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Prednizoloni-Neo #50 Tab
Systematic use corticosteroid mean

Generic  name:.Prednisolone.
ATС Code: HO2AB06.
Drug form: Tablets.
Pharmacological group: Systematic use corticosteroid means;
Composition:
Active substance: Prednisolone– 5 mg.
Aiding substances: Lactose, starch, calcium stearate, magnesium stearate, povidon.
Pharmacological operation:
Pharmacodynamics: “PREDNISOLON NEO” is a dehydrogenated analog of cortisone and hydrocortisone of adrenal gland hormone, which activity exceeds 4-5 times to cortisone and hydrocortisone – 3-4 times. Unlike them, Prednisolone doesn’t cause significant retain of sodium and water in the organism and increases potassium excretion insignificantly. The preparation is characterized with expressed anti-inflammatory, antiallergenic, anti-exudation, antishock and immunosuppressive action.   Effects on protein and carbohydrate metabolism, comparatively less - change of water and salt, reduces amount of proteins in plasma (at the expense of globulin), reinforces protein catabolism in the muscular tissue, increases albumin synthesis in the liver and accordingly increases albumin/ globulin coefficient.
Prednisolone facilitates distribution of fatty tissue, increases carbohydrate absorption from the gastrointestinal tract, increases activity of glucose-6-phosphatase and leads to increase glucose quantity in blood,  gluconeogenesis reinforce.
Prednisolone reduces calcium absorption from the intestine tract, increases bones wash out and excretion by kidneys.
Anti-inflammatory operation is stipulated by inflammation mediators release suppression by Prednisolone, hyaluronidase synthesis inhibition, capillaries conductance decrease, cells’ membrane stabilization, lymphocyte fromation and reduce of macrophage migration 
Antiallergenic operation of the preparation is stipulated by allergy mediator synthesis and straight suppression of secretion, quantity reduction of basophile, T and B lymphocyte, mast cells; also sensitivity lowering of effector cells toward allergy mediators and by changing the body's immune response.
The preparation causes lymphoid tissue involution, reduction of antibody formation, cytokine release suppression from lymphocyte and macrophage, which provides its immunodepressive effect.
“PREDNISOLON NEO” is characterized with antishock operation, reinforces catecholamine operation and restores receptors’ sensitivity toward catecholamine.
Pharmacokinetics:
After peroral intake the preparation is well absorbed from the gastrointestinal tract. Maximal concentration in the blood plasma is reached in 90 minutes. Semiejection period makes up 2-4 hours. 90% of Prednisolone relates to plasma proteins. Metabolizes in the liver. It is excreted from the organism mainly by kidneys. The preparation passes placental barrier and gets into the breast milk with small concentration. 
  Indication:
• Systemic diseases of connective tissue (systemic Lupus erythematosus, dermatomitosis, polymyositis, systemic vasculitis, rheumatic gout);
• Addison’s disease;
• Acute rheumatism, rheumatic carditis;
• Adrenal gland cortex acute insufficiency;
•  Bronchial asthma;
• Adrenogenital syndrome;
• Hepatitis;
• Acute and chronic allergic reactions (medicamentous allergy, serum sickness, nettle-rash, giant urticaria)
• Hypoglycemic state;
• Liver coma;
• Eye diseases;
• Skin diseases;
• Autoimmune character liver disease;
• Blood system diseases (agranulocytosis, various forms of leukosis, thrombocytopenic purpura, hemolytic anemia);
Contraindications:
Hypersensitivity toward glucocorticosteroids; stomach and duodenum ulcerative disease; Itsenko-Cushing syndrome, osteoporosis, disposition to thromboembolism, kidney insufficiency, heavy form of arterial hypertension, chicken-pox, simple herpes, vaccination period, different origin edema, active form of tuberculosis, diabetes mellitus, pregnancy.
Order of intake and dosage:
“PREDNISOLON NEO” is taken orally independent from food intake. Dosage regime and duration of treatment is established by the doctor individually. At time of dosage determination, it is significant to consider glucocorticosteroids secretion round-the-clock rhythm. Great part of dose or the whole dose is prescribed in the morning. Treatment should be terminated by gradual reduction of dose (sudden termination of the preparation may cause disease complication– “withdrawal syndrome”). After treatment completion is taken corticotropine (10-20 unit in a day) to avoid adrenal gland possible atrophy.
Initial dose for adult makes up 20-40 mg. in a day (4-6 pills),
Maintaining dose is 5-10 mg. in a day (1-2 pills).
Initial dose for children makes up 1-2 mg/kg. in a day (for 4-6 divided intake).
Maintaining dose is 0,3-0,6 mg/kg. in a day.
Maximal round-the-clock dose of “PREDNISOLON NEO” makes up 0,1 g.
Side effects:
Frequency of side effects occurrence depends on duration and dosage of preparation intake.
From the side of endocrine system:  Cushing syndrome, weight growth, hyperglycemia, adrenal gland cortex lowering, sexual development retention in children, menstrual cycle disturbance.
From the side of digestion system:   nausea, vomiting, increase of gastric juice acidity, ulcerogenic action, increased of decreased appetite.
From the side of cardiovascular system: arterial hypertension, arrhythmia, bradycardia.
From the side of osteoarticular system: myopathy, body mass reduction, muscle weakness, increased excretion of calcium, osteoporosis, children’s growth retention.
From the side of central nervous system:  mental disorder, headache, dizziness, sleep disorder, Euphoria.
Allergic reactions: generalized (rash, itch, anaphylactic shock) and local reactions.
Dermatologic reactions: retention of regeneration process, hyper or hypopigmentation, acne, thin skin.
From the side of sight system: glaucoma, intraocular pressure increase, exophthalmus.

Pregnancy and lactation: During pregnancy, especially in I term, Prednisolone is taken only in case of necessity.
 At lactation period, breast feeding must be stopped if preparation intake is necessary.
Interaction with other  medicines or other sort interaction:
Prednisolone increases cardiac glycoside toxicity (because of hypokaliemia development the risk of arrhythmia increases). Accelerates excretion of acetylsalicylic acid and reduces its concentration in the blood. Intake together with live antiviral vaccine, causes virus activation and infection development.
Increases hepatotoxic action of paracetamol (causes induction of liver enzymatic system and formation of paracetamol toxic metabolite).
Hypoglycemia caused by Prednisolone intake, increases muscle blockade expression and duration on the background of muscle relaxants. High dose of Prednisolone reduces somatotropin efficiency. Reduces hyperglycemic activity, reinforces coumarin produced anticoagulants operation.
Antacids reduce absorption of Prednisolone. Cyclosporine (suppresses metabolism) and ketoconazole (reduces clearance) increases its toxicity.
Thiazide diuretics, carbonic anhydrase inhibitors, other glucocorticosteroids and amphotericin B increase the risk of developing osteoporosis and hypokaliemia.
Nonsteroid anti-inflammation means and ethanol increases risk of ulcer and bleeding of the gastrointestinal tract mucous membrane.
Therapeutic operation of Prednisolone is reduced on the background of Phenytoinum, barbiturates, ephedrine, theophylline, rifampicinum and other liver microsomal enzyme inductors.
Clearance of Prednisolone is reduced on the background of taking thyroid hormones.
Immunosuppressant increases the risk of infection development.
Estrogens (including peroral contraceptives) reduces Prednisolone clearance, lengthens semiejection period, therapeutic and toxic effects.
Prednisolone intake together with neuroleptics and azathioprinum, increases the risk of cataract development.
Special instructions: 
During treatment (especially at time of prolonged treatment) ophthalmologist supervision is a must. Also control of arterial pressure, water- electrolytic balance, peripheral blood circulation and glucose amount in blood.
In order to avoid hypokaliemia, it is necessary to prescribe potassium preparations or appropriate diet.
At time of diabetes mellitus, Prednisolone is prescribed with especial care and only when necessary or treatment of insulin resistance.
At time of adrenal gland insufficiency, the preparation is prescribed together with mineralocorticoid.
Preparation isn’t recommended together with barbiturates for those patients who have Addison’s disease.
At time of prescribing preparation to children, it is necessary to control growth and development speed.
At time of infectious diseases and tuberculosis, the preparation is prescribed in combination with antibiotics and antituberculous menas.
Overdose:
In case of high-dose intake for a long time, the risk of side effect development increases. Treatment is symptomatic.
Influence of vehicle and mechanisms management:
Intake of “PREDNISOLON NEO” may course dizziness, sleepiness individually, so, patients whose activity needs attention concentration and quick psychomotor action should be careful. 
Package: 10 tablets on polyvinyl chloride blister, 5 blisterы in the box.
Storage conditions: Store on 15-25ºC temperature in a dark, dry place and keep away from children.
In case of visual defects and expiry of validity date, the preparation can not be used.
Order of issue:  Pharmaceutical product group II - issued with a doctor's prescription.
Validity: 2 years.



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