Medopred - Instructions For Use Of Ampoules, Drug Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Medopred

Medopred: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Medopred

ATX code: H02AB06

Active ingredient: prednisolone (Prednisolone)

Manufacturer: Medochemie, Ltd. (Medochemie, Ltd.) (Cyprus)

Description and photo update: 2019-08-10

Medopred - glucocorticosteroid drug; has anti-inflammatory, anti-allergic, immunosuppressive, anti-shock effect.

Release form and composition

The drug is produced in the form of a solution for intravenous (i / v) and intramuscular (i / m) administration: transparent colorless or with a yellow tint liquid (1 ml each in dark glass ampoules with a break strip, 5 ampoules in blisters, in cardboard box 2 packs and instructions for use Medopred; for hospitals - in a cardboard box 20 packs).

1 ampoule contains:

• active substance: prednisolone phosphate in the form of prednisolone sodium phosphate - 30 mg;
• auxiliary components: nicotinamide, phenol, sodium disulfite, disodium edetate, sodium hydroxide, water for injection.

Pharmacological properties

Pharmacodynamics

Medopred is a synthetic glucocorticosteroid drug that has anti-inflammatory, anti-allergic, immunosuppressive, anti-shock effects. Its active substance, prednisolone, is a dehydrated analogue of hydrocortisone, which increases the sensitivity of beta-adrenergic receptors to endogenous catecholamines. As a result of the interaction of prednisolone with cytoplasmic glucocorticosteroid receptors (GCS), a complex is formed that induces the formation of proteins (including enzymes that regulate vital processes in cells).

The anti-inflammatory effect of Medopred is due to the ability of prednisolone to inhibit the release of inflammatory mediators by eosinophils and mast cells, induce the formation of lipocortins, reduce the number of mast cells producing hyaluronic acid, reduce capillary permeability, stabilize the membranes of lysosomal or other cells and organelles. The effect of the substance is manifested at all stages of the inflammatory process. At the level of arachidonic acid, prednisolone inhibits the synthesis of prostaglandins, which contribute to the development of allergies, inflammatory and other processes. At the same time, it inhibits the synthesis of pro-inflammatory cytokines, including interleukin-1, a tumor necrosis factor alpha, increases the resistance of the cell membrane to the effects of all kinds of damaging factors.

Taking part in protein metabolism, prednisolone reduces the number of globulins in the plasma, helps to reduce the synthesis and increase the catabolism of protein in muscle tissue, and to activate the synthesis of albumin in the liver and kidneys.

Prednisolone affects lipid metabolism in the body, which is expressed by an increase in the synthesis of higher fatty acids and triglycerides, the redistribution of fat (accumulation of fat mobilized from the subcutaneous tissue of the extremities, mainly in the shoulder girdle, face and abdomen), and can lead to the development of hypercholesterolemia.

Acting on carbohydrate metabolism, Medopred promotes the development of hyperglycemia as a result of an increase in the absorption of carbohydrates from the gastrointestinal tract (GIT), the activity of PEP-carboxylase (phosphoenolpyruvate carboxylase) and the synthesis of aminotransferases (activation of gluconeogenesis), an increase in the activity of glucose-6-phosphatase, potentiating the entry into the blood glucose from the liver.

The substance affects the water-electrolyte metabolism - it retains sodium and water in the body. Its mineralocorticoid activity stimulates the excretion of potassium, reduces calcium absorption from the gastrointestinal tract, promotes its leaching from bones, decreases bone mineralization and increases renal calcium excretion.

The immunosuppressive effect of prednisolone is due to the emerging involution of lymphoid tissue, inhibition of the proliferation of lymphocytes (especially T-lymphocytes), suppression of the interaction of T- and B-lymphocytes, inhibition of the migration of B-lymphocytes, inhibition of the cytokine release process (interleukin-1, interleukin-2, interferon gamma) from lymphocytes and macrophages, a decrease in the formation of antibodies.

The development of an antiallergic effect is associated with a decrease in the synthesis and secretion of allergy mediators, inhibition of the release of biologically active substances (including histamine) from sensitized mast cells and basophils, a decrease in the number of circulating basophils, inhibition of the development of lymphoid and connective tissue, antibody production, a decrease in the number of T- and B-lymphocytes, mast cells, a decrease in the sensitivity of effector cells to allergy mediators, a change in the body's immune response.

The therapeutic effect of Medopred in obstructive diseases of the respiratory tract is primarily due to the inhibition of the inflammatory process, the prevention of edema of the mucous membranes of the bronchi or a decrease in its severity, a decrease in eosinophilic infiltration of the submucous layer of the bronchial epithelium, the deposition of circulating immune complexes in the bronchial mucosa, slowing down of erosion of mucous membranes and desquamation. Prednisolone increases the sensitivity of small and medium beta-adrenergic receptors of the bronchi to endogenous catecholamines and exogenous sympathomimetics, reduces the production and reduces the viscosity of mucus. Suppresses secondary synthesis of endogenous GCS, synthesis and secretion of adrenocorticotropic hormone (ACTH). In the course of the inflammatory process, by slowing down the connective tissue reactions, prednisone reduces the likelihood of scarring on the tissues.

Pharmacokinetics

The maximum concentration (C _max) of prednisolone in the blood after intravenous administration is reached in 0.5 hours. After intramuscular administration, the time to reach C _max is 0.5–1 hours. When injected into the thigh muscles, absorption occurs more rapidly than when injection into the gluteal muscles.

Plasma protein binding (transcortin or corticosteroid-binding globulin and albumin) up to 90% of the dose received.

Prednisolone is metabolized mainly in the liver by conjugation with glucuronic and sulfuric acid, partly in the kidneys and other tissues with the formation of inactive metabolites.

The half-life from plasma is about 3 hours. It is excreted through the intestine and through the kidneys by glomerular filtration (80–90% of the dose is reabsorbed by the tubules). The kidneys excrete 20% of the dose unchanged.

Indications for use

The use of Medopred is indicated as an emergency therapy in the following conditions that require a rapid increase in the level of GCS concentration in the body:

• shock (anaphylactic, traumatic, surgical, burn, toxic, blood transfusion) - in case of ineffectiveness of preliminary symptomatic therapy with other drugs, including vasoconstrictor and plasma substitutes
• acute severe forms of allergic reactions, anaphylactoid reactions, serum sickness;
• severe bronchial asthma, status asthmaticus;
• cerebral edema (including those caused by a brain tumor, head trauma, surgery, or radiation therapy);
• rheumatoid arthritis;
• systemic lupus erythematosus;
• acute hepatitis;
• hepatic coma;
• primary or secondary adrenal insufficiency;
• thyrotoxic crisis.

In addition, in case of poisoning with cauterizing liquids, Medopred in ampoules is prescribed in order to prevent cicatricial narrowings, reduce inflammation.

Contraindications

Absolute:

• the period of immunization with a live vaccine;
• an eye infection caused by the herpes simplex virus;
• breast-feeding;
• hypersensitivity to the components of the drug.

Care should be taken when prescribing Medopred to patients with the following diseases / conditions: gastric ulcer and duodenal ulcer, acute or latent peptic ulcer, ulcerative colitis with the threat of perforation or abscess formation, esophagitis, gastritis, diverticulitis, newly created intestinal anastomosis; infectious and parasitic diseases of a viral, bacterial or fungal nature (including recent or recent contact with a patient) - herpes simplex, viremic phase of herpes zoster, chickenpox, measles, tuberculosis (active or latent form), strongyloidosis, amebiasis, systemic mycosis; diseases of the cardiovascular system (including recent myocardial infarction, severe stage of chronic heart failure, arterial hypertension, hyperlipidemia), diabetes mellitus,III-IV stage of obesity, impaired glucose tolerance, hypothyroidism / hyperthyroidism, Itsenko-Cushing's disease, severe chronic hepatic failure, cirrhosis of the liver, severe chronic renal failure, nephrourolithiasis, nephrotic syndrome, hypoalbuminemia, acute psychosis, poliomyelitis (except for the bulbar form), systemic osteoporosis, myasthenia gravis, open and closed angle glaucoma, a period of eight weeks before and two weeks after vaccination, lymphadenitis after vaccination with the tuberculosis vaccine bacillus Calmette - Guerin (BCG), immunodeficiency states [including AIDS (syndrome acquired immunodeficiency) and HIV (human immunodeficiency virus)], pregnancy, growth in children.severe chronic hepatic failure, cirrhosis of the liver, severe chronic renal failure, nephrourolithiasis, nephrotic syndrome, hypoalbuminemia, acute psychosis, poliomyelitis (except for the form of bulbar encephalitis), systemic osteoporosis, myasthenia gravis (myasthenia gravis), open and closed-angle glaucoma eight weeks before and two weeks after vaccination, lymphadenitis after vaccination with the bacillus Calmette-Guerin (BCG) tuberculosis vaccine, immunodeficiency conditions [including AIDS (acquired immunodeficiency syndrome) and HIV (human immunodeficiency virus)], pregnancy, growth in children.severe chronic hepatic failure, cirrhosis of the liver, severe chronic renal failure, nephrourolithiasis, nephrotic syndrome, hypoalbuminemia, acute psychosis, poliomyelitis (except for the form of bulbar encephalitis), systemic osteoporosis, myasthenia gravis (myasthenia gravis), open and closed-angle glaucoma eight weeks before and two weeks after vaccination, lymphadenitis after vaccination with the bacillus Calmette-Guerin (BCG) tuberculosis vaccine, immunodeficiency conditions [including AIDS (acquired immunodeficiency syndrome) and HIV (human immunodeficiency virus)], pregnancy, growth in children.poliomyelitis (except for the form of bulbar encephalitis), systemic osteoporosis, myasthenia gravis, open and closed angle glaucoma, a period of eight weeks before and two weeks after vaccination, lymphadenitis after vaccination with the vaccine against tuberculosis bacillus Calmette - Guerin (BCG), immunodeficiency states [including AIDS (acquired immunodeficiency syndrome) and HIV (human immunodeficiency virus)], pregnancy, growth in children.poliomyelitis (except for the form of bulbar encephalitis), systemic osteoporosis, myasthenia gravis, open and closed angle glaucoma, a period of eight weeks before and two weeks after vaccination, lymphadenitis after vaccination with the vaccine against tuberculosis with bacillus Calmette - Guerin (BCG), immunodeficiency states [including AIDS (acquired immunodeficiency syndrome) and HIV (human immunodeficiency virus)], pregnancy, growth in children.period of pregnancy, period of growth in children.period of pregnancy, period of growth in children.

Medopred, instructions for use: method and dosage

Medopred solution in ampoules is intended for intravenous drip or jet and intramuscular injection.

Separate syringes and infusion sets are recommended for IV bolus and drip prednisolone.

The doctor sets the dose of the drug and the duration of the course of treatment on the basis of clinical indications and the severity of the disease individually.

When prescribing an intravenous injection of a solution, the first dose is usually injected in a stream, then by drip.

Recommended dosage of Medopred:

• acute adrenal insufficiency: single dose - 100-200 mg, daily dose - 300-400 mg;
• severe allergic reactions: 100-200 mg per day, course of 3-16 days;
• bronchial asthma (as part of complex therapy): the dose during the course of treatment can vary considerably and range from 75 to 675 mg for 3-16 days, in severe cases - up to 1400 mg with a gradual decrease;
• status asthmaticus: 500–1200 mg per day, with a gradual decrease to 300 mg and subsequent transition to a maintenance dose;
• thyrotoxic crisis: 100 mg 2-3 times a day. The maximum daily dose may be 1000 mg. Usually, treatment is continued no more than 6 days until a stable therapeutic effect is achieved;
• shock resistant to standard therapy: a single dose of 50–150 mg (severe cases - up to 400 mg). The first dose is usually injected intravenously in a stream, followed by a transition to intravenous drip, provided that within 1 / 6-1 / 3 hours after the initial dose is administered, blood pressure (blood pressure) increases. If there is no tendency to increase blood pressure, then you should repeat the introduction of Medopred in / in a jet. After removing the patient from the shock state, the drip injection of the drug must be continued at intervals of 3-4 hours until the blood pressure stabilizes. The daily dose can range from 300 mg to 1200 mg (with a subsequent decrease);
• acute hepatic / renal failure (including those arising against the background of acute poisoning, in the postoperative or postpartum period): usually - 25–75 mg per day, if necessary, the daily dose can be increased to 300–1500 mg or more;
• rheumatoid arthritis, systemic lupus erythematosus: daily dose of 75–125 mg, course of 7–10 days;
• acute hepatitis: 75-100 mg per day, course duration - 7-10 days;
• burns of the digestive tract and upper respiratory tract in case of poisoning with cauterizing liquids: daily dose of 75-400 mg, course of 3-18 days.

After the relief of the acute condition, the patient is transferred to the use of prednisolone in the form of tablets, followed by a gradual decrease in the daily dose. You can not abruptly stop long-term GCS therapy.

In the absence of the possibility of intravenous administration, Medopred is administered intramuscularly in the same doses.

Side effects

• on the part of the endocrine system: decreased glucose tolerance, manifestation of latent diabetes mellitus or steroid diabetes mellitus, Itsenko-Cushing syndrome (pituitary obesity, moon-shaped face, increased blood pressure, hirsutism, muscle weakness, dysmenorrhea, amenorrhea, striae), oppression in children - delayed sexual development;
• from the digestive system: decreased or increased appetite, hiccups, nausea, vomiting, flatulence, indigestion, pancreatitis, steroid ulcer of the stomach and duodenum, gastrointestinal bleeding and perforation of the wall of the gastrointestinal tract, erosive esophagitis; rarely - increased activity of hepatic transaminases, alkaline phosphatase;
• on the part of the cardiovascular system: arrhythmias, increased blood pressure, increased severity or development (in predisposed patients) of heart failure, changes in the electrocardiogram characteristic of hypokalemia, hypercoagulation, thrombosis, bradycardia (including cardiac arrest), in acute and subacute infarction myocardium - spread of the focus of necrosis, slowing down the formation of scar tissue (increasing the risk of rupture of the heart muscle);
• from the nervous system: headache, hallucinations, insomnia, dizziness, increased intracranial pressure, anxiety, nervousness, delirium, paranoia, disorientation, euphoria, vertigo, cerebellar pseudotumor, manic-depressive psychosis, convulsions, depression;
• from the sensory organs: increased intraocular pressure (including damage to the optic nerve), posterior subcapsular cataract, development of secondary bacterial, viral or fungal eye infections, exophthalmos, trophic changes in the cornea, sudden loss of vision (against the background of parenteral administration in the head area, scalp, neck, nasal concha, possible deposition of prednisolone crystals in the vessels of the eye);
• from the metabolic side: increased sweating, peripheral edema against a background of fluid and sodium retention, hypocalcemia, increased calcium excretion, increased body weight, negative nitrogen balance, hypernatremia, hypokalemic syndrome (symptoms - hypokalemia, arrhythmia, muscle spasm or myalgia, fatigue, unusual weakness);
• on the part of the musculoskeletal system: in children - premature closure of the epiphyseal growth zones (slowing down the processes of ossification and growth), osteoporosis (including very rare cases of pathological bone fractures, aseptic necrosis of the head of the humerus and femur), decreased muscle mass (atrophy), rupture tendon muscles, steroid myopathy;
• allergic reactions: skin rash, itching, local allergic reactions, anaphylactic shock;
• dermatological reactions: tendency to develop candidiasis or pyoderma, slow wound healing, thinning of the skin, petechiae, ecchymosis, hypopigmentation, hyperpigmentation, striae, steroid acne;
• local reactions: at the injection site - burning, tingling, numbness, pain, infections; rarely - necrosis of adjacent tissues, scarring; with i / m administration - atrophy of the skin and subcutaneous tissue (especially when injected into the deltoid muscle);
• others: withdrawal syndrome, leukocyturia; against the background of concomitant therapy with immunosuppressants or vaccination - the development or exacerbation of infections.

Overdose

Symptoms: pronounced manifestation of dose-dependent undesirable effects.

Treatment: immediate dose reduction of Medopred. Appointment of symptomatic therapy.

special instructions

In severe infectious diseases, the use of Medopred should be carried out against the background of specific antimicrobial therapy.

Caution should be exercised in the treatment of patients with acute and subacute myocardial infarction due to the increased risk of the spread of the necrosis focus, slowing the formation of scar tissue and rupture of the heart muscle.

The likelihood of side effects and the degree of their severity depends on the dose, duration of use, the possibility of observing the circadian rhythm of drug use.

Treatment (especially long-term) must be accompanied by monitoring blood pressure, the state of water and electrolyte balance, peripheral blood picture, blood glucose concentration and observation of an ophthalmologist.

The patient's diet should include food rich in proteins and vitamins, it is necessary to limit the intake of fats, carbohydrates and table salt.

With hypothyroidism and cirrhosis of the liver, the effect of Medopred is enhanced.

With prolonged use of the drug, the content of folic acid in the body may increase.

During the period of therapy, the existing mental disorders may increase, therefore, when Medopred is prescribed in high doses, the treatment of patients with a history of psychosis should be accompanied by careful medical supervision.

During stressful situations, the need for corticosteroids may increase, in connection with which a dose adjustment of maintenance therapy may be required.

A sudden cessation of Medopred administration, especially after the previous use of high doses, can cause withdrawal syndrome, the development of which is accompanied by nausea, anorexia, lethargy, generalized musculoskeletal pain, general weakness and exacerbation of the existing disease.

When vaccinating during treatment with Medopred, its effectiveness (immune response) may decrease, therefore, immunization should not be carried out during this period.

Prescription of the drug for the treatment of intercurrent infections, septic conditions and tuberculosis must be accompanied by the simultaneous use of antibiotics with bactericidal action.

Careful monitoring of the dynamics of growth and development of children with prolonged use of prednisone is required. If during the period of treatment the child was in contact with patients with measles or chickenpox, then in order to prevent infection, he must be prescribed specific immunoglobulins.

When replacing adrenal insufficiency, Medopred should be prescribed in combination with mineralocorticoids.

In patients with diabetes mellitus, if necessary, therapy should be adjusted taking into account the level of blood glucose.

X-ray control over the state of the osteoarticular system (including the spine and hands) is shown.

Medopred increases the concentration of 11- and 17-oxyketo corticosteroid metabolites.

Influence on the ability to drive vehicles and complex mechanisms

During the period of treatment, patients should be careful when engaging in potentially hazardous activities that require an increased concentration of attention and a high speed of psychomotor reactions, including driving and working with complex mechanisms.

Application during pregnancy and lactation

The use of the drug Medopred during gestation is possible in cases where the benefits of therapy for the mother outweigh the potential threat to the fetus. It should be borne in mind that long-term use of GCS during pregnancy increases the risk of impaired growth and non-closure of the upper palate in the fetus.

The use of Medopred during lactation is contraindicated, if necessary, breastfeeding is recommended to stop.

Pediatric use

Care should be taken when prescribing Medopred during the growth period in children due to the increased risk of developing adverse events associated with the processes of ossification, growth, and sexual development.

With impaired renal function

Medopred should be used with caution in severe chronic renal failure, nephrourolithiasis, nephrotic syndrome.

It should be borne in mind that with latent infectious diseases of the kidneys and urinary tract, leukocyturia may develop.

For violations of liver function

Medopred should be used with caution in severe chronic liver failure, liver cirrhosis.

Drug interactions

With the simultaneous use of Medopred:

• phenobarbital, rifampicin, ephedrine, phenytoin, theophylline, other inducers of liver microsomal enzymes: cause a decrease in the concentration of prednisolone;
• diuretics (especially thiazide and carbonic anhydrase inhibitors), amphotericin B: increase the excretion of potassium from the body, which increases the risk of heart failure;
• sodium-containing agents: can cause the development of edema, increase blood pressure;
• cardiac glycosides: prednisone impairs the tolerance of cardiac glycosides, against the background of caused hypokalemia, the risk of developing ventricular extrasystole increases;
• indirect anticoagulants: dose adjustment of indirect anticoagulants is required due to the violation (often weakening) of their action;
• anticoagulants, thrombolytics: the risk of gastrointestinal bleeding increases;
• ethanol, non-steroidal anti-inflammatory drugs (NSAIDs): contribute to an increase in the likelihood of erosive and ulcerative lesions and bleeding in the gastrointestinal tract. When treating arthritis in combination with NSAIDs, synergism occurs, which enhances the therapeutic effect, therefore, the dose of prednisolone can be reduced;
• paracetamol: as a result of interaction with prednisolone, liver enzymes are induced and the formation of a toxic metabolite of paracetamol, which leads to an increased risk of hepatotoxicity;
• acetylsalicylic acid: excretion is accelerated and its level in the blood decreases. It should be borne in mind that after the withdrawal of prednisolone, the risk of side effects increases due to an increase in the concentration of salicylates in the blood;
• insulin, oral hypoglycemic and antihypertensive drugs: there is a decrease in the effectiveness of these drugs;
• vitamin D (cholecalciferol): its effect on calcium absorption in the intestine decreases;
• growth hormone: prednisone reduces its effectiveness;
• praziquantel: the level of concentration of the anthelmintic drug in the blood decreases;
• tricyclic antidepressants, antihistamines and other m-anticholinergics, nitrates: against the background of concomitant therapy with these agents, intraocular pressure increases;
• tricyclic antidepressants: it is possible to increase the severity of depression caused by the intake of glucocorticosteroids;
• isoniazid: its metabolism is accelerated, which leads to a decrease in plasma concentrations;
• carbonic anhydrase inhibitors, loop diuretics: concomitant therapy with one of the listed agents can cause the development of osteoporosis;
• indomethacin: displaces prednisolone from the association with albumin and increases the likelihood of side effects;
• ACTH: the combination of adrenocorticotropic hormone enhances the action of Medopred;
• ergocalciferol, parathyroidin: the combination with these drugs prevents the development of osteopathy, often accompanying treatment with prednisolone;
• cyclosporine, ketoconazole: slow down the metabolism of prednisolone, increasing the risk of increasing its toxicity;
• androgens, steroid anabolic agents: increase the risk of hirsutism, acne, peripheral edema;
• estrogens, oral estrogen-containing contraceptives: concomitant estrogen therapy causes a decrease in the clearance of prednisolone and an increase in the severity of the action of GCS;
• live antiviral vaccines: against the background of any types of immunization, activation of viruses and an increase in the risk of developing infections is possible;
• neuroleptics (antipsychotics), azathioprine: can potentiate the development of cataracts;
• antacids: reduce the absorption of prednisolone;
• antithyroid drugs that inhibit the synthesis of thyroid hormones: reduce the clearance of prednisolone;
• thyroid hormones: increase the clearance of prednisone;
• muscle relaxants: the severity of hypokalemia and the duration of muscle blockade caused by GCS increase;
• inhibitors of adrenal cortex function (including mitotane): when combined with these drugs, it may be necessary to increase the dose of prednisolone;
• immunosuppressants: increase the risk of developing infections, lymphoproliferative disorders (including lymphoma) caused by the Epstein-Barr virus.

When Medopred solution is mixed with heparin, a precipitate is formed.

Analogs

The analogues of Medopred are Prednisolone, Prednisolone bufus, Prednisolone Nycomed, Prednisol, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, protected from moisture and light.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Medopred

Reviews about Medopred are mostly positive. Patients indicate the high efficacy of the drug in the treatment of severe forms of allergy, Quincke's edema.

The disadvantages of the drug include the frequent development of adverse events, as well as pain with intramuscular injection.

Price for Medopred in pharmacies

The price of Medopred, a solution for i / v and i / m administration, for a package containing 10 ampoules, can range from 116 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!