Kortineff

General characteristics. Structure:

Active ingredient: 0,1 mg of a fludrokortizon of acetate.

Excipients: lactose - 57,9 mg, potato starch - 40 mg, gelatin - 1 mg, magnesium stearate - 1 mg.

Mineralokortikosteroidny drug with pronounced antiinflammatory effect.

Pharmacological properties:

Pharmacodynamics. Kortineff is a synthetic adrenal hormone, to the fluorinated hydrocortisone derivatives having high mineralokortikoidny activity. Renders by 100 times stronger mineralokortikoidny action, and also at 10-15 times stronger antiinflammatory action, than a hydrocortisone.

Kortineff strengthens the return absorption of sodium and water in renal tubules, and also increases release of potassium and ions of hydrogen. Increase in volume of extracellular liquid and a delay of sodium in an organism lead to increase in arterial pressure. Kortineff in the doses exceeding therapeutic can brake activity of bark of adrenal glands, activity of a thymus and secretion of AKTG a hypophysis. Can also strengthen adjournment of a glycogen in a liver, and at insufficient amount of protein to bring in food to negative balance of nitrogen.

Indications to use:

- Primary insufficiency of bark of adrenal glands (Addison's disease, a state after a full adrenalectomy).
- Secondary insufficiency of bark of adrenal glands.
- Adrenogenital syndrome (inborn adrenal struma).
- Hypovolemia and arterial hypotension of various genesis.

Route of administration and doses:

Doses of drug establish individually, depending on indications, efficiency of therapy and a condition of the patient. In the course of treatment at change of a clinical picture or during stressful situations, such as surgery, an injury or an infection, dose adjustment can be necessary.

At adults at replacement therapy depending on a clinical picture the dose varies from 100 mkg 3 times a week to 200 mkg/days.

At an adrenogenital syndrome to children appoint 300 mkg/days in an initial dose, then within several months reduce a dose to 50-100 mkg/days.

The maintenance dose for babies makes from 100 to 200 mkg/days, for children years – 50-100 mkg/days are more senior.

Pill should be taken inside in the morning after food, washing down with a large amount of liquid. In case of use of high doses of Kortineff it is recommended to accept 2/3 doses in the morning and 1/3 – in the afternoon.

In case of the admission of reception of a dose it is necessary to accept drug as soon as possible or if time of the following reception comes, not to accept the passed dose. It is not necessary to accept a double dose at once.

Kortineff it is necessary to apply in minimum effective doses. In need of a dose of drug it is necessary to reduce gradually.

Features of use:

Reception of corticosteroids by women of childbearing age and pregnant women is admissible only when their potential advantage for mother exceed potential risk for a fruit. At insufficiency of bark of adrenal glands Kortineff's reception during pregnancy should be continued, at the same time his dose can increase. In need of use of drug during feeding by a breast, it is recommended to stop breastfeeding.

At Kortineff's reception by the patient has to observe instructions of the doctor precisely.

In case of stressful situations by the patient accepting Kortineff parenteral administration of corticosteroids is recommended.

The sudden termination of treatment can cause development of acute insufficiency of bark of adrenal glands therefore Kortineff's dose should be reduced gradually.

Kortineff can mask infection symptoms, reduce resistance to an infection and ability to its localization.

Prolonged use of Kortineff increases risk of development of consecutive fungal or viral infections.

The patients accepting Kortineff should not be vaccinated live virus vaccines. Introduction of the inactivated virus or bacterial vaccine can not cause the expected increase in quantity of antibodies. Besides, the patients accepting corticosteroids have an increased risk of neurologic complications during vaccination. At sudden cancellation of Kortineff, especially after long reception, development of the so-called withdrawal which is shown anorexia, fervescence, muscular and joint pains, the general weakness is possible. These symptoms can appear even in case insufficiency of bark of adrenal glands is noted.

At patients with a hypothyroidism or cirrhosis Kortineff's action amplifies. During Kortineff's use mental disorders, such as euphoria, sleeplessness, sharp changes of mood, change of the personality, a heavy depression, psychosis symptoms can develop. The existing earlier emotional instability or psychotic tendencies can amplify during treatment.

At treatment of patients with a prothrombinopenia it is necessary to appoint with care at the same time Kortineff and acetylsalicylic acid.

At prolonged treatment of children it is necessary to monitor their growth and development.

Influence on ability to manage vehicles, mechanisms. There are no data on Kortineff's influence on ability to manage vehicles and to be engaged in other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Special precautionary measures at destruction of unused medicine. Medicines cannot be thrown out in the sewerage or in house containers for waste. How to utilize unused drug, learn from the druggist. These actions will help to protect the environment.

Side effects:

Treat the main undesirable effects: arterial hypertension, peripheral hypostases, hypertrophy of a left ventricle of heart, circulatory unefficiency, hypernatremia, hypocalcemia.

At Kortineff's use for a long time or along with other corticosteroids development of the following side effects is possible.

From a musculoskeletal system. Muscular weakness, a steroid myopathy (meets at women more often; usually begins with muscles of a femoral belt and extends to proximal muscles of hands; seldom affects respiratory muscles), loss of muscle bulk, a rupture of sinews of muscles, osteoporosis, compression spinal fracture, an aseptic necrosis of heads of femoral and humeral bones, pathological fractures of long tubular bones.

From cardiovascular system. Arrhythmias, bradycardia (up to a cardiac standstill), the ECG changes characteristic of a hypopotassemia, hypercoagulation, fibrinferments, an obliterating endarteritis. Patients with an acute and subacute myocardial infarction have a distribution of the center of a necrosis, delay of formation of cicatricial fabric that can lead to a rupture of a cardiac muscle.

From the alimentary system. A steroid ulcer with a possible perforation and bleeding, pancreatitis, a meteorism, an ulcer esophagitis, digestion disturbances, nausea, increase or a loss of appetite, vomiting, a hiccups. In rare instances - increase in activity of "hepatic" transaminases and an alkaline phosphatase.

From integuments and mucous membranes. Atrophic strips, eels, the slowed-down healing of wounds; thinning of skin; petechias and hematomas, an erythema, the increased perspiration, allergic dermatitis, a small tortoiseshell, a Quincke's disease, ecchymomas, hyper - or hypopigmentation, tendency to development of a pyoderma and candidiases.

From a nervous system. Increase in intracranial pressure with a syndrome of a congestive optic papilla (a brain pseudoneoplasm – most often at children, usually after too bystry reduction of a dose, symptoms – a headache, deterioration in visual acuity or doubling in eyes); spasms, dizziness, headache, sleep disorders.

From endocrine system. Secondary adrenal and gipotalamo-pituitary insufficiency (especially during stressful situations, such as a disease, an injury, surgery); Cushing's syndrome; suppression of growth at children; disturbances of a menstrual cycle; decrease in tolerance to carbohydrates; manifestation of a latent diabetes mellitus and increase in need for insulin or peroral hypoglycemic drugs at patients with a diabetes mellitus; hirsutism.

From sense bodys. A back subkapsulyarny cataract (usually passes after the treatment termination, but can need surgical treatment), increase in intraocular pressure, glaucoma (usually after treatment within not less than a year), an exophthalmos, tendency to development of consecutive bacterial, fungal or viral infections of eyes, trophic changes of a cornea.

Mental disturbances. Most often appear within the first two weeks of treatment; symptoms can imitate schizophrenia, manias or a delirious syndrome; are most subject to emergence of mental disturbances of the woman.

From a metabolism. Negative nitrogenous balance as a result of a protein catabolism; hyperglycemia; a glucosuria, the increased removal of Sa2+, a hypocalcemia. Caused by mineralkortikoidny activity – a hypernatremia, a gipokaliyemichesky syndrome (a hypopotassemia, arrhythmia, a miyalgiya or спасм muscles, unusual weakness and fatigue).

Others. Anaphylactic reactions; increase in body weight; masking of symptoms of infectious diseases; faints; development or an exacerbation of infections (emergence of this side effect is promoted jointly by the applied immunodepressants and vaccination); leukocyturia; syndrome of" cancellation".

Interaction with other medicines:

Cardiac glycosides: increase in risk of disturbances of a cordial rhythm and the toxicity of glycosides connected with a hypopotassemia.

Barbiturates, antiepileptic drugs (Phenytoinum, carbamazepine), rifampicin, глютетимид accelerate metabolism of corticosteroids (by induction of microsomal enzymes), weaken their action.

Antihistaminic drugs weaken Kortineff's action.

Amphotericinum In, karboangidraza inhibitors: hypopotassemia, hypertrophy of the left zheudochk of heart, circulatory unefficiency.

Anabolic steroids, androgens: increase in risk of development of peripheral hypostases, eels; to apply carefully, especially in case of diseases of a liver and heart.
The peroral contraceptive drugs containing estrogen: increase in concentration of the globulins connecting corticosteroids in blood serum, metabolism delay, increase in duration of semi-removal, strengthening of action of Kortineff.

Anticoagulants (coumarin derivatives, индадион, heparin), Streptokinasa, urokinase: decrease, and some patients have an increase in efficiency; the dose has to be defined on the basis of a prothrombin time; increase in risk of ulceration and bleeding from digestive tract.

Tricyclic antidepressants can strengthen the mental disturbances connected with Kortineff's reception. It is not necessary to apply them to treatment of these disturbances.

Peroral hypoglycemic drugs, insulin: weakening of hypoglycemic action, increase in concentration of glucose in blood; carrying out dose adjustment of hypoglycemic drugs can be necessary.

Diuretic drugs: weakening of effect of diuretics (kaliysberegayushchy), hypopotassemia.

Purgatives: weakening of action, hypopotassemia.

Ephedrine can accelerate metabolism of corticosteroids, carrying out dose adjustment of Kortineff can be necessary.

Immunodepressive drugs: increase in risk of development of an infection, lymphoma and other limfoprolifertivny diseases.

The drugs blocking neuromuscular conductivity (the depolarizing muscle relaxants): the hypocalcemia connected using Kortineff can strengthen blockade of synapses, leading to increase in duration of neuromuscular blockade.

Non-steroidal anti-inflammatory drugs, acetylsalicylic acid: weakening of action, increase in risk of development of a peptic ulcer and bleeding from a GIT.

The drugs and food containing sodium: peripheral hypostases, arterial hypertension.

Need of restriction for a diet of sodium and medicines with the high content of sodium is possible; use of corticosteroids sometimes demands additional administration of sodium.

The vaccines containing live viruses: during use of immunodepressive doses of corticosteroids replication of viruses and development of diseases is possible; decrease in development of antibodies; simultaneous use is not recommended.

Other vaccines: the increased risk of neurologic complications and decrease in development of antibodies.

Contraindications:

System fungal infections and hypersensitivity to a fludrokortizon or other components of drug.

With care. Kortineff appoint at nonspecific ulcer colitis, a divertuculosis of intestines, a peptic ulcer of a stomach or duodenum, an acute or latent round ulcer, recently created intestines anastomosis, an esophagitis, gastritis, digestive tract operations in the anamnesis, abnormal liver functions, a renal failure, arterial hypertension, osteoporosis, a myasthenia, a hypoalbuminemia and states contributing to its emergence, a lipidemia.

It is ostorzhno necessary to apply флудрокортизон at a diabetes mellitus (including disturbance of tolerance to carbohydrate), a hypothyroidism, Itsenko-Cushing's disease, a thyrotoxicosis, obesity (the III-IV Art.), acute psychosis and mental disorders, poliomyelitis (except for a form of bulbar encephalitis).

It is necessary to be careful at treatment of patients with cardiovascular diseases, including after recently postponed myocardial infarction (at patients with an acute and subacute myocardial infarction distribution of the center of a necrosis, delay of formation of cicatricial fabric and thereof - a rupture of a cardiac muscle is possible), dekompensirovanny chronic heart failure.

With care Kortineff appoint at parasitic and infectious diseases of the bacterial nature (now or recently postponed, including recent contact with the patient) - the herpes simplex surrounding herpes (a viremichesky phase), the chicken pox, measles, the amebiasis, a strongyloidosis (established or suspected); active and latent tuberculosis. Use of a fludrokortizon at serious, infectious diseases is admissible only against the background of specific therapy. It is necessary to be careful at treatment of patients in the postvaccinal period (the period lasting 8 weeks to and 2 weeks after vaccination), lymphadenitis after BTsZh inoculation. The decision on use of corticosteroids for patients with HIV infection and with AIDS should be accepted after thorough examination of advantage and risk.

Overdose:

Symptoms of overdose of Kortineff are: arterial hypertension, peripheral hypostases, hypopotassemia, significant increase in body weight, hypertrophy of a cardiac muscle. In case of overdose it is necessary to cancel drug; symptoms usually pass within several days. Then treatment should be continued, having reduced Kortineff's dose. In case of the muscular weakness connected with potassium loss potassium completion is necessary. The overdose can be prevented, regularly controlling the arterial pressure and concentration of electrolytes in blood serum.

Storage conditions:

To store in the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years.

Issue conditions:

According to the recipe

Packaging:

Tablets of 0,1 mg. On 20 tablets in a bottle from dark glass with the label; Each bottle with the application instruction in a cardboard box.