Cortefum

Cortefum – glucocorticosteroid (GKS) drug with antiinflammatory action.

Form of release and structure

Dosage form – tablets: a round form, white color, with dividing risky and an engraving of "CORTEF10" (on 100 pieces in glass bottles of dark color, in a cardboard pack 1 bottle).

Active ingredient of Cortefum – a hydrocortisone, in 1 tablet – 10 mg.

Auxiliary components: starch corn, calcium stearate, sucrose, lactose, sorbic acid, mineral oil.

Indications to use

Use of Cortefum is shown:

• Endocrinology: a subacute thyroiditis, a hypercalcemia against the background of malignant new growths, an inborn adrenal struma, insufficiency of bark of adrenal glands (at replacement therapy as choice drug): primary (Addison's disease) – is more often in combination with mineralokortikoidny means, secondary – usually without mineralokortikoid;
• Dermatology: herpetiform violent dermatitis, pemphigus, exfoliative dermatitis, heavy multiformny erythema (Stephens-Johnson's syndrome), fungoid mycosis (Aliber's disease), heavy seborrheal dermatitis, severe form of psoriasis;
• Rheumatology: additional short-term therapy in the period of an aggravation or the acute attack: the pseudorheumatism (including a juvenile pseudorheumatism), the psoriasis arthritis ankylosing a spondylitis, a bursitis (acute and subacute), tendosinovit acute gouty arthritis, acute nonspecific, a posttraumatic osteoarthritis, an epicondylitis, a synovitis at an osteoarthritis; maintenance therapy: acute rheumatic carditis, system dermatomyositis (polymiositis), system lupus erythematosus;
• Allergology: for control of serious or disabling conditions, in the absence of adequate effect of the corresponding drugs: a serum disease, contact dermatitis, year-round or seasonal allergic rhinitises, bronchial asthma, atopic dermatitis, hypersensitivity reactions to medicines;
• Pulmonology: Leffler's syndrome (in case of lack of clinical effect at treatment by other means), the symptomatic sarcoidosis, a berylliosis, aspiration pneumonia disseminated or a fulminant pulmonary tuberculosis in a combination with antitubercular chemotherapy;
• Ophthalmology: chronic and serious acute illness of allergic and inflammatory genesis: damages of eyes at Herpes zoster, a keratitis, allergic conjunctivitis, an iritis and an iridocyclitis, allergic helcomas, a chorioretinitis, a diffusion back choroiditis and a uveitis, inflammatory pathologies of a front segment of an eye, a sympathetic ophthalmia, neuritis of an optic nerve;
• Oncology: palliative therapy: an acute leukosis at children, a leukosis and lymphoma at adults;
• Hematology: secondary thrombocytopenia at adults, an idiopathic Werlhof's disease at adults, inborn (erythroidal) hypoplastic anemia, the autoimmune (acquired) hemolitic anemia, erythrocyte anemia (eritroblastopeniya);
• Neurology: exacerbation of multiple sclerosis;
• Nephrology: a nephrotic syndrome without uraemia, idiopathic type or against the background of a system lupus erythematosus – stimulation of a diuresis or remission of a proteinuria;
• Others: tubercular meningitis at existence or threat of the subarachnoidal block (in combination with antitubercular chemotherapy).

Contraindications

• System fungal infections;
• The instruction in the anamnesis on hypersensitivity to drug components.

With extra care it is necessary to appoint Cortefum at the confirmed or suspected strongyloidosis.

Besides, patients should be careful at purpose of drug with hypertensia, a diverticulitis, nonspecific ulcer colitis, a fresh intestinal anastomosis, a latent or active round ulcer, osteoporosis, a renal failure, myasthenia gravis.

Purpose of drug to women of childbearing age, during pregnancy or breastfeeding demands assessment of the expected positive effect for mother and potential risk of the carried-out therapy for a fruit or the child.

Route of administration and dosage

Pill of Cortefum is taken inside.

The mode of dosing is appointed by the attending physician on the basis of clinical indications and disease severity.

Initial dose – from 20 mg to 240 mg a day, for achievement of therapeutic effect during treatment carrying out individual dose adjustment is possible. After achievement of proper response establish a maintenance dose, gradually reducing it to the smallest effective dose (during this period the patient needs careful medical observation).

Dose adjustment should be carried out in case of change of a clinical picture (remission or an exacerbation of a disease), individual hypersensitivity. During emergence of the stressful situations which are not connected with an initial disease, the dose of drug needs to be increased.

In the absence of clinical effect after long reception of Cortefum drug should be cancelled. Drug withdrawal after long therapy is recommended to be carried out by a gradual dose decline.

As at an exacerbation of multiple sclerosis the daily dose of GKS within the first week of therapy makes 200 mg of Prednisolonum, then – on 80 mg a day within a month, at purpose of a dose of drug it is necessary to consider that 5 mg of Prednisolonum are equivalent to 20 mg of a hydrocortisone.

Side effects

• Cardiovascular system: in certain cases – arterial hypertension, displays of congestive heart failure;
• Alimentary system: a meteorism, pancreatitis, a round ulcer with risk of a perforation and bleeding, an ulcer esophagitis; perhaps – passing increase in activity of alaninaminotranspherase (ALT), aspartate aminotransferase (nuclear heating plant), the alkaline phosphatase (AP);
• Musculoskeletal system: loss of muscle bulk, muscular weakness, osteoporosis, a steroid myopathy, a rupture of a sinew (is more often than an Achilles tendon), fractures of vertebras of compression genesis, an aseptic necrosis of heads humeral and a femur, pathological fractures of tubular bones;
• Endocrine system: Cushing's syndrome, a growth inhibition at children, secondary areactivity of a hypophysis and adrenal glands of various genesis, decrease in tolerance to carbohydrates, disturbances of a menstrual cycle, a latent diabetes mellitus, increase in need for insulin or peroral hypoglycemic means;
• Nervous system: a headache, edematization of an optic disk against the background of increase in intracranial pressure (a brain pseudoneoplasm), dizziness, spasms;
• Organs of sight: increase in intraocular pressure, glaucoma, back subkapsulyarny cataract, exophthalmos;
• Metabolism: negative nitrogenous balance because of a proteinaceous catabolism;
• Water and electrolytic balance: a delay in a liquid organism, a sodium delay, decrease in content of potassium, a gipokaliyemichesky alkalosis;
• Dermatological reactions: slow healing of wounds, decrease in durability and thinning of skin, ecchymomas, petechias, the increased sweating, an erythema of the person; perhaps – suppression of reaction of skin tests.

Special instructions

At emergence of secondary insufficiency of bark of adrenal glands against the background of use of Cortefum it is recommended to reduce a drug dose gradually. As secondary relative insufficiency after the end of treatment can remain within several months, during this period at emergence of stressful situations the patient needs to reappoint GKS. Because of risk of disturbance of secretion of mineralokortikoid the accompanying use of mineralokortikoid and/or electrolytes is necessary.

Drug reduces resistance of an organism to infections, its ability to localization of infectious process. Against the background of reception of GKS (monotherapy and a combination with other immunodepressants) emergence of viral, fungal, bacterial infections is possible, some infectious pathologies can proceed in the erased form. The probability of development of infectious complications has dozozavisimy character and increases with increase in a dose of drug.

The risk of development of a back subkapsulyarny cataract, glaucoma, damage of an optic nerve, accession of a consecutive viral or fungal infection increases at prolonged use of drug.

At a simple herpes infection of eyes it is necessary to appoint Cortefum with care not to allow perforation of a cornea.

GKS promote increase in removal of calcium.

Average or high doses of a hydrocortisone can cause increase in arterial pressure, the increased potassium removal, a liquid delay. The patient should limit consumption of table salt with food, to appoint potassium administration of drugs.

In case of use of the doses rendering immunodepressive effect introduction is contraindicated to the patient of live or live attenuated vaccines, introduction of the killed or the inactivated vaccines, reaction to which can be reduced, is shown. Immunization can be carried out according to the corresponding indications only at reception of a hydrocortisone in the doses which do not have an immunodepressive effect.

Purpose of GKS at latent tuberculosis or positive tuberkulinovy tests because of risk of activation of a disease is not recommended. In case of long therapy by drug sick prevention by antitubercular chemotherapy is necessary.

The patients receiving immunosuppressive doses of drug should avoid contact with the persons infected with measles or chicken pox as these diseases can have a heavy current up to death, especially at neimmunizirovanny children. In case of such contacts it is necessary to see a doctor immediately.

At purpose of GKS sick with nonspecific ulcer colitis the risk of development of perforation, abscess or purulent infections increases.

Effect of drug amplifies at cirrhosis and a hypothyroidism of a liver.

Use of Cortefum can increase the available emotional instability or psychotic tendencies, cause in the patient a mental disorder (instability of mood, euphoria, sleeplessness, change of the personality, a heavy depression, the expressed psychotic manifestations).

Against the background of drug use perhaps passing development of sarcoma of Kaposha.

Achievement of the expressed therapeutic effect at an exacerbation of multiple sclerosis requires purpose of rather high doses of GKS.

As development of side effects of drug depends on a dose and duration of treatment, the decision on need of therapy and the mode of dosing is accepted individually after comparison of potential risk and the expected advantage of use of GKS.

Long use of drug in pediatrics should be accompanied with careful control of development and growth of the child, including newborn.

In case of reception of considerable doses of GKS by mother during pregnancy the newborn needs carrying out careful inspection regarding identification of symptoms of insufficiency of bark of adrenal glands.

Medicinal interaction

At simultaneous use with Phenytoinum, phenobarbital, Rifampinum (inductors of microsomal enzymes of a liver) the clearance of Cortefum can increase therefore increase in its dose can be required.

At a combination with ketokonazoly and Oleandomycinum metabolism of a hydrocortisone can be suppressed and decrease its clearance (GKS dose decline is required).

As GKS can strengthen or reduce efficiency of peroral anticoagulants, it is necessary to appoint a combination with acetylsalicylic acid with care at a prothrombinopenia and to accompany with regular definition of indicators of coagulability.

Drug can increase clearance of the high doses of acetylsalicylic acid applied during the long period that can cause decrease in level of salicylates in serum or increase probability of their toxic reactions at cancellation of Cortefum.

Terms and storage conditions

To store at a temperature up to 25 °C. To protect from children.

Period of validity – 3 years.