Expiration date: 06/2026

The composition and form of issue:

Tablets. 1 tablet contains:

fludrocortisone acetate 0.1 mg

excipients: lactose potato starch gelatin magnesium stearate 

in orange glass bottles 20 PCs in a box 1 vial.

Description pharmaceutical form:

White with kremovatam white color, round-shaped pills with chamfer, flat surface, with the embossed letter "F" on one side and with a notch for a fault on the other side.

Description pharmacological action:

Is a synthetic hormone of the adrenal cortex, a fluorinated derivative of hydrocortisone has high mineralocorticoid activity.

Having 100 times more powerful mineralocorticoid effect, as well as 10-15-fold stronger anti-inflammatory action than hydrocortisone.

Reverse enhances the absorption of sodium and water in renal tubules and increases secretion of potassium and hydrogen ions.

The increase in the volume of extracellular fluid and sodium retention lead to increased blood pressure.

In doses higher than therapeutic, can inhibit the activity of the adrenal cortex, thymus gland and the secretion of ACTH by the pituitary gland. Can increase the deposition of glycogen in the liver, and if insufficient intake of protein in the diet can result in a negative nitrogen balance.

Indications:

• primary adrenal insufficiency (Addison's disease, condition after complete adrenalectomy)
  
• secondary adrenal insufficiency
  
• adrenogenital syndrome (congenital hyperplasia of the adrenal glands)
  
• gipovolemia and hypotension different Genesis.
  

Contraindications:

• hypersensitivity to fludrocortisone or other components of the drug
  
• systemic fungal infection.
  

With caution in: nonspecific ulcerative colitis, diverticulosis of intestine, ulcer of stomach or duodenal ulcers, acute or latent peptic ulcer, the recently established bowel anastomosis, esophagitis, gastritis, surgery in the digestive disease, liver dysfunction, renal insufficiency, hypertension, osteoporosis, myasthenia gravis, hypoalbuminemia and status, predisposing to its occurrence, hyperlipidemia, diabetes mellitus (incl. violation of tolerance to carbohydrates), hypothyroidism, disease Itsenko-Kushinga, thyrotoxicosis, obesity (grade III–IV), acute psychosis and mental disorders, polio (except bulbar form of encephalitis), the patients with cardiovascular diseases, including after recent myocardial infarction (in patients with acute and subacute myocardial infarction may spread of necrosis, slowing the formation of scar tissue and, consequently, rupture of the heart muscle), decompensated chronic heart failure, parasitic and infectious diseases of bacterial origin (currently or recently migrated, including contact with the patient) — herpes simplex, herpes zoster (vermicella phase), chickenpox, measles, amoebiasis, strongyloidiasis (established or suspected) active and latent tuberculosis is a serious infectious disease (valid only on the background of specific therapy) the treatment of patients in post-vaccination period (period of duration 8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination patients with HIV infection and AIDS (decision on the use of corticosteroids should be taken after careful consideration of benefit and risk for the patient).

Application of pregnancy and breast-feeding:

Taking corticosteroids women of childbearing age and pregnant women is allowed only when the potential benefit to the mother outweighs the potential risk to the fetus. In case of insufficiency of the adrenal cortex receiving Cortineff during pregnancy should be continued at this dose it can increase.

If necessary, use of the drug during lactation should stop breastfeeding.

Side effects:

The main unwanted effects include: hypertension, peripheral edema, hypertrophy of the left ventricle, insufficiency of blood circulation, hypernatremia, hypocalcemia.

The application of Cortineff for a long time or use it simultaneously with other corticosteroids are possible side effects.

From the musculoskeletal: muscle weakness, steroid myopathy (more common in women usually starts with the muscles of the pelvis the femoral belt and extends to the proximal muscles of the arms rarely affects respiratory muscles), loss of muscle mass, tendon rupture muscle, osteoporosis, spinal compression fracture, aseptic necrosis of heads of femoral and humerus bones, pathological fractures of long tubular bones.

From the CCC: arrhythmia, aetiology (until the heart failure), changes in the ECG, characteristic of hypokalemia, hypercoagulability, thrombosis, occlusive disease in patients with acute and subacute myocardial infarction — distribution 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 hemorrhage, pancreatitis, flatulence, ulcerative esophagitis, digestive disorders, nausea, increased or decreased appetite, vomiting, hiccups in rare cases — increase in liver transaminases and alkaline phosphatase.

With the skin and mucous membranes: atrophic bands, acne, slow wound healing, thinning of skin, petechiae and hematomas, erythema, increased sweating, allergic dermatitis, urticaria, angioedema, ekhimozy, Hyper - or hypopigmentation, the propensity to develop pyoderma and candidiasis.

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

Endocrine status: secondary adrenal and hypothalamic-pituitary failure (especially in stressful situations such as illness, injury, surgery), Cushing's syndrome, growth suppression in children, menstrual irregularities, reduced tolerance to carbohydrates, manifestation of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic means, hirsutism.

From the sensory organs: the rear subcapsular cataracts (typically takes place after the end of treatment, but may require surgical treatment), increased intraocular pressure, glaucoma (usually after treatment for at least a year), exophthalmos, propensity to develop secondary bacterial, fungal or viral eye infections, trophic changes of the cornea.

Mental disorders: often occur within the first 2 weeks of treatment, the symptoms can mimic schizophrenia, mania or delirium syndrome (the most exposed women).

From the metabolic: negative nitrogen balance as a result of protein catabolism, hyperglycemia, glycosuria, increased excretion of Ca2+, hypocalcemia due to mineralocorticoid activity — hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

Other: anaphylactic reactions, increasing of body mass, masking symptoms of infectious diseases, fainting, the development or worsening of infections (the manifestation of this side effect contribute jointly used immunosuppressants and vaccination), pyuria, the syndrome.

Drug interactions:

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

Barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutethimide: accelerates metabolism of corticosteroids (by induction of microsomal enzymes), weaken their action.

Antihistamines weaken the action of Cortineff.

Amphotericin b, carbonic anhydrase inhibitors: hypokalemia, left ventricular hypertrophy of the heart, circulatory insufficiency.

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

Oral contraceptive preparations containing estrogens: the increased concentration of globulins, corticosteroid binding in the serum, slower metabolism, longer T1/2, enhancing the effect of Cortineff.

Anticoagulants (coumarin derivatives, indandiona, heparin), streptokinase, urokinase: a decrease, and some patients — increased efficiency, the dose should be determined on the basis of PV, increasing the risk of ulceration and bleeding from the gastrointestinal tract.

Tricyclic antidepressants may increase mental disorders, associated with the reception of Cortineff (should not be prescribed for the treatment of these disorders).

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

Diuretics: reduce the action of diuretics (potassium-sparing), hypokalemia.

Laxatives: the weakening action hypokalemia.

Ephedrine can accelerate metabolism of corticosteroids (possible dose adjustment of Cortineff).

Immunosuppressive drugs: increased risk of developing infections, lymphomas and other lymphoproliferative diseases.

Drugs that block neuromuscular conduction (depolarizing muscle relaxants): hypocalcemia associated with the use of Cortineff, may enhance the blockade of synapses, resulting in an increase in the duration of neuromuscular blockade.

NPVS, incl. acetylsalicylic acid: a weakening of the action, increase the risk of ulcers and bleeding from the gastrointestinal tract.

Drugs and food containing sodium: peripheral oedema, hypertension (it may be necessary to limit the intake of sodium from food and medicines with high sodium content, but sometimes the use of corticosteroids requires the additional introduction of sodium).

Vaccines that contain live viruses during the use of immunosuppressive doses of corticosteroids possible replication of viruses (development of viral diseases) and reduced antibody production (concurrent use is not recommended).

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

Method of application and dose:

Inside, in the morning, after eating, squeezed more liquid. Dose set individually depending on indications, effectiveness of treatment and condition of the patient. In the process of treatment change the clinical picture or in stressful situations (surgery, trauma, infection) may be necessary correction doses.

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

Children with adrenogenital syndrome — the initial dose of 300 mg/day, then within a few months, reduce the dose to 50-100 mcg/day.

Maintenance dose: infants — 100-200 mg/day, children over 1 year — 50-100 mg/day.

In appointing large doses it is recommended that 2/3 of the dose taken in the morning and 1/3 in the afternoon.

If you missed a dose you should take the drug as soon as possible, but if it is approaching time for your next dose, missing dose not take. Do not take a double dose.

The drug should be used in minimal effective doses, the dose should be reduced gradually.

Overdose:

Symptoms: hypertension, peripheral oedema, hypokalemia, significant increase in body weight, hypertrophy of the heart muscle.

Treatment: removal of the drug (symptoms usually resolve within several days). Then the treatment should be continued, reducing the dose of the drug. When muscle weakness associated with loss of potassium, potassium replacement is necessary. Overdose can be prevented by regular control of blood pressure and concentration of electrolytes in the blood serum.

Special instructions:

Upon receipt of Cortineff the patient must be sure to observe the instructions of the doctor.

In case of stressful situations on patients who cortineff the recommended parenteral administration of corticosteroids.

Sudden discontinuation of treatment can cause development of acute insufficiency of the adrenal cortex, therefore, the dose of Cortineff should be reduced gradually.

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

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

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

With the sudden cancellation of Cortineff, especially after long-term use may develop the so-called withdrawal syndrome, manifested by anorexia, fever, muscle and joint pain, General weakness. These symptoms may appear even in the case when not marked insufficiency of the adrenal cortex.

In patients with hypothyroidism or cirrhosis of the liver the action of Cortineff increases.

During the application of Cortineff can appear mental disorders, such as euphoria, insomnia, abrupt mood changes, personality changes, severe depression, psychotic symptoms. Preexisting emotional instability or psychotic tendencies may intensify during treatment.

In the treatment of patients with hypoprothrombinemia should be used with caution at the same time Cortineff and acetylsalicylic acid.

Long-term treatment of children should observe their growth and development.