Polcortolone
Polcortolone: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Polcortolone
ATX code: H02AB08
Active ingredient: triamcinolone (triamcinolone)
Producer: Pabianice Pharmaceutical Works Polfa (Poland), Jelfa SA (Poland)
Description and photo update: 2019-02-09
Prices in pharmacies: from 233 rubles.
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Polcortolone is a synthetic glucocorticosteroid drug that has a pronounced anti-inflammatory and weak mineralocorticoid effect, as well as an anti-edema, antiallergic and antipruritic effect.
Release form and composition
- Tablets: round, flat, almost white or white, beveled, engraved on one side - "4 / mg", on the other - "O" (in blisters of 25 pcs., 2 blisters in a cardboard box);
- Ointment for external use 0.1%: an almost white or white translucent mass with the smell of an ointment base (in 15 g aluminum tubes, 1 tube in a cardboard box).
Each pack also contains instructions for the use of Polcortolone.
The active substance of the drug is triamcinolone (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 the ointment: lanolin, white petrolatum, propylene glycol, citric acid.
Pharmacological properties
Pharmacodynamics
Pills
Triamcinolone is the active substance of Polcortolone, a synthetic glucocorticoid, a fluorinated derivative of prednisolone. It has a strong anti-inflammatory effect and has a weak mineralocorticoid effect.
It helps to inhibit the development of symptoms of inflammation, which is provided by a decrease in capillary permeability and a decrease in the accumulation of macrophages, leukocytes and other cells in the area of inflammation. It has an immunosuppressive effect, including by suppressing the cellular immune response.
Other effects of triamcinolone:
- Suppression of the secretion of ACTH (adrenocorticotropic hormone) by the pituitary gland, which leads to a decrease in the production of glucocorticosteroids and androgens by the adrenal cortex;
- Increased catabolism of proteins, which causes an increase in the concentration of glucose in the blood. Also, triamcinolone affects lipid metabolism, increases the concentration of fatty acids in the blood serum. With prolonged use, the substance can be redistributed in adipose tissue.
Due to inhibition of bone tissue formation and a decrease in serum calcium concentration in the blood while taking triamcinolone, it is possible to suppress bone growth in children and adolescents and the occurrence of osteoporosis in patients of all age groups.
The anti-inflammatory effect of triamcinolone at a dose of 4 mg is believed to be equivalent to 5 mg prednisolone, 4 mg methylprednisolone, 0.75 mg dexamethasone, 20 mg hydrocortisone, and 0.6 mg betamethasone.
Ointment for external use
Polcortolone in the form of an ointment is an external glucocorticosteroid drug. It has antipruritic, anti-inflammatory, anti-edematous, anti-allergic effects. It inhibits the accumulation of leukocytes and macrophages in the area of inflammation. Reduces capillary permeability, which prevents the formation of edema.
Reduces the severity of inflammatory reactions from the skin, especially those of allergic origin.
Pharmacokinetics
Pills
After oral administration, triamcinolone is readily absorbed from the gastrointestinal tract. The biological availability of the substance is 20-30%. When taken simultaneously with food, the absorption of triamcinolone in the initial phase slows down, while the overall bioavailability of the drug remains unchanged.
Binds to plasma proteins (mainly globulins) at a level of 40%. Penetrates through the placental barrier, excreted in breast milk.
Biotransformation occurs primarily in the liver. The biological half-life is about 5 hours. It is excreted mainly in the form of inactive metabolites by the kidneys.
Ointment for external use
Triamcinolone penetrates into the stratum corneum of the skin easily, does not undergo biotransformation. The substance can accumulate in the cells of the stratum corneum. Penetrates into the systemic circulation slightly, is metabolized in the liver.
Absorption in children is more pronounced than in adults, it increases when applied to large areas of the skin, in areas of skin folds, on the face, when applied under occlusive dressings.
With frequent use of Polcortolone, the cumulation of triamcinolone in the skin increases. Binds to plasma proteins at a level of 40%. The half-life is 5 hours. It is excreted mainly in the form of inactive metabolites by the kidneys.
Indications for use
For tablets:
- Severe allergic diseases resistant to other therapeutic methods: atopic dermatitis, contact dermatitis, seasonal and perennial allergic rhinitis, drug hypersensitivity reactions, serum sickness;
- Dermatological diseases: severe forms of eczema, fungal mycosis, herpetiformis bullous dermatitis, pemphigus, exfoliative dermatitis, pemphigoid, severe seborrheic dermatitis, severe psoriasis, Stevens-Johnson syndrome (severe erythema multiforme);
- Systemic connective tissue diseases: systemic lupus erythematosus, periarteritis nodosa, granulomatous giant cell mesoarteritis, dermatomyositis, recurrent polychondritis, systemic scleroderma;
- Rheumatic diseases: Horton's disease, rheumatoid arthritis, polymyalgia rheumatica, rheumatic myocarditis, acute rheumatic fever, juvenile rheumatoid arthritis (with resistance to other treatments);
- Endocrine diseases: subacute thyroiditis, primary and secondary adrenal cortex insufficiency, congenital adrenal hyperplasia;
- Hematological diseases: secondary thrombocytopenia in adults, Werlhof's disease (idiopathic thrombocytopenic purpura) in adults, acquired autoimmune hemolytic anemia, hemolysis, anemia due to bone marrow hypoplasia, erythroid (congenital) hypoplastic anemia;
- Neurological diseases: multiple sclerosis during an exacerbation, tuberculous meningitis with subarachnoid block, or the risk of its development (in combination with anti-tuberculosis therapy);
- Diseases of the musculoskeletal system: acute tendovaginitis, acute and subacute bursitis, post-traumatic osteoarthritis, ankylosing spondylitis, psoriatic arthritis, epicondylitis;
- Respiratory diseases: Leffler's syndrome, aspiration pneumonitis, symptomatic sarcoidosis, beryllium disease, severe bronchial asthma, disseminated or fulminant pulmonary tuberculosis (in combination with anti-tuberculosis therapy);
- Severe acute and chronic inflammatory eye diseases: sympathetic ophthalmia, optic neuritis, severe sluggish uveitis (anterior and posterior);
- Liver diseases: chronic active hepatitis, alcoholic hepatitis with encephalopathy;
- Oncological diseases: acute leukemias in children, lymphomas and leukemias in adults;
- Hypercalcemia in malignant neoplasms.
In addition, Polcortolone tablets are used to treat and prevent transplant rejection during tissue or organ transplantation (in combination with other immunosuppressive agents).
For the ointment:
- Dermatitis (including allergic, contact and seborrheic);
- Pruritus;
- Eczema;
- Erythema multiforme;
- Strofulus;
- Insect bites.
Contraindications
For tablets:
- Systemic mycoses;
- Children under 3 years old;
- Lactation (or feeding should be interrupted);
- Hypersensitivity to drug components.
For the ointment:
- Chicken pox;
- Fungal and viral skin diseases;
- Lupus;
- Perioral dermatitis;
- Rosacea and acne vulgaris;
- Trophic ulcers of the legs due to varicose veins;
- Precancerous skin conditions;
- Skin neoplasms;
- Children under 2 years old;
- Hypersensitivity to any component of the drug.
Polcortolone tablets are used with caution in the following cases:
- Parasitic and infectious diseases of a fungal, bacterial and viral nature (including recently transferred, including recent contact with a patient): chickenpox, viremic phase of herpes zoster, herpes simplex, measles, active and latent tuberculosis, amebiasis, systemic mycosis, strongyloidosis and suspicion on him (for severe infectious diseases, the drug can be used simultaneously with specific therapy);
- Immunodeficiency states (including acquired immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV));
- Vaccination period (8 weeks before and 2 weeks after vaccination);
- Lymphadenitis after BCG vaccination;
- Diseases of the gastrointestinal tract: ulcerative colitis with the threat of perforation or abscess formation, gastritis, esophagitis, acute and latent peptic ulcer, diverticulitis, newly created intestinal anastomosis, gastric ulcer and 12 duodenal ulcer;
- Diseases of the cardiovascular system, incl. decompensated chronic heart failure, hyperlipidemia, arterial hypertension, recent myocardial infarction;
- Endocrine diseases: diabetes mellitus (including impaired carbohydrate tolerance), hypothyroidism, thyrotoxicosis, Itsenko-Cushing's disease;
- Open and closed angle glaucoma;
- Obesity III-IV degree;
- Chronic renal and / or hepatic failure of severe degree;
- Systemic osteoporosis;
- Myasthenia gravis;
- Hypoalbuminemia and conditions predisposing to its occurrence;
- Nephrourolithiasis;
- Poliomyelitis (except for the form of bulbar encephalitis);
- Acute psychosis;
- Pregnancy.
Polcortolone ointment should be used with caution in patients (especially the elderly) with poorly expressed subcutaneous fat, as well as during pregnancy and lactation.
Polcortolone, instructions for use: method and dosage
Pills
In tablets, Polcortolone is taken orally during a meal, usually 1 time per day, in the morning (in accordance with the daily rhythm of the secretion of endogenous glucocorticoids), but in some cases the doctor may recommend dividing the daily dose into several doses.
The dose for each patient is set individually depending on the indications, general condition and effectiveness of the therapy.
The daily dose for adults and adolescents over 14 years old can range from 4 to 48 mg, for children under 14 years old - 0.1-0.5 mg / kg.
Regardless of the disease, it is recommended to prescribe Polcortolone in the minimum effective dose. In the course of treatment, if necessary, the dose is gradually reduced.
If the next dose is missed, Polcortolone should be taken as soon as possible, but if the time for the next dose is already approaching, then the missed dose should not be taken. You can also not take a double dose at once.
Ointment for external use
In this dosage form, Polcortolone should be applied in a thin layer to the affected area and rubbed in.
At the beginning of treatment, the frequency of application is 2-3 times a day, then it is reduced to 1-2 times.
In case of excessive lichenization or hyperkeratosis, the drug can be applied under an occlusive dressing, but no more than 1 time within 24-48 hours.
The duration of treatment, depending on the clinical situation, is 1-2 weeks, if Polcortolone is applied to the skin of the face - no more than 7 days.
For children over 2 years old, the ointment can be applied only once a day on small body surfaces, without affecting the skin of the face.
Side effects
Possible side effects when using Polcortolone tablets:
- From the endocrine system: Itsenko-Cushing's syndrome (including hirsutism, pituitary obesity, moon face, myasthenia gravis, amenorrhea, dysmenorrhea, striae, increased blood pressure), secondary hypothalamic-pituitary and adrenal insufficiency (especially in stressful situations - diseases, injuries, surgical interventions), hirsutism, decreased glucose tolerance, menstrual irregularities, manifestation of latent diabetes mellitus and an increase in the need for insulin or oral hypoglycemic agents in patients with diabetes mellitus, delayed sexual development and growth suppression in children;
- From the digestive system: digestive disorders, hiccups, increased or decreased appetite, nausea, vomiting, flatulence, erosive esophagitis, pancreatitis, steroid gastric ulcer and 12 duodenal ulcer with possible perforation and bleeding; rarely - increased activity of hepatic transaminases and alkaline phosphatase;
- On the part of the cardiovascular system: changes in the electrocardiogram characteristic of hypokalemia, hypercoagulation, arterial hypertension, arrhythmias, thrombosis, increased severity or development of chronic heart failure (in predisposed patients), bradycardia (up to cardiac arrest); in patients with acute and subacute myocardial infarction - a slowdown in the formation of scar tissue and the spread of a necrosis focus, as a result of which a rupture of the heart muscle is possible;
- From the central and peripheral nervous system: vertigo, hallucinations, disorientation, headache, pseudotumor of the cerebellum, sleep disturbance, nervousness or anxiety, convulsions, euphoria, depression, manic-depressive psychosis, paranoia, delirium, pseudotumor of the brain, manifested by headache, worsening visual acuity or double vision (increased intracranial pressure with congestive optic papilla syndrome; most often in children, usually after reducing the dose too quickly);
- From the musculoskeletal system: growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones), steroid myopathy, muscle weakness, decreased muscle mass (atrophy), muscle tendon rupture, osteoporosis (very rarely - pathological bone fractures, aseptic necrosis the head of the humerus and femur, pathological fractures of the long bones, compression fracture of the spine);
- Metabolic disorders: hypocalcemia, increased calcium excretion, hypernatremia, peripheral edema (sodium and fluid retention in the body), weight gain, hyperglycemia, hypokalemic syndrome (hypokalemia, muscle spasm or myalgia, arrhythmia, unusual weakness, fatigue), increased sweating, glucosuria, negative nitrogen balance as a result of protein catabolism;
- From the side of the organ of vision: a tendency to develop secondary fungal, viral or bacterial eye infections, exophthalmos, glaucoma, increased intraocular pressure with possible damage to the optic nerve, posterior subcapsular cataract, trophic changes in the cornea;
- Dermatological reactions: thinning of the skin, slowing of wound healing, petechiae, striae, ecchymosis, a tendency to develop pyoderma and candidiasis, hematomas, steroid acne;
- Allergic reactions: itching, skin rash, anaphylactic shock;
- Others: withdrawal syndrome, leukocyturia; in the case of the simultaneous use of immunosuppressants or vaccination - the development and exacerbation of infections.
The severity and frequency of side effects depends on the dose of Polcortolone, the duration of its use and the possibility of observing the circadian rhythm of the appointment. With short courses of treatment, adverse reactions are rare.
Long-term use of Polcortolone ointment can cause the following local reactions in the area of application of the drug: bruising, skin hemorrhages, irritation and redness of the skin, atrophy of subcutaneous fat, hyperkeratosis, striae, excessive growth of the epidermis, slowing down the healing process.
Overdose
Pills
The main symptoms are: peripheral edema, increased blood pressure; side reactions may increase.
Therapy: gradual dose reduction and withdrawal of Polcortolone. If necessary, symptomatic treatment is prescribed.
Taking the drug in large doses does not cause acute intoxication. But with prolonged use of Polcortolone, especially in large doses, there is a possibility of overdose.
Ointment for external use
Overdose cases of Polcortolone in the form of an ointment are observed in rare cases.
The main symptoms: with frequent or prolonged use in significant quantities in large areas, symptoms of systemic exposure to the drug may be observed (manifested in the form of increased blood pressure, edema, immunosuppressive action).
Therapy: Cancellation of Polcortolone.
special instructions
Pills
In case of stressful situations, patients taking Polcortolone orally are recommended parenteral administration of glucocorticosteroids (GCS).
With a sudden cessation of treatment, adrenal insufficiency and withdrawal syndrome may develop, so the dose of the drug should be reduced gradually.
Polcortolone can mask the symptoms of an infectious process, reduce the body's resistance to infection and the ability to limit its spread.
During the period of treatment with this drug, immunization with live viral vaccines should not be carried out. When an inactivated bacterial or viral vaccine is administered, the expected increase in antibody levels may not occur. In addition, corticosteroids increase the risk of developing neurological complications during vaccination.
The effect of triamcinolone is enhanced in patients with liver cirrhosis and hypothyroidism.
Polcortolone should be used with caution in patients with hypoprothrombinemia who receive acetylsalicylic acid.
With long-term therapy of children, it is necessary to carefully monitor their growth and development.
Ointment for external use
Due to the increased risk of side effects, Polcortolone ointment is not recommended to be rubbed into the skin of the face.
Do not apply to the skin around the eyes.
During pregnancy and lactation, the drug can be prescribed only in exceptional cases, it should be used on limited areas of the skin and for a short time. Breastfeeding women should not be used on the skin of the mammary glands.
Application during pregnancy and lactation
Tablets:
- Pregnancy: the use of Polcortolone is possible only in cases where the expected benefit is higher than the possible harm;
- Lactation period: therapy is contraindicated.
It is not recommended to use Polcortolone ointment during pregnancy / lactation. With caution and in exceptional cases, short-term use is possible on limited areas of the skin. Do not use on the skin of the mammary glands.
Pediatric use
Contraindication:
- Tablets: up to 3 years; with prolonged therapy in children 3–18 years old, careful monitoring of growth and development is required;
- Ointment for external use: up to 2 years.
With impaired renal function
Polcortolone tablets for severe chronic renal failure should be used under medical supervision.
For violations of liver function
Polcortolone tablets in severe chronic hepatic failure should be used under medical supervision.
Drug interactions
Possible interaction reactions with the simultaneous use of Polcortolone in the form of tablets simultaneously with other drugs:
- Cardiac glycosides: the risk of developing cardiac arrhythmias and other toxic effects associated with hypokalemia increases;
- Anticonvulsants, barbiturates, glutethimide, rifampicin: metabolism decreases and the effect of triamcinolone is weakened;
- Blockers of histamine H 1 -receptors: the effect of triamcinolone decreases;
- Carbonic anhydrase inhibitors, amphotericin B: the risk of hypokalemia, circulatory failure, left ventricular myocardial hypertrophy increases;
- Hormonal contraceptives containing estrogens: the effect of triamcinolone is enhanced;
- Anabolic steroids, androgens: the risk of developing peripheral edema, acne increases (this combination requires caution, especially in the presence of liver and heart disease);
- Paracetamol: increases the likelihood of peripheral edema, hypocalcemia, hypernatremia, osteoporosis, increased calcium excretion and paracetamol hepatotoxicity;
- Anticholinergics (atropine): the risk of increased intraocular pressure increases;
- Anticoagulants (heparin, indandione, coumarin derivatives), urokinase, streptokinase: the effectiveness of Polcortolone changes (in some patients it decreases, in others it increases; in this case, the dose should be determined depending on the prothrombin time, the risk of ulceration and bleeding from the gastrointestinal path);
- Tricyclic antidepressants: increased mental disorders caused by taking Polcortolone (this combination is not recommended);
- Insulin and oral hypoglycemic drugs: their effect is weakened, due to which the concentration of glucose in the blood increases (dose adjustment is required);
- Antithyroid drugs, thyroid hormones: the function of the thyroid gland may change (in this case, dose adjustment or withdrawal of these drugs is required);
- Potassium-sparing diuretics, laxatives: their effect is weakened, there is a risk of hypokalemia;
- Ephedrine: the biotransformation of triamcinolone is accelerated (dose adjustment of Polcortolone may be required);
- Immunosuppressants: the likelihood of developing infections, lymphomas and other lymphoproliferative diseases increases;
- Isoniazid: its concentration in blood plasma decreases (mainly in patients with rapid acetylation; a change in the dose of the drug is required);
- Mexiletin: its metabolism is accelerated and the concentration in blood plasma decreases;
- Depolarizing muscle relaxants: the duration of neuromuscular blockade may increase in patients with hypocalcemia associated with the use of Polcortolone;
- Non-steroidal anti-inflammatory drugs (including acetylsalicylic acid), alcohol: the risk of ulceration and bleeding from the gastrointestinal tract increases;
- Folic acid: its effect decreases (an increase in its dose may be required);
- Live viral vaccines: development of viral diseases, viral replication and a decrease in antibody production are possible (these combinations are not recommended);
- Other vaccines: decreased antibody production, increased likelihood of neurological complications;
- Sodium preparations and food containing sodium: the risk of peripheral edema and the development of arterial hypertension increases (in this case, the abolition of sodium preparations and the introduction of dietary restrictions is required).
During the period of treatment with ointment for external use Polcortolone should not be vaccinated.
Analogs
Polcortolone analogs are: Kenalog, Ftorocort, Focort Darnitsa, Triamcinolone, Triamcinolone Nycomed, Triacort, Nazacort, Triam-Denk.
Terms and conditions of storage
Store in a dry, dark place, out of reach of children, at temperatures up to 25 ºС.
Shelf life of tablets - 3 years, ointments - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Polcortolone
Reviews of Polcortolone are few. They indicate both the high efficiency of the drug and the frequent development of side effects.
The price of Polcortolone in pharmacies
The approximate price for Polcortolone is: tablets (50 pcs.) - 356–398 rubles, ointment (1 tube of 15 g each) - 128 rubles.
Polcortolone: prices in online pharmacies
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Drug name Price Pharmacy |
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Polcortolone 4 mg tablets 50 pcs. 233 r Buy |
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Polcortolone tablets 4mg 50 pcs. 354 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
