Cortinef: instructions for using the medicine, structure, Contraindications

Active material: Fludrokortizon
When ATH: H02AA02
CCF: The hormone of the adrenal cortex. Mineralokortikoid
ICD-10 codes (testimony): E25, E27.1, E27.4, E86, i95
When CSF: 01.10.02.03
Manufacturer: Pharmaceutical Works Polfa in Pabianice Joint-Stock Company (Poland)

Cortinef: dosage form, composition and packaging

Pills white with Valium a color shade, round, flat, chamfered, embossed with the letter “F” on one side and a notch for a break – another.

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

20 PC. – vials of dark glass (1) – cardboard boxes.

Cortinef: pharmachologic effect

The synthetic analogue of the hormone of the adrenal cortex, fluorinated hydrocortisone. It possesses high mineralocorticoid activity.

Florinef enhances the reabsorption of sodium and water in the renal tubules, and also increases the excretion of potassium and hydrogen ions. The increase in the extracellular fluid and sodium retention in the body lead to increased blood pressure.

Florinef doses, exceeding therapeutic, can inhibit the activity of the adrenal cortex, Activity of the thymus gland and the secretion of ACTH by the pituitary gland. The drug may also enhance the deposition of glycogen in the liver, and if not enough protein in the diet lead to a negative nitrogen balance.

Florinef renders in 100 times stronger mineralocorticoid action and 10-15 times stronger anti-inflammatory effect, than hydrocortisone.

Cortinef: pharmacokinetics

Absorption

Once inside quickly and completely absorbed from the gastrointestinal tract. The active substance is detected in blood serum 10-20 minutes postdose 0.1 mg. C_max of active substance in plasma is approximately 1.7 h after administration.

Distribution

Plasma protein binding – 70-80%.

Metabolism

It is metabolized mainly in the liver, partially – kidney.

Deduction

T_1/2 – about 3.5 no. Excreted in the urine as inactive metabolites. T_1/2 fabric is 18-36 no.

Cortinef: testimony

• primary adrenal insufficiency (Addison's disease, condition after a full adrenalectomy);
• secondary adrenal insufficiency;
• congenital adrenal hyperplasia (congenital adrenal hyperplasia);
• hypovolemia and arterial hypotension of various origins.

Cortinef: dosing regimen

Dose set individually, depending on the evidence, efficacy and condition of the patient. During treatment in the clinical pattern or during stress, such as surgery, trauma or infection, It may be required dose correction.

Adults at replacement therapy depending on the clinical situation, the dose ranges from 100 g 3 once per week to 200 mg / day.

At adrenogenital syndrome children administered in an initial dose of 300 mg / day, then in a few months to reduce the dose 50-100 mg / day.

The maintenance dose for infants It is between 100 to 200 mg / day, to childrenolder 1 year – 50-100 mg / day.

The tablets should be taken in the morning, after meal, drinking plenty of fluids. In the case of high doses is recommended to take 2/3 dose in the morning and 1/3 day dose.

When you miss taking a dose of the drug should be taken as soon as possible. If you are approaching the next admission, the missed dose should not be accepted. Do not take a double dose at once.

Florinef should take the lowest effective dose. If necessary, the dose should be reduced gradually.

Cortinef: side effects

Side effects, associated with mineralocorticoid effect of the drug: arterial hypertension, peripheral edema, left ventricular hypertrophy, circulatory failure, kaliopenia, hypocalcemia.

When using Florinef for a long time or concurrently with other corticosteroids may develop following side effects:

On the part of the musculoskeletal system: muscular weakness, steroidnaya myopathy (more common in women, usually it starts with the muscles and the hip belt extends to the proximal arm muscles; rarely affects the respiratory muscles), loss of muscle mass, tendon rupture, osteoporosis, a compression fracture of the spine, aseptic necrosis of the femoral head and the shoulder bones, pathological fractures of long bones.

Cardio-vascular system: Arrhythmia, bradycardia (up to heart failure), ECG changes, typical of hypokalemia, hypercoagulation, thrombosis, occlusive disease. Patients with acute and subacute myocardial infarction – spread 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, increased or decreased appetite, vomiting, Ikotech; rarely – increase in liver transaminases and alkaline phosphatase.

Dermatological reactions: atrophic band, acne, delayed wound healing, thinning of the skin; petechiae and hematoma, эritema, increased sweating, ecchymosis, Hyper- or hypopigmentation, propensity to development of pyoderma and candidiasis.

Allergic reactions: hives, atopic dermatitis, angioedema, anaphylactic reactions.

CNS: convulsions, dizziness, headache, sleep disturbance, increased intracranial pressure syndrome stagnant nipples optic nerve (pseudotumor of the brain – most often in children, usually after too rapid dose reduction, symptoms – headache, deterioration of visual acuity or double vision); mental reactions, that can mimic schizophrenia, mania or delirium syndrome (often appear in women in the first two weeks of treatment); possible euphoria, insomnia, mood changes, personality changes, severe depression.

On the part of the endocrine system: secondary adrenal and hypothalamic-pituitary insufficiency (particularly during times of stress, such as illness, trauma, surgery), Cushing's syndrome, growth retardation in children; menstrual irregularities; reduced tolerance to carbohydrates, giperglikemiâ, glycosuria; a manifestation of latent diabetes mellitus and increase the need for insulin or oral hypoglycemic agents in diabetic patients; girsutizm.

On the part of the organ of vision: zadnyaya subkapsulyarnaya cataracts (usually resolves after discontinuation of treatment, but may require surgical treatment); increased intraocular pressure, glaucoma (usually after treatment for at least one year); exophthalmos, propensity to develop secondary bacterial, fungal or viral infections of the eye, trophic changes of the cornea.

Metabolism: negative nitrogen balance (resulting protein catabolic), increased excretion of calcium, hypocalcemia; mineralkortikoidnoy activity caused hypernatremia, ginokaliemichesky syndrome (kaliopenia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

Other: weight gain, masking of symptoms of communicable diseases, swoon, development or exacerbation of infection (the appearance of this side effect contribute jointly used immunosuppressants and vaccination), leucocyturia, withdrawal.

Cortinef: Contraindications

- Systemic mycosis;

- Hypersensitivity to fludrocortisone or any other components of the drug.

FROM caution Florinef should be appointed at UC, bowel diverticulosis, gastric ulcer or duodenal ulcer, acute or latent peptic ulcer, recently established intestinal anastomosis, when esophagitis, gastritis, operations on the gastrointestinal tract in history, hepatic dysfunction, renal failure, hypertension, osteoporosis, myasthenia, hypoalbuminemia and conditions, predisposing to its occurrence, giperlipidemii.

Caution should be used in diabetes fludrocortisone (incl. violation of carbohydrate tolerance), gipotireoze, Cushing's disease, thyrotoxicosis, obesity (III-IV degrees), acute psychosis and mental disorders, when polio (except bulbar form of encephalitis).

Caution should be exercised when treating patients with cardiovascular disease, incl. after recent myocardial infarction (in patients with acute and subacute myocardial infarction may spread necrosis, slowing the formation of scar tissue and therefore – rupture of the heart muscle), decompensated chronic heart failure.

Cortineff is prescribed with caution for parasitic and infectious diseases of a bacterial nature. (currently or recently transferred, including the recent contact with a patient) – herpes simplex, herpes zoster (viremicheskaya phase), enable vetryanaya, kor, ameʙiaz, strongiloidoz (or suspected); active and latent tuberculosis. Use of fludrocortisone for serious infectious diseases is permissible only against the background of specific therapy. Caution should be exercised when treating patients following immunization (period duration 8 weeks before and 2 weeks after vaccination), when lymphadenitis after BCG vaccination. The decision to use corticosteroids in patients with HIV and AIDS should be taken after a thorough evaluation of the benefits and risks.

Cortinef: Pregnancy and lactation

Florinef application at pregnancy is possible only in case, when the intended benefits to the mother outweighs the potential risk to the fetus.

When adrenal insufficiency receiving Florinef during pregnancy should continue, while it may increase the dose.

If necessary, use during lactation should stop breastfeeding.

Cortinef: Special instructions

When stressful situations (incl. surgery, trauma or infection) patients, receiving the drug, recommended parenteral administration of corticosteroids.

The sudden discontinuation of treatment can cause the development of adrenal insufficiency, therefore, the dose should be reduced gradually Florinef.

Florinef may mask the symptoms of infectious diseases, reduce the body's resistance to infection and ability to localization.

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

At long Florinef application may need to transfer a patient on a diet with restriction of sodium intake and increase in potassium content, and increase in the protein content.

At Florinef application should not be vaccinated live virus vaccines. Introduction of inactivated viral or bacterial vaccines can not cause the expected increase in antibody titer. Besides, patients, receiving corticosteroids, It increases the risk of neurological complications during vaccination.

It should be taken into account, that the abolition of the drug should be gradual. With the sudden cancellation of the drug, especially after long-term therapy, may develop withdrawal, characterized by anorexia, fever, myalgia and arthralgia, general weakness (These symptoms can occur even in the absence of signs of adrenal insufficiency).

In patients with hypothyroidism or cirrhosis Florinef action intensifies.

Against Florinef application existing earlier emotional instability or psychotic warehouse personality of the patient may increase.

Patients with gipoprotrombinemiey should be used with caution Florinef simultaneously with acetylsalicylic acid.

Use in Pediatrics

With prolonged use of Florinef in children should be closely monitored for their growth and development.

Cortinef: overdose

Symptoms: arterial hypertension, peripheral edema, kaliopenia, a significant increase in body weight, myocardial hypertrophy.

Treatment: cancel product. Symptoms usually go away within a few days. Then, the treatment should be continued, reducing the dose of Florinef. In the case of muscular weakness, associated with loss of potassium, Potassium is necessary to introduce drugs. To prevent an overdose should regularly monitor blood pressure and concentration of electrolytes in the blood serum.

Cortinef: drug interaction

With simultaneous application of cardiac glycosides with Florinef increases the risk of cardiac arrhythmias and increases the toxicity of glycosides on the background of hypokalemia.

With simultaneous use of barbiturates, antiepileptic drugs (phenytoin, Carbamazepine), rifampicin, glutetimid weaken Florinef action by accelerating the metabolism of fludrocortisone

Antihistamines weaken Florinef action.

Amphotericin B, carbonic anhydrase inhibitors, while the use Florinef may cause hypokalemia, left ventricular hypertrophy, circulatory failure.

With simultaneous use of Florinef with anabolic steroids, androgens increases the risk of peripheral edema, of acne (used with caution, especially in patients with liver disease and heart).

Oral contraceptives, containing estrogen, increase serum globulins, linking corticosteroids, enhance the effect of Florinef by slowing metabolism and increasing its fludrocortisone T_1/2.

Antykoahulyantы (coumarin derivatives, indadion, Heparin), streptokinase, urokinase reduce (some patients raise) efficiency Florinef. The dosage should be determined on the basis of the prothrombin time, and take into account the increased risk of ulceration and bleeding from the gastrointestinal tract.

Tricyclic antidepressants may enhance mental disorders, associated with taking Florinef (These drugs should not be used to treat these disorders).

With simultaneous use of Florinef reduces the effect of oral hypoglycemic agents, insulin, potassium-sparing diuretics, increases the concentration of glucose in the blood (may require dose adjustment of hypoglycemic drugs).

Florinef reduces the effectiveness of laxatives, potassium-sparing diuretics, it increases the risk of hypokalemia.

Ephedrine can accelerate the metabolism of fludrocortisone (may require dose adjustment Florinef).

With simultaneous use of Florinef with immunosuppressive drugs increases the risk of infection, lymphomas and other lymphoproliferative disorders.

Florinef while the use of depolarizing muscle relaxants may increase the duration of neuromuscular blockade, tk. hypocalcemia, associated with the use of Florinef, may intensify the blockade of synapses.

Florinef reduces the effect of NSAIDs (incl. acetylsalicylic acid), it increases the risk of ulcerative lesions and bleeding from the gastrointestinal tract development.

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

When the vaccines, containing live viruses, during treatment with immunosuppressive doses Florinef replication of viruses and development of viral diseases, reduction in antibody production (the combination is not recommended).

When applied simultaneously with other vaccines increases the risk of neurological complications, and reduced production of antibodies.

Cortinef: terms of dispensing from pharmacies

The drug is released under the prescription.

Cortinef: terms and conditions of storage

The drug should be stored in a dry, dark place at a temperature no higher than 25 ° C. Shelf life – 3 year.