Composition
1 tablet contains:
Active ingredient:
prednisone 5 mg;
Auxiliary substances:
lactose;
potato starch;
gelatin;
magnesium stearate
Pharmacological action
Prednisone is a synthetic glucocorticoid drug. It has anti-inflammatory, anti-allergic, immunosuppressive, anti-exudative and antipruritic effects.
The immunosuppressive effect is associated with inhibition of cytokine release from lymphocytes and macrophages. Other effects are caused by the stabilization of cell membranes, reduced capillary permeability, and improved microcirculation.
Prednisone has a catabolic effect, increases the level of glucose in the blood, causes the redistribution of adipose tissue. The drug inhibits the synthesis and secretion of ACTH and, secondarily, corticosteroids by the adrenal glands.
When applied externally and topically, the therapeutic activity of prednisone is due to anti-inflammatory, anti-allergic and anti-exudative (due to the vasoconstrictor effect) action.
Indications
For ingestion and/m: rheumatism;
rheumatoid arthritis;
dermatomyositis;
periarteritis nodosa;
scleroderma;
ankylosing spondylitis;
bronchial asthma, asthmatic status,
acute and chronic allergic disease;
Addison’s disease, acute adrenal insufficiency, adrenogenital syndrome;
hepatitis, hepatic coma, hypoglycemic States, lipid nephrosis;
agranulocytosis, various forms of leukemia, Hodgkin’s disease, thrombocytopenic purpura, hemolytic anemia;
chorea minor;
pemphigus, eczema, pruritus, exfoliative dermatitis, psoriasis, pruritus, seborrheic dermatitis, SLE, erythroderma, alopecia.
For use in ophthalmology: Â allergic, chronic and atypical conjunctivitis and blepharitis;
corneal inflammation with intact mucosa;
acute and chronic inflammation of the anterior segment of the vascular membrane, sclera and episclera;
sympathetic inflammation of the eyeball;
after injuries and operations with prolonged irritation of the eyeballs.
For intra-articular insertion: Â chronic polyarthritis, post-traumatic arthritis, osteoarthritis of large joints, rheumatic lesions of individual joints, arthrosis.
For infiltration into tissues: Â epicondylitis, tendovaginitis, bursitis, scapular periarthritis, keloids, sciatica, Dupuytren’s contracture, rheumatic and similar lesions of joints and various tissues.
Use during pregnancy and lactation
The use of corticosteroids in women of childbearing age and pregnant women is permissible only when its potential benefit to the mother exceeds the potential risk to the fetus. Women of childbearing age should be warned about the potential risk to the fetus.
There are not enough controlled human observations. In animal studies, corticosteroids have been shown to increase the incidence of cleft palate, miscarriage, placental insufficiency, and fetal growth retardation. Although the teratogenic effect of corticosteroids in humans has not been confirmed, there is evidence indicating an increased risk of placental
insufficiency, hypotrophy at birth, and fetal death in women who took corticosteroids during pregnancy. They can cause adrenal insufficiency in the fetus and newborn.
Breast-feeding should be discontinued for the duration of treatment. Prednisone is excreted in breast milk and can cause undesirable effects in the baby, such as growth retardation or inhibition of the production of endogenous hormones of the adrenal cortex.
Contraindications
Peptic ulcer of the stomach and duodenum, osteoporosis, Itsenko-Cushing syndrome, tendency to thromboembolism, renal failure, severe arterial hypertension, systemic mycoses, viral infections, vaccination period, active tuberculosis, glaucoma, productive symptoms in mental illnesses.
Hypersensitivity to prednisone. Infiltration introduction into the lesions of the skin and tissues – with chickenpox, specific infections, mycoses, with a local reaction to vaccination.
In ophthalmology-viral and bacterial eye diseases, primary glaucoma, corneal diseases with epithelial damage. In dermatology – bacterial, viral, fungal skin lesions, tuberculosis, syphilis, skin tumors.
Side effects
With short-term use of prednisone, as with other corticosteroids, side effects are rarely observed. When using prednisone for a long time, the following side effects may develop: :
Disorders of water and electrolyte metabolism: Â sodium and fluid retention in the body, hypokalemia, hypokalemic alkalosis.
From the cardiovascular system:  raising Blood pressure, circulatory failure.
From the musculoskeletal system: Â muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, compression fracture of the spine, aseptic necrosis of the femoral and humeral heads, pathological fractures of the long tubular bones.
From the digestive tract: Â steroid ulcer with possible perforation and bleeding, pancreatitis, flatulence, ulcerative esophagitis, digestive disorders, nausea, increased appetite.
From the side of the skin: Â atrophic streaks, acne, delayed wound healing, thinning of the skin, petechiae and hematomas, erythema, increased sweating, allergic dermatitis, urticaria, angioedema.
Nervous system and sensory disorders: Â increased intracranial pressure with congestive nipple syndrome of the optic nerve (pseudotumor of the brain-more often in children, usually after too rapid a dose reduction, symptoms-headache, deterioration of visual acuity or double vision); convulsions, dizziness, headache, sleep disorders, posterior subcapsular cataract, increased intraocular pressure, glaucoma; exophthalmos.
Endocrine status: Â secondary adrenal and hypothalamic-pituitary insufficiency (especially during stressful situations, such as illness, trauma, surgery); Cushing’s syndrome; growth suppression in children; menstrual disorders; decreased tolerance to carbohydrates; manifestation of latent diabetes mellitus and increased need for insulin or oral antidiabetic drugs in patients with diabetes mellitus, hirsutism.
From the side of metabolism: Â negative nitrogen balance as a result of protein catabolism, hyperglycemia, glucosuria.
Mental disorders: Â symptoms that mimic schizophrenia, mania, or delirium syndrome (most often appear during the first two weeks of treatment). Women and patients with lupus erythematosus are most susceptible to mental disorders.
Other services: Â anaphylactic and hypersensitivity reactions, obliterating endarteritis, weight gain, masking the symptoms of infectious diseases, syncope.
Interaction
Cardiac Glycosides: Â increased risk of cardiac arrhythmias and glycoside toxicity associated with hypokalemia.
Barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutetimide accelerate the metabolism of corticosteroids (by inducing microsomal enzymes), weaken their effect.
Antihistamines weaken the effect of prednisone.
Amphotericin B, carbonic anhydrase inhibitors: Â hypokalemia, left ventricular myocardial hypertrophy, circulatory failure.
Paracetamol: Â hypernatremia, peripheral edema, increased calcium excretion, risk of hypocalcemia and osteoporosis. Increased risk of paracetamol hepatotoxicity.
Anabolic steroids, androgens: Â increased risk of developing peripheral edema, acne; use cautiously, especially in the case of liver and heart disease.
Oral contraceptives containing estrogens: Â an increase in the concentration of globulins binding glucocorticosteroids in the blood serum, slowing of metabolism, an increase in T1 / 2, an increase in the effect of prednisone.
Anticholinergic drugs (mainly atropine)Â – increased intraocular pressure.
Anticoagulants (coumarin derivatives, indandion, heparin), streptokinase, urokinase: reduced and, in some patients, increased efficacy; the dose should be determined based on PV; increased risk of ulceration and bleeding from the gastrointestinal tract.
Tricyclic antidepressants may increase the psychiatric disorders associated with taking prednisone. They should not be used to treat these disorders.
Oral antidiabetic drugs, insulin: Â weakening of the hypoglycemic effect, an increase in the concentration of glucose in the blood. It is possible to adjust the dose of antidiabetic drugs.
Antithyroid drugs, thyroid hormones — changes in the function of the thyroid gland (it is possible to adjust the dose of these drugs or stop taking them).
Diuretics: Â weakening of the action of diuretics (potassium-sparing), hypokalemia.
Laxatives: Â weakening of the action, hypokalemia.
Ephedrine can accelerate the metabolism of corticosteroids (dose adjustment of prednisone is possible).
Immunosuppressive drugs: Â increased risk of infection, lymphoma, and other lymphoproliferative diseases.
Isoniazid: Â decrease in the concentration of isoniazid in blood plasma, mainly in individuals with rapid acetylation (possible dose change).
Mexiletin: Â accelerating the metabolism of mexiletine and reducing its concentration in the blood serum.
Drugs that block neuromuscular conduction (depolarizing muscle relaxants):hypocalcemia associated with prednisone use may increase synapse blockage, leading to an increase in the duration of neuromuscular blockage.
NSAIDs, acetylsalicylic acid, alcohol:Â weakening of the action, increased risk of peptic ulcer disease and bleeding from the gastrointestinal tract.
Preparations and food containing sodium:Â peripheral edema, arterial hypertension (it may be necessary to reduce the intake of sodium with food and drugs with a high sodium content; sometimes the use of corticosteroids requires additional sodium use).
Live virus-containing vaccines:Â during the use of immunosuppressive doses of corticosteroids, viral replication and the development of viral diseases are possible; a decrease in antibody production (simultaneous use is not recommended).
Other vaccines:Â increased risk of neurological complications and decreased antibody production.
Folic Acid:Â increased need for this drug.
How to take, course of use and dosage
Inside, it is recommended to take 1 time a day, in the morning; if necessary, more frequent reception is possible. The dose is set individually depending on the indications, the effectiveness of therapy and the patient’s condition. After achieving a therapeutic effect, it is recommended to gradually reduce the dose to the minimum effective one.
Average recommended doses: adults-5-60 mg per day, maximum daily dose-200 mg. For multiple sclerosis in the acute period-200 mg per day for 7 days, then 80 mg per day for 1 month.
Children — 0.14-2 mg / kg per day in 3-4 doses.
If you miss a dose, the drug should be taken as soon as possible, but if the time for the next dose is approaching, then the missed dose is not taken. Do not take a double dose.
Overdose
The risk of overdose increases with prolonged use of prednisone, especially in large doses.
Symptoms: raising Blood pressure, peripheral edema, increased undesirable effects described above.
Treatment:Â You should temporarily stop taking the drug or reduce the dose.
Special instructions
Prednisone is contraindicated in patients with systemic fungal infections due to the risk of increased infection. The drug can in some cases be used for fungal infections treated with amphotericin B to reduce its side effects, but in these cases it can cause circulatory failure and left ventricular hypertrophy of the heart, as well as severe hypokalemia. Taking the drug with a meal can reduce side effects from the gastrointestinal tract.
The effectiveness of antacids in preventing ulceration, bleeding from the digestive tract, or intestinal perforation has not been confirmed. With long-term treatment, it may be necessary to limit sodium and increase the potassium content, as well as increase the protein content in food.
In the case of steroid myopathy, if prednisone therapy cannot be discontinued, replacing it with another corticosteroid may alleviate the symptoms.
The risk of developing osteoporosis associated with prolonged use of corticosteroids can be reduced by taking calcium and vitamin D or, if the patient’s condition allows, by performing appropriate physical exercises.
If psychosis or depression occurs, reduce the dose or discontinue the drug if possible. If necessary, phenothiazines or lithium compounds can be used.
Acetylsalicylic acid or other NSAIDs may be prescribed to mitigate some of the symptoms of corticosteroid withdrawal (without suppressing the hypothalamic-pituitary-adrenal system).
Form of production
Tablets
Storage conditions
At temperatures below 25 °C.
Shelf life
3 years
Active ingredient
Prednisone
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Purpose
For adults as directed by your doctor
Indications
Bronchial Asthma, Osteoarthritis and Arthritis, Rheumatoid Arthritis, Osteoarthritis, Tuberculosis, Dermatitis, Allergies, Inflammatory Eye Diseases, Cancer, Hepatitis
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