Cortineff® [Fludrocortisone]

Brand Polfa

In stock 1205 Items

Available since: 2019-09-19

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Clinical Pharmacology

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

Cortineff 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 in the body lead to an increase in blood pressure.

Cortineff in doses exceeding therapeutic may 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 enhance the deposition of glycogen in the liver, and, with an insufficient amount of protein in the diet, 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, the state after complete adrenalectomy).
Secondary insufficiency of the adrenal cortex.
Adrenogenital syndrome (congenital adrenal hyperplasia).
Hypovolemia and arterial hypotension of various genesis.

Composition

1 tablet contains:

Active substance: fludrocortisone acetate 100 μg;

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

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Dosage and Administration

The dose of the drug is set individually, depending on the evidence, the effectiveness of therapy and the patient's condition. In the course of treatment, when the clinical picture changes or during stressful situations, such as surgery, trauma or infection, dose adjustment may be necessary.

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

When adrenogenital syndrome children: Assign in the initial dose of 300 mg / day, then within a few months the dose is reduced to 50-100 mg / day. The maintenance dose for infants ranges from 100 to 200 mcg / day, for children over the age of 1 year - 50-100 mcg / day.

pills should be taken in the morning after meals with plenty of fluids. In the case of use in high doses, it is recommended to take 2/3 doses in the morning and 1/3 doses in the afternoon.

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

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

Adverse reactions

From the 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 aseptic necrosis of the femoral head and humerus, pathological fractures of long tubular bones.

From the CCC: 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.

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 bands, acne, delayed wound healing, thinning of the skin, petechiae and hematomas, erythema, increased sweating, allergic dermatitis, urticaria, angioedema, ecchymosis, hyper- or hypopigmentation, susceptibility to the development of pyoderma and candidosis.

From the nervous system: increased intracranial pressure syndrome with optic nerve stagnant syndrome (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's syndrome, growth suppression in children, menstrual disorders, decrease in carbohydrate tolerance, manifestation of latent diabetes mellitus and increased insulin or oral hypoglycemic agents, hirsutism.

From the senses: posterior subcapsular cataract (usually goes away 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 .

Mental disorders: 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, development or exacerbation of infections (jointly used immunosuppressants and vaccination contribute to the manifestation of this side effect), leukocyturia, withdrawal syndrome.

Contraindications

Systemic mycoses; Hypersensitivity to fludrocortisone or other components of the drug.

Drug interactions

With simultaneous use of Corineffe with cardiac glycosides increases the risk of developing cardiac arrhythmias and increases the toxicity of glycosides on the background of hypokalemia.

With the simultaneous use of barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, gluthethimide weaken the action of Cortineff by accelerating the metabolism of fludrocortisone

Antihistamines weaken the action of Florinef.

Amphotericin B, carbonic anhydrase inhibitors, when used simultaneously with Cortineff, can cause hypokalemia, left ventricular hypertrophy of the heart, circulatory failure.

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

Oral contraceptives containing estrogen, increase the serum level of globulins that bind corticosteroids, enhance the action of Cortineff by slowing the metabolism of fludrocortisone and increasing its T 1/2.

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

Tricyclic antidepressants can exacerbate the mental disorders associated with taking Cortineff (these drugs should not be used to treat these disorders).

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

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

Ephedrine can accelerate the metabolism of fludrocortisone (a dose adjustment of Cortineff may be necessary).

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

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

Cortineff reduces the effect of NSAIDs (including) acetylsalicylic acid, while increasing the risk of ulcerative lesions and the development of bleeding from the gastrointestinal tract.

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

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

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

Pregnancy and Lactation

Application of Cortineff during pregnancy is possible only when the intended 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 lactation is recommended to stop breastfeeding.

Special instructions

Caution should be given to Kortineff for NUC, intestinal diverticulosis, gastric ulcer or duodenal ulcer, acute or latent peptic ulcer, newly created intestinal anastomoses, with esophagitis, gastritis, gastrointestinal surgery in history, liver dysfunction, renal insufficiency, extirpation of the stomach, gastritis, gastrointestinal surgery osteoporosis, myasthenia, hypoalbuminemia and conditions predisposing to its occurrence, hyperlipidemia.

Fludrocortisone should be used with caution in diabetes mellitus (including impaired carbohydrate tolerance), hypothyroidism, Itsenko-Cushing's disease, thyrotoxicosis, obesity (III-IV degree), acute psychosis and mental disorders, and poliomyelitis (except for bulbar form encephalitis).

Care must be taken in treating patients with cardiovascular diseases, incl. 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), with decompensated chronic heart failure.

With caution, Cortineff is prescribed for parasitic and infectious diseases of a bacterial nature (currently or recently suffered, including recent contact with a patient) - herpes simplex, herpes zoster (viraemic phase), chicken pox, measles, amebiasis, strongyloidosis (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 the post-vaccination period (a period of 8 weeks before and 2 weeks after vaccination), for lymphadenitis after BCG vaccination. The decision to use corticosteroids in patients with HIV infection and AIDS should be made after a thorough evaluation of the benefits and risks.

In stressful situations (including surgery, trauma or infection) patients receiving the drug, recommended parenteral administration of GCS. Cortineff can mask the symptoms of infectious diseases, reduce the body's resistance to infection and the ability to localize it. Prolonged use of Florinef increases the risk of 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 the potassium content, as well as an increase in the protein content.

When applying Corineffe should not be vaccinated with live virus vaccines. The introduction of an inactivated viral or bacterial vaccine may not cause the expected increase in antibody titer. In addition, patients receiving corticosteroids, increases the risk of neurological complications during vaccination.

It should be borne in mind that the abolition of the drug should be carried out gradually.With the sudden withdrawal of the drug, especially after long-term therapy, the development of withdrawal syndrome, characterized by anorexia, fever, myalgia and arthralgia, general weakness (these symptoms may appear even in the absence of signs of adrenal insufficiency). In patients with hypothyroidism or cirrhosis of the liver, the action of Corineffe is enhanced. Against the background of the use of Cortineff, the previously existing emotional instability or psychotic warehouse of the patient’s personality may increase. Patients with hypoprothrombinemia should be carefully prescribed Corineff simultaneously with acetylsalicylic acid.

With prolonged use of Kortineff in children requires careful monitoring of their growth and development. In patients with cirrhosis of the liver, the action of Corineffe is enhanced. With caution, Cortineff is prescribed for abnormal liver function, hyperlipidemia.

Overdosage

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

Treatment: cancel the drug. Symptoms usually go away within a few days. Then treatment should be continued, reducing the dose of Florinef. In the case of muscle weakness associated with potassium loss, the administration of potassium preparations is necessary. For the prevention of overdose should regularly monitor blood pressure and electrolyte concentration in the serum.

Studies and clinical trials of Fludrocortisone (Click to expand)