Index of drugs

Replacement therapy of primary and secondary adrenocortical insufficiency in Addison's disease and treatment of adrenal and genital syndrome with salt loss.

1 tabl contains 100 μg of fludrocortisone acetate. The preparation contains lactose.

9-α-fluorohydrocortisone acetate is a synthetic adrenocortical hormone, a fluorinated Hydrocortisone derivative with high mineralocorticoid activity. Inflammation is not an indication for the use of fludrocortisone. Fludrocortisone acts on the tubules of the distal renal tubules increasing the reabsorption of sodium and water retention and increasing the excretion of potassium and hydrogen ions. Fludrocortisone may suppress adrenocortical function, thymic activity and ACTH secretion by the pituitary gland. It may also increase glycogen deposition in the liver, reduce the number of eosinophil granulocytes, and also in the case of insufficient protein supply in the diet, lead to a negative nitrogen balance. After oral administration, they are quickly and completely absorbed from the gastrointestinal tract. Fludrocortisone is hydrolyzed to non-esterified alcohol. When administered as acetate, only unsterified alcohol can be determined in the blood. The maximum concentration in the blood reaches after 4-8 h. In 70-80% it is associated with plasma proteins, mainly with the globulin fraction. In 80% it is excreted in the urine and the remaining 20% ​​in other ways.

Hypersensitivity to fludrocortisone or any of the other ingredients. Systemic infection if specific treatment is not used.

In patients using a long-term drug, in situations of increased stress (injury, surgery or severe course of the disease), supportive corticosteroid may be necessary, both during treatment with the preparation and in later years. Fludrocortisone can mask the symptoms of infection and reduce their severity, reduce immunity to infection and the ability to locate it. Patients who receive immune blockers are more susceptible to infection than healthy patients. Chickenpox, shingles and measles may be more severe after corticosteroids. Patients who have not had these diseases before, should avoid exposure to them. Patients who have not had chickenpox and oral corticosteroids for reasons other than substitution treatment should be included in the risk of severe pox. It is advisable to administer the immunoglobulin after exposure to chickenpoxvaricella zoster (VZIG) to patients who are currently using corticosteroids or to those who used them within the three months prior to exposure. VZIG should be given within 3 days, however not later than 10 days after exposure to chickenpox. Do not stop using corticosteroids, but increase their dose. After exposure to measles, immunoglobulin (IG) should be administered. Patients treated with fludrocortisone should not be vaccinated with live virus vaccines. During treatment with fludro Cortisone, exacerbations of diseases such as pneumonia, hepatitis and disseminated intravascular coagulation may occur. Caution is advised to use fludrocortisone in fresh intestinal anastomoses, intestinal diverticulitis, thrombophlebitis, and rash diseases. Caution should be exercised when administering fludrocortisone in the following cases: chronic nephritis or renal failure, osteoporosis (especially in postmenopausal women), active or latent peptic ulcer, muscle fatigue, fungal or local or systemic infection, glaucoma (or family history of glaucoma) ), hyperlipidemia, hypoalbuminemia. The administration of fludrocortisone to patients with active tuberculosis should be limited to cases of disseminated or fulminant tuberculosis and only with concomitant antituberculous treatment. Patients with latent tuberculosis or a positive tuberculin test receiving fludrocortisone should be observed due to the risk of tuberculosis. In the case of long-term use of corticosteroids should receive prophylactically antituberculous drugs.Caution should be exercised when using fludrocortisone in hypertensive patients, congestive heart failure, steroidal myopathy, epilepsy, impaired hepatic function and acute psychosis and mental disorders. Emotional instability or psychotic tendencies that have been previously present may increase with the use of fludrocortisone. In patients with hypothyroidism or cirrhosis, fludrocortisone works more strongly. Patients with diabetes may get worse, requiring a higher dose of insulin. Fludrocortisone may reveal latent diabetes. Exercise caution in patients who have been hypersensitive to other medicines. In patients with hypoprotrombinemia, caution should be exercised when treating with Acetylsalicylic acid together with fludrocortisone. Infants and children treated for a long time should be monitored for abnormal growth and development. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of Glucose and galactose.

Do not use in pregnant women and in childbearing age, if it is not absolutely necessary. Patients who have preeclampsia and fluid retention in the body should remain under strict control. Do not use during breast-feeding.

Adverse effects associated with the mineralocorticotropic effect of the drug include fluid and electrolyte disturbances: retention of sodium and body fluids, edema, congestive heart failure, potassium loss, arrhythmias or ECG changes associated with potassium deficiency, hypokalemiem alkalosis, increased Calcium excretion and hypertension. Short-term use of fludrocortisone, like other corticosteroids, only sporadically results in side effects associated with glucocorticotropic activity. The risk of adverse reactions mainly affects patients who receive fludrocortisone for a long time or simultaneously with other corticosteroids. The following may occur: muscle weakness, posteroidal myopathy, loss of muscle mass, osteoporosis, compression of spinal fractures, aseptic necrosis of the femoral and humerus head, pathological long bone fractures, digestive disorders, peptic ulcer with the possibility of perforation and bleeding, colon perforation and (or ) thin, especially in patients with intestinal inflammation, pancreatitis, bloating, ulcerative esophagitis, candidiasis, impaired wound healing, thinning of the skin, ecchymosis and haemorrhages, erythema, increased sweating, purpura, dermatoses, hirsutism, acne, skin lesions reminiscent of changes associated with lupus erythematosus, weakness in skin tests, euphoria, personality disorders, depression, insomnia, convulsions, increased intracranial pressure with congestive disc (pseudocomial tumor - usually after too fast dose reduction), dizziness, pain g fistulas, neuritis or paresthesia, severity of psychosis symptoms, epilepsy, irregular menses or lack of it, Cushing's syndrome, growth inhibition in children, secondary adrenal insufficiency and pituitary gland, especially in stressful situations (disease, trauma, surgery), reduced carbohydrate tolerance , revealed diabetes and increased need for insulin and hypoglycemic agents in patients with overt diabetes, weight gain, negative protein and calcium balance, increased appetite, posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos, corneal or scleral thinning, exacerbation of eye diseases caused by fungi and viruses, necrotizing vasculitis or lymphangitis, thrombophlebitis and arteritis, leukocytosis, insomnia, hypersensitivity reactions.
Abrupt discontinuation of the drug, after prolonged use, can lead to acute adrenal insufficiency, hypotension and death. The following symptoms of withdrawal syndrome may occur: fever, muscle and joint pain, rhinitis, conjunctivitis, painful, itchy nodules and weight loss. During long-term use of fludrocortisone, adrenocortical atrophy develops, which may persist for many years after discontinuation of treatment.

Orally. Doses are set individually, depending on the type of disease and the patient's response to treatment.Dose adjustment may be necessary during treatment, depending on the course of the disease or in a stressful situation such as surgery, injury or infection. Typically, 100-300 μg (1-3 tables) per day or 200-300 μg (2-3 tables) are used every second or third day. The tablets are administered between meals; they should not be divided.