CORTINEFF 0.1 mg. 20 tablets
9-α-fludrocortisone acetate is a synthetic hormone adrenal cortex, fluorine derivative of hydrocortisone. Exhibits one hundred times stronger mineralkortikotropno and 10-15 times more potent anti-inflammatory effect compared to hydrocortisone. Fludrocortisone amplifies reuptake and sodium reabsorption, and also increases the excretion of potassium and hydrogen ions. Fludrocortisone in doses exceeding the therapeutic can inhibit the function of the adrenal cortex, the activity of the thymus, and the secretion of ACTH and also result in a negative nitrogen balance. After oral fludrocortisone subject to rapid and complete absorption from the digestive tract. Maximum serum concentration is reached 1.7 hours after ingestion.
Fludrocortisone metabolized primarily in the liver, partial kidney. Is eliminated in the urine as inactive metabolites.
Indications for use
Primary adrenal insufficiency, congenital dysplasia (abnormal development) of the adrenal gland, Addison's disease, a condition after full epinefrektomiya (removal of adrenal);
Secondary adrenal insufficiency;
Adrenogenital syndrome with loss of salts;
Idiopathic orthostatic hypotension;
Symptomatic, in cases of significant overload (decrease circulating blood volume), hyperkalemia (excess of potassium ions in the blood) and after drug hyponatremia (low concentration of sodium ions in the blood).
2. Before you use Cortineff tablets ...
Cortineff tablets does not apply in cases of:
Hypersensitivity to fludrocortisone or any of the other components of the product;
Systemic fungal infection.
Be used with caution because:
Fludrocortisone is contraindicated in patients with systemic fungal infections due to risk of worsening of the infection. Can be applied to limit the side effects in fungal infections treated with amphotericin B, but in these cases it is possible to cause congestive phenomena in circulation and megalokardiya, and severe hypokalemia;
Prolonged administration of fludrocortisone can cause cataracts, glaucoma with possible damage to the optic nerve, but also increase the risk of secondary fungal or viral infection;
In case of intake of large doses of fludrocortisone possible increase in blood pressure, edema and increased weight;
Treated with fludrocortisone patients should not be vaccinated with live virus vaccines. Application of inactivated viral or bacterial vaccine can not cause the expected growth level protivotelata. When the vaccine is administered to patients treated with glucocorticoids, there is an increased risk of complications of the nervous system;
In patients with thyroid hypofunction or liver cirrhosis fludrocortisone effect is stronger;
In patients with hypoprothrombinemia caution is required during treatment with acetyl salicylic acid and fludrocortisone;
The patient reported to the physician in case he was suffering from any of the following diseases - ulcerative colitis, intestinal diverticular, ulcers of the stomach or duodenum, renal insufficiency, hypertension, osteoporosis, myasthenia, diabetes mellitus, liver disease, glaucoma, fungal or viral infection or has recently undergone surgery in the gastrointestinal tract;
With prolonged treatment of infants and children need supervision, due to the potential disturbances in the growth and development;
Patients treated with corticosteroids, in a situation of increased stress to accept an increased dose of fast-acting glucocorticoid;
Fludrocortisone be used in the smallest effective doses;
Discontinuation after prolonged use can cause failure of the adrenal cortex, so to reduce the dose gradually. Patients treated with fludrocortisone strictly comply with the doctor's instructions. Termination of long-term treatment may cause withdrawal symptoms - fever, muscle and joint pain, poor self-esteem. Such symptoms can occur even in cases where there is clear failure of the adrenal cortex;
To consult the doctor, even if this finding applies to a situation of the past.
Application of Kortinef tablets with food and drink:
Adoption of tablets Cortineff going between meals.
Particular attention is required for certain categories of patients:
With prolonged treatment of infants and children need supervision, due to the potential disturbances in growth and development.
In patients with impaired kidney function or liver
Be taken with caution.
In elderly patients
There are no adequate quantitative research in human fertility after taking corticosteroids. Animal studies have shown the existence of risk.
In this regard, the adoption of the medicinal product by pregnant women in the period of fertility is permissible only when the benefit to the mother outweighs the risk to the fetus. Adopted during pregnancy fludrocortisone can cause adrenal insufficiency in the fetus and neonate.
Before using the product to consult a doctor.
Fludrocortisone is excreted in the female milk and may cause side effects in the child, such as holding back the growth and release of endogenous hormones from the adrenal cortex.
Do not breastfeed during treatment with fludrocortisone.
Before using the product to consult a doctor.
Effects on ability to drive and use machines
Usually does not affect psihodvigatelnata activity. Can sometimes cause dizziness and headaches, and even mental disorders. In such cases it is necessary to refrain from performing activities requiring psychophysical performance.
Use in conjunction with other drugs
It is necessary to tell the doctor about all adopted recently and currently medicinal products, even those which are available without prescription.
Fludrocortisone increases the risk of abnormal heart rhythm and increased toxicity of cardiac glycosides (glycosides of thimble);
Barbiturates, antiepileptic products (phenytoin, carbamazepine), rifampicin, glutethimide accelerating metabolism of corticosteroids (by way of induction of microsomal enzymes) and decrease the power of their operation;
Antihistaminnnite products reduce the potency of fludrocortisone;
Co-administration of fludrocortisone or amphotericin B or carbonate anhydrase inhibitors can cause hypokalemia, myocardial hypertrophy, circulatory insufficiency with congestive phenomena;
Concomitant administration of anabolic steroids, androgens and fludrocortisone may allow for swelling and inflammatory changes of the sebaceous glands;
Oral contraceptives containing estrogens decrease the metabolism of fludrocortisone and weaken his relationship with proteins, leading to prolonged half-life and enhancing the action of fludrocortisone;
Concomitant administration of fludrocortisone anticoagulant coumarin derivatives, indadiona, heparin, streptokinase, urokinase decreased and in some people it increases the efficiency of these products. The dosage should be determined on the basis of prothrombin time. Also increases the risk of ulceration and bleeding from the digestive tract;
Tricyclic antidepressants may enhance mental disorders associated with the administration of fludrocortisone. Do not apply at the same time;
Fludrocortisone inhibits the action of oral antidiabetics and insulin, as well as diuretics. Enhances hypokalemia;
Concomitant administration of immunosuppressants increases the risk of infections, development of lymphocytoma and other lymphoproliferative disorders;
Co-administration of fludrocortisone and non-steroidal anti-inflammatory drugs, as well as acetylsalicylic acid increases the risk of peptic ulcer, bleeding from the gastrointestinal tract and hypertension;
Enhances cumulation of sodium in the body, causing swelling, increases blood pressure. May need to limit the sodium in the diet;
During concomitant administration of vaccines containing live viruses and immunosuppressive doses of glucocorticoids, it is possible that viral infections and decrease the effectiveness of the vaccines. Application of fludrocortisone other vaccines carry the risk of complications of the nervous system, and also reduces the formation of antibodies.
3. How to use Cortineff tablets?
The product should be applied in accordance with the doctor's instructions.
If in doubt again ask your doctor or pharmacist.
Doses are selected individually depending on the disease and the response of the patient during treatment. It is possible to require dose modification, depending on the course of disease or stress, for example, surgery, trauma or infection.
Generally from 0.1 to 0.2 mg per day.
In the event of the occurrence of a transient hypotension during the infusion, the dose should be reduced to 0.05 mg per day.
Generally from 0.05 to 0.1 mg per day.
Contact your doctor if the medicinal product seems too strong or weak.
In case of acceptance of a higher dosage than prescribed ...
Symptoms of overdose include increased blood pressure, edema, hypokalemia, significantly overweight megalokardiya. If overdose is necessary to stop taking the product to take symptomatic and supportive treatment.
In case of muscle weakness associated with loss of potassium, effective could be supplementation of potassium.
Overdosing may be prevented by regular monitoring of blood pressure and the electrolyte concentration in the serum.
In case of missed dose ....
In case of a missed dose of the product is necessary to adopt as quickly as possible. If it is almost time for the adoption of the next, the missed dose should not be compensated by doubling.
After discontinuation ...
Upon abrupt cessation of treatment with fludrocortisone possible adrenal insufficiency, so fludrocortisone dose is gradually reduced. Termination of long-term treatment can lead to fever, muscle or joint pain, poor self-esteem.
4. Possible side effects
Like any medicine fludrocortisone can cause side effects.
Most side effects are associated with mineralkortikotropnoto action of fludrocortisone. Thereto belong hypertension, edemas, myocardial hypertrophy, congestive phenomena in the circulation, potassium loss, hypokalemic alkalosis.
In case of low doses of fludrocortisone adverse reactions associated with glyukokortikotropnata activity does not constitute a problem. It is necessary, however, for them to remember especially when fludrocortisone was administered long, or together with another glucocorticoid.
Violations by the skeletal system
Decreased muscle strength, poststeroidna myopathy, loss of muscle mass, osteoporosis, compression dislocation of aseptic necrosis of femoral and humeral bone, pathologic fracture of long bones.
Peptic ulcer with the possibility of perforation and bleeding, perforation of the colon and / or the intestine, especially in patients with inflammation in the intestine, pancreatitis, swelling, inflammation, ulcer of the esophagus, stomach disorders, appetite increased.
Striae, inflammatory changes of the sebaceous glands, difficult wound healing, thin skin, pinpoint bleeding, erythema, increased sweating, allergic skin irritation, hives.
Increased intracranial pressure, cramps, dizziness, headache.
Secondary failure cortex adrenal and pituitary glands, especially in stressful situations such as illness, injury, surgery, overactive adrenal cortex, suppress growth in children, menstrual irregularities, decreased tolerance to hydrocarbons, proven diabetes and increased demand for insulin and antidiabetic products in patients with overt diabetes mellitus, body hair.
Rear cataracts, increased intraocular pressure, glaucoma, bulge of the eyeball.
Negative nitrogen balance, hyperglycemia, glycosuria.
Hypersensitivity reactions, thromboembolic syndrome, obesity, increased appetite, nausea, poor self-esteem, sleep disorders, masking symptoms of infection, unconscious.
Product acceptance during feeding may reduce digestive disorders and irritation of the digestive tract. The risk of osteoporosis associated with prolonged administration of corticosteroids may be reduced by intake of calcium and vitamin D and physical exercises if the patient's condition allows.
In some patients during treatment with Kortinef can display other undesirable effects. In the event of listed reactions should be reported to the doctor.
5. Special storage conditions.
Do not store above 25 ° C
Protect from light and moisture.
Keep out of the reach and sight of children.