Cortisone tablets 25mg, no. 80

• Chronic adrenal insufficiency (Addison's disease, hypocorticism after bilateral adrenalectomy, hypopituitarism with secondary hypocorticism, etc.)

• Congenital dysfunction of the adrenal cortex - in combination with mineralocorticoids.
  For the rest of the indications available for other glucocorticosteroids, it is currently not used.

Cortisone tablets are administered orally. In chronic adrenal insufficiency, the usual average maintenance dose is 2550 mg per day.
The daily dose of the drug is prescribed in 2 doses, reproducing the daily rhythm of cortisone secretion - 2/3 of the daily dose in the morning (at 6-8 hours) and 1/3 of the daily dose in the evening (at 17-18 hours). With the threat of stress, the daily dose is increased by 2-3 times and prescribed in 3-4 doses (after 6-8 hours).
In congenital dysfunction of the adrenal cortex, Cortisone is used at a dose of 25 mg per day in combination with other drugs (prednisolone, dexamethasone).
The maximum doses for adults: single -150 mg, daily - 300 mg.
For children, Cortisone is prescribed in smaller doses depending on age. Maximum doses for children: up to 5 years: single - 25 mg, daily - 75 mg; from 5 to 10 years: single - 50 mg, daily - 150 mg; over 10 years: single - 75 mg, daily -225 mg.
If it is necessary to replace Cortisone with other drugs with glucocorticosteroid activity, it should be remembered that 25 mg of cortisone is equivalent in effect to 20 mg of hydrocortisone; 5 mg prednisone or prednisone; 4 mg methylprednisolone or triamcinolone; 0.75 mg dexamethasone.

Active substance: cortisone acetate - 0.025 g.

Excipients: sugar, potato starch, stearic acid.

For short-term use for health reasons, the only contraindication is hypersensitivity to cortisone acetate or drug components.
In children during the period of growth, GCS should be used only for absolute indications and under the particularly careful supervision of the attending physician. With caution, the drug should be prescribed for the following diseases and conditions:

• Diseases of the gastrointestinal tract - peptic ulcer of the stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, recently created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis.

• Parasitic and infectious diseases of a viral, fungal or bacterial nature (ongoing or recently transferred, including recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chickenpox, measles; amebiasis, strongyloidosis; systemic mycosis; active and latent tuberculosis. Application for severe infectious diseases is permissible only against the background of specific therapy.

• Pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency states (including AIDS or HIV infection).

• Diseases of the cardiovascular system, incl. recent myocardial infarction (in patients with acute and subacute myocardial infarction, it is possible to spread the focus of necrosis, slow down the formation of scar tissue and, as a result, rupture of the heart muscle), severe chronic heart failure, arterial hypertension, hyperlipidemia.

• Endocrine diseases - diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease, obesity (III-IV century).

• Severe chronic renal and / or hepatic failure, nephrourolithiasis. Hypoalbuminemia and conditions predisposing to its occurrence.

• Systemic osteoporosis, myasthenia gravis, acute psychosis, poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma.

• Pregnancy.

Trade name of the drug : Cortisone

International Non- Proprietary Name (INN) : Cortisone

Chemical name : (17а, 21-dihydroxypregn-4-ene-3,11,20-trione 21-acetate)

Dosage form : tablets

Composition :
Active substance : cortisone acetate - 0.025 g.
Excipients : sugar, potato starch, stearic acid.

Description : Tablets, white or white with a yellowish sheen, flat-cylindrical, with a bevel.

Pharmacotherapeutic group : Glucocorticosteroid
ATX code Ќ02ј¬10

Pharmacological action
Cortisone is a synthetic glucocorticosteroid. It has anti-inflammatory, anti-allergic and immunosuppressive effects, increases the sensitivity of beta-adrenergic receptors to endogenous catecholamines.
Interacts with specific cytoplasmic receptors (receptors for glucocorticosteroids (GCS) are present in all tissues, especially in the liver) to form a complex that induces the formation of proteins (including enzymes that regulate vital processes in cells.)
Protein metabolism: reduces the amount of globulins in the plasma, increases the synthesis of albumin in the liver and kidneys (with an increase in the albumin / globulin ratio), reduces the synthesis and enhances the catabolism of protein in muscle tissue. Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (fat accumulation occurs mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia. Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract; increases the activity of glucose-6-phosphatase (increasing the flow of glucose from the liver into the blood); increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases (activation of gluconeogenesis); promotes the development of hyperglycemia.
Water-electrolyte metabolism: retains Na + and water in the body, stimulates the excretion of K + (mineralocorticoid activity), reduces the absorption of Ca2 + from the gastrointestinal tract, causes calcium 'leaching' from bones and increases its renal excretion, reduces bone mineralization.
The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils and mast cells; inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes (especially lysosomal) and organelle membranes. Acts at all stages of the inflammatory process: inhibits the synthesis of prostaglandins (Pg) at the level of arachidonic acid (lipocortin inhibits phospholipase A2, inhibits the liberation of arachidonic acid and inhibits the biosynthesis of endoperoxides, leukotrienes that promote inflammation, allergies, etc.), the synthesis of pro-inflammatory cytokines (pro-inflammatory) interleukin 1, tumor necrosis factor alpha, etc.); increases the resistance of the cell membrane to the action of various damaging factors.
The immunosuppressive effect is caused by the involution of lymphoid tissue caused by the inhibition of the proliferation of lymphocytes (especially T-lymphocytes), suppression of the migration of B-cells and the interaction of T- and B-lymphocytes, inhibition of the release of cytokines (interleukin-1, 2; gamma-interferon) from lymphocytes and macrophages and a decrease in the formation of antibodies.
The antiallergic effect develops as a result of a decrease in the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of circulating basophils, suppression of the development of lymphoid and connective tissue, a decrease in the number of T- and B-lymphocytes, obese cells, reducing the sensitivity of effector cells to allergy mediators, inhibition of antibody production, changes in the body's immune response.
In obstructive respiratory diseases, the action is mainly due to the inhibition of inflammatory processes, the prevention or reduction of the severity of edema of the mucous membranes, a decrease in eosinophilic infiltration of the submucous layer of the bronchial epithelium and the deposition of circulating immune complexes in the bronchial mucosa, as well as inhibition of erosion and desquamation of the mucosa. Increases the sensitivity of beta-adrenergic receptors of the bronchi of small and medium caliber to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by reducing its production.
Suppresses the synthesis and secretion of ACTH and, secondarily, the synthesis of endogenous GCS. It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.
The drug is almost completely absorbed from the gastrointestinal tract. Its maximum concentration in the blood is achieved in 1-2 hours, the effect of the drug lasts for 6-8 hours.

Indications for use

• Chronic adrenal insufficiency (Addison's disease, hypocorticism after bilateral adrenalectomy, hypopituitarism with secondary hypocorticism, etc.);

• Congenital dysfunction of the adrenal cortex - in combination with mineralocorticoids.
  For the rest of the indications available for other glucocorticosteroids, it is currently not used.

Contraindications
For short-term use for health reasons, the only contraindication is hypersensitivity to cortisone acetate or drug components.
In children during the period of growth, GCS should be used only for absolute indications and under the particularly careful supervision of the attending physician. With caution, the drug should be prescribed for the following diseases and conditions:

• Diseases of the gastrointestinal tract - peptic ulcer of the stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, recently created intestinal anastomosis, ulcerative colitis with the threat of perforation or abscess formation, diverticulitis.

• Parasitic and infectious diseases of a viral, fungal or bacterial nature (ongoing or recently transferred, including recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chickenpox, measles; amebiasis, strongyloidosis; systemic mycosis; active and latent tuberculosis. Application for severe infectious diseases is permissible only against the background of specific therapy.

• Pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination. Immunodeficiency states (including AIDS or HIV infection).

• Diseases of the cardiovascular system, incl. recent myocardial infarction (in patients with acute and subacute myocardial infarction, it is possible to spread the focus of necrosis, slow down the formation of scar tissue and, as a result, rupture of the heart muscle), severe chronic heart failure, arterial hypertension, hyperlipidemia.

• Endocrine diseases - diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, Itsenko-Cushing's disease, obesity (III-IV century).

• Severe chronic renal and / or hepatic failure, nephrourolithiasis. Hypoalbuminemia and conditions predisposing to its occurrence.

• Systemic osteoporosis, myasthenia gravis, acute psychosis, poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma.

• Pregnancy.

Method of administration and dosage
Cortisone tablets are administered orally. In chronic adrenal insufficiency, the usual average maintenance dose is 2550 mg per day.
The daily dose of the drug is prescribed in 2 doses, reproducing the daily rhythm of cortisone secretion - 2/3 of the daily dose in the morning (at 6-8 hours) and 1/3 of the daily dose in the evening (at 17-18 hours). With the threat of stress, the daily dose is increased by 2-3 times and prescribed in 3-4 doses (after 6-8 hours).
In congenital dysfunction of the adrenal cortex, Cortisone is used at a dose of 25 mg per day in combination with other drugs (prednisolone, dexamethasone).
The maximum doses for adults: single -150 mg, daily - 300 mg.
For children, Cortisone is prescribed in smaller doses depending on age. Maximum doses for children: up to 5 years: single - 25 mg, daily - 75 mg; from 5 to 10 years: single - 50 mg, daily - 150 mg; over 10 years: single - 75 mg, daily -225 mg.
If it is necessary to replace Cortisone with other drugs with glucocorticosteroid activity, it should be remembered that 25 mg of cortisone is equivalent in effect to 20 mg of hydrocortisone; 5 mg prednisone or prednisone; 4 mg methylprednisolone or triamcinolone; 0.75 mg dexamethasone.

Side effects
The frequency of development and the severity of side effects depends on the duration of use, the size of the dose used and the possibility of observing the circadian rhythm of the appointment of Cortisone.
When using Cortisone, the following may be noted:
From the endocrine system : decreased glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing's syndrome (moon face, pituitary obesity, hirsutism, increased blood pressure, dysmenorrhea, dysmenorrhea , muscle weakness, striae), delayed sexual development in children.
From the digestive system: nausea, vomiting, pancreatitis, steroid stomach and duodenal ulcer, erosive esophagitis, bleeding and gastrointestinal perforation, increased or decreased appetite, indigestion, flatulence, hiccups. In rare cases, an increase in the activity of hepatic transaminases and alkaline phosphatase.
From the side of the cardiovascular system : arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of heart failure, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of the focus of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle.
From the nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, cerebellar pseudotumor, headache, convulsions.
From the senses : posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral eye infections, trophic changes in the cornea, exophthalmos.
From the side of metabolism : increased excretion of calcium, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating.
Due to mineralocorticoid activity- fluid and sodium retention (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).
From the side of the musculoskeletal system : growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the humerus and femur head), muscle tendon rupture, steroid myopathy, decreased muscle mass (atrophy).
On the part of the skin and mucous membranes : delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, acne, striae, a tendency to develop pyoderma and candidiasis.
Allergic reactions: skin rash, itching, anaphylactic shock.
Others : the development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccinations), leukocyturia, withdrawal syndrome.

Overdose
It is possible to increase the side effects described above. The dose of cortisone must be reduced. Treatment is symptomatic.

Interaction with other drugs
Simultaneous administration of Cortisone with:
inducers of 'hepatic' microsomal enzymes (phenobarbital, rifampicin, phenytoin, theophylline, rifampicin, ephedrine) leads to a decrease in its concentration;
diuretics (especially 'thiazide' and carbonic anhydrase inhibitors) and amphotericin B can lead to increased excretion of K + from the body; with sodium-containing drugs - edema and increased blood pressure.
amphotericin B increases the risk of developing heart failure.
cardiac glycosides, their tolerance worsens and the likelihood of developing ventricular extrasystole (due to induced hypokalemia) increases.
indirect anticoagulantsweakens (less often enhances) their effect (dose adjustment is required).
anticoagulants and thrombolytics increase the risk of bleeding from ulcers in the gastrointestinal tract.
ethanol and non-steroidal anti-inflammatory drugs (NSAIDs) increase the risk of erosive and ulcerative lesions in the gastrointestinal tract and the development of bleeding (in combination with NSAIDs in the treatment of arthritis, it is possible to reduce the dose of glucocorticosteroids due to the summation of the therapeutic effect).
paracetamol increases the risk of hepatotoxicity (induction of liver enzymes and the formation of a toxic metabolite of paracetamol).
acetylsalicylic acidaccelerates its excretion and reduces the concentration in the blood (with the abolition of Cortisone, the level of salicylates in the blood increases and the risk of side effects increases).
insulin and oral hypoglycemic drugs, antihypertensive drugs , their effectiveness decreases.
vitamin D decreases its effect on the absorption of Ca2 + in the intestine. growth hormone reduces the effectiveness of the latter, and with praziquantel - its concentration.
M-anticholinergics (including antihistamines and tricyclic antidepressants) and nitrates increase intraocular pressure.
isoniazid and mexelitineincreases their metabolism (especially in 'slow' acetylators), which leads to a decrease in their plasma concentrations.
Carbonic anhydrase inhibitors and loop diuretics may increase the risk of osteoporosis.
Indomethacin, displacing cortisone from its association with albumin, increases the risk of developing its side effects.
ACTH enhances the action of Cortisone.
Ergocalciferol and parathyroid hormone inhibit the development of osteopathy caused by cortisone.
Cyclosporine and ketoconazole, by slowing down the metabolism of cortisone, may in some cases increase its toxicity.
The simultaneous administration of androgens and steroid anabolic drugs with Cortisone contributes to the development of peripheral edema and hirsutism, the appearance of acne.
Estrogens and oral estrogen-containing contraceptives reduce the clearance of cortisone, which may be accompanied by an increase in the severity of its action. Mitotan and other inhibitors of adrenal cortex function may necessitate an increase in the dose of cortisone.
When used simultaneously with live antiviral vaccines and against the background of other types of immunizations, it increases the risk of virus activation and the development of infections.
Antipsychotics (neuroleptics) and azathioprine increase the risk of developing cataracts when cortisone is given.
The simultaneous administration of antacids reduces the absorption of cortisone.
With simultaneous use with antithyroid drugs, it decreases, and with thyroid hormones, the clearance of Cortisone increases.

Special instructions
During treatment with Cortisone (especially long-term), it is necessary to observe an ophthalmologist, control blood pressure, the state of water and electrolyte balance, as well as a picture of peripheral blood and blood glucose levels.
In order to reduce side effects, antacids can be prescribed, as well as the intake of K + into the body (diet, potassium preparations) can be increased. Food should be rich in proteins, vitamins, with limited content of fats, carbohydrates and table salt.
The effect of the drug is enhanced in patients with hypothyroidism and liver cirrhosis. The drug can exacerbate existing emotional instability or psychotic disturbances. If a history of psychoses is indicated, high doses of cortisone are prescribed under the strict supervision of a physician.
In stressful situations during supportive treatment (for example, surgery, trauma or infectious diseases), the dose of the drug should be adjusted due to the increased need for glucocorticosteroids.
With a sudden cancellation, especially in the case of previous use of high doses, it is possible to develop a withdrawal syndrome (anorexia, nausea, lethargy, generalized musculoskeletal pain, general weakness), as well as exacerbation of the disease for which Cortisone was prescribed. During treatment with Cortisone, vaccination should not be given due to a decrease in its effectiveness (immune response).
Prescribing for intercurrent infections, septic conditions and tuberculosis, it is necessary to simultaneously treat with antibiotics with bactericidal action.
In children, during long-term treatment with Cortisone, careful monitoring of the dynamics of growth and development is necessary. Children who, during the period of treatment, were in contact with patients with measles or chickenpox, are prophylactically prescribed specific immunoglobulins.
Due to the insufficiently pronounced mineralocorticoid effect for replacement therapy for adrenal insufficiency, Cortisone is used in combination with mineralocorticoids.
In patients with diabetes mellitus, blood glucose should be monitored and, if necessary, therapy should be corrected.
X-ray control of the osteoarticular system is shown (images of the spine, hand).
Cortisone in patients with latent infectious diseases of the kidneys and urinary tract can cause leukocyturia, which may be of diagnostic value.
Cortisone increases the content of 11- and 17-oxyketocorticosteroid metabolites.

Application during pregnancy and breastfeeding
During pregnancy (especially in the 1st trimester) it is used only for health reasons.
Since glucocorticosteroids pass into breast milk, if it is necessary to use the drug during breastfeeding, it is recommended to stop breastfeeding.

Release form
Tablets of 0.025 g.
Packing : 10 tablets in a blister strip packaging. 8 blister strip packs together with instructions for use are placed in a pack.

Storage conditions
In a dry, dark place and out of reach of children, at a temperature not exceeding 25 ? C.
List B.

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

Terms of dispensing from pharmacies
Prescription.