CORTINEFF PILLS 0.1MG

Composition and release form:

in orange glass bottles of 20 pcs.; in the box 1 bottle.

Description of the dosage form:

White with a creamy shade of color, a round tablet, with a facet, with flat surfaces, with an extruded letter “F” - on one side and with a notch for breaking - on the other side.

Pharmacodynamics:

It is a synthetic hormone of the adrenal cortex, a fluorinated Hydrocortisone derivative, which has a high mineralocorticoid activity.

It has a 100-fold stronger mineralocorticoid effect, as well as 10–15 times stronger anti-inflammatory effect than hydrocortisone.

Enhances the reabsorption of sodium and water in the renal tubules, and also increases the excretion of potassium and hydrogen ions.

An increase in extracellular fluid volume and sodium retention result in an increase in blood pressure.

In doses exceeding therapeutic, can inhibit the activity of the adrenal cortex, thymus gland and the secretion of ACTH by the pituitary gland. It can increase the deposition of glycogen in the liver, and in case of insufficient intake of protein from food - lead to a negative nitrogen balance.

Indications:

primary adrenal cortex insufficiency (Addison's disease, condition after complete adrenalectomy);

secondary insufficiency of the adrenal cortex;

adrenogenital syndrome (congenital adrenal hyperplasia);

hypovolemia and arterial hypotension of various genesis.

Contraindications:

hypersensitivity to foodcortisone or other components of the drug;

systemic fungal infections.

Carefully:

ulcerative colitis, intestinal diverticulosis, gastric ulcer or duodenal ulcer, acute or latent peptic ulcer, a newly created intestinal anastomosis, esophagitis, gastritis, gastrointestinal surgery in history, impaired liver function, renal failure, arterial hypertension, osteoporosis, anesthesia, osteoporosis and conditions predisposing to its occurrence, hyperlipidemia;

diabetes mellitus (including carbohydrate tolerance), hypothyroidism, Cushing's disease, thyrotoxicosis, obesity (stage III – IV), acute psychosis and mental disorders, polio (with the exception of the form of bulbar encephalitis);

patients with cardiovascular diseases, including after a recent myocardial infarction (in patients with acute and subacute myocardial infarction, the focus of necrosis may spread, slowing the formation of scar tissue and, consequently, rupture of the heart muscle), decompensated chronic heart failure.

parasitic and infectious diseases of a bacterial nature (currently or recently transferred, including contact with a patient) - herpes simplex, herpes zoster (viremic phase), chicken pox, measles, amebiasis, strongyloidosis (established or suspected); active and latent tuberculosis;

severe infectious diseases (permissible only against the background of specific therapy);

treatment of patients in the post-vaccination period (a period of 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination;

patients with HIV infection and AIDS (the decision to use corticosteroids should be made after careful consideration of the benefits and risks for the patient).

Use during pregnancy and lactation:

Reception of corticosteroids by women of childbearing age and pregnant women is permissible only when their potential benefit to the mother outweighs the potential risk to the fetus. In case of insufficiency of the adrenal cortex, the reception of Corineffe during pregnancy should be continued, while its dose may increase.

If necessary, the use of the drug during breastfeeding is recommended to stop breastfeeding.

Side effects:

The main undesirable effects include: arterial hypertension, peripheral edema, left ventricular hypertrophy of the heart, circulatory failure, hypernatremia, hypocalcemia.

When using Cortineff for a long time or applying it simultaneously with other corticosteroids, the following side effects are possible.

Musculoskeletal system: muscle weakness, steroid myopathy (more common in women; usually begins with the pelvic muscles of the femoral girdle and spreads to the proximal arm muscles; rarely affects the respiratory muscles), muscle loss, muscle tendon rupture, osteoporosis, compression fracture of the spine, and femoral nephrosis humerus, pathological fractures of long tubular bones.

Cardiovascular: arrhythmias, bradycardia (up to cardiac arrest), ECG changes characteristic of hypokalemia, hypercoagulation, thrombosis, endarteritis obliterans; in patients with acute and subacute myocardial infarction - the spread of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.

Gastrointestinal: steroid ulcer with possible perforation and bleeding, pancreatitis, flatulence, ulcerative esophagitis, digestive disorders, nausea, increased or decreased appetite, vomiting, hiccups; in rare cases - increased activity of hepatic transaminases and alkaline phosphatase.

From the skin and mucous membranes: atrophic bands, acne, delayed wound healing, thinning of the skin, petechiae and hematomas, erythema, increased sweating, allergic dermatitis, urticaria, angioedema, ecchymosis, hyper- or hypopigmentation, a tendency to develop pyoderma and candidosis.

Nervous system: increased intracranial pressure with stagnant nipple syndrome of the optic nerve (brain pseudotumor - most often in children, usually after a too rapid dose reduction, symptoms - headache, decreased visual acuity or double vision), convulsions, dizziness, headache, sleep disturbances.

Endocrine status: secondary adrenal and hypothalamic-pituitary insufficiency (especially in stressful situations such as illness, trauma, surgery), Cushing syndrome, growth suppression in children, menstrual disorders, decrease in carbohydrate tolerance, manifestation of latent diabetes mellitus and increased insulin or oral hypoglycemic agents, hirsutism.

Special senses: posterior subcapsular cataract (usually disappears after stopping treatment, but may require surgical treatment), increased intraocular pressure, glaucoma (usually after treatment for at least a year), exophthalmos, a tendency to develop secondary bacterial, fungal or viral infections of the eye, trophic changes of the cornea.

Psychological: appear most frequently during the first 2 weeks of treatment, symptoms may mimic schizophrenia, mania, or delirious syndrome (women are most susceptible).

Metabolism: negative nitrogen balance as a result of protein catabolism, hyperglycemia, glycosuria, increased Ca excretion2+hypocalcemia; caused by mineralocorticoid activity - hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

Other: Anaphylactic reactions, weight gain, masking of symptoms of infectious diseases, syncope, the development or exacerbation of infections (jointly used immunosuppressants and vaccination contribute to the manifestation of this side effect), leukocyturia, withdrawal syndrome.

Interaction:

Cardiac glycosides: increased risk of cardiac arrhythmias and glycoside toxicity associated with hypokalemia.

Barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutetimid: accelerate the metabolism of corticosteroids (by inducing microsomal enzymes), weaken their action.

Antihistamines weaken the action of cortineff.

Amphotericin B, carbonic anhydrase inhibitors: hypokalemia, left ventricular hypertrophy of the heart, circulatory failure.

Anabolic steroids, androgens: increased risk of peripheral edema, acne (use caution, especially in diseases of the liver and heart).

Oral contraceptive drugs containing estrogens: increase in the concentration of globulins that bind corticosteroids in the serum, slowing metabolism, increasing the duration of T1/2, enhancing the action of cortineff.

Anticoagulants (coumarin derivatives, indandion, heparin), streptokinase, urokinase: a decrease, and in some patients - an increase in efficiency, the dose should be determined on the basis of PV, an increase in the risk of ulceration and bleeding from the gastrointestinal tract.

Tricyclic antidepressants may exacerbate the mental disorders associated with taking Corineffe (they should not be prescribed for the treatment of these disorders).

Oral hypoglycemic drugs, insulin: weakening of the hypoglycemic action, an increase in the concentration of glucose in the blood (correction of the dose of hypoglycemic drugs is possible).

Diuretic drugs: weakening of the action of diuretics (potassium-sparing), hypokalemia.

Laxatives: weakening action hypokalemia.

Ephedrine may accelerate the metabolism of corticosteroids (a correction of the dose of Corineffe is possible).

Immunosuppressive drugs: increased risk of developing infection, lymphoma and other lymphoproliferative diseases.

Neuromuscular blocking drugs (depolarizing muscle relaxants): hypocalcemia associated with the use of Cortineff may increase the blockade of synapses, leading to an increase in the duration of the neuromuscular blockade.

NSAIDs, incl. Acetylsalicylic acid : weakening of the action, increasing the risk of developing ulcers and bleeding from the gastrointestinal tract.

Preparations and food containing sodium: peripheral edema, arterial hypertension (it may be necessary to limit sodium intake with food and drugs with high sodium content, but sometimes the use of corticosteroids requires additional administration of sodium).

Vaccines containing live viruses: during the use of immunosuppressive doses of corticosteroids, viral replication is possible (development of viral diseases) and a decrease in antibody production (simultaneous use is not recommended).

Other vaccines: increased risk of neurological complications and reduced antibody production.

Dosage and administration:

Inside, in the morning after eating, drinking plenty of water. Dose set individually depending on the evidence, the effectiveness of therapy and the patient's condition. In the course of treatment, if the clinical picture changes or in stressful situations (surgery, trauma, infection), dose adjustment may be necessary.

Adults with replacement therapy - from 100 mcg 3 times a week to 200 mcg / day.

Children with adrenogenital syndrome - in the initial dose of 300 mcg / day, then within a few months the dose is reduced to 50-100 mcg / day.

Maintenance dose: infants - 100–200 mcg / day, children older than 1 year - 50–100 mcg / day.

When prescribing large doses, it is recommended to take 2/3 doses in the morning and 1/3 in the afternoon.

When you skip the dose, you should take the drug as soon as possible, but if the time of the next dose is coming, do not take the missed dose. Do not take a double dose.

The drug should be used in the minimum effective doses, if necessary, the dose should be reduced gradually.

Overdose:

Symptoms: arterial hypertension, peripheral edema, hypokalemia, a significant increase in body weight, cardiac muscle hypertrophy.

Treatment: drug withdrawal (symptoms usually disappear within a few days). Then treatment should be continued, reducing the dose of the drug. In case of muscular weakness associated with potassium loss, potassium replacement is necessary. Overdose can be prevented by regular monitoring of blood pressure and serum electrolyte concentrations.

Special instructions:

At reception of Korteneff the patient should precisely observe instructions of the doctor.

In the event of a stressful situation, parenteral administration of corticosteroids is recommended for patients taking Corineffe.

Sudden cessation of treatment can cause the development of acute adrenal insufficiency, so the dose of Corineffe should be reduced gradually.

Cortineff can mask the symptoms of infection, reduce resistance to the infection and the ability of its localization.

Prolonged use of Florinef increases the risk of developing secondary fungal or viral infections.

Patients taking Corinef should not be vaccinated with live viral vaccines. The introduction of an inactivated viral or bacterial vaccine may not cause the expected increase in the amount of antibodies. In addition, patients taking corticosteroids, there is an increased risk of neurological complications during vaccination.

With the sudden cancellation of Cortineff, especially after a long reception, the development of a so-called. withdrawal syndrome, manifested by anorexia, fever, muscle and joint pain, general weakness.These symptoms may appear even when there is no marked adrenal insufficiency.

In patients with hypothyroidism or cirrhosis of the liver, the action of Corineffe is enhanced.

Mental disorders such as euphoria, insomnia, sharp changes in mood, personality changes, severe depression, symptoms of psychosis may appear during the application of Cortineff. Pre-existing emotional instability or psychotic tendencies may increase during treatment.

When treating patients with hypoprothrombinemia, caution should be used at the same time as Florineff and acetylsalicylic acid.

With long-term treatment of children should be monitored for their growth and development.