Medrol - Instructions For The Use Of Tablets, Price, Reviews, Analogues

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

Medrol

Medrol: 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. In case of impaired renal function
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Medrol

ATX code: H02AB04

Active ingredient: methylprednisolone (methylprednisolone)

Producer: Pfizer Italia SrL (Italy)

Description and photo updated: 2019-27-08

Prices in pharmacies: from 152 rubles.

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Medrol is a glucocorticosteroid (GCS) for oral administration.

Release form and composition

Dosage form - tablets: elliptical, white, on one side there are two notches (criss-cross), on the other - logo engraving, 4 mg each (10 pcs. In blisters, in a cardboard box of 1, 3 or 10 blisters; 30 pcs. in glass bottles of dark color, in a cardboard box 1 bottle); 16 mg each (in a blister strip of 10 pcs., in a cardboard bundle 5 packs, or 14 pcs., in a cardboard bundle 1 package; 50 pcs. in glass bottles of dark color, in a carton bundle 1 bottle); 32 mg each (20 or 50 pieces in dark glass vials, 1 vial in a cardboard box). Each pack also contains instructions for the use of Medrol.

The active ingredient is methylprednisolone, in 1 engraved tablet:

• UPJOHN - 4 mg;
• UPJOHN 73 - 16 mg;
• UPJOHN 176 - 32 mg.

Auxiliary components of tablets with an inscription:

• UPJOHN: lactose, corn starch, dried corn starch, sucrose, calcium stearate;
• UPJOHN 73 and UPJOHN 176: liquid paraffin, calcium stearate, lactose, corn starch, sucrose.

Pharmacological properties

Pharmacodynamics

Methylprednisolone - the active substance of Medrol, is a glucocorticosteroid. Penetrates through cell membranes and forms complexes with specific cytoplasmic receptors. Subsequently, these complexes penetrate into the cell nucleus, where they bind to DNA (deoxyribonucleic acid, in particular, chromatin) and stimulate the transcription of mRNA (matrix ribonucleic acid) and the subsequent biosynthesis of various enzymes. This mechanism of action determines the effect of GCS from systemic use.

Methylprednisolone has a significant effect on the immune response and the inflammatory process, the substance also affects carbohydrate, fat and protein metabolism, cardiovascular and central nervous systems and skeletal muscles.

Like other GCS, methylprednisolone has anti-inflammatory, anti-allergic and immunosuppressive properties. Thanks to this, the following therapeutic effects are achieved:

• inhibition of phagocytosis;
• a decrease in the number of immunoactive cells near the focus of inflammation, as well as the production of prostaglandins and related compounds;
• stabilization of lysosomal membranes;
• decreased vasodilation.

The severity of the anti-inflammatory effect of 4 mg methylprednisolone and 20 mg hydrocortisone is comparable.

Methylprednisolone has only a slight mineralocorticoid activity (methylprednisolone at a dose of 200 mg is equivalent to 1 mg of deoxycorticosterone).

The catabolic effect on proteins is manifested in the form of the conversion of amino acids released in the process of gluconeogenesis in the liver into glycogen and glucose. At the same time, there is a decrease in glucose consumption in peripheral tissues, which can lead to glucosuria and hyperglycemia, especially in patients at risk of diabetes mellitus.

The lipolytic effect of methylprednisolone is manifested primarily in the limbs. Also, the substance has a lipogenetic effect, which is most pronounced in the chest, head and neck. Together, this contributes to the redistribution of body fat.

The maximum pharmacological activity of methylprednisolone is manifested not at the peak of plasma concentration, but after it. From this it follows that the action of Medrol is mainly due to the effect on the activity of enzymes.

Pharmacokinetics

Absorption of the substance occurs mainly in the proximal part of the small intestine (the amount of absorption is approximately 2 times higher than that in the distal part).

The level of binding to proteins (transcortin and albumin) is approximately 40–90%.

The metabolic process of methylprednisolone occurs in the liver, it is qualitatively similar to the metabolism of cortisol. The main metabolites are 20p-hydroxy-6a-methylprednisone and 20p-hydroxymethylprednisolone.

Excretion of metabolites occurs mainly in an unbound form with urine. Also, the substance is excreted in the form of sulfates and glucuronides, which are formed in the liver (mainly) and in the kidneys (partially).

Methylprednisolone is a corticosteroids with an intermediate duration of action. Due to intracellular activity, there is a pronounced difference between T _1/2 (half-life) from blood plasma (about 3.3 hours) and T _1/2 from the body as a whole (about 12-36 hours). The pharmacotherapeutic effect of methylprednisolone persists even when the level of the active substance in the blood is no longer determined.

Indications for use

• Aspiration pneumonitis, symptomatic sarcoidosis, disseminated or fulminant pulmonary tuberculosis (as part of the corresponding anti-tuberculosis chemotherapy), Leffler's syndrome (in the absence of the effect of therapy with other drugs), beryllium;
• Combination therapy of tuberculous meningitis with subarachnoid block or with the threat of block;
• Endocrine pathologies: congenital adrenal hyperplasia, primary and secondary adrenal insufficiency, subacute and chronic thyroiditis, hypercalcemia against the background of malignant neoplasms;
• Idiopathic thrombocytopenic purpura and secondary thrombocytopenia (in adult patients), autoimmune hemolytic anemia, congenital hypoplastic anemia, erythrocytic anemia;
• Treatment of acute forms of systemic connective tissue diseases in rheumatic heart disease, systemic dermatomyositis (polymyositis), systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis (in some cases indicated as supportive therapy);
• Skin pathologies: pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), bullous dermatitis herpetiformis, fungal mycosis, exfoliative dermatitis, severe seborrheic dermatitis, severe psoriasis;
• Additional (short-term) therapy of diseases of the musculoskeletal system, including rheumatic pathologies: with exacerbation or acute forms of psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, bursitis, nonspecific tendosynovitis, gouty arthritis, or postarthritis osteoarthritis;
• Treatment of severe (disabling) conditions (in the case of ineffectiveness of conventional therapy) with seasonal or year-round allergic rhinitis, drug hypersensitivity reactions, serum sickness, contact dermatitis, atopic dermatitis, bronchial asthma;
• Chronic and severe acute inflammatory and allergic processes associated with eye diseases: keratitis, optic neuritis, chorioretinitis, iritis and iridocyclitis, allergic marginal corneal ulcers, inflammation of the anterior segment of the eye, allergic conjunctivitis, sympathetic ophthalmia, diffuse posterior uveitis and choroid
• Palliative therapy for oncological diseases: in adults - leukemia and lymphoma, in children - acute leukemia;
• Stimulation of diuresis and achievement of remission of proteinuria in patients with nephrotic syndrome without uremia, against the background of systemic lupus erythematosus or idiopathic type;
• Acute forms of ulcerative colitis and regional enteritis (to remove the patient from a critical state);
• Trichinosis with damage to the nervous system or myocardium;
• Edema of the brain against the background of a brain tumor, exacerbation of multiple sclerosis;
• As part of complex therapy for organ transplantation.

Contraindications

• Breastfeeding period;
• Hypersensitivity to drug components.

Care must be taken to prescribe Medrol tablets to patients with esophagitis, gastric ulcer and duodenal ulcer, gastritis, intestinal anastomosis (in the immediate history), latent or acute peptic ulcer, diverticulitis, ulcerative colitis (with the threat of perforation or abscess), diabetes mellitus and a predisposition to it, osteoporosis, myasthenia gravis, hypothyroidism, acute psychosis, hyperthyroidism, subacute and acute myocardial infarction, arterial hypertension, congestive heart failure, severe renal or liver dysfunction (especially against the background of concomitant hypoalbuminemia), open-angle glaucoma; with herpes simplex (eye form), HIV infection (AIDS), measles, chickenpox, strongyloidosis.

With latent and active tuberculosis, severe forms of viral or bacterial infections, the use of Medrol is possible only as part of a specific therapy (masks the symptoms of the disease and increases the risk of developing superinfection).

The appointment is not recommended for systemic fungal infections.

During pregnancy, the use of Medrol is permissible only for absolute indications.

Medrol, instructions for use: method and dosage

Medrol tablets are taken orally.

The dosage regimen is prescribed by the doctor based on clinical indications.

The dose selection must be made individually, taking into account the patient's reaction to therapy.

Recommended daily dosage:

• Adults: the initial dose is 4-48 mg, then the correction is made depending on the nature of the disease and the patient's condition. So in case of multiple sclerosis, the dose can be 200 mg, cerebral edema - 200-1000 mg, organ transplantation - at the rate of up to 7 mg per 1 kg of body weight per day. In the absence of a therapeutic effect as a result of a sufficient period of taking Medrol, the drug should be replaced with another agent;
• Children: the dose is determined taking into account the body surface area or weight of the child, so for the treatment of adrenal insufficiency, the dose can be 3.33 mg per 1 m ² or 0.18 mg per 1 kg per day, for other indications - 12.5-50 mg per 1 m ² or 0.42-1.67 mg per 1 kg per day. The daily dose is evenly distributed over 3 doses.

Cancellation of Medrol after prolonged use should be carried out gradually.

With positive dynamics of treatment, gradually reducing the initial dose, the patient should select the lowest maintenance dose that will maintain the achieved clinical effect.

The use of the drug must be accompanied by constant monitoring of the dosage regimen. A dose adjustment may be required when the clinical condition changes in the event of an exacerbation of the disease, the onset of remission, the patient's individual response to Medrol, or against the background of stressful situations not directly related to the disease.

The use of Medrol is indicated using the method of alternating therapy, in which a doubled daily dose is taken 1 time in the morning every other day. This method of treatment allows, with prolonged use, to achieve the maximum clinical effect and significantly reduce the side effects of the drug associated with growth retardation in children, suppression of the pituitary-adrenal system, GCS withdrawal syndrome.

Side effects

• Digestive system: gastric bleeding, peptic ulcer (with the risk of perforation and bleeding), pancreatitis, bowel perforation, esophagitis, increased activity of alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase in serum (usually the changes are transient and insignificant);
• Metabolism: chronic heart failure in predisposed patients, sodium retention, increased blood pressure, potassium loss, hypokalemic alkalosis, fluid retention in the body, negative nitrogen balance against the background of protein catabolism;
• Endocrine system: development of Cushing's syndrome, hirsutism, suppression of the pituitary-adrenal system, decreased tolerance to carbohydrates, the appearance of latent diabetes mellitus, in patients with diabetes mellitus, an increase in the need for oral hypoglycemic agents or insulin, menstrual irregularities; in children - growth retardation;
• Musculoskeletal system: muscle weakness, steroid myopathy, osteoporosis, tendon ruptures (usually the Achilles tendon), vertebral compression fractures, pathological fractures, aseptic necrosis of the epiphyses of tubular bones;
• Nervous system: increased intracranial pressure, mental disorders, pseudotumor of the brain, convulsions;
• Organ of vision: increased intraocular pressure with the risk of damage to the optic nerve, posterior subcapsular cataract, exophthalmos;
• Allergic reactions: hypersensitivity reactions, including allergic systemic reactions, possibly suppression of reactions with skin tests;
• Dermatological reactions: petechiae and ecchymosis, retardation of wound healing processes, decreased strength and thinning of the skin;
• Others: activation of latent infections, distortion of the clinical picture in infectious pathologies, the occurrence of opportunistic infections, GCS withdrawal syndrome.

Overdose

The clinical symptoms of acute overdose have not been described. There is practically no information on cases of acute toxicity in case of an overdose of GCS.

The main symptoms (with frequent repeated admission - daily or several times a week, over a long period): Cushing's syndrome and other complications characteristic of long-term GCS therapy.

Therapy: symptomatic.

There is no specific antidote. Methylprednisolone is excreted during dialysis.

special instructions

Given the high risk of complications during glucocorticoid therapy, Medrol should be prescribed in the lowest doses that provide a clinical effect. In case of correction of the therapy regimen, the dose of the drug is reduced gradually.

The use of Medrol can potentiate the development of mental disorders, including insomnia, euphoria, depression, acute psychotic manifestations, or increase the patient's existing emotional instability. Patients prone to psychotic reactions during or after stress are shown to increase the dose of the drug.

During the period of taking Medrol in a dose producing an immunosuppressive effect, the patient should not be injected with live or live attenuated vaccines, the administration of killed or inactivated vaccines is indicated, while the response to their administration may be reduced. If the dose is not immunosuppressive, immunization may be appropriate if indicated.

Medrol's action can erase the clinical picture of some infections or cause the development of new ones. During the period of taking the drug, the body may lose resistance to infections or the ability to localize the infectious process.

The risk of developing infectious complications increases in proportion to the increase in the dose of Medrol taken both in monotherapy and in combination with other immunosuppressants. Infections caused by pathogenic microorganisms (viruses, fungi, bacteria, helminths, or protozoa) can be mild and severe, even fatal.

In active tuberculosis, the use is indicated in the treatment of disseminated and fulminant tuberculosis, in combination with appropriate anti-tuberculosis chemotherapy. When prescribed to patients with positive tuberculin tests or latent tuberculosis, reactivation of the process may occur, therefore, treatment should be accompanied by strict medical supervision. Long-term use of methylprednisolone in such patients should be carried out with the simultaneous appointment of appropriate prophylactic treatment.

Caution should be used in the treatment of herpes simplex of the eye due to the risk of corneal perforation.

Long-term drug therapy can contribute to the attachment of a secondary ocular viral or fungal infection, cause the development of allergic reactions, the occurrence of posterior subcapsular cataract, glaucoma with possible damage to the optic nerve.

High doses of methylprednisolone can cause an increase in blood pressure, potassium excretion, and sodium and water retention. During the period of treatment, the patient should limit the consumption of table salt and prescribe the intake of potassium preparations.

Medrol increases calcium excretion.

Osteoporosis is a common side effect of long-term use of high doses of the drug.

A long daily dosing regimen with Medrol taken several times a day in the treatment of children should be used only for absolute indications, since it can cause a growth retardation in the child. Alternative therapy minimizes or avoids this unwanted effect.

A gradual decrease in the dose of the drug allows you to minimize the manifestations of secondary adrenal cortex insufficiency. This type of pathology can be observed after the end of treatment for several more months, therefore, if any stressful situations arise during this period, it is necessary to reapply Medrol. In connection with a possible violation of the secretion of mineralocorticoids, concomitant administration of mineralocorticoids and / or electrolytes is indicated.

A more pronounced effect of glucocorticosteroids is observed in patients with liver cirrhosis and hypothyroidism.

Therapy can mask the signs of peptic ulcers, so without severe pain, the patient may experience bleeding or perforation.

Against the background of therapy, cases of development in patients with Kaposi's sarcoma were noted, with the abolition of Medrol, the onset of clinical remission is possible.

The negative effect on reproductive function, mutagenic and carcinogenic effects of the drug has not been established.

Influence on the ability to drive vehicles and complex mechanisms

Since dizziness, weakness and visual impairment may develop during Medrol therapy, it is recommended that people who drive vehicles, as well as those engaged in activities that require a quick psychomotor reaction and high concentration of attention, be careful.

Application during pregnancy and lactation

• pregnancy: the use of Medrol is possible only for absolute indications;
• lactation period: therapy is contraindicated.

Appropriate studies of the effect of GCS on human reproductive function have not been conducted. If it is necessary to use Medrol in women of childbearing age or during pregnancy, an assessment of the possible positive effect in comparison with the potential risk to the embryo, fetus or mother is required.

With impaired renal function

Medrol is prescribed with caution in patients with severe renal impairment.

For violations of liver function

Patients with severe impairment of hepatic function (especially with concomitant hypoalbuminemia) Medrol is prescribed with caution.

Drug interactions

• inducers of microsomal liver enzymes (phenytoin, ephedrine, phenobarbital, theophylline, rifampicin): reducing the therapeutic effect of methylprednisolone; in such cases, an increase in the dose of Medrol may be required;
• cyclosporine: mutual inhibition of metabolism, while the likelihood of side effects of these drugs increases; there is information about the development of seizures with the combined use of funds;
• acetylsalicylic acid (long-term therapy in high doses): an increase in its clearance; this may lead to a decrease in serum salicylate levels or an increased risk of salicylate toxicity if methylprednisolone is discontinued; with combined therapy with salicylates, the likelihood of developing gastropathy increases. Patients with hypoprothrombinemia should be prescribed acetylsalicylic acid in combination with Medrol with extreme caution;
• ketoconazole, oleandomycin, oral estrogen-containing contraceptives: suppression of methylprednisolone metabolism and a decrease in its clearance, an increase in T _1/2, therapeutic and toxic effects; in order to reduce the likelihood of an overdose, the dose of Medrol should be reduced;
• cardiac glycosides: their toxicity increases; development of arrhythmias is possible;
• oral anticoagulants: increasing or decreasing their effect; in order to maintain the required effect of the anticoagulant, it is necessary to constantly determine the coagulation parameters;
• sodium-containing drugs: the risk of edema and increased blood pressure increases;
• carbonic anhydrase inhibitors, thiazide diuretics, amphotericin B, other corticosteroids: the risk of hypokalemia increases;
• paracetamol: the risk of developing hepatotoxicity increases (associated with the formation of a toxic metabolite of paracetamol and the induction of liver enzymes);
• alcohol and non-steroidal anti-inflammatory drugs: the likelihood of bleeding and the development of ulceration of the gastrointestinal tract increases; it may be necessary to reduce the dose of methylprednisolone, which is associated with the summation of the therapeutic effect;
• antacids: absorption of methylprednisolone decreases;
• hypoglycemic agents: their effectiveness decreases;
• androgens: the risk of developing edema increases;
• somatotropin: its effectiveness decreases (in combination with high doses of methylprednisolone);
• mitotane and other inhibitors of adrenal cortex function: development of interaction, which may require an increase in dose;
• vaccines: their effectiveness decreases (against the background of methylprednisolone, live vaccines can cause the corresponding disease);
• isoniazid, mexiletine: acceleration of their metabolism, this leads to a decrease in plasma concentrations of drugs, especially in fast acetylators;
• thyroid hormones and antithyroid drugs: clearance of methylprednisolone decreases in hypothyroidism and increases in hyperthyroidism, and therefore the dose of Medrol should be selected based on the results of functional tests.

Analogs

Medrol's analogues are: Deltason, Prednisolone, Metipred, Depo-Medrol, Solu-Medrol, Lemod.

Terms and conditions of storage

Store at 20-25 ° C. Keep out of the reach of children.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Medrol

Reviews of Medrol indicate the high effectiveness of the drug in comparison with analogues. It is noted that constant therapy is needed to achieve improvement and maintain it. They also report the development of side effects, in some cases they are pronounced. The cost is often assessed as high.

Price for Medrol in pharmacies

The approximate price for Medrol is: 4 mg (30 pcs.) - 150–201 rubles, 16 mg (50 pcs.) - 626–746 rubles, 32 mg (20 pcs.) - 663–726 rubles.

Medrol: prices in online pharmacies

Drug name Price Pharmacy

Medrol 4 mg tablets 30 pcs. 152 RUB Buy

Medrol tab. 4mg n30 195 RUB Buy

Medrol 32 mg tablets 20 pcs. RUB 699 Buy

Medrol 16 mg tablets 50 pcs. 735 RUB Buy

Medrol tab. 16mg n50 774 RUB Buy

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!