Triamcinolone-FPO - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Glucocorticosteroid agent (SCS), interleukin 2 (IL2), γ-interferon (γ-IF) from lymphocytes and macrophages. Has anti-inflammatory, antiallergic, desensitizing, anti-shock, antitoxic and immunosuppressive action. Suppresses the release of pituitary beta-lipotropin, but does not reduce the concentration of circulating beta-endorphin.Oppressing the secretion of thyroid-stimulating hormone (TSH) and follicle-stimulating hormone (FSH). Increases the excitability of the central nervous system (CNS), reduces the number of lymphocytes and eosinophils, increases erythrocytes (stimulates the production of erythropoietins).

Interacts with specific cytoplasmic receptors and forms a complex penetrating into the nucleus of the cell, and stimulates the synthesis of mRNA; the latter induces the formation of proteins, incl. lipocortin, mediating cellular effects. Lipocortin depresses phospholipase A2, suppresses the formation of arachidonic acid and inhibits the synthesis of endoperoxides, prostaglandins, leukotrienes, contributing to inflammation processes, allergies.

Reduces the amount of protein in the plasma (due to globulins) with an increase in the albumin / globulin ratio, increases the synthesis of albumins in the liver and kidneys; enhances protein catabolism in muscle tissue.

Increases the synthesis of higher fatty acids and triglycerides (TG), redistributes fat (accumulation of fat mainly in the area of the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Increases the absorption of carbohydrates from the gastrointestinal tract (GIT); enhancesactivity of glucose-6-phosphatase, leading to an increase in the intake of glucose from the liver into the blood; increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases leading to activation of gluconeogenesis.

Delays sodium and water in the body, stimulates the excretion of potassium, reduces the absorption of calcium from the digestive tract, "flushes" calcium from the bones, increases the excretion of calcium by the kidneys.

The anti-inflammatory effect is associated with the inhibition of eosinophil release by inflammatory mediators; inducing lipocortin formation and reducing the number of mast cells producing hyaluronic acid; with a decrease in the permeability of capillaries; stabilization of cell membranes and membranes of organelles (especially lysosomal).

The antiallergic effect develops as a result of suppression of synthesis and secretion of mediators of allergy, inhibition of release from sensitized mast cells and basophils of histamine and other biologically active substances, reduction of the number of circulating basophils, suppression of lymphoid and connective tissue development, decrease in the number of T- and B-lymphocytes, mast cells , reducing the sensitivity of effector cells to mediators of allergy, inhibition of antibody formation, changes in the immune response of the body.

Immunodepressive effect is due to inhibition of the release of cytokines (IL1, IL2, γ-IF) from lymphocytes and macrophages.

Suppresses the synthesis and secretion of ACTH and, again, the synthesis of endogenous GCS.

By its action triamcinolone is close to cortisone and hydrocortisone. For anti-inflammatory effect is more active than prednisolone in 1,5-2 times. Mineralocorticosteroid activity is practically absent.

Pharmacokinetics:After oral administration, it is easily absorbed from the digestive tract. Bioavailability - 20-30%. Connection with plasma proteins - 40%. Metabolized in the liver with the formation of inactive metabolites. The half-life (T1 / 2) in plasma is 2-5 hours, in tissues - 18-36 hours. It is excreted by the kidneys in the form of inactive metabolites.

Indications:

- rheumatism;

- systemic diseases of connective tissue (rheumatoid arthritis, systemic lupus erythematosus, scleroderma, etc.);

- rheumatic fever, acute rheumatic heart disease;

- acute allergic reactions;

- severe form of bronchial asthma;

- allergic dermatitis;

- erythema multiforme;

- hemorrhagic diathesis;

- hemolytic anemia;

- acute and chronic leukemia.

Contraindications:

For short-term use according to vital indications, the only contraindication is hypersensitivity to the components of the drug.With prolonged systemic administration, contraindications are: peptic ulcer of the stomach or duodenum; newly developed intestinal anastomosis; diverticulitis; systemic osteoporosis; tuberculosis; diabetes; thrombophlebitis; acute viral, bacterial, fungal systemic infections (in the absence of appropriate therapy); the Itenko-Cushing syndrome; condition after surgical interventions and severe injuries; children under 3 years of age, congenital intolerance to fructose, glucose-galactose malabsorption or insufficiency of sucrose-isomaltase (due to the presence of sucrose in the composition).

Carefully:

- Diseases of the gastrointestinal tract: hepatic insufficiency, chronic hepatitis, cirrhosis, esophagitis, gastritis, ulcerative colitis;

- diseases of the urinary tract: chronic renal failure, nephrourolythiasis, hypoalbuminemia and conditions predisposing to its occurrence (nephrotic syndrome);

- diseases of the cardiovascular system, in t.ch. recently suffered myocardial infarction (in patients with acute and subacute myocardial infarction it is possible to spread a foci of necrosis,slowing the formation of scar tissue and, as a result, rupture of the heart muscle), severe chronic heart failure, hypertension, hyperlipidemia;

- Endocrine diseases: hypothyroidism, hyperthyroidism, obesity (III-IV st.), a violation of tolerance to carbohydrates;

- from the immune system: pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination); lymphadenitis after BCG vaccination; immunodeficiency states (including AIDS or HIV infection);

- from the side of the nervous system: myasthenia gravis gravis, Poliomyelitis (with the exception of the form of bulbar encephalitis), acute psychosis;

-pregnancy.

Pregnancy and lactation:It is not recommended for use during pregnancy and breastfeeding. Use during pregnancy is possible if the expected benefit for the mother exceeds the potential risk to the fetus. If it is necessary to take triamcinolone during lactation, breastfeeding of the baby should be discontinued.

Dosing and Administration:Apply inside; during or after a meal, once a day (in the morning) or 2 times a day, if the daily dose exceeds 16 mg (in the morning and at lunch).The usual daily dose for adults is 4 to 32 mg. When the desired effect dose necessary to gradually decrease (2 mg every 2-3 days) until the optimal maintenance dose (typically 4 mg daily). In children older than 3 years old with a body weight over 25 kg use the same dose as in adults. In children with a body weight of less than 25 kg, the initial dose is 12 mg per day. The duration of application of FPO-Triamcinolone depends on the nature of the pathological process and the effectiveness of treatment, ranging from several days to several months or more. Treatment is stopped gradually.

Side effects:

The frequency and severity of side effects depend on the duration of application, size of the dosage used and the possibility of compliance circadian rhythm appointedtion.

Co the endocrine system: reduced glucose tolerance, "steroid" diabetes or a manifestation of latent diabetes mellitus, adrenal function suppression, Cushing's syndrome (moon face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae) delayed sexual development in children.

From the digestive system: nausea, vomiting, pancreatitis, steroid ulcer of the stomach and duodenum, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increase or decrease in appetite, flatulence, hiccups, increased activity of "liver" transaminases and alkaline phosphatase.

From the CAS side: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of CHF, changes in ECG, characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.

Co the sides of the nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor, cerebral palsy, headache, convulsions.

From the sense organs: posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, propensity to develop secondary bacterial,fungal or viral infections-eye, trophic changes in the cornea, exophthalmos.

From the side of metabolism: increased excretion of calcium, hypocalcemia, weight gain, negative nitrogen balance (increased protein breakdown), increased sweating. Conditioned by ISS activity - fluid and sodium retention (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, - arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the musculoskeletal system: slowing of growth and ossification processes in children (premature closure of epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur), tendon rupture muscles, "steroid" myopathy, decrease in muscle mass (atrophy).

From the skin and mucous membranes: delayed wound healing, petechiae, ecchymoses, skin thinning, hyper- or hypopigmentation, steroid acne, striae, propensity to develop pyoderma and candidiasis.

Allergic reactions: generalized (skin rash, itching, anaphylactic shock), local allergic reactions.

Other: development or exacerbation of infections (the emergence of this side effect is facilitated by jointly used immunosuppressants and vaccination), leukocyturia, withdrawal syndrome.

Overdose:

Symptoms: Itenko-Cushing syndrome, hyperglycemia, glucosuria.

Treatment: symptomatic on the background of a gradual cancellation.

Interaction:

Interaction with other medicinal products

Triamcinolone increases the toxicity of cardiac glycosides (because of the emerging hypokalemia, the risk of arrhythmias increases).

Accelerates the removal of acetylsalicylic acid, reduces its concentration in the blood (with the elimination of triamcinolone, the concentration of salicylates in the blood increases and the risk of side effects increases).

With simultaneous use with live antiviral vaccines and against other types of immunizations, increases the risk of virus activation and the development of infections. Increases the metabolism of isoniazid, mexiletine (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations.

Increases the risk of developing hepatotoxic reactions of paracetamol (induction of "hepatic" enzymes and the formation of a toxic metabolite of paracetamol).Increases (with prolonged therapy) the concentration of folic acid.

Hypokalemia caused by SCS can increase the severity and duration of muscle blockade against the background of muscle relaxants.

In high doses reduces the effect of somatropin.

Antacids reduce the absorption of GCS. Triamcinolone reduces the effect of hypoglycemic JIC; enhances the anticoagulant effect of coumarin derivatives.

Weaken the influence of vitamin D on calcium absorption in the lumen of the intestine. Ergocalciferol and parathyroid hormone interfere with the development of osteopathy caused by GCS. Reduces the concentration of praziquantel in the blood.

Cyclosporine (inhibits metabolism) and ketoconazole (reduces clearance) increase toxicity.

Thiazide diuretics, carbonic anhydrase inhibitors, other glucocorticosteroids and amphotericin B increase the risk of hypokalemia, sodium-containing JIC swelling and increased blood pressure. Non-steroidal anti-inflammatory drugs (NSAIDs) and ethanol increase the risk of ulceration of the gastrointestinal mucosa and bleeding, in combination with NSAIDs for the treatment of arthritis, it is possible to reduce the dose of GCS due to the summation of the therapeutic effect.

Indomethacin, displacing triamcinolone from association with albumin increases the risk of developing its side effects.

Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.

The therapeutic effect of GCS decreases under the influence of phenytoin, barbiturates, ephedrine, theophylline, rifampicin and other inducers of "hepatic" microsomal enzymes (an increase in metabolic rate).

Mitotane and other inhibitors of the function of the adrenal cortex may necessitate an increase in the dose of GCS.

The clearance of GCS rises against the background of thyroid hormones.

Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus. Estrogens (including oral estrogen-containing contraceptives) reduce the clearance of SCS, extend T1 / 2 and their therapeutic and toxic effects. The emergence of hirsutism and acne is facilitated by the simultaneous use of other steroid hormonal JIC - androgen, estrogen, anabolic, oral contraceptives.

Tricyclic antidepressants can increase the severity of depression caused by SCS (not shown for the therapy of these side effects).

The risk of developing cataracts increases when used against the background of other SCS, antipsychotic JIC (neuroleptics) carbutamide and azathioprine.

Simultaneous appointment with m-holinoblokatorami (including antihistamines, tricyclic antidepressants), nitrates contributes to the development of increased intraocular pressure.

Special instructions:Use with caution in the following diseases and conditions: parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transferred, including recent contact with the patient): herpes simplex, herpes zoster (viremic phase), chicken pox, measles; amoebiasis, strongyloidiasis (or suspected); systemic mycosis; active and latent tuberculosis. The use in severe infectious diseases is permissible only against the background of specific therapy.

Post-vaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after vaccination against tuberculosis vaccine (BCG). When oral use of a dose exceeding 4 mg / day, suppression of the activity of the hypothalamic-pituitary system can develop in 6-12 weeks.Cancellation of the drug is carried out gradually.

Do not use for 8 weeks before preventive vaccinations and within 2 weeks after their implementation.

To prevent adrenocortical insufficiency, corticotropin is administered at the end of the treatment for several days.

During treatment it is recommended to take vitamin D and eat foods rich in calcium.

In children during the growth period, SCS should be used only in absolute indications and under the strictest supervision of the attending physician.

Effect on the ability to drive transp. cf. and fur:Against the background of treatment with triamcinolone, care should be taken when driving and working with potentially dangerous mechanisms.

Form release / dosage:

Tablets 4 mg.

Packaging:

By 10, 15 20 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

On 1,2,3,4,5 contour cellular packings together with the instruction on application in a pack from a cardboard.

Storage conditions:In dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:5 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N001984 / 01-2002

Date of registration:08.08.2011

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp23.09.2015

Illustrated instructions

Instructions

Triamcinolone-FPO® (Triamcinolone-FPO®)