The instruction for medical use
the Trade name
the International unlicensed
name Prednisolonum Dosage Form
of the Tablet of 5 mg
One tablet contains
active agent: Prednisolonum – 5.00 mg,
excipients: sucrose, lactoses monohydrate (sugar milk), gelatin, stearate calcium monohydrate, potato starch.
of the Tablet of white color, a ploskotsilindrichesky form with a facet and risky
Pharmacotherapeutic group Corticosteroids for system use. Glucocorticosteroids. Prednisolonum.
The ATX H02AB06 code
Pharmacokinetics At properties intake Prednisolonum is well soaked up from digestive tract. The maximum concentration in blood is reached in 11.5 h after oral administration. Up to 90% of drug contacts proteins of plasma: transcortinum (kortizolsvyazyvayushchy globulin) and albumine. Prednisolonum is metabolized in a liver, partially in kidneys and other fabrics, generally by conjugation with glucuronic and sulfuric acids. Metabolites are inactive.
It is removed with bile and kidneys by glomerular filtration and for 80-90% it reabsorbirutsya by tubules. 20% of a dose are removed by kidneys in not changed look. Plasma elimination half-life after oral administration makes 2-4 hours.
Prednisolonum – synthetic glucocorticosteroid drug, the dehydrogenated hydrocortisone analog. Has anti-inflammatory, antiallergic, immunodepressive effect, antishock action, increases sensitivity of beta adrenoceptors to endogenous catecholamines.
Interacts with specific cytoplasmatic receptors (receptors for glucocorticosteroids (GKS) are in all fabrics, especially their is a lot of in a liver) with formation of the complex inducing formation of proteins (including the enzymes regulating the vital processes in cells).
The anti-inflammatory effect is connected with release oppression by eosinophils and mast cells of mediators of inflammation, induction of formation of lipokortin and reduction of quantity of the mast cells producing hyaluronic acid with reduction of permeability of capillaries, stabilization of cellular membranes (especially lizosomalny) and membranes of organellas. Affects all stages of inflammatory process: inhibits synthesis of prostaglandins (Pg) at the level of arachidonic acid (lipokortin oppresses A2 phospholipase, suppresses a liberation of arachidonic acid and inhibits biosynthesis of endoperoxides, the leukotrienes promoting processes of inflammation, an allergy, etc.), synthesis of pro-inflammatory cytokines (interleukin 1, tumor necrosis factor an alpha, etc.) increases resistance of a cellular membrane to action of various disturbing factors.
Protein metabolism: reduces amount of globulins in plasma, increases synthesis of albumine in a liver and kidneys (with increase in coefficient albumine/globulin), reduces synthesis and strengthens catabolism of protein in muscle tissue.
Lipidic exchange: increases synthesis of higher fatty acids and triglycerides, redistributes fat (accumulation of fat happens mainly in the field of a shoulder girdle, a face, a stomach), leads ment of a hypercholesterolemia.
Carbohydrate metabolism: increases absorption of carbohydrates from digestive tract, increases activity of glyukozo-6-phosphatase (increase in intake of glucose from a liver in blood), increases activity of a fosfoenolpiruvatkarboksikinaza and synthesis of aminotransferases (activation of a gluconeogenesis), contributes to the development of a hyperglycemia.
Water eletrolitny exchange: detains ions of sodium (Na+) and water in an organism, stimulates removal of potassium ions (K+) (mineralokortikosteroidny activity), reduces absorption of calcium ions (Ca2+) from digestive tract, causes washing away of calcium ions from bones and increase in its renal excretion, reduces a mineralization of a bone tissue.
The immunosuppressive effect is caused the adenoid tissue caused by involution, oppression of proliferation of lymphocytes (especially T lymphocytes), suppression of migration of V-cells and interactions of T – and V-lymphocytes, slowing down of release of cytokines (interleukin-1, 2, gamma interferon) from lymphocytes and macrophages and decrease in antibody formation.
The antiallergic effect develops as a result of decrease in synthesis and secretion of mediators of an allergy, slowing down of release from sensitized mast cells and basophiles of a histamine, etc. biologically active agents, reduction of number of the circulating basophiles, suppression of development of adenoid and connective tissue, reduction of number of T – and V-lymphocytes, mast cells, decrease in sensitivity of effector cells to mediators of an allergy, oppression of antibodyformation, change of the immune response of an organism.
In obstructive respiratory diseases the action is caused, mainly, by slowing down of inflammatory processes, prevention or reduction of severity of hypostasis of mucous membranes, decrease in eosinophilic infiltration of a submucosal layer of an epithelium of bronchial tubes and adjournment in mucous bronchial tubes of the circulating cell-bound immune complexes and also braking of an erozirovaniye and desquamation of a mucous membrane. Increases sensitivity of beta adrenoceptors of bronchial tubes of small and average caliber to endogenous catecholamines and exogenous sympathomimetics, reduces viscosity of slime due to reduction of its products.
Suppresses synthesis and secretion of AKTG and again – synthesis of endogenous GKS.
– general diseases of connective tissue (system lupus erythematosus, a scleroderma, a nodular periarteritis, a dermatomyositis, a pseudorheumatism)
– acute and chronic inflammatory diseases of joints – gouty and psoriasis arthritis, an osteoarthritis (including posttraumatic), polyarthritis, the humeroscapular periarthritis ankylosing a spondylarthritis (Bekhterev’s disease), juvenile arthritis, Steel’s syndrome at adults, a bursitis nonspecific tendosinovit, a synovitis and an epicondylitis
– rheumatic fever, an acute rheumatic carditis
– bronchial asthma, the asthmatic status
– acute and chronic allergic diseases – including allergic reactions to medicines and foodstuff, a serum disease, a small tortoiseshell, allergic rhinitis, a Quincke’s edema, a medicinal dieback, a pollinosis, etc.
– skin diseases – a bladderwort, psoriasis, eczema, atopic dermatitis (widespread neurodermatitis), contact dermatitis (with defeat of a big surface of skin), a toxidermia, seborrheal dermatitis, exfoliative dermatitis, a toxic epidermal necrolysis (Lyell’s disease), bullous herpetiform dermatitis, Stephens-Johnson’s syndrome
– wet brain (including. against the background of a tumor of a brain or connected with surgical intervention, radiation therapy or an injury of the head) after preliminary parenteral use
– allergic diseases of eyes – allergic forms of conjunctivitis
– inflammatory diseases of eyes – a sympathetic ophthalmia, heavy slow lobbies and back uveites, an optic neuritis
– primary or secondary adrenal insufficiency (including a state after removal of adrenal glands)
– congenital adrenal hyperplasia
– diseases of kidneys of autoimmune genesis (including an acute glomerulonephritis), a nephrotic syndrome (including against the background of a lipoid nephrosis)
– a subacute thyroiditis
– diseases of blood and the system of a hemopoiesis – an agranulocytosis, a panmyelopathia, autoimmune hemolytic anemia, lympho- and myeloid leukoses, a lymphogranulomatosis, a Werlhof’s disease, secondary thrombocytopenia at adults, an eritroblastopeniya (erythrocyte anemia), inborn (erythroidal) hypoplastic anemia
– interstitial diseases of lungs – an acute alveolitis, a pneumosclerosis, a sarcoidosis of the II-III stage
– tubercular meningitis, a pulmonary tuberculosis, aspiration pneumonia (in combination with specific chemotherapy)
– a berylliosis, Leffler’s syndrome (which is not giving in to other therapy), lung cancer (in a combination with cytostatics)
– multiple sclerosis
– gastrointestinal diseases – ulcer colitis, Crohn’s disease, local enteritis
– prevention of reaction of graft rejection at organ transplantation
– a hypercalcemia against the background of oncological diseases
– a multiple myeloma
the Route of administration and doses
the Dose of drug and duration of treatment is established by the doctor individually depending on indications and disease severity.
It is recommended to accept all daily dose of drug once or a double daily dose – every other day taking into account a circadian rhythm of endogenous secretion of glucocorticosteroids in the range from 6 up to 8 o’clock in the morning. The high daily dose can be distributed on 2-4 receptions, at the same time in the mornings it is necessary to accept a high dose. A pill should be taken inside in time or directly after a meal, washing down with a small amount of liquid.
At acute conditions and as replacement therapy by the adult appoint 20-30 mg/days in an initial dose, the maintenance dose makes 5-10 mg/days. If necessary the initial dose can make 15-100 mg/days, supporting – 5-15 mg/days.
For children since 3 years the initial dose is also more senior makes 1-2 mg/kg of body weight a day in 4-6 receptions, supporting – 0.3-0.6 mg/kg/days.
When obtaining therapeutic effect the dose is gradually reduced on 5 mg, then on 2.5 mg with intervals in 3-5 days, canceling at first later receptions. At long administration of drug the daily dose should be reduced gradually. Long therapy cannot be stopped suddenly! Cancellation of a maintenance dose is carried out by that more slowly, than glucocorticosteroid therapy was longer performed.
At stressful influences (infection, allergic reaction, an injury, operation, a nervous stress) in order to avoid exacerbation of a basic disease the dose of Prednisolonum has to be temporarily increased (in 1.5-3, and in hard cases – at 5-10 times).
Very often (& gt, 1/10), it is frequent (& gt, 1/100, & lt, 1/10), infrequently (& gt, 1/1000, & lt, 1/100), is rare (& gt, 1/10000, & lt, 1/1000), is very rare (& lt, 1/10000), it is not known (it cannot be estimated on the basis of the available data).
In general, the frequency of development of the predicted side effects, including suppression gipotalamo – a hypophysial and adrenal system, depends on a dose, time of reception and duration of treatment. Side effects can be minimized if to use the lowest effective dose during, as far as possible, minimum span.
– the increased susceptibility to an infection, aggravation of the available infection, activation of latent infection and masking of symptoms of an infection (owing to immunosuppressor and anti-inflammatory effect of Prednisolonum)
– decrease in quantity of eosinophils and lymphocytes
– masking or aggravation of the existing disease
– the insufficiency of adrenal glands (which is beginning with inhibition of a hypothalamus and coming to the end with a true atrophy of bark of adrenal glands) at constant oral administration of Prednisolonum, a withdrawal owing to insufficiency of adrenal glands (headache, nausea, dizziness, anorexia, weakness, emotional instability, apathy and inadequate reaction to stressful situations), steroid diabetes with low sensitivity to insulin, increase in level of sugar of blood at the patients who already have diabetes (100%). Growth inhibition at children as a result of disturbance of secretion of growth hormone and decrease in sensitivity to it
– increase in intraocular pressure (up to 40% of the patients receiving treatment by oral drug), cataracts (at 30% of patients at long oral drug treatment)
– lung abscess (12%)
– oral cavity candidiasis, especially at cancer patients (33%)
– fungal infections of mucous membranes (30%)
– osteoporosis with such symptoms as a dorsodynia, limited mobility, an acute pain, compression fractures of vertebras and reduction of growth, fractures of long bones (25% at long-term treatment by oral drug), a myopathy (10%) at treatment by high doses
– increase in quantity of leukocytes and thrombocytes
– Cushing’s syndrome, including change of nature of an adiposity (crescent-shaped face, trunk obesity, a bull hump) at constant reception of oral doses above physiological (usually more than 50 mg a day), a hypopotassemia owing to deduction of sodium instead of potassium, an amenorrhea at women of childbearing age, increase in level of cholesterol, triglycerides and lipoproteins at treatment by the high doses accepted inside, the increased appetite and increase in weight
– euphoria, a depression, psychosis induced by corticosteroids
– hypertensia (owing to sodium deduction that leads to liquid deduction), aggravation of stagnant heart failure (as a result of sodium deduction)
– the increased risk of developing tuberculosis
– strengthening of symptoms and increase in risk of development of gastrointestinal perforation, colitis, ileitis, diverticulitis
– an extension, acneform rash, formation of bruises, dermatitis, an ecchymoma, an erythema of the person, an atrophy, a hirsutism, slow healing of wounds, the increased sweating, teleangiectasias and thinning of skin, masking or deterioration in the available skin diseases
– increase in frequency of night urination
– allergic reactions
– diabetes (& lt, 1%) at treatment by small oral doses, increase in level of cholesterol, triglycerides and lipoproteins at treatment by low oral doses
– insomnia, mood swings, changes of the personality, a mania and hallucinations
– a myopathy of respiratory muscles
– stomach ulcer or a duodenum at a concomitant use of acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NPVS), gastrointestinal bleedings (0.5%), gastrointestinal perforation
– aseptic necrosis of a bone tissue
– urinary stones owing to the increased excretion of calcium and phosphate
– risk of thrombosis owing to increase in fibrillation
– change of function of a thyroid gland
– possible increase in duration of a coma in cerebral malaria, cognitive disturbances (for example, bad memory), dementia, epidural lipomatoz
– high risk of destruction of a cornea of an eye in a simultaneous herpes infection of eyes (in view of masking of this infection), glaucoma (at long oral drug treatment)
Is very rare
– ketoacidosis and a giperosmolyarny coma, manifestation of a latent hyperparathyreosis, tendency to porphyrias, a syndrome of lysis of a tumor, disturbance of secretion of sex hormone (periods disorders, a hirsutism, impotence)
– manifestation of latent epilepsy, a brain pseudoneoplasm (benign intracranial hypertensia with such symptoms as a headache, not clear sight and disorders of vision)
– an exophthalmos (after long-term treatment)
– a cardiomyopathy with risk of decrease in warm activity, arrhythmia owing to a hypopotassemia, vascular collapse
– pancreatitis (after long-term treatment by high doses)
– an epidermal necrolysis, Stephens-Johnson’s syndrome
– a tendinopatiya of an Achilles sinew and sinew of a patella
it is not known
– the increased risk of developing atherosclerosis and thrombosis, a vasculitis (can also occur, as a withdrawal after long therapy)
– ulcers and candidiasis of a gullet
– a muscular atrophy, diseases of sinews, a tendinitis, ruptures of sinews
– forslow healing of wounds, disturbance of appetite
At excessively fast reduction of a dose after long-term treatment such problems as muscular and articulate pain, fever, rhinitis, conjunctivitis and loss of weight can develop.
– hypersensitivity to Prednisolonum or components of drug
– deficiency of lactase, a lactose intolerance, deficiency of invertase/isomaltase, intolerance of fructose, glyukozo-galaktozny malabsorption
– children’s age up to 3
one or III years a trimester of pregnancy and the period of a lactation
With care it is necessary to use drug in the following diseases and states:
– a peptic ulcer of a stomach and duodenum, an esophagitis, gastritis, an acute or latent round ulcer, recently created intestines anastomosis, nonspecific ulcer colitis with threat of perforation or abscessing, a diverticulitis
– the parasitic and infectious diseases of the virus, fungal or bacterial nature (proceeding now or which are recently postponed including recent contact with the patient) – the herpes simplex surrounding herpes (viremichesky phase), chicken pox, measles, an amebiasis, a strongyloidosis, system mycosis, active and latent tuberculosis. Use in serious infectious diseases is admissible only against the background of specific therapy
– pre- and the vaccine-challenged period (8 weeks to and 2 weeks after vaccination), lymphadenitis after BCZh inoculation. Immunodeficiency (including AIDS or HIV infection)
– diseases of a cardiovascular system, including dekompensirovanny chronic heart failure, arterial hypertension, a lipidemia
– diabetes (including. disturbance of tolerance to carbohydrates), a thyrotoxicosis, a hypothyroidism, Itsenko-Cushing’s disease, obesity (III-IV St)
– a heavy chronic renal and/or liver failure, nefrourolitiaz
– the hypoalbuminemia and states contributing to its emergence (cirrhosis, a nephrotic syndrome)
– system osteoporosis, gravis myasthenia, acute psychosis, poliomyelitis (except for a form of bulbar encephalitis), open and closed-angle glaucoma
– at children during a growth period the glucocorticosteroids have to be applied only according to absolute indications and under especially careful observation of the attending physician
Simultaneous use of Prednisolonum with:
inductors of liver microsomal enzymes (phenobarbital, rifampicin, Phenytoinum, theophylline, ephedrine) leads to decrease in its concentration,
diuretics (especially thiazide and inhibitors of a karboangidraza) and Amphotericinum B can lead to strengthening of removal from an organism of ions of K+,
with natriysoderzhashchy drugs – ment of hypostases and increase in arterial blood pressure,
Amphotericinum B – risk of developing heart failure increases,
cardiac glycosides – their shipping worsens and the likelihood of developing ventricular premature ventricular contraction (because of the caused hypopotassemia),
indirect anticoagulants raises – weakens (strengthens) their action less often (dose adjustment is required)
anticoagulants and trombolitika – risk of developing bleedings from ulcers in digestive tract increases,
ethanol and non-steroidal anti-inflammatory drugs (NPVP) – the risk of developing of erosive cankers in digestive tract amplifies and development of bleedings (in a combination with NPVP at treatment of arthritises the dose decline of glucocorticosteroids because of summation of therapeutic effect),
paracetamol – increases risk of development of hepatotoxicity (induction of liver enzymes and formation of a toxic metabolite of paracetamol),
acetylsalicylic acid – accelerates its removal and reduces concentration in blood (is possible at Prednisolonum cancellation the level of salicylates in blood increases and increases risk of development of by-effects),
insulin and oral hypoglycemic drugs, antihypertensives – decreases their efficiency,
vitamin D – decreases its influence on absorption of calcium ions (Ca 2+) in intestines,
somatotropic hormone – reduces efficiency of the last, and with prazikvantely – its concentration,
M-holinoblokatorami (including antihistaminic drugs and tricyclic antidepressants with m-holinoblokiruyushchey activity) and nitrates – promotes increase in intraocular pressure,
an isoniazid and meksiletiny – increases their metabolism (especially at slow acetylizers) that leads to decrease in their plasma concentration.
Inhibitors of a karboangidraza and loopback diuretics can increase risk of developing osteoporosis.
Indometacin, forcing out Prednisolonum from communication with albumine, increases risk of development of its side effects.
Adrenocorticotropic hormone (AKTG) strengthens effect of Prednisolonum.
Ergocalciferol and parathormone interfere with development of the osteopathy caused by Prednisolonum.
Cyclosporine and ketokonazol, slowing down Prednisolonum metabolism, can increase its toxicity in some cases.
Simultaneous use of androgens and steroid anabolic drugs with Prednisolonum contributes to the development of peripheral hypostases and a hirsutism, appearance of eels.
Are oestrogenic and oral estrogensoderzhashchy contraceptives reduce clearance of Prednisolonum that can be followed by strengthening of expressiveness of its action.
Mitotanum and other inhibitors of function of bark of adrenal glands can cause need of increase in a dose of Prednisolonum.
At simultaneous use with live antiviral vaccines and against the background of other types of immunizations – increases risk of activation of viruses and development of infections.
Antipsychotic means (neuroleptics) and Azathioprinum increase risk of developing a cataract at Prednisolonum use.
Immunodepressants increase risk of developing infections and a lymphoma or other limfoproliferativny disturbances caused by Epstein’s virus – Barrel.
Simultaneous use of antacids reduces Prednisolonum absorption.
At simultaneous use with anti-thyroid drugs decreases, and with thyroid hormones – the clearance of Prednisolonum increases.
Before an initiation of treatment (at impossibility because of a state urgentnost in the course of treatment) the patient has to be examined regarding identification of possible contraindications. Clinical inspection has to include a research of a cardiovascular system, X-ray inspection of lungs, a research of a stomach and duodenum, the system of urination, organs of sight, control of a blood count, content of glucose and electrolytes in blood plasma.
During treatment by Prednisolonum (especially long) observation of the oculist, control of arterial blood pressure, a condition of water and electrolytic balance and also a picture of peripheral blood and concentration of glucose of blood is necessary.
For the purpose of reduction of by-effects it is possible to apply antacids and also to increase receipt of potassium ions (K+) in an organism (diet, potassium drugs). Food has to be protein-rich, vitamins, with restriction of content of fats, carbohydrates and table salt.
Effect of drug amplifies at patients with a hypothyroidism and cirrhosis. Drug can enhance the existing emotional instability or psychotic disturbances. At the instruction on psychoses in the anamnesis Prednisolonum in high doses is applied under stringent control of the doctor.
In stressful situations during the supporting treatment (for example, surgeries, an injury or infectious diseases) it is necessary to carry out dose adjustment of drug in connection with increase in need for glucocorticosteroids. It is necessary to watch carefully patients within a year after the end of long therapy with Prednisolonum in connection with possible development of relative insufficiency of bark of adrenal glands in stressful situations.
At sudden cancellation, especially in case of the previous use of high doses, development of a withdrawal (anorexia, nausea, block, generalized musculoskeletal pains, the general weakness) and also exacerbation of a disease concerning which Prednisolonum was appointed is possible.
During treatment it is not necessary to carry out by Prednisolonum vaccination in connection with decrease in its efficiency (immune response).
Applying Prednisolonum in intercurrent infections, septic states and tuberculosis, it is necessary to carry out treatment by antibiotics of bactericidal action at the same time.
At children during long-term treatment by Prednisolonum careful observation of dynamics of growth and development is necessary. To children who during treatment were in contact with patients with measles or chicken pox preventively apply specific immunoglobulins.
Owing to weak mineralokortikosteroidny effect to replacement therapy at adrenal insufficiency Prednisolonum is applied in a combination from mineralokortikosteroida.
At patients with diabetes it is necessary to control the content of glucose of blood and if necessary to korrigirovat therapy.
Radiological control of a bone and articulate system (pictures of a backbone, a brush) is shown.
Prednisolonum with latent infectious diseases of kidneys and urinary tract is capable to cause a leukocyturia in patients that can have diagnostic value.
Prednisolonum increases the maintenance of metabolites of 11 and 17-oxyketocorticosteroids.
Pregnancy and a lactation
At pregnancy in I and II trimester apply only according to vital indications.
At long therapy during pregnancy there is a fruit growth disorder. In the III trimester of pregnancy the fruit has a danger of emergence of an atrophy of bark of adrenal glands that can demand performing replacement therapy of the newborn.
As glucocorticosteroids pass into breast milk, in case of need uses of drug during breastfeeding, feeding by a breast is recommended to be stopped.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during use needs to refrain from control of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
strengthening of dose-dependent by-effects is possible. It is necessary to reduce Prednisolonum dose. Symptomatic treatment.
Form of release and packing
of the Tablet of 5 mg.
On 60 tablets place in banks polymeric the BP type.
Each can together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions in the place protected from light at a temperature not higher than 25 wasps.
To store out of children’s reach!
not to use a period of storage after an expiration date.
According to the prescription
JSC Biosintez Producer,
Russian Federation 440033, Penza, Druzhby St., 4, ph. / fax (8412) 57-72-49,
the Name and the country of the owner of the registration certificate
of JSC Biosintez, the Russian Federation
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of JSC Biosintez,
Russian Federation 440033, Penza, Druzhby St., 4, ph. / fax (8412) 57-72-49,