Instructions for Polcortolon tablets 4 mg No. 50
Composition
active ingredient: triamcinolone;
1 tablet contains 4 mg of triamcinolone;
Excipients: lactose monohydrate; potato starch, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets of white or almost white color, round shape, with flat surfaces, with a bevel, engraved on one side with the letter "o", on the other with the sign "4 mg".
Pharmacotherapeutic group
Corticosteroids for systemic use. Glucocorticoids. ATC code H02A B08.
Pharmacological properties
Pharmacodynamics
The main effects of triamcinolone in humans are glucocorticoid action and suppression of inflammatory responses. Glucocorticoid activity leads to increased gluconeogenesis and decreased glucose uptake in tissues. Protein catabolism is accelerated and the synthesis of proteins supplied with food is reduced, although the overall effect on nitrogen balance depends on other factors, including diet, dose, and duration of treatment. Negative nitrogen balance may occur at doses of 12 to 24 mg per day. Fat is broken down and its deposition on the shoulders, face, and abdomen increases. Triamcinolone has a mineralocorticoid effect. During corticosteroid therapy, the number of erythrocytes and neutrophils increases; the number of eosinophilic and basophilic leukocytes decreases, as does the mass of lymphoid tissue.
Corticosteroids prevent or suppress the initial signs of the inflammatory process, namely: redness, soreness, increased temperature at the site of inflammation, swelling, as well as delayed effects, including fibroblast proliferation and collagen deposition.
Pharmacokinetics
Like prednisone, triamcinolone is likely to be metabolized in the liver. After absorption through the skin, topical corticosteroids behave in the same way as systemic corticosteroids: metabolism occurs primarily in the liver.
Most of the triamcinolone is converted to 6-beta-hydroxytriamcinolone.
Systemically administered corticosteroids pass into breast milk in amounts that are unlikely to have adverse effects on the infant.
The plasma half-life of oral triamcinolone ranges from 2 to more than 5 hours.
According to the results of the studies, the pharmacokinetics of triamcinolone depend on the dose. In the group of patients receiving the average half-life was 85 minutes; in the group receiving 10 mg/kg - 88 minutes. Total clearance was 61.6 l/h in the group receiving 5 mg/kg and 48.2 l/h in the group receiving 10 mg/kg. The difference was statistically significant. Less than 15% of the drug is excreted unchanged in the urine.
Indication
Allergic reactions, including neurodermatitis, bullous dermatitis, drug hypersensitivity reactions, serum sickness. In anaphylactic reactions, corticosteroids should not be used for the treatment of the acute condition, but they may be effective for the prevention of the last stage of an allergic reaction. Rheumatic diseases, especially severe rheumatoid arthritis, if it is necessary to achieve a beneficial effect from long-acting antirheumatic drugs. Corticosteroids are indicated for the short-term treatment of extra-articular rheumatism (epicondylitis, post-traumatic osteoarthritis, synovitis, bursitis) and psoriatic arthritis. In the latter indication, corticosteroids are recommended in case of exacerbation and as maintenance therapy. Dermatological diseases: dermatitis herpetiformis, exfoliative dermatitis, severe erythema multiforme, severe psoriasis, severe seborrheic dermatitis, eczema, discoid lupus erythematosus, alopecia areata, and various acute and chronic dermatoses. Ophthalmological diseases: severe acute and chronic allergic and inflammatory conditions, including allergic conjunctivitis, allergic corneal marginal ulcers, anterior segment inflammation, chorioretinitis, diffuse posterior uveitis and choroiditis, herpes zoster ophthalmicus, iritis and iridocyclitis, keratitis, optic neuritis, and sympathetic ophthalmia. Endocrine diseases: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia, hypercalcemia due to malignancy, subacute thyroiditis, and Addison's disease. Digestive system diseases: regional enteritis (Crohn's disease) and ulcerative colitis during exacerbation. Respiratory tract diseases: aspiration pneumonitis, berylliosis, Leffler's syndrome, sarcoidosis and acute miliary tuberculosis. Other diseases: tuberculous meningitis, multiple sclerosis (corticosteroids are used to treat exacerbations of multiple sclerosis; they reduce the duration of exacerbations, but do not stop the progression of the disease).
Contraindication
Hypersensitivity to triamcinolone or to other components of the drug.
Systemic fungal infections. History of proximal myopathy.
Diverticulitis, glaucoma.
Children's age up to 3 years.
Malignant neoplasms with metastases.
Active inflammation and infection
Corticosteroids may mask signs of infection and reduce resistance to infection.
Corticosteroids may impair the response to infection and activate or exacerbate local or systemic infections or active infections not treated with antimicrobials, as well as latent or cured tuberculosis.
Corticosteroid therapy increases the risk of tuberculosis in patients with latent tuberculosis or a positive Mantoux test. Corticosteroid treatment for active tuberculosis should be limited to use in subacute or acute miliary disease, in which the corticosteroid is prescribed in conjunction with an appropriate antituberculosis regimen.
Corticosteroids increase the risk of serious, including fatal, infections in patients who have a viral infection such as chickenpox or measles.
Corticosteroids should be used with caution in patients with ocular herpes simplex due to the possibility of corneal perforation.
Patients receiving corticosteroid therapy who have not previously had this viral disease are at increased risk of developing varicella. Such patients should avoid contact with infectious patients, but if they have had contact, passive immunization is recommended.
Diabetes mellitus
Disease control may become more difficult during corticosteroid therapy.
Triamcinolone may increase blood glucose levels, which may lead to glycosuria or diabetes mellitus.
Osteoporosis
With long-term use of corticosteroids, osteoporosis may be complicated, especially in elderly patients; there is a risk of vertebral collapse. Corticosteroids should be used with caution in patients with osteoporosis.
Myopathy
A history of corticosteroid-induced proximal myopathy is a contraindication because of the risk of this side effect, which is particularly associated with triamcinolone. Myopathy usually resolves within a few months after corticosteroid withdrawal. Children are at highest risk of this side effect.
Peptic ulcer
Peptic ulcer disease is somewhat associated with the use of corticosteroids, and there is a risk of hemorrhage or perforation. Patients who are also taking nonsteroidal anti-inflammatory drugs are at particularly high risk. Corticosteroids should be used with caution in patients with active or latent peptic ulcers.
Psychosis
Corticosteroids can cause psychiatric disorders ranging from euphoria, insomnia, mood swings, personality changes to severe depression and marked psychosis. Corticosteroids may also exacerbate existing emotional instability or psychotic tendencies. Especially in patients with a history of paranoia or depression, taking this drug increases the risk of suicide.
Wound healing
Delayed wound healing may be of importance for patients with a recent intestinal anastomosis.
Vaccination
Patients receiving corticosteroid therapy should not receive vaccinations, especially against smallpox. In particular, no other vaccinations should be given to patients taking high doses of corticosteroids because of the possibility of neurological complications or lack of antibody response.
Interaction with other medicinal products and other types of interactions
When used simultaneously with amphotericin B and potassium-sparing agents, the patient should be monitored for the possible development of hypokalemia.
Anticholinesterase agents have an antagonistic effect on corticosteroids.
Paracetamol – hypernatremia, edema, increased calcium excretion; increased risk of paracetamol hepatotoxicity.
Anticoagulants, coumarin derivatives, indadione, heparin, streptokinase, urokinase - reduced, and in some patients increased effectiveness; increased risk of ulceration and bleeding from the gastrointestinal tract.
Immunosuppressive drugs – increase the risk of infection, development of lymphangitis and other lymphoproliferative diseases.
Corticosteroids antagonize antihypertensives and diuretics. The hypokalemic effect of diuretics, including acetazolamide, is more pronounced.
Anti-tuberculosis drugs: serum concentrations of isoniazid may increase.
Cyclosporine: Careful monitoring is required for increased cyclosporine toxicity when used concomitantly with corticosteroids.
Estrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance may be decreased.
Hepatic enzyme inducers (including barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide) may increase the metabolic clearance of triamcinolone. The patient should be closely monitored for possible reduction in steroid effects with appropriate dosage adjustment.
Human growth hormone: the growth-promoting effect may be inhibited.
Ketoconazole: possible reduction in clearance of corticosteroids and, as a result, increased effects.
Thyroid drugs: Metabolic clearance of adrenocorticoids is decreased in patients with hypothyroidism and increased in patients with hyperthyroidism. Changes in the patient's thyroid status may require adjustment of adrenocorticoid dosage.
The combination of a corticosteroid with nonsteroidal anti-inflammatory drugs increases the risk of peptic ulcers and gastrointestinal bleeding.
Aspirin should be taken with caution with corticosteroids in hypothrombinemia.
Concomitant administration of corticosteroids and neuromuscular relaxants has been reported to counteract neuromuscular blockade.
Sodium – edema, increased blood pressure; dietary sodium restriction and high-sodium medication may be necessary.
Clinical studies have shown that when taken concomitantly, corticosteroids affect the action of oral anticoagulants, enhancing or weakening it.
Phenytoin has been shown to increase the hepatic metabolism of corticosteroids and reduce the effectiveness of triamcinolone.
Concomitant use with mexiletine leads to an acceleration of mexiletine metabolism and a decrease in its serum concentration.
Concomitant use with alcohol increases the risk of ulcers and bleeding from the gastrointestinal tract.
Triamcinolone increases the body's need for folic acid.
Concomitant use with tricyclic antidepressants (e.g. clomipramine) may cause hypokalemia, increasing the risk of ventricular fibrillation.
Vaccines containing live viruses – when using immunosuppressive doses of glucocorticosteroids, the development of viral diseases and a decrease in the effectiveness of vaccination are possible.
Other vaccines – increased risk of neurological complications, as well as reduced antibody formation.
Concomitant influenza vaccination and therapy with immunosuppressive agents (including corticosteroids) has been associated with a deterioration in the immune response to the vaccine.
Corticosteroid therapy tends to increase blood glucose in patients with diabetes, so higher doses of insulin may be necessary.
Concomitant use with testosterone, other androgenic hormones, or anabolic steroids may cause increased fluid retention in the body and edema.
Concomitant administration of phenobarbital and corticosteroids may result in decreased plasma levels and therapeutic effects of the corticosteroid.
When used simultaneously with isoniazid, the concentration of isoniazid in the blood serum may increase.
The risk of hypokalemia may increase if triamcinolone is administered concomitantly with sympathomimetics and theophylline, which reduce plasma potassium levels, and with potassium-sparing diuretics; hypokalemia may also potentiate the effects of cardiac glycosides. The risk of hypokalemia may also increase with concomitant use with carbonic anhydrase inhibitors (e.g. acetazolamide).
Coadministration of glucocorticoids and CYP3A inhibitors, including products containing cobicistat, is expected to increase the risk of systemic adverse reactions. Such interactions should be avoided unless the benefit outweighs the increased risk of systemic adverse reactions associated with glucocorticoids; in which case the patient should be monitored for systemic effects of glucocorticoids.
Possible systemic effects include: Cushing's syndrome, Cushingoid syndrome, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma.
Application features
Since complications of glucocorticoid therapy (including triamcinolone) are dose- and duration-dependent, a risk/benefit assessment of dose and duration of treatment should be made in each individual case. Patients receiving corticosteroid therapy who are exposed to stress should receive rapid-acting corticosteroid therapy, and the dose should be increased before, during, and after the stressful situation.
Adrenal suppression may persist for several months after discontinuation of treatment; therefore, replacement therapy may be necessary during periods of stress.
Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis, fresh anastomosis, renal failure, hypertension, and myasthenia gravis.
The drug should be used with extreme caution after a recent intestinal anastomosis, with thrombophlebitis present at the time of use or in the history of severe affective disorder, especially steroid psychosis, with exanthematous diseases, congestive heart failure, acute glomerulonephritis.
In patients with thyroid insufficiency or in patients with liver cirrhosis, triamcinolone acts more actively, so the drug should be used in lower doses.
Drug-induced secondary adrenocortical insufficiency can be minimized by gradual dose reduction. This type of insufficiency may persist for months after discontinuation of therapy.
Laboratory parameters that may increase during corticosteroid treatment include: white blood cell count (greater than 20,000/mm3) without signs of inflammation or neoplasm, blood glucose, cholesterol, triglycerides, and low-density lipoproteins.
Decreased urinary levels of 17-ketosteroid and 17-hydroxysteroid may occur as a result of adrenal suppression during triamcinolone therapy.
Triamcinolone in large doses can cause increased blood pressure, fluid and sodium retention, and increased excretion of potassium and calcium.
In people who have arrived from tropical countries, infection with dysentery amoeba must be excluded before using the drug.
Patients with hypoprothrombinemia should be treated with caution with acetylsalicylic acid together with triamcinolone.
Triamcinolone should be used with caution, and only when indicated, in the presence of abscesses or other purulent infections, muscle fatigue, impaired liver function, candidal or viral infection, hyperlipidemia, hypoalbuminemia, hypoalbuminemia, epilepsy.
Visual disturbances. Visual disturbances may occur with systemic and topical corticosteroids. If a patient experiences symptoms such as blurred vision or other visual problems, consideration should be given to consulting an ophthalmologist to rule out possible causes such as cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which has been reported with systemic and topical corticosteroids.
In the event of perforation of the digestive tract in patients taking triamcinolone in large doses, symptoms of peritonitis may be minor or absent.
Abrupt discontinuation of treatment may cause adrenal insufficiency, so the dose of triamcinolone should be reduced gradually.
Special information about some of the excipients of Polcortolon
Polcortolone contains lactose. Patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
Corticosteroids may cause sedation, depression, insomnia, personality changes, mania, hallucinations, or psychosis. Corticosteroids may also exacerbate existing emotional instability or psychotic tendencies. Therefore, patients should avoid driving or operating machinery until their individual sensitivity to this drug has been established.
Use during pregnancy or breastfeeding
Triamcinolone is contraindicated in pregnant and lactating women. Women taking triamcinolone should discontinue breastfeeding.
Method of administration and doses
The dose of triamcinolone should be individualized, depending on the disease and the patient's response to treatment. Treatment should be initiated with the lowest effective dose of corticosteroids, and if possible, dose reduction should be gradual.
Tablets can be taken either once a day (preferably in the morning) or in several doses, especially if the total daily dose exceeds 16 mg.
The usual daily dose for adults is 4 to 32 mg. After achieving the desired effect, the dose should be gradually reduced (by 4 mg every 2 to 3 days) until an adequate maintenance dose is reached (usually about 4 mg per day).
Children weighing more than 25 kg should receive the dose recommended for adults.
Children weighing up to 25 kg should receive an initial dose of 12 mg per day, with subsequent doses depending on the type of disease and the patient's response to treatment. Therapeutic results should be expected after 2 or 3 weeks. However, even more than six weeks of therapy may be required before certain positive results are observed.
Children
Triamcinolone in tablet form is contraindicated in children under 3 years of age.
In pediatrics, glucocorticosteroids should be used for absolute indications and under close medical supervision. With long-term treatment with triamcinolone, the child's growth and development should be constantly monitored, and the frequency of administration should be chosen (daily or periodically).
Overdose
There have been rare reports of acute overdose, including fatal outcome due to acute corticosteroid overdose.
Very high doses, usually only after a few weeks of administration, can cause hyperadrenocorticism, adrenal suppression, muscle weakness, osteoporosis, and erosive lesions of the stomach and duodenum. Treatment is symptomatic. Abrupt discontinuation of therapy should be avoided. A single dose of a large number of tablets does not cause clinically significant intoxication. Hemodialysis is ineffective for removing triamcinolone from the body.
Adverse reactions
The frequency of adverse reactions is defined as follows:
Very common: (≥ 1/10), common: (≥ 1/100 to < 1/10), uncommon: (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000) including isolated cases frequency unknown: frequency cannot be estimated from the available data.
From the side of the cardiovascular system
From the side of the blood and lymphatic systems
Frequency unknown: granulocytosis, lymphopenia, monocytopenia.
From the nervous system
Frequency unknown: convulsions, intracranial hypertension with congestive disc, headache, dizziness.
From the organs of vision
Frequency not known: posterior subcapsular cataract, blurred vision, cataract, increased intraocular pressure, glaucoma1 with possible optic nerve damage and optic nerve oedema (associated with benign intracranial hypertension), exophthalmos, visual impairment.
Gastrointestinal tract
Frequency unknown: pancreatitis, duodenal ulcer, peptic ulcer with possible perforation and/or gastrointestinal bleeding, perforation of the large or small intestine, especially in patients with inflammation of the small intestine, melena, black vomiting, flatulence, ulcerative esophagitis, dyspepsia, indigestion, nausea, vomiting, increased appetite, purulent inflammation of the pharynx, dry mouth.
Skin and subcutaneous tissue disorders
Frequency unknown: skin stretch marks, acne, bruising, petechiae and hematomas, erythema, allergic dermatitis, urticaria, angioedema, acneiform ulcers, contusions, dermatitis, ecchymoses, facial erythema, atrophy, hirsutism, poor wound healing, increased sweating, wrinkles, telangiectasia and skin thinning, vasomotor edema, striae.
Musculoskeletal and connective tissue disorders
Frequency unknown: muscle weakness, steroid myopathy, muscle wasting, spinal compression fractures, aseptic necrosis of the femoral and humeral heads, pathological fractures of long bones, myopathy, osteonecrosis, osteoporosis2 (bone loss is greatest in the first 6 months of treatment and mainly affects cancellous bone), avascular necrosis, decreased muscle mass, bone fragility, pathological bone fractures, tendon rupture, growth retardation and ossification processes in children, premature closure of epiphyseal growth plates.
From the endocrine system
Frequency unknown: irregular menstruation, menstrual disorders, Cushing's syndrome, growth suppression in children (long-term treatment), secondary adrenal and pituitary insufficiency, especially in stressful situations such as illness, trauma, surgery; development of diabetes mellitus or increased need for insulin and antidiabetic agents in patients with existing diabetes mellitus, hirsutism, sodium retention (causing fluid retention and arterial hypertension and compensatory increase in renal potassium excretion, leading to hypokalemia), adrenal suppression, complications of existing diabetes mellitus, hypoglycemia (in those without diabetes mellitus).
Metabolism and digestion
Frequency unknown: negative nitrogen balance, increased blood and urine glucose concentration, weight gain (central obesity), porphyria, increased levels of total cholesterol, low-density lipoproteins, triglycerides, sodium retention in the body.
Infections and infestations
Frequency unknown: oropharyngeal candidiasis, septic necrosis (especially in patients with systemic lupus erythematosus or rheumatoid arthritis), secondary fungal and viral infections.
From the vascular system
Frequency unknown: thromboembolic syndromes, swelling of the lower legs and feet, arterial hypertension, cardiac arrhythmias, congestive circulatory failure, hypokalemic alkalosis.
On the part of the immune system
Frequency unknown: hypersensitivity reactions, including severe allergic reactions (skin rash, urticaria, angioedema, bronchospasm, respiratory arrest and anaphylactic reaction, itching, difficulty breathing, tightness in the chest, swelling of the face, lips and tongue).
From the reproductive system and mammary glands
Frequency unknown: menstrual irregularities and vasomotor symptoms, impotence, increased or decreased sperm motility and count.
Mental disorders
Frequency unknown: euphoria, sudden mood swings, personality changes, severe depression, symptoms of psychosis (symptoms vary between schizophrenia, mania or delirium), sedation, depression, insomnia, mania, hallucinations, mental disorders, suicidal thoughts, worsening of epilepsy and other mental illnesses, sleep disorders, anxiety, psychomotor hyperactivity, aggression (especially in children).
Respiratory, thoracic and mediastinal disorders
Frequency unknown: pulmonary tuberculosis, dysphonia, irritated dry throat (after use of corticosteroid oral inhalers).
General disorders and administration site conditions
Frequency unknown: malaise, secondary fungal or viral infections, increased or decreased sperm motility and quantity, disturbances of water and electrolyte metabolism (sodium and fluid retention, potassium loss, potassium deficiency alkalosis, increased calcium excretion), sleep disturbances, prolonged sore throat, chills or fever, avascular necrosis, local skin discoloration, skin atrophy, tendon damage.
2 To prevent osteoporosis, the lowest effective dose of corticosteroids should be used, and topical and inhaled preparations should be used whenever possible, despite the fact that osteoporosis has also developed in patients taking inhaled preparations.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Store in the original packaging in order to protect from light and moisture. Keep out of the reach of children.
Packaging
25 tablets in a blister; 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Adamed Pharma SA, Poland.
Location of the manufacturer and its business address
ul. Marsz. J. Pilsudskiego 5, Pabianice, 95 – 200, Poland.
