Active substanceFludrocortisoneFludrocortisone
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  • Cortineff
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  • Fludrocortisone
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  • Dosage form: & nbsppills
    Composition:

    One tablet contains:

    Active substance:

    Fludrokortiacetate - 0.1 mg.

    Excipients: lactose - 57.9 mg, potato starch - 40.0 mg, gelatin 1.0 mg, magnesium stearate -1.0 mg.

    Description:

    Tablets are white with a creamy shade of color, round in shape with a bevel, with flat surfaces, with a squashed letter "F" on one side and with a risk on the other side.

    Pharmacotherapeutic group:Mineralocorticoid
    ATX: & nbsp

    H.02.A.A.02   Fludrocortisone

    Pharmacodynamics:

    Cortineff is a synthetic hormone of the adrenal cortex, a fluorinated derivative of hydrocortisone, which has a high mineralocorticoid activity. Has a 100 times more potent mineralocorticoid action, and 10-15 times more powerful anti-inflammatory effect than hydrocortisone.

    Cortineff enhances the inverse absorption 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, can inhibit the activity of the adrenal cortex, the activity of the thymus gland and the secretion of ACTH by the pituitary gland. Can also strengthen the deposition of glycogen in the liver, and with insufficient amount of protein in the food lead to a negative balance of nitrogen.

    Indications:

    Primary insufficiency of the adrenal cortex (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:

    Systemic fungal infections.

    Hypersensitivity to fludrocortisone or other components of the drug.

    Carefully:

    Florinef is prescribed for ulcerative colitis, diverticulosis colon, gastric ulcer or duodenal ulcer, acute or latent peptic ulcer, recently established intestinal anastomosis, esophagitis, gastritis, operations in the gastrointestinal tract in history, hepatic dysfunction, renal failure, hypertension , osteoporosis, myasthenia gravis, hypoalbuminemia and conditions predisposing to its occurrence, hyperlipidemia.

    It should be used carefully fludrocortisone with diabetes mellitus (including a violation of carbohydrate tolerance), hypothyroidism, Itenko-Cushing's disease, thyrotoxicosis, obesity (III-IVst.), acute psychosis and mental disorders, poliomyelitis (except for the form of bulbar encephalitis).

    Care should be taken in the treatment of patients with cardiovascular diseases, including after a recent myocardial infarction (in patients with acute and subacute myocardial infarction, it is possible to spread the necrosis foci, slow the formation of scar tissue and, as a result, rupture of the heart muscle), decompensated chronic cardiac insufficiency.

    With care, Cortineff is prescribed for parasitic and infectious diseases of bacterial nature (currently or recently transferred, including recent contact with the patient) - herpes simplex, herpes zoster (viremic phase), chicken pox, measles, amebiasis, strongyloidiasis (established or suspected); active and latent tuberculosis.The use of fludrocortisone in severe infectious diseases is permissible only against the background of specific therapy. Care should be taken when treating patients in post-immunization period (the period of duration 8 weeks before and 2 weeks post vaccination), lymphadenitis after BCG vaccination. The decision on the use of corticosteroids in patients with HIV and AIDS should be taken after careful consideration of risks and benefits.
    Pregnancy and lactation:

    Corticosteroids in women of childbearing age and pregnant women is only valid if their potential benefit to the mother outweighs the potential risk to the fetus. If the adrenal cortex is deficient, Cortineff's intake during pregnancy should be continued, and the dose may increase.

    If it is necessary to use the drug during breastfeeding, it is recommended to stop breastfeeding.
    Dosing and Administration:

    Doses of the drug are set individually, depending on the indications, the effectiveness of therapy and the patient's condition. During treatment, when changing clinical picture, or during times of stress, such as surgery, trauma or infection, may be required dose correction.

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

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

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

    Tablets should be taken orally in the morning after eating, squeezed with plenty of liquid. In the case of large doses of Cortineff, it is recommended to take 2/3 of the dose in the morning and 1/3 in the afternoon.

    In case of missing the dose, the drug should be taken as soon as possible or, if the next appointment is approaching, the missed dose should not be taken. Do not take a double dose at once.

    Cortineff should be used in minimally effective doses. If necessary, the dose should be reduced gradually.

    Side effects:

    The main undesirable effects include: arterial hypertension, peripheral edema, hypertrophy of the left ventricle of the heart, circulatory insufficiency, hyponatremia, hypocalcemia.

    When applying Cortineff for a long time or simultaneously with other corticosteroids, it is possible to develop the following side effects:

    From the side of the musculoskeletal system:

    Muscle weakness, steroid myopathy (more common in women and usually begins with the muscles of the femoral belt and extends to the proximal muscles of the arms, rarely affects the respiratory muscles), loss of muscle mass, tendon rupture, muscle, osteoporosis, vertebral compression fracture, aseptic necrosis of the femoral head and humerus, pathological fractures of long tubular bones.

    From the side of the cardiovascular system:

    Arrhythmia, bradycardia (up to cardiac arrest), ECG changes typical 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, hiccough. In rare cases - increased activity of "liver" transaminases and alkaline phosphatase.

    From the skin and mucous membranes:

    Atrophic bands, acne, delayed healing of wounds; thinning of the skin; petechiae and hematomas, erythema, excessive sweating, allergic dermatitis, urticaria, angioedema, ecchymosis, hyper- or hypopigmentation, a tendency to develop pyoderma and candidiasis.

    From the nervous system:

    Increase in intracranial pressure with the syndrome of the congestive nipple of the optic nerve (pseudotumor of the brain - most often in children, usually after too rapid reduction of the dose, symptoms - headache, deterioration of visual acuity or double vision); convulsions, dizziness, headache, sleep disturbances.

    From the endocrine system:

    Secondary adrenal and hypothalamic-pituitary insufficiency (especially during stressful situations such as illness, trauma, surgery); Cushing's syndrome; suppression of growth in children; menstrual cycle disorders; decreased tolerance to carbohydrates; manifestation of latent diabetes mellitus and increased need for insulin or oral hypoglycemic drugs in patients with diabetes mellitus; hirsutism.

    From the sense organs:

    Posterior subcapsular cataract (usually occurs after discontinuation of treatment, but may need 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 eyes, trophic changes in the cornea.

    Mental disorders:

    Most often appear during the first two weeks of treatment; symptoms can mimic schizophrenia, mania, or delirious syndrome; most susceptible to the emergence of mental disorders of women.

    From the side of metabolism:

    Negative nitrogen balance due to protein catabolism; hyperglycemia; glucosuria, 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; increase in body weight; masking the symptoms of infectious diseases; fainting; development or exacerbation of infections (the emergence of this side effect is facilitated by jointly used immunosuppressants and vaccination); leukocyturia; withdrawal syndrome.

    Overdose:

    Symptoms of an overdose of Cortineff are: arterial hypertension, peripheral edema, hypokalemia, a significant increase in body weight, cardiac muscle hypertrophy. In case of an overdose, the drug should be discontinued; symptoms usually last for several days. Then the treatment should be continued, reducing the dose of Cortineff. In the case of muscle weakness associated with potassium loss, potassium supplementation is necessary. Overdosing can be prevented by regularly monitoring blood pressure and the concentration of electrolytes in the blood serum.

    Interaction:

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

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

    Antihistamines weaken the action of Cortineff.

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

    Anabolic steroids, androgens: increased risk of peripheral edema, acne; apply cautiously, especially in cases of liver and heart disease.

    Oral contraceptive preparations containing estrogens: enlargement the concentration of globulins binding corticosteroids in the serum, slowing metabolism, increasing the half-life, enhancing the effect of Cortineff.

    Anticoagulants (coumarin derivatives, indadion, heparin), streptokinase, urokinase: decrease, and in some patients increased efficiency; the dose should be determined based on prothrombin time; increased risk of ulceration and bleeding from the gastrointestinal tract.

    Tricyclic antidepressants can enhance mental disorders associated with taking Cortineff. Do not use them to treat these disorders.

    Oral hypoglycemic drugs, insulin: weakening of hypoglycemic action, increase in the concentration of glucose in the blood; it may be necessary to correct dose of hypoglycemic drugs.

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

    Laxatives: weakening of action, hypokalemia.

    Ephedrine can accelerate the metabolism of corticosteroids, it may be necessary to carry out dose correction Cortineff.

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

    Drugs that block neuromuscular conduction (depolarizing muscle relaxants): hypocalcemia associated with the use of Cortineff, can enhance the blockade of synapses, leading to an increase in the duration of the neuromuscular blockade. Nonsteroidal anti-inflammatory drugs, acetylsalicylic acid: weakened action, increased risk of developing peptic ulcer and bleeding from the gastrointestinal tract.

    Preparations and food containing sodium: peripheral edema, arterial hypertension. There may be a need for restriction in the sodium diet and drugs with a high sodium content; The use of corticosteroids sometimes requires additional sodium injection.

    Vaccines containing live viruses: during the period of application of immunosuppressive doses of corticosteroids, virus replication and disease development are possible; decreased production of antibodies; simultaneous application is notrecommended.

    Other vaccines: increased risk of neurologic complications and decreased production of antibodies.

    Special instructions:

    When taking Cortineff, the patient should strictly follow the doctor's instructions.

    In the case of stressful situations, patients receiving Cortineff, recommended parenteral administration of corticosteroids.

    A sudden cessation of treatment can cause the development of acute adrenal cortex insufficiency, so the dose of Cortineff should be reduced gradually.

    Cortineff can mask the symptoms of infection, reduce resistance to infection and the ability to localize it.

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

    Patients taking Cortineff should not be vaccinated with live viral vaccines. The introduction of an inactivated viral or bacterial vaccine may not produce 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 a long period of admission, it is possible to develop a so-called withdrawal syndrome, manifested by anorexia,increased body temperature, muscle and joint pain, general weakness. These symptoms may appear even in case, when there was no insufficiency of the adrenal cortex.

    In patients with hypothyroidism or cirrhosis, Cortineff's action is enhanced.

    During the application of Cortineff, mental disorders such as euphoria, insomnia, sudden mood changes, personality changes, severe depression, and symptoms of psychosis may appear. The emotional instability or psychotic tendencies that existed earlier may increase during treatment.

    In the treatment of patients with hypoprothrombinemia, Cortineff and acetylsalicylic acid should be administered with caution.

    With prolonged treatment of children should monitor their growth and development.

    Medicinal products should not be disposed of in drains or inwaste containers. ABOUT how to dispose of unused medication, check with a pharmacist. These activities will help protect the environment.

    Effect on the ability to drive transp. cf. and fur:

    There is no evidence of the influence of Cortineff on the ability to drive vehicles and engage in other potentially hazardous speciesactivities that require increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:
    Tablets 0.1 mg.
    Packaging:

    For 20 tablets in a bottle of dark glass with a label. Each vial with instructions for use in a cardboard box.

    For 20 tablets in a blister of white PVC film and aluminum foil. Each blister with instructions for use in a cardboard box.

    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013538 / 01
    Date of registration:19.12.2007 / 11.08.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Pabianicki Pharmaceutical Plant Polfa, JSCPabianicki Pharmaceutical Plant Polfa, JSC Poland
    Manufacturer: & nbsp
    Representation: & nbspAdamed RASHA LLCAdamed RASHA LLCRussia
    Information update date: & nbsp05.02.2018
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