lactation.

Side effects

The frequency and severity of side effects depend on the duration of use, the amount of dose used, and the ability to follow the circadian rhythm of administration.

In short-term use of Polcortolone, like other glucocorticosteroids, side effects are rare. The following side effects are possible when using Polcortolone for a long time:

Endocrine system side effects:

Secondary adrenal and hypothalamic-pituitary insufficiency (especially during stressful situations such as illness, trauma, surgery); Icenko-Cushing’s syndrome (moon-shaped face, pituitary-type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia grafts), delayed sexual development and growth suppression in children, menstrual disorders, reduced glucose tolerance, manifestation of latent diabetes and increased need for insulin or oral hypoglycemic agents in diabetic patients, hirsutism.

Digestive system disorders:

“Steroid” gastric and 12 duodenal ulcer with possible perforation and bleeding, pancreatitis, flatulence, erosive esophagitis, digestive disorders, nausea, vomiting, increased or decreased appetite, hiccups. In rare cases – increased activity of “liver” transaminases and alkaline phosphatase.

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 – expansion of the focus of necrosis, delayed formation of scar tissue, which may lead to rupture of the heart muscle.

Nervous system disorders:

Delirium, disorientation, euphoria, hallucinations, manic-depressive -psychosis, depression, paranoia, increased intracranial pressure with congestive optic nipple 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 cerebri, seizures, dizziness, headache, nervousness or restlessness, sleep disturbances.

Sensory organs:

Posterior subcapsular catarrh, increased intraocular pressure with possible damage to the optic nerve, glaucoma, exophthalmos, tendency to develop secondary bacterial, fungal or viral eye infections, trophic corneal changes.

Metabolic disorders:

. Negative nitrogen balance due to protein catabolism, hyperglycemia, glucosuria, increased Ca2+ excretion, hypocalcemia, weight gain, increased sweating, sodium and fluid retention in the body (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

Musculoskeletal disorders:

. Slow growth and ossification processes in children (premature closure of epiphyseal growth zones), osteoporosis (very rare – pathological bone fractures, spinal compression fracture, aseptic necrosis of the head of the humerus and femur, pathological fractures of long tubular bones), muscle tendon rupture, muscle weakness, “steroid” myopathy, decrease in muscle mass (atrophy).

Skin and mucous membranes:

Steroid acne, stretch marks, delayed wound healing, skin thinning, petechiae, ecchymosis, hematoma, tendency to develop pyoderma and candidiasis.

Allergic reactions: skin rash, itching, anaphylactic shock.

Other:

The development and exacerbation of infections (the appearance of this side effect is promoted by co-administration of immunosuppressants and vaccination), leukocyturia, “withdrawal” syndrome.

Overdose

Pregnancy use

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