Prednisolone contraindications and side effects. Glucocorticosteroid drug for severe forms of allergic reactions - ampoules and tablets Prednisolone: ​​instructions for use and dosage of the medication. Interaction with other drugs

Prednisolone is a systemic and local hormone-based drug that has a medium-duration effect. It is an analogue of the hormone hydrocortisone synthesized by the adrenal glands.

The active substance of the drug is several times more active than the natural hormone. The drug extinguishes an allergic reaction or prevents its occurrence, has an anti-inflammatory and anti-shock effect, and reduces the activity of the immune system.

Article outline:

Prednisolone - what is it?

Prednisolone is a synthetic drug based on glucocorticosteroids.

It has an antiallergic effect, suppresses immune activity, extinguishes the inflammatory reaction, and makes beta-adrenergic receptors more sensitive to phenylethylamines.

Actively involved in the transformation metabolic processes in organism. How does the drug affect metabolism?

Chemical composition and dosage forms

Prednisolone is produced by many pharmaceutical companies. In preparations from different manufacturers, the concentration active substance is the same, but the auxiliary components may differ. Prednisolone is sold in four dosage forms.

Why is Prednisolone prescribed?

What are the tablets taken and used for? injection solutions? Using these dosage forms, the following diseases are cured:

Injections of the drug are given in critical situations: when severe symptoms allergies or anaphylactic shock. The medicine is administered to the patient through injections for several days, then the tablets must be taken.

The drug in tablet form is often prescribed for bronchitis and bronchial asthma, and it also contributes to the successful engraftment of transplants.

Why is Prednisolone ointment prescribed? The external remedy is used to eliminate allergic dermatitis and inflammatory skin pathologies of non-infectious origin. The following diseases are cured with the ointment:

• neurodermatitis;
• psoriasis;
• eczema;
• discoid lupus;
• all types of dermatitis;
• various types of rash;
• toxidermy.

Why are Prednisolone eye drops prescribed? Drops are used to eliminate eye inflammation of non-infectious origin. The following eye diseases are treated with the drug:

• allergic conjunctivitis;
• iritis;
• uveitis;
• keratitis;
• scleritis;
• blepharitis;
• ophthalmia.

Instructions for use of tablets

With hormone replacement therapy, adult patients should take 4–6 tablets per day, with maintenance therapy – 1–2 tablets.

IN in some cases the daily dose can be 100 mg of the active substance, that is, 20 tablets is the maximum.

The dosage for children is selected by a pediatrician and is determined by the age of the child and the intensity of the pathological process.

Typically, infants from two months to a year are prescribed 0.15 mg of active substance per kilogram of body weight per day, this amount is divided into three doses. Children under 14 years of age take 1 mg of active substance per kilogram of body weight per day.

It is advisable to take the drug in the morning. You should not stop using the medication abruptly; the daily dose should be reduced gradually.

Abrupt withdrawal of the medication may result in kidney failure.

After the first week of taking the drug, the daily dose is reduced by 20%; during the second week, the dose should be reduced by 2 mg daily.

Instructions for use of ointment

The ointment is applied to the sore skin three times a day. The minimum therapeutic course is 5 days, the maximum is 2 weeks.

Instructions for use of the injection solution

The medicine is injected into muscles or veins. The daily dose for an adult patient is from 4 to 60 mg of the active substance. For children, the medicinal solution is injected into the buttock; the dosage and duration of treatment are determined by the doctor. Typically, children from 6 to 12 years old are prescribed 25 mg of the active substance per day, children from 12 years old - up to 50 mg.

Pharmacokinetics

The tablet is quickly broken down in the intestines, the active substance is completely in the blood an hour and a half after administration. Metabolism of the active substance is carried out by combining with sulfuric and glucuronic acids mainly in the liver, to a small extent in the kidneys.

The substance used is excreted from the body in urine and bile.

Use during pregnancy, childhood and old age

What effect does Prednisolone have on the body of pregnant women, the elderly and children?

1. During pregnancy, especially early stages, the use of the drug is allowed only in extreme cases. Glucocorticosteroids can accumulate in breast milk, therefore, during lactation the use of the medicine is prohibited.
2. In older people, taking glucocorticosteroids is often accompanied by severe side effects.
3. In children, glucocorticosteroid drugs can slow growth. Therefore, pediatricians prescribe Prednisolone in a shortened course at the minimum effective dose.

How is the drug harmful?

Since Prednisolone is a hormonal drug, it begins to act a few days after the first dose. The patient is forced to take the medicine for a long time, which inevitably leads to side effects.

Prednisolone causes quite serious harm to the body: it suppresses the immune system, negatively affects the functioning of the cardiovascular, endocrine, reproductive, digestive, central nervous system. The consequences of drug treatment are as follows:

• hypokalemia;
• arrhythmia;
• bradycardia;
• thromboembolism;
• heart failure;
• hyperglycemia;
• arterial hypertension;
• glycosuria;
• muscle cramps;
• psychosis;
• hypercortisolism;
• increased intracranial pressure;
• inhibition of the hypothalamus, pituitary gland, adrenal glands.

Contraindications

Since the drug gives multiple side effects, it is prohibited for many categories of patients to take it. Prednisolone is contraindicated for:

• peptic ulcer;
• renal and liver failure;
• polio;
• syphilis;
• tuberculosis;
• diabetes mellitus;
• hypertension;
• viral skin and eye diseases;
• depression and mental disorders;
• myopathies;
• herpes;
• lymphadenitis;
• osteoporosis;
• hypercortisolism;
• deep mycosis;
• cataracts and glaucoma.

Injections should not be given if the injection sites are infected.

The drug is hormonal drug, which is usually used when acute diseases that threaten life. When is Prednisolone prescribed to children for allergies and in what form is it used?

The drug is produced by several companies, and next to the name of the drug there is sometimes a word that indicates the manufacturer. "Prednisolone" is available in the following dosage forms:

1. Flat-cylindrical tablets of white color, in one package there are from ten to one hundred and twenty pieces.
2. Ointment is used for external treatment skin. This is a thick white mass, which is placed in aluminum tubes with a volume of ten or fifteen grams.
3. Ampoules with solution, which are used for injection into a muscle or vein. This form contains one or two ml of a clear solution. The liquid can be clear, yellowish or greenish. One package can contain 3-5 ampoules.

The drug is not produced in suppositories, drops, capsules, suspensions or other forms.

Compound

All dosage forms contain one active ingredient - prednisolone. It is available in the following dosages:

• in one tablet - one or five mg;
• in solution for injection - fifteen or thirty mg;
• in ointment - five mg.

Operating principle

The drug is considered a chemical hormone from the group of glucocorticosteroids and acts similarly to hormonal compounds that are produced in the adrenal glands.

In addition, the drug suppresses the active secretion of fluid from inflamed tissues, and also prevents the occurrence of an allergic reaction and eliminates rash, swelling, and itching. Prednisolone stops the active proliferation of cells at the site of injury, which prevents the appearance of scars.

All these effects of the drug occur very quickly, and the effect of the drug itself is considered very strong, so it is used in life-threatening situations or in situations where other medications have not had the desired effect. If there is a possibility of replacing Prednisolone with other medications, it should be used.

The drug also has the following properties:

• activates protein breakdown in tissues and bloodstream;
• increases blood glucose;
• reduces the absorption of potassium in the gastrointestinal tract and stimulates its excretion from the body;
• suppresses the production of glucocorticoids.

Such effects of the drug are not considered therapeutic, but must be taken into account, since they are the ones that form adverse reactions. Children can take Prednisolone only under the supervision of a doctor.

When is an antibiotic prescribed?

According to the instructions for use, "Prednisolone" in tablets and injections is prescribed in following situations:

1. Quincke's edema (a reaction to various biological and chemical factors, often of an allergic nature).
2. Urticaria (skin disease, dermatitis, usually of allergic origin, which is characterized by the rapid appearance of severely itchy blisters).
3. Anaphylactic shock (severe systemic immediate allergic reaction that develops upon contact with foreign substances-antigens).
4. Cerebral edema ( pathological process, manifested by excessive accumulation of fluid in the cells of the brain or spinal cord and the intercellular space).
5. Bronchial asthma (chronic inflammation of the airways involving a variety of cells).
6. Rheumatoid arthritis (a rheumatic process characterized by erosive and destructive lesions of predominantly peripheral small joints).
7. Scleroderma (tissue damage, the main manifestations of which are sclerosis of the skin and narrowing of small capillaries).
8. Joint damage.
9. Inflammatory process in the joints, as well as acute disorder functioning of the adrenal glands.
10. Allergic conjunctivitis(damage to the conjunctiva, which is provoked defensive reactions body in response to the appearance of an allergen).
11. Uveitis (inflammation of various parts of the uveal tract, manifested by pain in the eyes).
12. Agranulocytosis (a pathology in which there is a decrease in leukocytes in the blood due to granulocytes and monocytes).
13. Acute leukemia (a tumor disease of the hematopoietic system, the basis of which is immature cells that displace normal hematopoietic germs).
14. Thrombocytopenic purpura (a hematological pathological process characterized by a lack of platelets in the blood).
15. Hemolytic anemia (enough rare disease blood, a characteristic feature of which is considered to be a reduction life cycle erythrocytes).
16. Organ transplantation.
17. Acute hepatitis (anatomical and functional disorder in the liver).
18. Hepatic coma (severe illness associated with extensive liver damage).
19. (serious disease that threatens life as a complication of diffuse toxic goiter).
20. Thyroiditis (inflammation of the endocrine gland).
21. Myeloma ( malignancy bone marrow, consisting of plasma cells that, as a result of transformation, are transformed into malignant myeloma cells).
22. Sarcoidosis (a systemic disease with a chronic course, which is characterized by the formation of granulomas in various organs and tissues).
23. Tuberculosis (infectious disease, the main source of which is infection with Koch bacilli).
24. Aspiration pneumonia (an inflammatory process in the lungs that occurs when various substances are inhaled or passively penetrated into the lungs).

According to the instructions, Prednisolone is prescribed to children as an ointment for the following conditions:

• eczema (non-contagious inflammation of the surface of the skin, which causes rashes, burning and a tendency to recur);
• atopic dermatitis (chronic skin lesions that occur with exacerbations and remissions);
• contact dermatitis (inflammatory reaction of the skin to contact with an irritant);
• toxicerma (acute inflammation of the skin under the influence of substances that enter the body and have allergic or toxic-allergic properties);
• psoriasis (non-infectious lesion of the skin surface, which is accompanied by the appearance of rashes and peeling);
• tenosynovitis (an illness characterized by damage to the tendon and its surrounding membrane);
• bursitis (damage to mucous areas, usually in the joint area);
• keloid scars (pathological growth of scar tissue).

At what age can the drug be used?

There are no age restrictions on the use of Prednisolone for children, but due to the fact that such a drug can adversely affect the growth of the body in childhood, this hormonal drug is usually prescribed only if serious illnesses and only under the supervision of a doctor.

In addition, it must be remembered that such a remedy is used only for acute diseases and they always try to prescribe it in the minimum dosage and for the shortest possible period.

What contraindications does the drug have?

If the medicine is prescribed to a child for vital signs, then there is only one contraindication for its use - intolerance to the components of the drug.

However, most diseases require increased attention from a medical specialist when prescribing Prednisolone. According to the instructions, ampoules for children are contraindicated for various pathologies, for example:

• chickenpox ( viral disease, which is transmitted by airborne droplets);
• measles (an acute viral illness with hypersensitivity, which is characterized by elevated temperature, as well as damage to the mucous membranes of the oral cavity and respiratory system, conjunctivitis and characteristic maculopapular rashes on the skin, as well as general intoxication);
• herpes (a viral disease with a characteristic rash of grouped blisters on the skin and mucous membranes);
• tuberculosis (an infection that occurs in two main forms);
• diseases of the endocrine gland;
• severe liver pathologies;
• glaucoma (a disease of the visual organ, which is characterized by increased intraocular pressure, the occurrence of optical neuropathy and visual impairment).

If a child has any serious illness, the question of using the drug is decided individually.

Adverse reactions

During therapy with Prednisolone in injections or tablets, various negative phenomena may be observed, for example:

1. Vomiting.
2. Nausea.
3. Adrenal exhaustion.
4. Neuroendocrine damage that develops as a result of a violation of the hypothalamic-pituitary system, as well as increased secretion and secondary hyperfunction of the adrenal cortex.
5. Loss of appetite.
6. The occurrence of diabetes mellitus.
7. Erosive esophagitis (an inflammatory process that develops on the esophageal mucosa and is characterized by the appearance of erosions and ulcers).
8. Bleeding from the stomach or intestines.
9. Teroid gastric ulcer.
10. Delayed sexual development (a sign of pathology in which there is a violation physiological development teenagers).
11. Arrhythmia (pathological condition that leads to disruption of the rhythm of heart contraction).
12. Increased blood pressure.
13. Bradycardia (decreased heart rate).
14. Flatulence (increased accumulation of gases in the intestines).
15. Depressive disorders.
16. Increased intracranial or intraocular pressure.
17. Migraine ( neurological disease, the most common and characteristic feature which is considered episodic or regular pain).
18. Insomnia (a sleep disorder characterized by insufficient duration or quality of sleep, or a combination of these phenomena over a significant period).
19. Hyperhidrosis (a pathological condition accompanied by increased sweating throughout the body or only in certain areas in armpits, on the feet or palms, in large folds).
20. Weight gain.
21. Eye infection.
22. The appearance of peripheral edema.
23. Myalgia.
24. Hypokalemia (low concentration of potassium ions in the blood).
25. The appearance of stretch marks or acne.
26. Skin rashes.
27. Exacerbation of infectious diseases.

What dosage of Prednisolone is prescribed to children?

If injections into a vein are not possible, the drug is used intramuscularly, and if it improves, it is replaced with tablets. If the medication is prescribed for a long period, you should stop taking it gradually, reducing the daily dosage. The longer the therapy was carried out, the slower the drug was discontinued.

Prednisolone tablets are usually given once every six to eight hours in the morning, since it is at this time that glucocorticoids are formed in the human body. If the concentration of the active substance is very high, it can be divided into several uses.

At the same time, in the morning, children are usually prescribed the maximum possible dosage of Prednisolone, and the remainder is used at twelve o’clock. The use of tablets is recommended during meals or immediately after them. The drug is washed down with water.

The dosage form, dosage and duration of use of the drug are determined by the doctor, taking into account many factors, including diagnosis, age of the child, weight.

According to the instructions for use, "Prednisolone" in ampoules can be administered intravenously to children either by stream or through a dropper. It is intravenous injections that are carried out in acute diseases, when it is necessary to provide emergency assistance.

Prednisolone ointment is applied to damaged areas of the skin one to three times a day. It is not recommended to cover the medication with a bandage and use it for more than two weeks.

According to the instructions for use, Prednisolone can be prescribed to small patients in the form of inhalations. Such measures eliminate swelling, eliminate spasms and cough syndrome, therefore they are used for the following diseases:

• laryngeal stenosis (narrowing of the lumen of the larynx, which leads to difficulty passing air during breathing);
• laryngitis (inflammation of the mucous membranes of the larynx);
• obstructive bronchitis.

For manipulation, the drug is used in ampoules and an inhaler. A medical specialist should calculate the dose of Prednisolone for children, determine the frequency of inhalations and the duration of therapy.

Overdose

When taking too much medication, blood pressure increases, swelling occurs, and other side effects intensify. In this case, you must immediately contact medical care.

What drugs does Prednisolone interact with?

According to reviews, "Prednisolone" for children must be used with caution; it is also worth considering the use of any other drugs, since such a hormone is not recommended to be combined with many other medications, so as not to cause side effects or not to strengthen them.

In addition, Prednisolone cannot be combined with antiviral vaccines, so a certain time must pass between vaccination and the use of glucocorticoid.

Storage conditions

Prednisolone is dispensed from pharmacies strictly according to prescription. The cost of the drug varies from 100 to 130 rubles. The tablets must be kept at a temperature of twenty-five degrees, and the ampoules and ointment should be kept in a cool place.

Prednisolone (in Latin - Prednisolon) is an anti-inflammatory drug that is used to treat children and adults. It is often the first line of therapy.

Prednisolone is an anti-inflammatory drug that is used to treat children and adults.

Dosage active substance depends on the form of release:

1. Tablets can contain 1 and 5 mg of the main component. They also contain stearic acid, milk sugar, povidone, and starch.
2. The solution for intravenous administration per 1 ml contains 15 or 30 mg. The preparation includes water for injection, nicotinamide, sodium mitabisulfite and other substances as auxiliary components.
3. In drops the concentration is 0.5% (per 1 g - 5 mg).
4. The ointment consists of the following components: active substance (50 mg), glycerin, petroleum jelly, stearic acid and other components.

Release form

The product has several forms of release:

1. Ointment. Packaged in tubes of 10 and 15 g.
2. Pills white, round, flat on both sides, with a notch for dividing. Packing - contour blister pack contains 10 pcs., in one cardboard box There can be up to 10 blisters or a polymer jar containing from 20 to 60 tablets.
3. Lyophilisate (for preparing solution for injection). There are 5 ampoules in 1 cardboard box, placed in a blister pack.
4. Drops. Glass dropper bottle with a capacity of 5 ml, packed in a cardboard box.
5. The solution for injection is transparent, colorless or with a greenish-yellowish tint. In a cardboard package there are 3 ampoules of 1 ml each in a plastic tray.

pharmachologic effect

Pharmacodynamics: the product has:

• anti-inflammatory;
• antiallergic;
• immunosuppressive;
• anti-shock properties.

A complex of a steroid hormone with a receptor is delivered to the cell nucleus, where it begins to interact with effector elements concentrated in areas of chromatin, resulting in a change in messenger RNA and proteins.

Artificial suppression of immunity leads to a decrease in the number of T-lymphocytes and their influence on B-lymphocytes, and accelerates the production of immunoglobulins.

The antiallergic effect is explained by inhibition of the production of allergy provocateurs and a decrease in the development of lymphoid tissue. The product is effective for rapid allergic reactions.

Accelerates the breakdown of proteins and reduces their amount in plasma, accelerates gluconeogenesis in the liver and ensures the formation of enzyme proteins, accelerates the synthesis of albumin in the liver and kidneys. Promotes the redistribution of fat, increases the formation of higher fatty acids.

The antishock effect is associated with a slowdown in the synthesis of platelet activation.

Pharmacokinetics:

• binds to plasma proteins by 90-95%;
• the biotransformation process occurs in the liver, small intestine, kidneys and bronchi;
• the half-life from the blood takes 3-4 hours, from tissues – 17-36 hours;
• excreted through the kidneys, penetrates the placental barrier.

ATX

According to the anatomical-therapeutic-chemical classification, it has the code H02AB06.

What is Prednisolone for?

The drug is used to relieve inflammation of varying severity and reduce body temperature. It is also used as a suppressant allergic reactions, which can threaten human life (Quincke's edema, anaphylactic shock), allergic rhinitis, dermatitis.

The medicine is administered for swelling of the brain that develops as a result of injury, for inflammation and progression of infection, after neurosurgery. Has a beneficial effect on severe burns of the gastrointestinal tract and respiratory tract, severe injuries, used for severe forms bronchial asthma, systemic lupus erythematosus, scleroderma, rheumatoid arthritis.

Prescribed for adrenal hyperplasia, berylliosis, multiple sclerosis, acute hepatitis, hepatic coma and other pathologies. Used for inhalation for problems with the respiratory system, ophthalmology, and oncology.

How to take Prednisolone and how much?

The choice of drug form and treatment regimen depend on the pathology and general condition of the patient. The instructions for use must be strictly followed.

Use of tablets

Treatment with tablets is long-term and is used for mild conditions.

During replacement therapy, 20-30 mg per day is prescribed for oral administration.

For nephrotic syndrome and rheumatic pathologies, the number of tablets increases. At mental disorders high doses are prescribed in exceptional cases, treatment is carried out under constant medical supervision.

For children, the dose for treatment is 1-2 mg per 1 kg of weight, divided 4-6 times a day; to maintain the condition, 0.3-0.6 mg per 1 kg of weight is prescribed, with most or the entire dose taken in the morning.

Prednisolone in ampoules

Injections are given intramuscularly, through a vein or into a joint. The use of ampoules does not involve mixing the product with other medications in a syringe or dropper.

Drug dose:

1. For adults, 4-60 mg is administered intravenously or intramuscularly per day.
2. Children from 6 to 12 years old are given 25-25 mg per day; for children over 12 years old this dose is 25-50 mg. It is injected deep into the gluteal muscle and used strictly as prescribed by a doctor and under his supervision. The course of treatment and administration regimen are selected individually.
3. When diagnosed with Addison's disease, the dose for an adult is 4-60 mg intramuscularly or intravenously.
4. Ulcerative colitis is treated for 5-6 days with a dose of 8-12 ml per day; for severe Crohn's disease, the dose is from 10 to 13 ml per day, the course is 5-7 days.
5. In severe conditions, it is administered slowly intravenously (about 3 minutes) or through a dropper, the dose is 30-60 mg. If it is impossible to inject the drug through a vein, inject it intramuscularly deeply. The dose is increased individually, according to indications.
6. When administered intra-articularly for an adult, the dose is for large joints is 30 mg, for medium - 10-25 mg, for small - 5-10 mg. The procedure is carried out after 3 days, treatment – ​​up to 3 weeks.

Ointment

The product is applied in a thin layer to the skin up to 3 times a day, lightly rubbed in. The course is chosen individually, depends on the disease and the effectiveness of treatment, lasts from 6 to 14 days, no more.

For children over one year of age, treatment lasts 3-7 days, and warming and fixing bandages should not be applied to the site where the ointment is applied, so as not to increase the absorption of corticosteroids.

Eye drops

The drug in the form of a 0.5% solution is injected into the eye 3 times a day, 1-2 drops. In acute conditions, the procedure is carried out every 2-4 hours. After eye surgery, the product is applied 3 or 5 days after surgery.

Before or after meals

The product is used during meals or after meals.

In the morning or evening

special instructions

Prescribed with caution for diabetes mellitus. For tuberculosis and other infections, it is prescribed with antibiotics or tuberculostatic agents.

During treatment, it is necessary to monitor blood pressure and vision, monitor glucose levels in the blood and urine, and donate stool for occult blood. With sudden withdrawal, nausea, lethargy, and anorexia may develop.

Use during pregnancy and lactation

During pregnancy, especially in the first trimester, the drug is prescribed for health reasons, when the benefits of treatment outweigh the harm from using the drug.

It is best to start feeding 4 hours after taking the drug.

Can Prednisolone be given to children?

There are no age restrictions for use, but the drug can negatively affect some processes occurring in the child’s body, therefore it is prescribed strictly according to indications and under the constant supervision of a doctor.

Use in old age

In old age, glucocorticosteroids can have a negative effect on the body, so you need to take the drug with caution and strictly according to the recommendations of doctors.

Use for renal impairment

Not used to treat patients with severe renal failure.

Use for liver dysfunction

Prohibited in case of severe liver failure.

Alcohol compatibility

A one-time consumption of alcoholic beverages during treatment will not have a negative effect on the body, but the systematic combination of alcohol and glucocorticoid treatment can lead to serious consequences.

Impact on the ability to drive vehicles and complex mechanisms

The drug sometimes causes dizziness and other side effects, so it should be taken with caution when driving a car or operating complex machinery where quick reactions and concentration are required.

How to reduce the dosage of Prednisolone

The dosage of the drug is reduced slowly, according to the scheme chosen by the doctor. If you abruptly stop using the drug, the disease may recur.

How long does it take for Prednisolone to work?

The drug in tablets begins to act 90 minutes after administration for 18-36 hours. At intramuscular injection the medicine takes effect within 15 minutes, and when intravenous administration- in 3 minutes.

The product in the form of ointment and drops has an effect immediately after use.

How is the drug harmful?

The product is a systemic drug, therefore it affects the entire body and, along with the benefits, can have negative impact on organs and systems. When taken continuously, the hormonal drug reduces immunity, so it is prescribed in short courses.

Prednisolone withdrawal regimen

When reducing the dose, it is necessary to take into account the results of blood tests. The withdrawal of the drug occurs gradually. After reducing the daily dose to 10 mg per day, the reduction should be made by less than 1 mg per month. This could be 1 mg every 2 months.

The initial dose is reduced by 2.5 mg every month or to 10 mg per day every 2 weeks, then by 1 mg every 6-8 weeks until complete cessation of treatment.

Contraindications

Does not apply in the following cases:

1. At hypersensitivity to the substances included in the product.
2. Diseases of the stomach and duodenum.
3. For osteoporosis.
4. Itsenko-Cushing's disease.
5. Thromboembolism.
6. Development of renal failure, nephrourolithiasis.
7. Development of hypoalbuminemia.
8. Hypertension.
9. Internal and external viral infections.
10. Diabetes.
11. Vaccination of any kind.
12. Systemic mycosis.
13. Tuberculosis is active and in latent form.
14. Cataract and glaucoma.
15. Progressive mental illnesses, depressive states.
16. Herpes.
17. Syphilis.
18. Pregnancy and lactation period.
19. Infections at the injection site during intra-articular injections.

Side effects

The occurrence of side effects depends on the duration of the course of treatment, the dose and regimen of the drug.

Negative consequences can occur from all organs and systems. A person’s blood pressure may increase; due to the drug’s effect on glucose production, obese patients have problems losing weight and diabetes mellitus progresses.

Numerous digestive problems, pancreatitis, and internal bleeding may occur. Arrhythmia and bradycardia develop, after a heart attack the area of ​​necrosis increases, the growth of scar tissue slows down, which can lead to heart rupture. Nervous system disorders, euphoria, hallucinations, psychoses occur, intracranial pressure increases, insomnia, convulsions, severe headaches, and problems with the cerebellum appear.

Problems with the organs of vision arise: intraocular pressure increases, which may cause damage to the optic nerve; cataracts and secondary infections may develop. In children, the formation of the musculoskeletal system is disrupted; in adults, osteoporosis and other problems with bones and cartilage develop.

Numerous rashes may appear on the skin, healing of damage slows down, and candidiasis develops. Night urination becomes more frequent and urolithiasis appears.

Full list adverse reactions you need to ask your doctor.

Overdose

In case of overdose, the manifestation of side effects increases.

Drug interactions

Combining medications can have a negative effect on the body.

When treating, the following conditions must be taken into account:

1. Ephedrine, Phenobarbital and Theophylline reduce the concentration of the active substance. Combination with diuretics accelerates the removal of potassium from the body. Sodium-containing drugs increase blood pressure and provoke the formation of edema.
2. TO heavy bleeding and ulcers in the gastrointestinal tract can be caused by combination with anticoagulants and thrombolytics. Indomethacin increases side effects.
3. The drug enhances the negative effect of Paracetamol on the liver and reduces the effect of taking insulin.
4. Intraocular pressure increases when used together with antidepressants and nitrates.
5. When using a drug to reduce adrenal activity, an increase in the dose of the active substance may be required.
6. Neuroleptics provoke the development of cataracts.
7. Vaccines containing live viruses increase the risk of contracting viral infections.

When treating, the doctor takes into account all possible risks from combining drugs.

Analogs

The following analogues have a general structure:

• Metypred, Dexamed, Dexamethasone;
• Betamethasone, Diprospan, Maxidex;
• Flosterone, Kenalog, Hydrocortisone;
• Suprastin.

Conditions of release and storage

Sold in pharmacies upon presentation of a prescription.

Best before date

Tablets and solution in ampoules are stored for 5 years, the product in the form of an ointment is allowed to be used for 2 years.

Price

The price of the drug depends on the manufacturer and the quantity in 1 package. Tablets cost from 50 to 700 rubles. The ointment can be purchased at prices ranging from 14 to 450 rubles. Injection solution costs from 20 to 200 rubles, drops - from 50 to 200 rubles.

Synthetic glucocorticosteroid drug, dehydrogenated analogue of hydrocortisone. It has anti-inflammatory, antiallergic, immunosuppressive effects, increases the sensitivity of beta-adrenergic receptors to endogenous catecholamines.

Protein metabolism: reduces the amount of globulins in plasma, increases albumin synthesis in the liver and kidneys (with an increase in the albumin/globulin ratio), reduces synthesis and increases protein catabolism in muscle tissue.

Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (fat accumulation occurs mainly in the area shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Carbohydrate metabolism: increases the absorption of carbohydrates from gastrointestinal tract; increases the activity of glucose-6-phosphatase (increasing the flow of glucose from the liver into the blood); increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases (activation of gluconeogenesis); promotes the development of hyperglycemia.

Water-electrolyte metabolism: retains sodium and water in the body, stimulates the excretion of potassium (mineralocorticoid activity), reduces calcium absorption from the gastrointestinal tract, reduces bone mineralization.

Important: description of the drug Prednisolone is not intended for prescribing treatment without the participation of a doctor.

Instructions for use:

Pharmacological properties

Pharmacodynamics

It has anti-inflammatory, antiallergic, immunosuppressive, antishock and antitoxic effects. In relatively large doses, it inhibits the activity of fibroblasts, the synthesis of collagen, reticuloendothelium and connective tissue(inhibition of the proliferative phase of inflammation), delays synthesis and accelerates protein catabolism in muscle tissue, but increases its synthesis in the liver.

The antiallergic and immunosuppressive properties of the drug are due to inhibition of the development of lymphoid tissue with its involution with long-term use, a decrease in the number of circulating T- and B-lymphocytes, inhibition of mast cell degranulation, and suppression of antibody production.

The antishock effect of the drug is due to an increase in the vascular response to endo- and exogenous vasoconstrictor substances, with restoration of the sensitivity of vascular receptors to catecholamines and an increase in their hypertensive effect, as well as a delay in the excretion of sodium and water from the body.

The antitoxic effect of the drug is associated with stimulation of protein synthesis processes in the liver and acceleration of inactivation of endogenous toxic metabolites and xenobiotics in it, as well as with increased stability cell membranes, incl. hepatocytes.

Enhances the deposition of glycogen in the liver and the synthesis of glucose from the products of protein metabolism. An increase in blood glucose levels activates the release of insulin. Inhibits the uptake of glucose by fat cells, which leads to activation of lipolysis.

However, due to increased insulin secretion, lipogenesis is stimulated, which promotes fat accumulation. Reduces calcium absorption in the intestine, increases its leaching from bones and excretion by the kidneys.

Suppresses the release of adrenocorticotropic hormone and b-lipotropin by the pituitary gland, and therefore, with long-term use, the drug can contribute to the development of functional insufficiency of the adrenal cortex.

The main factors limiting long-term prednisone therapy are osteoporosis and Itsenko-Cushing syndrome. Prednisolone inhibits the secretion of thyroid-stimulating and follicle-stimulating hormones.

In high doses, it can increase the excitability of brain tissue and help lower the threshold for convulsive readiness. Stimulates excess secretion of hydrochloric acid and pepsin in the stomach, which may contribute to the development of peptic ulcers.

Pharmacokinetics

When administered intramuscularly, it is absorbed into the blood quickly, however, compared to reaching the maximum level in the blood, the pharmacological effect of the drug is significantly delayed and develops within 2-8 hours.

In plasma, most of prednisolone binds to transcortin (cortisol-binding globulin), and when the process is saturated, to albumin. With a decrease in protein synthesis, a decrease in the binding capacity of albumin is observed, which can cause an increase in the free fraction of prednisolone and, as a consequence, the manifestation of its toxic effect when using normal therapeutic doses.

The half-life in adults is 2-4 hours, in children it is shorter. It is biotransformed by oxidation mainly in the liver, as well as in the kidneys, small intestine, and bronchi. Oxidized forms are glucuronidated or sulfated and excreted by the kidneys in the form of conjugates.

About 20% of prednisolone is excreted from the body unchanged by the kidneys; a small part is excreted in bile. In liver diseases, the metabolism of prednisolone slows down and the degree of its binding to plasma proteins decreases, which leads to an increase in the half-life of the drug.

Indications for use of Prednisolone

Intramuscular, intravenous administration

Systemic connective tissue diseases

• systemic lupus erythematosus,
• dermatomyositis,
• scleroderma,
• periarteritis nodosa,
• Bekhterev's disease.

Hematological diseases

• acute hemolytic anemia,
• lymphogranulomatosis,
• granulocytopenia,
• thrombocytopenic purpura,
• agranulocytosis,
• various forms of leukemia.

Skin diseases

• ordinary eczema,
• exudative erythema multiforme,
• pemphigus ordinary,
• erythroderma,
• exfoliative dermatitis,
• seborrheic dermatitis,
• psoriasis,
• alopecia,
• adrenogenital syndrome.

Replacement therapy

Addison's crisis.

Emergency conditions

• severe forms of nonspecific ulcerative colitis and Crohn's disease,
• shock (burn, traumatic, surgical, anaphylactic, toxic, transfusion),
• status asthmaticus,
• acute adrenal insufficiency,
• hepatic coma,
• severe allergic and anaphylactic reactions,
• hypoglycemic reactions.

Intra-articular injection

• chronic polyarthritis,
• osteoarthritis of large joints,
• rheumatoid arthritis,
• post-traumatic arthritis,
• arthrosis

Directions for use and doses

Mixing and simultaneous use of prednisolone with other drugs in the same infusion system or syringe is not allowed! The drug is prescribed for intravenous, intramuscular or intra-articular administration. The dose of prednisolone depends on the severity of the disease.

For the treatment of adults, the daily dose is 4-60 mg intravenously or intramuscularly. For children, the drug is prescribed intramuscularly (deep into the gluteal muscle) strictly according to indications and under the supervision of a physician: children aged 6-12 years – 25 mg/day, over 12 years – 25–50 mg/day.

The duration of use and the number of injections of the drug are determined individually. For Addison's disease, the daily dose for adults is 4-60 mg intravenously or intramuscularly.

In severe forms of ulcerative colitis, 8-12 ml/day (240-360 mg Prednisolone) for 5-6 days, in severe forms of Crohn's disease - 10-13 ml/day (300-390 mg Prednisolone) for 5 -7 days.

At emergency conditions Prednisolone is administered intravenously, slowly (over approximately 3 minutes) or drip, at a dose of 30-60 mg.

If intravenous infusion is difficult, the drug is administered intramuscularly, deeply. With this method of administration, the effect develops more slowly. If necessary, the drug is re-administered intravenously or intramuscularly at a dose of 30-60 mg every 20-30 minutes. In some cases, an increase in the indicated dose is allowed, which is decided by the doctor individually in each specific case.

For adults, the dose of intra-articular prednisolone is 30 mg for large joints, 10-25 mg for joints average size and 5-10 mg – for small joints. The drug is administered every 3 days. The course of treatment is up to 3 weeks.

Features of application

At infectious diseases and latent forms of tuberculosis, the drug should be prescribed only in combination with antibiotics and anti-tuberculosis drugs. If it is necessary to use prednisolone while taking oral hypoglycemic drugs or anticoagulants, it is necessary to adjust the dosage regimen of the latter.

In patients with thrombocytopenic purpura, the drug is used only intravenously. After cessation of treatment, withdrawal syndrome, adrenal insufficiency, and exacerbation of the disease for which prednisolone was prescribed may occur.

If functional adrenal insufficiency occurs after cessation of treatment with prednisolone, the drug should be resumed immediately and the dose reduced very slowly and with caution (e.g. daily dose should be reduced by 2-3 mg over 7-10 days).

Due to the risk of developing hypercortisolism new course treatment with cortisone, after previous long-term treatment with prednisolone over several months, should always be started with low initial doses (except in acute life-threatening conditions).

Electrolyte balance should be especially carefully monitored when prednisolone is used in combination with diuretics. With long-term treatment with prednisolone to prevent hypokalemia, it is necessary to prescribe potassium supplements and an appropriate diet due to a possible increase in intraocular pressure and the risk of developing subcapsular cataracts.

During treatment, especially long-term treatment, observation by an ophthalmologist is necessary. If there is a history of psoriasis, prednisolone in high doses is used with extreme caution. If there is a history of psychosis or seizures, prednisolone should be used only in minimal effective doses.

Also prescribed with caution after a recent myocardial infarction (in patients with acute, subacute myocardial infarction, expansion of the focus of necrosis, slowdown in the formation of scar tissue, and rupture of the heart muscle are possible).

It is prescribed with particular caution for liver failure, conditions that cause the occurrence of hypoalbuminemia, and obesity of the 3rd - 4th degree. Women during menopause need to undergo research regarding possible occurrence osteoporosis.

When treated with glucocorticoids for a long time, it is recommended to regularly monitor blood pressure, determine the level of glucose in the urine and blood, perform a fecal occult blood test, blood clotting tests, and x-ray monitoring of the spine.

Before starting treatment with glucocorticoids, a thorough examination of the gastrointestinal tract should be performed to exclude gastric and duodenal ulcers.

Side effects

The development of severe adverse reactions depends on the dose and duration of treatment. Adverse reactions usually develop with long-term treatment with the drug. Over a short period, the risk of their occurrence is unlikely.

Infections and infestations

Increased sensitivity to bacterial, viral, fungal infections, their severity with masking of symptoms, opportunistic infections.

Blood system and lymphatic system

An increase in the total number of leukocytes with a decrease in the number of eosinophils, monocytes and lymphocytes. The mass of lymphoid tissue decreases. Blood clotting may increase, which leads to thrombosis and thromboembolism.

Endocrine system and metabolism

Suppression of the hypothalamic-pituitary-adrenal system, growth retardation in children and adolescents, disturbance menstrual cycle, impaired secretion of sex hormones (amenorrhea), postmenopausal bleeding, Cushingoid face, hirsutism, weight gain, decreased tolerance to carbohydrates, increased need for insulin and oral hypoglycemic drugs, hyperlipidemia, negative nitrogen and calcium balance, increased appetite, impaired mineral metabolism and electrolyte balance, hypokalemic alkalosis, hypokalemia, possible fluid and sodium retention in the body.

Mental disorders

Irritability, euphobia, depression, suicidal tendencies, insomnia, labile mood, increased concentration, psychological dependence, mania, hallucinations, exacerbation of schizophrenia, dementia, psychosis, anxiety, sleep disturbance, epileptic seizures, cognitive dysfunction (including amnesia and impaired consciousness), increased intracranial pressure, which is accompanied by nausea and disc edema optic nerve in children.

Nervous system

Increased intracranial pressure, epileptic seizures, peripheral neuropathies, paresthesia, dizziness, headache, autonomic disorders.

Organs of vision

Increased intraocular pressure, glaucoma, swelling of the optic nerve, cataracts, thinning of the cornea and sclera, exacerbation of eye viral and fungal infections, exophthalmos.

The cardiovascular system

Myocardial rupture due to myocardial infarction, arterial hypo- or hypertension, bradycardia, combined ventricular arrhythmia, asystole (due to rapid administration of the drug), atherosclerosis, thrombosis, vasculitis, heart failure, peripheral edema.

The immune system

Allergic reactions that cause anaphylactic shock with a fatal outcome, angioedema, allergic dermatitis, changes in reaction to skin tests, relapse of tuberculosis, immunosuppression.

Gastrointestinal tract

Nausea, bloating, bad taste in the mouth, dyspepsia, peptic ulcers with perforation and bleeding, esophageal ulcer, esophageal candidiasis, pancreatitis, perforation gallbladder, gastric bleeding, local ileitis and ulcerative colitis. During the use of the drug, an increase in ALT, AST and alkaline phosphatase may be observed, which is usually not important and is reversible after discontinuation of the drug.

Leather

Slowing of regeneration, skin atrophy, formation of hematomas and atrophic stripes of the skin (striae), telangiectasia, acne, acne, hirsutism, microhemorrhages, ecchymosis, purpura, hypo- or hyperpigmentation, post-steroid panniculitis, which is characterized by the appearance of erythematosis, hot subcutaneous thickenings for 2 weeks after discontinuation of the drug, Kaposi's sarcoma.

Musculoskeletal system

Proximal myopathy, osteoporosis, tendon rupture, muscle weakness, atrophy, myopathy, fractures of the spine and long bones, aseptic osteonecrosis. Urinary system: increased risk of urolith formation and Instructions for use: leukocytes and red blood cells in the urine without obvious kidney damage.

Are common

Malaise, persistent hiccups when using the drug in high doses, adrenal insufficiency, which leads to arterial hypotension, hypoglycemia, and death in stressful situations such as surgery, trauma, or infection unless the prednisolone dose is increased.

With abrupt withdrawal of the drug, withdrawal syndrome is possible, the severity of symptoms depends on the degree of adrenal atrophy, headache, nausea, pain in the adrenal glands are observed. abdominal cavity, dizziness, anorexia, weakness, mood changes, lethargy, fever, myalgia, arthralgia, rhinitis, conjunctivitis, skin pain, weight loss.

In more severe cases - severe mental disorders and increased intracranial pressure, steroid pseudorheumatism in patients with rheumatism, death. Reactions at the injection site: pain, burning, pigmentation changes (depigmentation, leucoderma), skin atrophy, sterile abscesses, rarely - lipoatrophy.

Interaction with other drugs

Anticoagulants: when used simultaneously with glucocorticoids, the effect of anticoagulants may be increased or decreased. Parenteral administration of prednisolone causes the thrombolytic effect of vitamin K antagonists (fluindione, acenocoumarol).

Salicylates and other non-steroidal anti-inflammatory drugs: Concomitant use of salicylates, indomethacin and other non-steroidal anti-inflammatory drugs may increase the likelihood of gastric ulcers. Prednisolone reduces the level of salicylates in the blood serum, increasing their renal clearance.

Caution is necessary when reducing the dose of prednisolone during long-term concomitant use. Hypoglycemic drugs: Prednisolone partially inhibits the hypoglycemic effect of oral hypoglycemic agents and insulin. Hepatic enzyme inducers, for example, barbiturates, phenytoin, pyramidone, carbamazepine and rifampicin increase the systemic clearance of prednisolone, thereby reducing the effect of prednisolone by almost 2 times.

CYP3A4 inhibitors, such as erythromycin, clarithromycin, ketoconazole, diltiazem, aprepitant, itraconazole and oleandomycin, increase the elimination and plasma levels of prednisolone, which increases the therapeutic and side effects of prednisolone.

Estrogen may potentiate the effect of prednisolone by slowing its metabolism. It is not recommended to adjust the dose of prednisolone for women using oral contraceptives, which contribute not only to an increase in the half-life, but also to the development of the atypical immunosuppressive effect of prednisolone.

Fluoroquinolones: Concomitant use may cause tendon damage. Amphotericin, diuretics and laxatives: Prednisolone may increase potassium excretion in patients receiving these drugs concomitantly.

Immunosuppressants: Prednisolone has active immunosuppressive properties, which may cause an increase in therapeutic effects or the risk of developing various adverse reactions when used simultaneously with other immunosuppressants.

Only some of them can be explained by pharmacokinetic interactions. Glucocorticoids increase the antiemetic effectiveness of antiemetic drugs that are used in parallel during therapy with anticancer drugs that cause vomiting.

Corticosteroids may increase plasma concentrations of tacrolimus when used concomitantly; when they are discontinued, plasma concentrations of tacrolimus decrease. Immunization: Glucocorticoids may reduce the effectiveness of immunization and increase the risk of neurological complications.

The use of therapeutic (immunosuppressive) doses of glucocorticoids with live viral vaccines may increase the risk of developing viral diseases. Emergency vaccines may be used during drug therapy.

Anticholinesterase agents: In patients with myasthenia gravis, the use of glucocorticoids and anticholinesterase agents may cause muscle weakness, especially in patients with myasthenia gravis.

Others: Two serious cases of acute myopathy have been reported in elderly patients who took doxocarium chloride and high-dose prednisolone. With long-term therapy, glucocorticoids may reduce the effect of somatotropin.

Cases of acute myopathy have been described with the use of corticosteroids in patients who are simultaneously receiving treatment with neuromuscular transmission blockers (for example, pancuronium).

Cases of seizures have been reported with the simultaneous use of prednisolone and cyclosporine. Because coadministration of these drugs causes mutual inhibition of metabolism, it is likely that seizures and other side effects associated with the use of each of these drugs as monotherapy may occur more frequently when administered concomitantly.

Concomitant use may cause an increase in plasma concentrations of other drugs. Antihistamines reduce the effect of prednisolone. When prednisolone is used simultaneously with antihypertensive drugs, the effectiveness of the latter may be reduced.

Contraindications

Hypersensitivity to the components of the drug; peptic ulcer of the stomach and duodenum, osteoporosis, Itsenko-Cushing's disease, tendency to thromboembolism, renal failure, arterial hypertension, viral infections (including viral lesions of the eyes and skin), decompensated diabetes mellitus, vaccination period (at least 14 days before and after preventive immunization), lymphadenitis after BCG vaccination, active form of tuberculosis, glaucoma, cataracts, productive symptoms with mental illness, psychosis, depression; systemic mycosis, herpetic diseases, syphilis, severe myopathy (except for myasthenia gravis), poliomyelitis (except for the bulbar-encephalitic form), pregnancy and lactation. For intra-articular injections – infections at the injection site.

Overdose

Symptoms

In case of overdose, nausea, vomiting, bradycardia, arrhythmia, increased symptoms of heart failure, cardiac arrest are possible; hypokalemia, increased blood pressure, muscle cramps, hyperglycemia, thromboembolism, acute psychosis, dizziness, headache, possible development of symptoms of hypercortisolism: weight gain, development of edema, arterial hypertension, glucosuria, hypokalemia.

In children with an overdose, suppression of the hypothalamic-pituitary-adrenal system, Itsenko-Cushing syndrome, decreased excretion of growth hormone, and increased intracranial pressure is possible. There is no specific antidote.

Treatment

Stopping the use of the drug symptomatic therapy, if necessary, correction of electrolyte balance.

Questions and answers about the drug "Prednisolone"

Question:Hello, our daughter is 5 years old. We were admitted to the hematology department with a diagnosis of hemorrhagic vasculitis in the mildest form (only a rash on the legs). At the hospital they gave me a deep bath and injected him with heparin. Thank God the stains are almost gone. When I was discharged, I was prescribed prednisolone 3.5 tablets per day for 2 weeks, followed by a decrease. After 10 days, we abruptly stopped giving it, as the child began to gain weight. We haven't drunk for 3 days now. The child feels fine. We were scared that there might be consequences due to a sudden refusal. Please tell me, if the child feels fine for the 3rd day, should we be afraid of anything?

Answer: TO dangerous consequences symptoms that occur after cessation of Prednisolone therapy include: return of pathological symptoms, including pain syndrome; headache; sudden fluctuations in body weight; worsening mood; digestive disorders. In this case, it is recommended to resume taking the drug, and then, under the supervision of a doctor, gradually reduce the single and daily dosages. Monitor the child's condition; if it worsens, contact your doctor.

Question:Hello. Red rashes with white dots appeared on the skin, like nettles. It might come from the raspberries you ate last night, but it might also be due to nervousness. They prescribed us to drink Zodak at home, drink Enterosgel and a diet. And there in the hospital I got an injection with uprastin and prednisolone. That’s actually the question, suprastin is understandable, but why prednisolone?

Answer: Hello. Prednisolone is used to relieve shock and severe allergic reactions.

Question:Hello! My child is 7 months old. fell ill with the flu, or an acute respiratory infection (during a flu epidemic) with all the symptoms. At the children's clinic they told me that to alleviate the condition and relieve spasm of the larynx, I need to inject no-shpu. Together with no-shpa we were injected with prednisolone. At that time I didn’t know what kind of drug it was, because... I haven't encountered him. The nurse said that it was an anti-inflammatory, not an antibiotic - and I agreed. In the evening the child had a stomach ache, cramping pain and foamy diarrhea. Now there is no diarrhea, but he still poops differently than before. The smell is somewhat sour and the consistency of the stool is thinner than before. I’ve read a lot about prednisolone on the Internet and now I’m afraid that maybe it’s increased stomach acidity. Tell me why this injection is dangerous for my child and how I can minimize its consequences. Of course, I’m not going to wave my fists after a fight, especially since it’s my own fault - I didn’t know what prednisolone was and gave an injection of a medicine unknown to me. The child was not in a dangerous condition. We were then prescribed the antibiotic agumetin, it seems, but we didn’t drink it, and we got better without it.

Answer: The doctors did everything right. Prednisolone injection, a single injection, does not produce any side effects. Moreover, the child had indications for its administration. Abnormal bowel movements and abdominal pain are associated with the disease itself and are not a side effect of the drug. Now you need to do a coprocytogram and take a probiotic, for example, acipol (1 capsule 2 times a day - 10 days) to normalize stool.

Question:Hello. Please tell me, I have the following problem: after giving birth, problems began with the joints in my hands, they became inflamed and painful. I went through a bunch of examinations, but no diagnosis was made. I even took tests for Le cells, but they were not confirmed. I was prescribed to take prednisolone 2 tablets a day. The pain went away and the swelling in the joints subsided; periodically in spring and autumn the joints in the hands become inflamed, but after a week everything goes away. Can I replace prednisolone with more light drug? And how to gradually stop taking it altogether?

Answer: Prednisolone should be discontinued gradually. Start doing it like this: On even days, take 2 tablets as before, on odd days – 1.5 tablets. And so on for 3 weeks. Then for another 3 weeks: on even days, take 2 tablets as before, on odd days – 1 tablet. The next 3 weeks: even - 2 tablets. Odd numbered: 1/2 tablet. The next 3 weeks: even - 2 tablets. Odd numbered: do not accept. The next 3 weeks: even - 1.5 tablets. Odd numbered: do not accept. The next 3 weeks: even - 1 tablet. Odd numbered: do not accept. In the future, do not take prednisolone, but take an infusion of licorice root for 3 weeks (licorice root is sold in a pharmacy), take it according to the instructions on the package. At this time, you can also start taking Wobenzym - 3 tablets 3 times a day for 2 months.

Dosage form"type="checkbox">

Dosage form

Tablets 5 mg

Compound

One tablet contains

active substance – prednisolone 5 mg,

excipients: magnesium stearate, talc, corn starch, lactose monohydrate, pregelatinized starch.

Description

Tablets are white, round in shape, flat on both sides with beveled edges, with engravings “PD” and “5.0” and a line between them.

Pharmacotherapeutic group

Corticosteroids for systemic use. Glucocorticoids. Prednisolone.

ATX code H02AB06

Pharmacological properties"type="checkbox">

Pharmacological properties

Pharmacokinetics

Suction:
Prednisolone, when taken orally, is quickly and completely absorbed from the gastrointestinal tract (up to 85% of the dose), bioavailability is lower at higher doses. Maximum plasma concentrations are reached after approximately 1-2 hours. However, the maximum biological effect is achieved much later (usually no earlier than 4-8 hours).
Food intake slows down the achievement of the maximum concentration of prednisolone in the blood plasma, but does not affect the overall bioavailability.

Distribution:
As a rule, the binding of prednisolone is 90-95%, which predominantly occurs with corticosteroid binding globulin (transcortin), as well as with plasma albumin when saturation of transcortin occurs.
Only 5-10% of prednisolone is in unbound form and is biologically active.

Metabolism:
Prednisolone is the main active metabolite of prednisone. Prednisolone is primarily metabolized in the liver; 25% is excreted unchanged through the kidneys.

Elimination:
The biological half-life is 18-36 hours. The half-life from blood plasma is 2–4 hours, which is reduced medicines, inducing liver enzymes.

Pharmacokinetics special groups patients:

In patients with severe liver disease (hepatitis, cirrhosis), the clearance of prednisolone is lower and the half-life is longer. The free active fraction may increase significantly in patients with liver disease associated with hypoalbuminemia. In patients with severe liver dysfunction, bioavailability may also be reduced.

Pharmacodynamics:

Prednisolone 5 mg tablets is a corticosteroid with glucocorticoid, anti-inflammatory, and mineralocorticoid activity, although to a lesser extent. Like other corticosteroids, Prednisolone Nycomed induces several mechanisms, including anti-inflammatory activity, immunosuppressive properties, and antiproliferative effects. Other mechanisms include effects on carbohydrate metabolism, fat distribution, hematologic parameters, calcium excretion, growth, mood, and hypothalamic-pituitary-adrenal axis suppression. The threshold dose for the development of Cushing's syndrome is 7.5 mg/day.

1. The anti-inflammatory effect is achieved by reducing the formation and reduced activity of inflammatory mediators (quinine, histamine, liposomal enzymes, prostaglandins and leukotrienes), reducing the initial manifestations of the inflammatory process. Prednisolone reduces the migration of cells into the affected areas, reduces vasodilation and increased vascular permeability in these areas. The vasoconstrictor effect reduces vascular permeability, as a result of which the movement of blood serum through the walls of blood vessels into the intercellular spaces is reduced and, as a result, swelling and patient complaints are reduced.

2. Immunosuppressive properties reduce the response to delayed and immediate hypersensitivity reactions (types III and IV) by inhibiting toxic antigen-antibody complexes that cause allergic vasculitis in the walls of skin vessels, as well as by inhibiting lymphokines, target cells and macrophages (causing allergic contact dermatitis when acting together).

3. Antiproliferative effects reduce inflammation, expressed by the formation of a crust on the skin, formed as a result of increased proliferative activity of white blood cells - lymphocytes and excessive formation of small capillaries in the superficial skin layer, with dermatological diseases(such as psoriasis).

Indications for use

Pharmacodynamic therapy

Rheumatic diseases, including collagenoses

Allergic diseases ( hay fever, bronchial asthma, urticaria, drug allergies)

Respiratory tract diseases: chronic bronchitis (prescribed in conjunction with antibacterial treatment)

Pulmonary fibrosis, sarcoidosis

Ulcerative ileitis/colitis

Proliferative glomerulonephritis (lipoid nephrosis), nephrotic syndrome

Acute severe dermatoses (pemphigus vulgaris, erythroderma, Lyell's syndrome)

Thrombocytopenic purpura, chronic lymphadenosis with autoimmune phenomenon (hemolytic anemia, thrombopenia)

Tumors (used in combination with chemotherapy)

Replacement therapy

Primary adrenal insufficiency (Addison's disease) and hypopituitarism (Sheehan syndrome)

Directions for use and doses

When initiating therapy with any corticosteroid, the following guidelines should be considered and followed. The initial dose should be appropriate to achieve the desired therapeutic effect and will depend on the clinical response. It is necessary to periodically evaluate this dose, since the severity of the underlying disease may change, or complications may develop during therapy. The dose should be gradually reduced to the minimum value while achieving and maintaining a satisfactory clinical response to treatment. It may be necessary to increase the dose during long-term therapy or in case of exacerbation of the underlying disease.

If long-term prednisolone therapy (usually more than 3 weeks) is to be discontinued, withdrawal should be gradual and stepwise to avoid “withdrawal syndrome.” Abrupt cessation of therapy may lead to fatal outcome. The dose should be reduced over weeks or even months depending on the dose size, duration of therapy, the patient's underlying disease, and the patient's individual response to treatment. It is unlikely that abrupt discontinuation of treatment with Prednisolone Nycomed for less than 3 weeks will result in clinically significant suppression of the hypothalamic-pituitary-adrenal axis in most patients, however, it should be borne in mind that the response to and tolerability of corticosteroid withdrawal may vary widely. Thus, it is necessary to consider a gradual dose reduction when discontinuing drugs after short courses or when taking higher doses and in patients with other risk factors for the development of adrenocortical insufficiency.

The dosage regimen for gradual dose reduction should be selected individually. Most patients tolerate a reduction in the dose of Prednisolone Nycomed by 2.5 mg every 3-7 days until reaching a dose of Prednisolone Nycomed 5-10 mg/day. Higher doses should be reduced gradually over 9-12 months.

When tapering the dose, the evening dose should be skipped first, followed by the midday, afternoon or evening doses, so that eventually only the morning dose is taken after 10 days. Long-term intermittent treatment with glucocorticoid therapy (1 dose every other day in the morning) has shown to be effective due to the lack of suppression of the adrenal cortex.

Directions for use: taken orally with a small amount of liquid after meals.

Adults: The usual dose ranges from 5 to 60 milligrams/day, depending on the disease being treated. In general, the entire daily dose should be taken in the morning between 6 and 8 o'clock. (Circadian therapy - circadian secretory rhythms should be taken into account when prescribing).

Doses for special groups of patients

Dosage in patients with hypothyroidism: Dosage reduction may be necessary in patients with hypothyroidism.

Dosage in patients with hepatic impairment: Patients with hepatic impairment are more likely to develop severe adverse reactions due to decreased protein binding due to hypoalbuminemia. Dose adjustment may be necessary.

Dosage in patients with renal impairment: No dosage adjustment is required in patients with renal impairment.

Dosage in elderly patients: No dose adjustment is required, however, it should be noted that long-term use of corticosteroids in elderly patients may cause exacerbation of diabetes mellitus, hypertension, congestive heart disease, osteoporosis or depression.

Doses for children: no experience of use in children. Children are considered to be particularly at risk for growth retardation, and the indication for use of the drug requires a particularly strict assessment of the condition of children.
In children during the growth period, treatment should generally be periodic or intermittent. A gradual dose reduction to a dose that provides satisfactory clinical response and minimal side effects is necessary.

Anti-inflammatory or immunosuppressive effects: the usual dose of prednisolone is 0.1-2 mg/kg/day. The dose can be divided into 1-4 doses per day. The lowest effective dose is usually determined by clinical response.

Exacerbation of bronchial asthma: usually the dose of prednisolone is 1-2 mg/kg/day; this dose can be divided into 1-2 doses/day for 3-5 days.

Replacement therapy: the usual dose is 4 to 5 mg/m2/day.

Nephrotic syndrome: the usual dose is 2 mg/kg/day ( maximum dose 60-80 mg/day), which is given in 2-4 doses.

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Side effects

Very often (>1/10), often (>1/100,<1/10), нечасто (>1/1000, <1/100), редко (>1/10000, <1/1000), очень редко (<1/10000), не известно (не может быть оценено на основе имеющихся данных).

In general, the incidence of predicted side effects, including suppression of the hypothalamic-pituitary-adrenal axis, depends on the dose, timing of administration and duration of treatment. Side effects can be minimized by using the lowest effective dose for the shortest possible period of time.

Often

Increased susceptibility to infection, worsening of existing infection, activation of latent infection and masking of symptoms of infection (due to the immunosuppressive and anti-inflammatory effect of prednisolone)

Decrease in the number of eosinophils and lymphocytes

Masking or worsening an existing disease

Adrenal insufficiency (starting with suppression of the hypothalamus and ending with true atrophy of the adrenal cortex) with constant oral use of prednisolone, withdrawal syndrome due to adrenal insufficiency (headache, nausea, dizziness, anorexia, weakness, emotional instability, apathy and inadequate reaction to stressful situations), “steroid diabetes mellitus” with low insulin sensitivity, increased blood sugar levels in patients already suffering from diabetes mellitus (100%), growth retardation in children as a result of impaired secretion of growth hormone and decreased sensitivity to it

Increased intraocular pressure (up to 40% of patients treated with an oral drug), cataracts (in 30% of patients with long-term oral treatment with the drug)

Lung abscess (12%)

Oral candidiasis, especially in patients with cancer (33%)

Fungal infections of mucous membranes (30%)

Osteoporosis manifested by back pain, limited mobility, acute pain, vertebral compression fractures and decreased height, long bone fractures (25% with long-term oral treatment), myopathy (10%) with high-dose treatment

Increased white blood cell and platelet counts

Cushing's syndrome, including changes in the pattern of fat deposition (moon face, trunk obesity, "bull hump") with chronic intake of oral doses higher than physiological (usually more than 50 mg per day), hypokalemia due to sodium retention and potassium excretion, amenorrhea in women of childbearing age, increased levels of cholesterol, triglycerides and lipoproteins when treated with high doses taken orally, increased appetite and weight gain

Euphoria, depression, psychosis (corticosteroid-induced)

Hypertension (due to sodium retention, resulting in fluid retention), worsening congestive heart failure (due to sodium retention)

Increased risk of developing tuberculosis

Increased symptoms and increased risk of developing gastrointestinal perforations, colitis, ileitis, diverticulitis

Stretch marks, acne, bruising, dermatitis, ecchymosis, facial erythema, atrophy, hirsutism, slow wound healing, increased sweating, telangiectasias and thinning of the skin, masking or worsening of existing skin conditions

Increased frequency of nighttime urination

Allergic reactions

Diabetes (<1%) при лечении малыми пероральными дозами, повышение уровня холестерина, триглицеридов и липопротеинов при лечении низкими пероральными дозами

Insomnia, mood swings, personality changes, mania and hallucinations

Myopathy of the respiratory muscles

Ulcers of the stomach or duodenum while taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding (0.5%), gastrointestinal perforation

Aseptic necrosis of bone tissue

Urinary stones due to increased excretion of calcium and phosphate

Risk of thrombosis due to increased blood clotting

Changes in thyroid function

Possible increased duration of coma in cerebral malaria, cognitive impairment (eg, poor memory), dementia, epidural lipomatosis

High risk of destruction of the cornea with simultaneous herpetic eye infection (due to masking of this infection), glaucoma (with long-term oral treatment with the drug)

Very rarely

Ketoacidosis and hyperosmolar coma, manifestation of latent hyperparathyroidism, tendency to porphyria, tumor lysis syndrome, disorders of sex hormone secretion (menstrual disorders, hirsutism, impotence)

Manifestation of latent epilepsy, pseudotumor cerebri (benign intracranial hypertension with symptoms such as headache, blurred vision and visual disturbances)

Exophthalmos (after long-term treatment)

Cardiomyopathy with risk of decreased cardiac activity, arrhythmias due to hypokalemia, vascular collapse

Pancreatitis (after long-term treatment with high doses)

Epidermal necrolysis, Stevens-Johnson syndrome

Achilles and patellar tendinopathy

Not known

Increased risk of atherosclerosis and thrombosis, vasculitis (may also occur as a withdrawal syndrome after long-term therapy)

Ulcers and candidiasis of the esophagus

Muscle atrophy, tendon diseases, tendinitis, tendon ruptures

Delayed wound healing, loss of appetite

Note:
If the dose is reduced too quickly after long-term treatment, problems such as muscle and joint pain, fever, rhinitis, conjunctivitis and weight loss may develop.

Contraindications

Prednisolone Nycomed is contraindicated in the following conditions/disorders:

Hypersensitivity to Prednisolone Nycomed or to any excipient in the drug

Systemic mycoses

Vaccination with live viral or bacterial vaccines is contraindicated during immunosuppressive therapy with corticosteroids (an insufficient immune response may allow the live attenuated vaccine to cause an infectious disease)

With long-term therapy:

Duodenal ulcers

Stomach ulcers

Severe forms of osteoporosis

Severe myopathy (excluding myasthenia gravis of pregnancy)

Psychiatric history

Acute viral infections (herpes zoster, herpes simplex, chicken pox)

Chronic active hepatitis (with Hbs Ag-positive reaction)

Glaucoma

Polio

Lymphadenitis after BCG vaccination

Pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination)

Drug interactions

The corticoid effect is weakened by the use of CYP3A4 inducers such as rifampicin, phenytoin, primidone, barbiturates, carbamazepine and aminoglutethimide.
The corticoid effect is enhanced by the use of substances that block CYP3A4: (ketoconazole, ritonavir), erythromycin, troleandromycin.

Organs of the gastrointestinal tract and metabolism

Hypoglycemic drugs

Prednisolone Nycomed interferes with the effect of hypoglycemic drugs by increasing blood sugar levels. Undesirable effect: increased risk of hyperglycemia.

Cardiovascular drugs

Diuretics that remove potassium (thiazides, furosemide, etc.)

Cardiac glycosides

Glycosidic effect due to potassium deficiency.

Angiotensin-converting enzyme (ACE) inhibitors

Increased risk of changes in blood count.

Antihypertensive

Reducing already low blood pressure.

Hormones for systemic use

Oral contraceptives

The level of prednisolone in the blood serum may increase due to its reduced metabolism. Undesirable effect: increased risk of developing side effects of corticosteroids. Excessive use of glucocorticoids may inhibit the growth-promoting effects of growth hormone.

Antimicrobials

Rifampicin

Increased metabolism of prednisolone. Undesirable effect: decreased effectiveness of prednisolone.

Amphotericin B

The effect of additional potassium loss in the kidneys. Undesirable effect: increased risk of hypokalemia and subsequent cardiac arrhythmias.

Fluoroquinolones

Undesirable effect: increased risk of tendon rupture.

Ketoconazole

Undesirable effect: may enhance the effects of prednisolone.

Products for the muscular, joint and skeletal system

Acetylsalicylic acid (ASA)

Acetylsalicylic acid is known to irritate the stomach, and prednisolone may mask this side effect. The mechanism is unknown. An increase in the clearance of acetylsalicylic acid due to the effects of prednisolone has been reported. There is an increased risk of developing gastrointestinal bleeding and ulcers, as well as a risk of reduced effectiveness of acetylsalicylic acid. Thus, the side effects of salicylates will appear when prednisolone is discontinued.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

NSAIDs are irritating to the stomach, and prednisolone may mask these adverse effects. Undesirable effect: increased risk of gastrointestinal bleeding and ulceration.

Non-depolarizing muscle relaxants

Undesirable effect: prolonged muscle relaxation.

central nervous system

Barbiturates

Barbiturates stimulate liver enzymes and increase the metabolism of prednisolone. Undesirable effect: decreased effectiveness of prednisolone.

Phenytoin and fosphenytoin

Increased metabolism of prednisolone in the liver. Undesirable effect: decreased effectiveness of prednisolone.

Quetiapine

Corticosteroid-induced induction of P450-mediated quetiapine metabolism. Undesirable effect: decreased serum quetiapine levels.

To maintain control of symptoms of schizophrenia, an increase in the dose of quetiapine may be necessary.

Bupropion

Concomitant use with systemic glucocorticoids may increase the risk of seizures.

Immunosuppressants

Methotrexate

The mechanism is unknown. Strengthening the effect of prednisolone.

Cyclosporine

Prednisolone may increase plasma levels of cyclosporine.

Impact on laboratory testing and research

Skin reactions to allergy tests may be suppressed. The decrease in thyroid-stimulating hormone (TSH) increases.

Other agents

A reduced immune response makes it possible for infections caused by live vaccines to occur and may also lead to decreased effectiveness of vaccination.
There is an increased risk of developing generalized, potentially life-threatening infections when vaccinated with live vaccines.

The metabolism of glucocorticoids may be accelerated and, therefore, their effectiveness may be reduced.

Laxatives and beta sympathomimetics

Increased potassium loss.

Chloroquine, hydroxychloroquine, mefloquine

Increased risk of myopathies, cardiomyopathies

Coumarin derivatives

Reduced effectiveness due to the action of prednisolone.

Theophylline

Undesirable effect: increased clearance during treatment with prednisolone.

Cyclophosphamide

Single doses of prednisolone can inhibit the activation of cyclophosphamide, but the level of activation increases after long-term use.

Thalidomide

May enhance the effect of prednisolone.

Praziquantel

Possible decrease in the concentration of praziquantel in the blood due to the use of corticosteroids.

Undesirable effect: intraocular pressure may increase when taken simultaneously with prednisolone.

Inhibition of corticosteroid metabolism by licorice. Undesirable effect: Increased risk of corticosteroid side effects.

special instructions

Patients with certain physical problems, such as fever, injury, or surgery, may require a temporary adjustment of the daily corticoid dosage during treatment.

The risk of tendon disease, tendonitis, or tendon rupture will be increased when fluoroquinolones and corticosteroids are used concomitantly

Long-term use of the drug should be accompanied by an examination by an ophthalmologist every three months.

Long-term use may be associated with rapid progression of Kaposi's sarcoma

With the exception of replacement therapy, corticosteroids have a palliative rather than curative effect due to their anti-inflammatory and immunosuppressive properties. Long-term use, depending on the dose and duration of treatment, is associated with an increased incidence of undesirable effects. Patients receiving long-term systemic corticosteroid therapy should be monitored for hypothalamic-pituitary-adrenal (HPA) axis suppression (adrenal insufficiency), Cushing's syndrome, hyperglycemia, and glycosuria.

After long-term therapy with corticosteroids, treatment should be discontinued gradually to prevent “withdrawal syndrome”. Adrenocortical insufficiency may persist for months after corticosteroid treatment is stopped, and replacement therapy may be required during periods of stress (surgery, illness). The risk of adrenal insufficiency may be reduced by giving the drug every other day instead of daily doses.

Due to the anti-inflammatory and immunosuppressive effects of corticosteroids, their use in doses higher than those required for replacement therapy increases susceptibility to infection, leads to aggravation of existing infectious diseases and activation of latent infections. The anti-inflammatory effect can lead to masking of symptoms until the infectious disease reaches an advanced stage. If new infections occur during treatment, the fact must be taken into account that it will be impossible to localize such an infection

In patients with latent tuberculosis (TB), corticosteroid therapy may increase the risk of developing TB. Such patients should be closely monitored for reactivation of TB and, if long-term corticosteroid treatment is required, anti-TB chemotherapy may be indicated. The use of corticosteroids in patients with active tuberculosis should be limited to cases such as exacerbation or dissemination of TB if their use to treat the disease is planned in conjunction with appropriate anti-tuberculosis therapy

Systemic corticosteroid therapy may increase the risk of severe or fatal infections in persons exposed to viral diseases such as chickenpox or measles (patients should be warned to avoid this risk and to seek prompt medical attention if it occurs). Corticosteroids may promote the development of bacterial and fungal infections (Candida infections). Corticoids may reactivate latent amoebic infections, so it is important to exclude them before starting corticoid therapy

Prednisolone enhances gluconeogenesis. Approximately 20% of patients treated with high doses of steroids develop benign "steroid diabetes" with low insulin sensitivity and a low renal threshold for glucose. The condition is reversible when therapy is discontinued. In established diabetes mellitus, treatment with corticosteroids usually leads to imbalance, which can be compensated by adjusting the insulin dose

Long-term treatment with prednisolone affects calcium and phosphate metabolism and increases the risk of osteoporosis. Prednisolone helps reduce calcium and phosphate levels, which affects vitamin D levels, thereby causing a dose-dependent decrease in serum osteocalcin (a bone matrix protein that correlates with bone formation)

Treatment with prednisone for several weeks puts children at risk of developing growth retardation due to decreased secretion of growth hormone and decreased peripheral sensitivity to this hormone.

Corticosteroids may cause psychiatric disturbances, including euphoria, insomnia, mood swings, personality changes, depression and psychotic tendencies

Long-term use of systemic corticosteroids may cause posterior subcapsular cataracts and glaucoma (due to increased intraocular pressure), as well as an increased risk of eye infections. Ophthalmological examination and treatment are mandatory in cases of glaucoma, ulcers and corneal trauma. Patients with herpes infection have an increased risk of developing corneal damage because prednisolone may mask the infection.

Corticosteroids should be used with caution in the following conditions:

Gastrointestinal diseases such as ulcerative colitis and diverticulitis due to the possibility of colonic perforation, colonic abscess or other pyogenic infections, colonic obstruction, severe fistulas and sinus tracts, fresh intestinal anastomoses and latent peptic ulcers. The anti-inflammatory properties of glucocorticoids may mask signs of gastrointestinal perforations and thus lead to delayed diagnosis and, consequently, potentially fatal outcomes.

High blood pressure or congestive cardiovascular disease (due to the mineralocorticoid effect of prednisolone, which can lead to fluid and salt retention)

Osteoporosis (because corticosteroids may worsen symptoms of osteoporosis)

Known and suspected infections

Known lymphatic tumors, as there have been reports of acute tumor lysis syndrome following administration of glucocorticoids

Heart or renal failure: concomitant effective therapy for the underlying disease and ongoing constant monitoring

Liver disease

Hypothyroidism

Myasthenia gravis, which may lead to increased myopathy

Cerebral malaria (coma may be prolonged, incidence of pneumonia and gastrointestinal bleeding may increase)

Latent epilepsy

Hyperparathyroidism (as prednisone may promote disease)

Treatment of patients with acetylsalicylic acid or non-steroidal anti-inflammatory drugs (due to increased risk of ulcer formation)

Diuretics that remove potassium.

In patients prescribed corticoids, the diet should be high in potassium, protein, and vitamins, but low in fat, carbohydrates, and salt.

In elderly patients, especially during long-term therapy, side effects such as osteoporosis and tendon diseases should be monitored. If possible, circadian or intermittent treatment is recommended for children during the growing period.

Patients with rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pregnancy and lactation

Prednisolone crosses the placenta. Animal studies have shown an increase in side effects depending on the dose (cleft palate, effects on growth and brain development). However, overall, these studies suggest a low risk to the fetus when prednisolone is used during pregnancy. But prednisolone therapy during pregnancy should be carried out only after a careful assessment of the benefits and risks to the fetus. If glucocorticoids are used late in pregnancy, there is a theoretical risk of fetal adrenal suppression, which may require a gradual reduction in the dose of replacement therapy in the newborn.
The amount of prednisolone excreted into breast milk is estimated to be 0.1% of the dose received by the mother. The dose received by the child can be minimized by avoiding breastfeeding for 3 to 4 hours after the mother receives a dose of prednisolone. Children of mothers taking daily doses of 40 mg or more should be monitored for signs of adrenal suppression.