Cortineff, pills 0.1 mg, 20 pcs.

Composition

Active ingredient: fludrocortisone acetate 100 mcg;

Excipients: lactose, potato starch, gelatin, magnesium stearate.

Pharmacological action

Cortineff is a synthetic analog of the adrenal cortex hormone, a fluorinated derivative of hydrocortisone. It has a high mineralocorticoid activity.

Cortineff increases the reabsorption of sodium and water in the renal tubules, and also increases the release of potassium and hydrogen ions. An increase in the volume of extracellular fluid and sodium retention in the body lead to an increase in blood pressure.

Cortineff in doses exceeding therapeutic levels can inhibit the activity of the adrenal cortex, the activity of the thymus gland, and the secretion of ACTH by the pituitary gland. The drug can also increase the deposition of glycogen in the liver, and with insufficient protein in food, lead to a negative nitrogen balance.

Cortineff has a 100-fold stronger mineralocorticoid effect and 10-15-fold stronger anti-inflammatory effect than hydrocortisone.

Indications

• Primary insufficiency of the adrenal cortex (Addison’s disease, a condition after complete adrenalectomy).
• Secondary insufficiency of the adrenal cortex.
• Adrenogenital syndrome (congenital adrenal hyperplasia).
• Hypovolemia and arterial hypotension of various origins.

Contraindications

• From the musculoskeletal system: muscle weakness, steroid myopathy (more common in women; usually begins with the pelvic muscles of the femoral girdle and extends to the proximal muscles of the arms; rarely affects the respiratory muscles), loss of muscle mass, rupture of muscle tendons, osteoporosis, compression fracture of the spine, aseptic necrosis of the femoral and humerus heads, pathological fractures of the long tubular bones.

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

  From the digestive system: 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 streaks, acne, delayed wound healing, thinning of the skin, petechiae and hematomas, erythema, increased sweating, allergic dermatitis, urticaria, angioedema, ecchymoses, hyper-or hypopigmentation, a tendency to develop pyoderma and candidiasis.

  Nervous system disorders: promotion level ICP with congestive nipple syndrome of the optic nerve (pseudotumor of the brain-most often in children, usually after too rapid a dose reduction, symptoms-headache, decreased visual acuity or double vision), convulsions, dizziness, headache, sleep disorders.

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

  From the side of the senses: posterior subcapsular cataract (usually resolves after discontinuation of 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 in the cornea.

  Mental disorders: most often appear during the first 2 weeks of treatment, symptoms may mimic schizophrenia, mania, or delirium syndrome (women are most susceptible).

  From the side of metabolism: negative nitrogen balance due to protein catabolism, hyperglycemia, glucosuria, increased Ca2+ excretion, hypocalcemia; due to mineralocorticoid activity-hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

  Other services: anaphylactic reactions, weight gain, masking the symptoms of infectious diseases, fainting, development or exacerbation of infections (this side effect is caused by the combined use of immunosuppressants and vaccination), leukocyturia, withdrawal syndrome.

Side effects

From the musculoskeletal system: muscle weakness, steroid myopathy (more common in women; usually begins with the pelvic muscles of the femoral girdle and extends to the proximal muscles of the arms; rarely affects the respiratory muscles), loss of muscle mass, rupture of muscle tendons, osteoporosis, compression fracture of the spine, aseptic necrosis of the femoral and humerus heads, pathological fractures of the long tubular bones.

From the cardiovascular system: thrombosis, arrhythmias, bradycardia (up to cardiac arrest), ECG changes characteristic of hypokalemia, hypercoagulation, obliterating endarteritis;

in patients with acute and subacute myocardial infarction-spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.

From the digestive system: 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 streaks, acne, delayed wound healing, thinning of the skin, petechiae and hematomas, erythema, increased sweating, allergic dermatitis, urticaria, angioedema, ecchymoses, hyper-or hypopigmentation, a tendency to develop pyoderma and candidiasis.

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

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

From the side of the senses: posterior subcapsular cataract (usually resolves after discontinuation of 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 in the cornea.

Mental disorders: most often appear during the first 2 weeks of treatment, symptoms may mimic schizophrenia, mania, or delirium syndrome (women are most susceptible).

From the side of metabolism: negative nitrogen balance due to protein catabolism, hyperglycemia, glucosuria, increased Ca2+ excretion, hypocalcemia; due to mineralocorticoid activity-hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

Other services: anaphylactic reactions, weight gain, masking the symptoms of infectious diseases, fainting, development or exacerbation of infections (this side effect is caused by the combined use of immunosuppressants and vaccination), leukocyturia, withdrawal syndrome.

Interaction

Concomitant use of Cortineff with cardiac glycosides increases the risk of developing cardiac arrhythmias and increases the toxicity of glycosides against the background of hypokalemia.

When used concomitantly, barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, and glutetimide weaken the effect of Cortineff by accelerating fludrocortisone metabolism

Antihistamines weaken the effect of Cortineff.

Amphotericin B, carbonic anhydrase inhibitors when used concomitantly with Cortineff can cause hypokalemia, left ventricular hypertrophy, and circulatory failure.

Concomitant use of Cortineff with anabolic steroids, androgens increases the risk of developing peripheral edema, acne (use with caution, especially in patients with liver and heart diseases).

Oral contraceptives containing estrogens increase the serum level of globulins binding corticosteroids, enhance the effect of Cortineff by slowing the metabolism of fludrocortisone and increasing its T 1/2.

Anticoagulants (coumarin derivatives, indadion, heparin), streptokinase, urokinase reduce (in some patients increase) the effectiveness of Cortineff. The dose should be determined based on prothrombin time and take into account the increased risk of ulceration and bleeding from the gastrointestinal tract.

Tricyclic antidepressants may increase the psychiatric disorders associated with taking Cortineff (these drugs should not be used to treat these disorders).

When used concomitantly, Cortineff weakens the effect of oral hypoglycemic drugs, insulin, potassium-sparing diuretics, increases the concentration of glucose in the blood (it may be necessary to adjust the dose of hypoglycemic drugs).

Cortineff reduces the effectiveness of laxatives, potassium-sparing diuretics, and increases the risk of hypokalemia.

Ephedrine may accelerate fludrocortisone metabolism (Cortineff dose adjustment may be required).

Concomitant use of Cortineff with immunosuppressive drugs increases the risk of infection, lymphoma, and other lymphoproliferative diseases.

Cortineff, when used concomitantly with depolarizing muscle relaxants, may increase the duration of neuromuscular blockade, since hypocalcemia associated with the use of Cortineff may increase synapse blockade.

Cortineffa reduces the effect of NSAIDs (including acetylsalicylic acid), while increasing the risk of ulceration and bleeding from the gastrointestinal tract.

With the simultaneous use of Cortineff and drugs and food containing sodium, peripheral edema and arterial hypertension are possible.

When using vaccines containing live viruses, against the background of the use of immunosuppressive doses of Cortineff, viral replication and the development of viral diseases, a decrease in antibody production are possible (the combination is not recommended).

When used concomitantly with other vaccines, the risk of neurological complications increases and antibody production decreases.

How to take, course of administration and dosage

The dose of the drug is set individually, depending on the indications, the effectiveness of therapy and the patient’s condition. During treatment, when the clinical picture changes or during stressful situations, such as surgery, injury or infection, dose adjustment may be necessary.

Adults with substitution therapy, depending on the clinical situation, the dose varies from 100 mcg 3 times a week to 200 mcg / day.

With adrenogenital syndrome, children are prescribed an initial dose of 300 mcg/day, then within a few months the dose is reduced to 50-100 mcg/day.

The maintenance dose for children is from 100 to 200 mcg / day, for children over the age of 1 year – 50-100 mcg/day.

Tablets should be taken in the morning, after meals, with plenty of fluids. If used in high doses, it is recommended to take 2/3 of the dose in the morning and 1/3 of the dose in the afternoon.

If you miss a dose, you should take the drug as soon as possible. If the time for the next dose is approaching, the missed dose should not be taken. Do not take a double dose at once.

Cortineff should be taken in the minimum effective doses. If necessary, the dose of the drug should be reduced gradually.

Overdose

Symptoms: arterial hypertension, peripheral edema, hypokalemia, significant weight gain, myocardial hypertrophy.

Treatment: discontinue the medication. Symptoms usually resolve within a few days. Then the treatment should be continued by reducing the dose of Cortineff. In case of muscle weakness associated with loss of potassium, administration of potassium supplements is necessary. To prevent overdose, blood pressure and serum electrolyte concentrations should be monitored regularly.

Special instructions

In stressful situations (including surgery, trauma, or infection), parenteral administration of corticosteroids is recommended for patients receiving the drug.

Sudden discontinuation of treatment may cause the development of adrenal insufficiency, so the dose of Cortineff should be reduced gradually.

Cortineff can mask the symptoms of infectious diseases, reduce the body’s resistance to infection and the ability to localize it.

Prolonged use of Cortineff increases the risk of developing a secondary fungal or viral infection.

With prolonged use of Cortineff, it may be necessary to transfer the patient to a diet with limited sodium intake and an increase in potassium content, as well as with an increase in protein content.

When using Cortineff, vaccination with live viral vaccines should not be carried out. Administration of an inactivated viral or bacterial vaccine may not cause the expected increase in antibody titer. In addition, patients receiving corticosteroids have an increased risk of neurological complications during vaccination.

It should be borne in mind that the withdrawal of the drug should be carried out gradually. With sudden withdrawal of the drug, especially after prolonged therapy, withdrawal syndrome may develop, characterized by anorexia, fever, myalgia and arthralgia, general weakness (these symptoms may appear even if there are no signs of adrenal insufficiency).

In patients with hypothyroidism or cirrhosis of the liver, the effect of Cortineff is enhanced.

With the use of Cortineff, the patient’s pre-existing emotional instability or psychotic personality may increase.

Patients with hypoprothrombinemia should be cautiously prescribed Cortineff concomitantly with acetylsalicylic acid.

Use in pediatrics

With prolonged use of Cortineff in children, careful monitoring of their growth and development is necessary.

Form of production

Tablets

Storage conditions

The drug should be stored in a dry place protected from light at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Fludrocortisone

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 15 gr.