Dehydrocortisone 5mg. 60 tablets

Prednisone tablets Dehydrocortisone

Drug substance per tablet: Prednisone 5 mg

Excipients: corn starch, lactose monohydrate, povidone, talc, magnesium stearatDehydrocortison tablets 5 mg tablets, 30 pieces in blister PVC / AL foil, 2 blister pack



1. WHAT Dehydrocortisone AND WHAT IT IS USED?

Dehydrocortisone is the group of the so. Called steroids with potent anti-inflammatory action and reduced mineralocorticoid activity. It also has anti-allergic, protivoeksudativno, immunosuppressive and anti-toxic action. Dehydrocortisone apply to: Dehydrocortisone is applied for the treatment of

Endocrine diseases - Addison's disease, secondary hypocorticism after hypophysectomy and pituitary tumors, hirsutism, Adrenal genital syndrome, thyroiditis, endocrine ophthalmopathy, hypercalcemia; Hematologic diseases - lymphoblastic leukemia, myeloid leukemia, Hodgkin's disease, non-Hodgkin lymphomas, chronic limfolevkoza, plasmacytoma, hemolytic anemia, thrombocytopenia, aplastic anemia, bone marrow transplantation;

Pulmonary diseases -alergichen rhinitis, bronchial asthma, sarcoidosis, pulmonary granulomatosis other;

Gastrointestinal diseases - chronic active hepatitis, ulcerative colitis, regional enteritis;

Nephrological diseases - glomerulonephritis, nephropathies in other diseases (SLE, capillary dysfunctions syndrome Goodpaschar, Wegener's disease, polyarteritis nodosa), kidney transplant;

Cardiovascular diseases - pericarditis, infarction syndrome;

Systemic connective tissue diseases - systemic lupus erythematosus, polymyositis, dermatomyositis, scleroderma, Sharp syndrome, Sjogren's syndrome, vasculitis - poliarteriitis nodosum, erythema nodosum, capillary dysfunctions, Horton's disease, Kawasaki disease, Wegener's granulomatosis, syndrome Goodpaschar, Behcet's disease, Takayasu's arteritis; Inflammatory joint diseases - rheumatism, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile chronic arthritis;

Dermatological diseases - pemphigus, erythema multiforme, exfoliative dermatitis, mycosis fungoides, atopic dermatitis, urticaria, alopecia areata, psoriasis fulgaris;

Neurological disorders - antioedematous - where cerebral edema of various etiologies, myasthenia gravis, multiple sclerosis;

Eye diseases - allergic conjunctivitis, uveitis, retrobulbar neuritis, chorioretinitis, iridocyclitis.

2. WHAT YOU NEED TO KNOW BEFORE starting treatment with Dehydrocortisone

Dehydrocortisone not apply to:

• Hypersensitivity to the active substance or excipients in the product;

• Active peptic ulcer bleeding;

• Diabetes with ketoacidosis;

• Severe psychoses;

• Severe refractory arterial hypertension;

• systemic fungal infection.

In this medicinal product, please note the following:

It should be used with caution and under medical supervision in patients with the following conditions: chronic infections refractory to antibiotic treatment, diabetes, ulcers of the stomach and duodenum, Cushing's disease, severe liver and kidney disease, polio conditions flowing immunodeficient, thromboembolism, osteoporosis. In patients on steroid therapy, subject to stress should be applied rapidly acting corticosteroids before, during and after the stressful situation.

Corticosteroids may mask symptoms of infection, and to develop additional infections. They may be due to the treatment with the product due to immunosuppressive (immunity suppressive) effects but which influences the cellular and humoral immunity and neutrophil function. These infections may be mild or severe, sometimes fatal. By increasing the dose of corticosteroid is increased and the incidence of infections.

Prolonged administration of corticosteroids may result in the development of posterior subcapsular cataract (cataract), increased intraocular pressure (glaucoma) with possible damage to the optic nerve head and can improve the probability of secondary ocular infections caused by fungi or viruses. Medium and high doses may cause kortikorsteroidi increase in blood pressure, retention of salt and water and hard excretion of potassium. These effects are less likely with synthetic products, except at high doses. Sometimes it is necessary restriction of dietary salt and adding potassium products. All corticosteroids increase the excretion of calcium. Application of live attenuated (weakened) vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. In such patients can apply killed or inactivated vaccines, although the response to vaccination may be weak.

Dehydrocortisone use in patients with active tuberculosis should be restricted to cases of acute and disseminated tuberculosis in which corticosteroids are applied in addition to the Anti-tuberculosis therapy.

If necessary administering the product to patients with a hidden (latent) tuberculosis, this must be done under supervision because of the risk of tuberculosis reactivation process. During corticosteroid therapy for these patients should be administered chemoprophylaxis. Patients receiving immunosuppressive therapy are more susceptible to infections than healthy individuals. In these cases, chickenpox and measles can be serious, even fatal in children and adults. In such patients should be avoided 'contact with patients with these infections. In contact with someone with chickenpox should be given prophylaxis with varicella zoster immunoglobulin. Upon exposure to measles applies prophylaxis with intramuscular immunoglobulin. If you develop chickenpox should discuss treatment with antiviral products. Corticosteroids should be used with caution in patients with suspicion or presence of worms. In these patients, treatment with the product may lead to the proliferation and migration of the larvae, often combined with severe enterocolitis and potentially fatal blood infection (septicemia). Drug-induced secondary adrenal insufficiency can be avoided by gradually reducing the dose. This type of failure can last for months after discontinuation of therapy, such as in situations of stress during this period, treatment should be resumed. Since mineralocorticoid secretion may be impaired, the required intake of salt and / or mineralocorticoid. An increased effect of corticosteroids in patients with underactive thyroid gland and cirrhosis. Corticosteroids are administered with caution in patients with ocular herpes simplex because of the risk of corneal perforation.

For Disease Control should be administered the lowest possible dose of corticosteroid, such as dose reduction should be gradual. During treatment with Dehydrocortisone may occur mental changes, ranging from euphoria (high spirits), insomnia, mood swings, personality changes, severe depression to overt psychotic features. Existing emotional instability or psychotic manifestations may be worse during treatment. Steroids are used with caution in nonspecific ulcerative (ulcerative) colitis when there is a risk of perforation, abscess, or development of yeast infection in diverticulitis, fresh intestinal anastomosis, active or hidden ulcer, renal insufficiency, hypertension, osteoporosis (bone thinning ) and myasthenia gravis.

Growth and development of children of corticosteroid therapy should be closely monitored. Since complications of corticosteroid treatment depends on the dose and duration in each individual case should be doing benefit / risk assessment.

Application Dehydrocortisone and intake of foods and beverages

No evidence of the need for special diets or restrictions on certain types of foods and beverages during treatment with this product.

Pregnancy

Before taking any medicine, consult your doctor or pharmacist
Do not use in the first three months of pregnancy. In the remaining period shall be appointed with caution, taking into account the benefit / risk ratio.

Breastfeeding

Before intake of any medicine, consult your doctor or pharmacist
Dehydrocortisone passes into breast milk, but does not cause side effects in the infant.

Driving and using machines

No data to influence the ability to drive and use machines.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they have not been prescribed by your doctor.
Some of these interactions Dehydrocortisone are clinically important. Drugs that activate liver enzymes such as phenobarbital, phenytoin and rifampin may increase the secretion of corticosteroids and require increased dose of corticosteroids to achieve a satisfactory answer. Drugs such as troleandomycin and ketoconazole may inhibit the processing of corticosteroids and reduce their separation. Therefore, the dose of corticosteroids should be titrated to avoid steroid toxicity. Corticosteroids may increase the secretion of chronic high-dose acetylsalicylic acid (acetysal). This may lead to low blood levels of salicylates or salicylate increase the risk of toxicity interruption of corticosteroid therapy. The products of acetylsalicylic acid should be used with caution in combination with Dehydrocortisone in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants (drugs that reduce blood clotting) is variable. Report is enhanced or diminished effects of anticoagulants when given concurrently with corticosteroids.

3. HOW TO USE Dehydrocortisone?

Always take Dehydrocortisone according to the instructions of the doctor! Necessity, the choice of medicine, dosage and route of administration are strictly individual, must be respected as the "benefit / risk" of drug administration.

Methods of application:

• fractionating - at high dose product is taken in 2 to 4 administrations per day (from 30 to 80 mg);

• In the lower maintenance dose (5 to 10 mg) was taken once in the morning;

• alternate therapy - used in the need for long-term maintenance treatment - the dose in 48 hours is taken once in a day. In such a reception is largely avoid phenomena of hypocorticism, reduces the suppression of the pituitary-adrenal system and to achieve the desired therapeutic effect;

Upon treatment with Dehydrocortison starting with an initial higher dose (40-60 mg per day), the dose is gradually reduced up to the minimum effective dose. A reduction to 30 mg per day may be from 1 to 2 tablets of 7-10 days. Then to the maintenance dose of 5 to 10 mg reduced by 1 tablet 10-15 days. First stop evening dose, then - lunch. In intercurrent illness dose should be increased. Dose of 5 mg daily does not suppress pituitary-adrenal system.

Children

• Treatment of nephrosis in children aged 18 months to 4 years of age - 5 to 10 mg four times daily;

from 4 to 10 years of age - 4 times 15 mg per day orally; over 10 years - 4 times 20 mg per day

• Treatment of revmokardit, blood diseases and tumors dose is 0,5 mg / Kg or 15 mg / m2, administered 4 times daily for two weeks, then 0,375 mg / Kg or 11,25 mg / m2 4 times per day for 4 to 6 weeks.

If you take a large amount of the drug:

By taking a higher dose than prescribed, immediately contact a doctor for help! Overdose intensify the side effects. Treatment is symptomatic. If you forget to take Dehydrocortisone It is desirable not to be missed drug intake, especially if the product is assigned to a single dose. If this happens, the tablet must be taken immediately, but if the next administration is almost should not take the missed dose.

4. POSSIBLE SIDE EFFECTS

Like any other medicine, Dehydrocortisone can cause side effects.

Disturbances in electrolytes - sodium retention and liquids, congestive heart failure, potassium loss, hypertension Musculoskeletal reactions - muscle weakness, muscle wasting, osteoporosis (bone density dilution), rupture of tendons, in particular Achilles, fractures vertebrae, crushing the heads of the femur and humerus bones and fractures of the long bones;

Gastrointestinal effects - gastric ulcer with possible perforation and hemorrhage, inflammation of the pancreas, stomach swelling, ulcer inflammation of the esophagus; elevated transaminases and alkaline phosphatase. These changes are usually mild, not in connection with clinical syndromes and are reversible upon discontinuation of treatment.

Skin reactions - impaired wound healing, thin and fragile skin, skin bleeding, flushing, increased sweating; suppression of some skin tests;

Exchange reactions - negative nitrogen balance of protein catabolism;

Neurological effects - increased intracranial pressure with expansion of pupils (usually after treatment), convulsions, dizziness and headache;

Endocrine effects - menstrual disorders; secondary adrenocortical pituitary insufficiency, especially during times of stress such as trauma, surgery or diseases; growth suppression in children; decreased carbohydrate tolerance; manifestations of latent diabetes; increased need for insulin or oral hypoglycemic agents in patients with diabetes; Eye reactions - back subcapsular cataracts, increased intraocular pressure, glaucoma and exophthalmos (bulging eyeballs) Other - hives and other allergic, anaphylactic and hypersensitivity reactions.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist!

5. Storage

At temperatures below 25 ° C. Keep out of reach of children! Do not use after the expiry date stated on the package! Shelf life - 5 (five) years