Cortef - oral glucocorticosteroid (GCS).
Release form and composition
Cortef is available in the form of tablets (50 or 100 pieces in dark glass bottles, 1 bottle in a carton box).
1 tablet contains:
- Active ingredient: hydrocortisone - 5, 10 or 20 mg;
- Auxiliary components: mineral oil, lactose, sorbic acid, calcium stearate, corn starch, sucrose.
Indications for use
- Subacute thyroiditis;
- Congenital adrenal hyperplasia;
- Hypercalcemia in malignant tumors;
- Adrenal cortex insufficiency (hydrocortisone is the drug of choice for replacement therapy): primary (Addison's disease; usually in combination with mineralocorticoid preparations); secondary (more often without the addition of mineralocorticoids).
- Mushroom mycosis (Alibert's disease);
- Exfoliative dermatitis;
- Severe psoriasis;
- Severe erythema multiforme;
- Severe seborrheic dermatitis;
- Dermatitis herpetiformis;
- Autoimmune (acquired) hemolytic anemia;
- Secondary thrombocytopenia in adults;
- Erythrocyte anemia (erythroblastopenia);
- Idiopathic thrombocytopenic purpura in adults;
- Erythroid (congenital) hypoplastic anemia.
In Allergology: the control of disabling or severe allergic conditions that are not amenable to adequate treatment with appropriate drugs:
- Atopic dermatitis;
- Contact dermatitis;
- Serum sickness;
- Seasonal or perennial allergic rhinitis;
- Bronchial asthma;
- Hypersensitivity reactions to drugs.
- Symptomatic sarcoidosis;
- Leffler syndrome, not treatable with other drugs;
- Disseminated or fulminant pulmonary tuberculosis (in combination with appropriate anti-tuberculosis chemotherapy);
- Aspiration pneumonia.
In ophthalmology: chronic and severe acute inflammatory and allergic diseases involving the eyeball and its appendages:
- Irit and iridocyclitis;
- Damages of eyes at shingles;
- Allergic ulcers of the cornea;
- Inflammatory diseases of the anterior segment of the eye;
- Diffuse posterior uveitis and choroiditis;
- Sympathetic ophthalmia;
- Allergic conjunctivitis;
- Neuritis of the optic nerve.
In oncology: palliative treatment in the following cases:
- Acute leukemia in children;
- Leukemia and lymphomas in adults.
- Exacerbation of multiple sclerosis.
- To stimulate diuresis or remission of proteinuria caused by nephrotic syndrome without uremia, idiopathic type or developed due to systemic lupus erythematosus.
As an additional short-term therapy (in the period of exacerbation or acute attack) in the following cases:
- Post-traumatic osteoarthritis;
- Acute gouty arthritis;
- Sinovitis in osteoarthritis;
- Acute non-specific tendosynovit;
- Rheumatoid arthritis, incl. juvenile (in some cases, it may be necessary to conduct maintenance therapy with small doses);
- Acute and subacute bursitis;
- Psoriatic arthritis;
- Ankylosing spondylitis.
As maintenance therapy or exacerbation, Cortef may be prescribed in the following cases:
- Systemic dermatomyositis (polymyositis);
- Systemic lupus erythematosus;
- Acute rheumatic heart disease.
Other indications for use:
- Tuberculous meningitis with a subarachnoid block or with a threat of block (in combination with appropriate anti-tuberculosis chemotherapy).
- Systemic fungal infections;
- Hypersensitivity to the drug in history.
Relative (special caution required):
- Fresh intestinal anastomoses;
- Active or latent peptic ulcer;
- Renal failure;
- Myasthenia gravis;
- Herpes infection of the eye;
- Latent tuberculosis and positive tuberculin tests;
- Confirmed or suspected strongyloidiasis;
- Nonspecific ulcerative colitis;
- Cirrhosis of the liver.
Dosing and Administration
Kortef take inside. Depending on the evidence and the severity of the disease, the initial dose may vary from 20 to 240 mg. In the future, if necessary, change the dose until it reaches the desired effect. After that, a maintenance dose is established: for this, gradually (at certain intervals), under therapeutic medical supervision, the therapeutic dose is reduced until the lowest dose is achieved that is able to maintain the desired effect.
In the case of increased individual sensitivity to the drug and when the clinical picture changes due to exacerbation or remission of the disease, the dose is adjusted. In stressful situations, not related to the disease about which the treatment is carried out, the dose is temporarily (for this period) increased.
If it is necessary to discontinue therapy after long-term use of Cortef, it is recommended to gradually reduce the dose.
If after a sufficiently long treatment the clinical effect cannot be achieved, Cortef is canceled and alternative therapy is prescribed.
When exacerbation of multiple sclerosis during the first week, 200 mg of hydrocortisone is prescribed per day, during the next month - 80 mg per day. It is important to note that 20 mg of hydrocortisone is equivalent to 5 mg of prednisone.
- Cardiovascular system: in some cases - arterial hypertension, manifestations of congestive heart failure;
- Water and electrolyte balance: loss of potassium, fluid and sodium retention in the body, hypokalemic alkalosis;
- Musculoskeletal system: osteoporosis, loss of muscle mass, tendon rupture (especially Achilles tendon), steroid myopathy, muscle weakness, vertebral compression fractures, pathological fractures of tubular bones, aseptic necrosis of the heads of the humeral and femoral bones;
- Central nervous system: dizziness, headache, convulsions, increased intracranial pressure, accompanied by the development of optic disc edema (brain pseudotumor, often developing after discontinuation of the drug);
- Digestive system: flatulence, ulcerative esophagitis, pancreatitis, peptic ulcer with possible perforation and bleeding; in some cases - an increase in the activity of alanine aminate transferase, aspartate aminotransferase, alkaline phosphatase (usually insignificant, not associated with any clinical syndromes and reversible after cessation of treatment);
- Endocrine system: Cushing's syndrome, menstrual disorders, secondary reactivity of the pituitary and adrenal glands of various origins, reduced tolerance to carbohydrates, increased insulin or oral hypoglycemic agents, the manifestation of latent diabetes mellitus, growth retardation in children;
- Metabolism: negative nitrogen balance due to protein catabolism;
- Organ vision: increased intraocular pressure, exophthalmos, glaucoma, posterior subcapsular cataract;
- Dermatological reactions: increased sweating, petechiae, thinning and reducing the strength of the skin, ecchymosis, slow healing of wounds, facial erythema, suppression of the reaction during skin tests.
In stressful situations, patients need higher doses of fast-acting corticosteroids.
Secondary insufficiency of the adrenal cortex, caused by the therapy, can be minimized by gradually reducing the dose. This type of relative insufficiency can last several months after the end of the course of treatment, therefore, in any stressful situation during this period, GCS should be reappointed. Given the possible violation of the secretion of mineralocorticoids, the concomitant use of mineralocorticoid preparations and / or electrolytes is necessary.
It is important to keep in mind that some infectious diseases when taking GCS can occur in erased form. The development of infections caused by protozoa, viruses, fungi, worms or bacteria, may be associated with the use of Cortef as a single agent or in combination with other immunosuppressants. The probability of infectious complications increases with increasing doses of hydrocortisone. The severity of the disease may vary. GCS reduces both the ability of the body to localize the infection process and resistance to infections.
With caution Cortef used in patients with a simple herpetic eye infection, because possible perforation of the cornea. To control the state after the end of treatment, prescribed minimum effective doses of the drug, and the reduction is carried out gradually.
Hydrocortisone in medium and high doses can lead to fluid retention, increased potassium excretion, and high blood pressure. Therefore, during treatment, it is necessary to limit the intake of table salt with food and taking potassium preparations.
Like all glucocorticosteroids, Cortef increases calcium excretion.
When using the drug in doses that have an immunosuppressive effect, live and live attenuated vaccines cannot be administered, but inactivated and killed vaccines can be administered. However, it should be borne in mind that the reaction to such drugs may be reduced. When using hydrocortisone in doses that do not have an immunosuppressive effect, if indicated, immunization can be carried out.
With an active form of tuberculosis, Cortef should be limited to cases of disseminated and fulminant forms of the disease, and the treatment should be carried out simultaneously with the appropriate anti-tuberculosis chemotherapy.
Careful observation is necessary for latent tuberculosis and positive tuberculin samples, because there is a possibility of activating the disease. With long-term Cortef treatment, this category of patients needs chemoprophylaxis of tuberculosis.
Patients receiving the drug in immunosuppressive doses should avoid contact with measles and chickenpox. They should be warned that in case of contact you should immediately consult a doctor. This is due to the fact that in unimmunized patients receiving GCS, these diseases can be difficult, may be fatal.
Treatment with strongyloidosis and suspicion of it is carried out with special care. Immunosuppression caused by Cortef in such patients leads to hyperinfection and dissemination of the process with the widespread migration of larvae, often accompanied by enterocolitis and gram-negative septicemia, which can be fatal.
Patients with nonspecific ulcerative colitis should be under constant observation during the treatment period, since there is a risk of perforation, abscess or purulent infections.
The effect of the drug is enhanced with hypothyroidism and liver cirrhosis.
Kaposi's sarcoma is possible in patients receiving SCS. However, after discontinuation of the drug there is a chance of clinical remission.
With long-term treatment of children, including newborns, you need to carefully monitor their growth and development.
Drugs, which are inducers of microsomal liver enzymes (rifampin, phenytoin and phenobarbital), can increase the clearance of hydrocortisone, therefore, it is necessary to increase its dose.
Ketoconazole and oleandomycin can inhibit the metabolism of hydrocortisone, so it is necessary to reduce its dose.
Cortef can increase the clearance of acetylsalicylic acid in the case of its use in high doses for an extended period. This can lead to a decrease in the concentration of salicylates in the serum, and in the case of withdrawal of hydrocortisone - to an increase in the risk of their toxic reactions. With caution, this combination should be prescribed for hypoprothrombinemia.
Cortef affects the effectiveness of oral anticoagulants: there are reports of both a decrease and an increase in their effects, therefore constant monitoring of blood clotting indicators is necessary.
Terms and conditions of storage
To store at a temperature up to 25 ºС in the place, inaccessible for children.
Shelf life - 3 years.