Cortef, tablets 10 mg 100 pcs

Special Instructions

• Patients who may be exposed to stress against the background of GCS therapy, rapid-acting GCS drugs are indicated in high doses before, during and after the stress situation.
• With GCS therapy, some infections may proceed in a sterile form, in addition, new infections may develop. With the use of GCS, the resistance to infections may decrease, as well as the ability of the body to localize the infectious process. The development of infections caused by various pathogenic organisms such as viruses, bacteria, fungi, protozoa or helminths that localize in different systems of the human body can be associated with the use of GCS, either as monotherapy or in combination with other immunosuppressants affecting cellular immunity, humoral immunity or neutrophil function. These infections may be mild, but in some cases a severe course or even death is possible. Infectious complications are more likely if higher doses of GCS are used.
• In herpes simplex virus infection in the eye, GCS should be used with caution because it may cause corneal perforation.
• Long-term use of GCS may result in posterior subcapsular cataracts, glaucoma with possible optic nerve involvement and provoke secondary ocular fungal or viral infection.
• Medium to high doses of hydrocortisone can cause increased blood pressure, electrolyte and fluid retention and increased potassium excretion. These effects are less likely with synthetic analogues unless used in high doses. Restriction of salt intake with food and administration of potassium preparations are necessary. All GCS increase calcium excretion.
• Patients treated with GCS at doses that are immunosuppressive are contraindicated in live or live-weakened vaccines, but killed or inactivated vaccines may be given, but response to administration of such vaccines may be reduced. Patients treated with GCS in doses that are not immunosuppressive may be immunized for appropriate indications.
• The use of the drug in active tuberculosis should be limited to cases of fulminant and disseminated tuberculosis where GCS is used to treat the disease in combination with appropriate anti-tuberculosis chemotherapy.
• If the drug is prescribed to patients with latent tuberculosis or with positive tuberculin tests, treatment should be performed under close medical supervision because reactivation of the disease is possible. During long-term therapy with the drug, these patients should receive appropriate prophylactic treatment.
• Patients receiving drugs that suppress the immune system are more susceptible to infections than healthy individuals. For example, chickenpox and measles can be more severe, up to and including death, in unimmunized children or adults receiving GCS. In such children or adults who do not yet have the disease, measures should be taken to prevent contact with sick people. It is not known how the dosage, route of administration, and duration of GCS treatment affect the risk of disseminating infection. The role of underlying disease and/or pretreatment with GCS in the risk of developing infection is also unknown. Prophylactic administration of VZIG (varicella serotherapy immunoglobulin) may be indicated for chickenpox infection. Intramuscular injection of immunoglobulin (IgG) may be indicated if exposed to the measles pathogen (see VZIG and IgG instructions for more information). Treatment with antiviral medications should be considered if chickenpox develops. GCS should also be administered with great caution to patients with confirmed or suspected strongyloidiasis. GCS-induced immunosuppression in these patients leads to strongyloid hyperinfection and dissemination of the process with widespread larval migration, often with the development of severe enterocolitis and Gram-negative septicemia with possible lethal outcome.

Patient information: Persons receiving GCS at immunosuppressive doses should avoid contact with patients with chickenpox or measles; patients should be informed that if contact occurs, they should seek immediate medical attention.

• Secondary adrenal cortical insufficiency caused by taking the drug can be minimized by gradually reducing the dose. This type of relative insufficiency may persist for several months after treatment ends, so GCS should be reappointed for any stressful situations during this period. Because mineralocorticoid secretion may be impaired, concomitant administration of electrolytes and/or mineralocorticoids is necessary.
• In patients with hypothyroidism and cirrhosis, the effect of GCS is enhanced. Dose reduction should be performed gradually to control the condition after treatment.
• Mild psychiatric disorders may occur with GCS therapy: from euphoria, insomnia, mood swings, personality changes and severe depression to acute psychotic reactions. In addition, pre-existing emotional instability or tendencies to psychotic reactions may increase.
• The growth and development of infants and children should be carefully monitored when prescribing long-term GCS treatment.
• Caposi sarcoma has been reported in patients who received GCS therapy. Clinical remission may occur when GCS is discontinued.
• While controlled clinical trials have shown GCS to be effective in rapidly controlling exacerbations of multiple sclerosis, no effect of GCS on disease course or outcome has been identified. These studies show that in these cases, high doses of GCS drugs are necessary to achieve a significant therapeutic effect (see section “Administration and Doses”).
• Since complications of GCS therapy depend on the dose and duration of treatment, a case-by-case decision on the need for such treatment and the duration and frequency of treatment is determined based on a risk/benefit ratio analysis.

Influence on driving and operating ability Due to the possibility of dizziness, seizures and decreased blood pressure, Cortef® should be used with caution in persons driving vehicles and engaged in activities requiring high concentration and rapid motor reaction.

Contraindications

• Systemic fungal infections.
• High sensitivity to any drug component in history.

Cautions Non-specific ulcerative colitis with threat of perforation, abscess, or other purulent infection; diverticulitis; intestinal anastomosis (immediate history); acute or latent peptic ulcer, gastric or duodenal ulcer, esophagitis, gastritis; osteoporosis; myasthenia gravis; hypoalbuminemia and conditions predisposing to its occurrence, including liver cirrhosis; renal failure;Diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, Icenko-Cushing’s disease, hypothyroidism; acute psychosis; herpes simplex (ocular form); strongyloidosis; varicella, measles, active or latent tuberculosis, severe bacterial or viral infectious diseases (increases the risk of superinfection, masks the symptoms of the disease, the drug is only allowed against a background of specific antimicrobial therapy), glaucoma, AIDS, HIV infection; arterial hypertension; acute and subacute myocardial infarction.

Side effects

The side effects listed below are typical for all GCS.
Frequency of development and severity of side effects depend on the duration of use, the size of the dose used and the possibility of taking in accordance with the circadian rhythm.

Endocrine system disorders: adrenal function inhibition, secondary adrenal and pituitary reactivity of various genesis, development of Icenko-Cushing’s syndrome, menstrual disorders, decreased glucose tolerance, manifestation of latent diabetes, increased requirement for insulin or oral hypoglycemic agents in diabetic patients.

Digestive system disorders: peptic ulcer with possible perforation and bleeding, pancreatitis (nausea, vomiting), abdominal bloating, erosive/ulcerative esophagitis.

After GCS treatment, increases in serum alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase have been observed.Usually these changes are mild, not associated with any clinical syndrome and are reversible after discontinuation of treatment.

Cardiovascular system disorders: chronic heart failure in patients with appropriate predisposition, increased arterial pressure, in patients with acute and subacute myocardial infarction – expansion of necrosis focus, delayed formation of scar tissue, which may lead to rupture of the heart muscle.

Nervous system disorders:increased intracranial pressure with optic disc edema (pseudotumor of the brain), especially after treatment, seizures, dizziness, headache, delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia.

Sensory organs:posterior subcapsular cataract, increased intraocular pressure, glaucoma with possible optic nerve damage, exophthalmus, tendency to develop secondary bacterial, fungal or viral eye infections.

Metabolic side:negative nitrogen balance due to protein catabolism.

Induced by ISS activity:sodium and fluid retention in the body,hypokalemic alkalosis,muscle weakness,potassium loss.

Motor system disorders: “steroid” myopathy, decreased muscle mass, osteoporosis, tendon ruptures, especially Achilles tendon, vertebral compression fractures, aseptic necrosis of femoral and humerus epiphyses, pathological fractures of long bones, growth retardation in children.

The skin: slow wound healing, thinning and decreased skin strength, petechiae, ecchymosis, facial erythema, possible suppression of reaction in skin tests, hirsutism, increased sweating.

Allergic reactions:generalized (skin rash/ hives).

When using other GKS there have been reports of the following side effects: increased appetite, hiccups, arrhythmias, hypercoagulation, thrombosis, corneal trophic changes, increased calcium excretion, hypocalcemia, development or worsening of infections (the appearance of this side effect is contributed by co-administration of immunosuppressants and vaccination). When using Cortef® there are currently no reports of the above side effects.

Overdose

Clinical syndrome of acute overdose of the drug has not been described. Reports on cases of acute toxicity in GCS overdose are extremely rare. There is no specific antidote. Treatment is symptomatic. Hydrocortisone is excreted by dialysis.

Pregnancy use

Since no studies on the effects of GCS on human reproduction have been conducted to date, the use of these drugs during pregnancy, in nursing mothers, or in women of childbearing age requires an assessment of the likely beneficial effects of the drug versus the potential risks to the mother, embryo, or fetus.

Children born to mothers who have received significant doses of GCS during pregnancy should be carefully evaluated for possible symptoms of adrenal hypofunction.

Similarities

Locoid, Laticort, Hydrocortisone, Hydrocortisone-Pos, Locoid Lipokrem, Hydrocortisone ointment