Description
Latin name
Cortineff
form Release
Tablets
Packaging
In 1 bottle of dark glass 20 tablets. In a cardboard box 1 bottle.
Indications
Primary adrenal insufficiency (Addison’s disease, condition after complete adrenalectomy).
Secondary adrenal cortex insufficiency.
Adrenogenital syndrome (congenital adrenal hyperplasia).
Hypovolemia and arterial hypotension of various origins.
Contraindications
Systemic mycoses hypersensitivity to fludrocortisone or other components of the drug.
Use during pregnancy and lactation
Use of Cortineff during pregnancy is possible only when the intended benefits to the mother outweigh the potential risk to the fetus.
In case of insufficiency of the adrenal cortex, Cortineff should be continued during pregnancy, and its dose may increase.
If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.
Composition
1 tablet contains:
Active ingredient: fludrocortisone acetate 100 mcg
Excipients: lactose, potato starch, gelatin, magnesium stearate.
Dosage and administration
Soluble tablets Solpadein Fast before oral administration should be dissolved in at least 100 ml (half a glass) of water.
Adults (including the elderly) and children over 12 years of age are prescribed 1-2 tablets. 3-4 times / day, if necessary. The interval between doses is at least 4 hours. Maximum one-time d If necessary, the dose should be reduced gradually.
Side effects
From the musculoskeletal system: muscle weakness, steroid myopathy (more common in women usually begins with the muscles of the pelvis of the femur and extends to the proximal muscles of the hands rarely affects the respiratory muscles), loss of muscle mass, rupture of the tendons of the muscles, osteoporosis, compression fracture of the spine, aseptic necrosis of the femoral and humerus heads, pathological fractures long tubular bones.
From the CCC side: arrhythmias, bradycardia (up to cardiac arrest), ECG changes characteristic of hypokalemia, hypercoagulation, thrombosis, obliterating endarteritis in patients with acute and subacute myocardial infarction – spread of the focus of necrosis, slowing down the formation of scar tissue, which may 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 stripes, acne, delayed wound healing, thinning of the skin, petechiae and hematomas, erythema, excessive sweating, allergic dermatitis, urticaria, angioedema, ecchymosis, hyper- or hypopigmentation, tendency to develop pyodia candidiasis.
On the part of the nervous system: increased ICP with congestive optic nerve syndrome (pseudotumor of the brain – most often in children, usually after a too rapid dose reduction, symptoms – headache, decreased visual acuity or double vision), cramps, 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 inhibition in children, menstrual irregularities, decreased carbohydrate tolerance, manifestation of latent diabetes mellitus and increased need for insulin or oral hypoglycemic agents, hirsutism.
On the part of the sensory organs: posterior subcapsular cataract (usually disappears after discontinuation of treatment, but may require surgical treatment), increased intraocular pressure, glaucoma (usually after treatment for at least a year), exophthalmos, tendency to develop secondary bacterial, fungal or viral eye infections, trophic changes in the cornea.
Mental disorders: most often appear during the first 2 weeks of treatment, symptoms can mimic schizophrenia, mania, or delirious syndrome (women are most susceptible).
Metabolism: negative nitrogen balance due to protein catabolism, hyperglycemia, glucosuria, increased Ca2 + excretion, hypocalcemia due to mineralocorticoid activity – hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and.
Other: anaphylactic reactions, weight gain, masking of the symptoms of infectious diseases, fainting, the development or exacerbation of infections (the use of immunosuppressants and vaccination contribute to this side effect), leukocyturia, withdrawal syndrome.
Drug Interaction
Co-administration of Cortineff with cardiac glycosides increases the risk of cardiac arrhythmias and increases the toxicity of glycosides against hypokalemia.
When used concurrently with barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutethimide attenuate Cortineff’s action by accelerating the metabolism of fludrocortisone
.
Amphotericin B, carbonic anhydrase inhibitors when used with Cortineff can cause hypokalaemia, left ventricular hypertrophy, insufficiency of blood circulation.
When used with Cortineff with anabolic steroids, androgens, there is an increased risk of peripheral edema and blackheads (used with caution, especially in patients with liver and heart disease).
Oral estrogen-containing contraceptives increase the serum levels of corticosteroid-binding globulins, enhance Cortineff action by slowing the metabolism of fludrocortisone and increasing its T 1/2.
Anticoagulants (coumarin derivatives, indadion, heparin), streptokinase, urokinase reduce (in some patients increase) the effectiveness of Cortineff. The dose should be determined on the basis of prothrombin time and the increased risk of ulcer and gastrointestinal bleeding should be considered.
Tricyclic antidepressants can increase the mental disorders associated with taking Cortineff (these drugs should not be used to treat these disorders).
When administered concurrently, Cortineff weakens the effects of oral hypoglycemic drugs, insulin, potassium-sparing diuretics, increases blood glucose (dose adjustment of hypoglycemic drugs may be required).
Cortineff reduces the effectiveness of laxatives, potassium-sparing diuretics, while increasing the risk of hypokalaemia.
Ephedrine may accelerate the metabolism of fludrocortisone (Cortineff dose adjustment may be required).
With the use of Cortineff with immunosuppressive drugs, the risk of infection, lymphoma and other lymphoproliferative diseases is increased.
Cortineff, when used with depolarizing muscle relaxants, can increase the duration of neuromuscular blockade, since hypocalcaemia associated with Cortineff use may exacerbate synapse blockade.
Cortineff reduces the action of NSAIDs (including) acetylsalicylic acid, thereby increasing the risk of ulcerative lesions and the development of gastrointestinal bleeding.
Peripheral edema, hypertension may occur with the use of Cortineff and sodium-containing drugs and foods.
When using vaccines containing live viruses, against the use of immunosuppressive doses of Cortineff, replication of viruses and the development of viral diseases are possible, reducing the production of antibodies (the combination is not recommended).
When used with other vaccines, the risk of neurological complications is increased and antibody production is reduced.
Overdose
Symptoms: arterial hypertension, peripheral edema, hypokalemia, significant weight gain, myocardial hypertrophy.
Treatment: cancel the drug. The symptoms usually go away within a few days. The treatment should then be continued by reducing the dose of Cortineff. In the case of muscle weakness associated with the loss of potassium, the introduction of potassium preparations. For the prevention of overdose, blood pressure and serum electrolyte concentrations should be monitored regularly.
Storage conditions
The drug should be stored in a dry, dark place at a temperature not exceeding 25 ° C.
The Expiration of
is 3 years.
Deystvuyuschee substances
Fludrokortyzon
s17lduct pharmacy terms for prescription
pharmacy s16l recf16 vocational
Dosage form
dosage form
tablets
