Medrol, tablets 16 mg 50 pcs

A synthetic glucocorticoid with anti-inflammatory, anti-allergic, immunosuppressive activity.

In action of Medrol the number of immunoactive cells around the inflammatory focus, reduction of vasodilation, stabilization of lysosomal membranes, inhibition of phagocytosis, reduced production of prostaglandins and related substances.

Medrol in a dose of 4 mg has the same anti-inflammatory effect as hydrocortisone in a dose of 20 mg. The drug has minimal mineralocorticoid action (200 mg of the drug is equivalent to 1 mg of deoxycorticosterone).

The drug has a catabolic effect. It reduces glucose uptake by peripheral tissues, which may lead to hyperglycemia and glucosuria, especially in patients predisposed to diabetes.

Medrol has lipolytic effects, mainly in the extremities, also lipogenic effects, most evident in the chest, neck and head, leading to redistribution of fat deposits. It can cause osteoporosis.

Indications

Active ingredient

Composition

1 tablet contains:

The active ingredient:

methylprednisolone 16 mg;

Excipients:

calcium stearate;

corn starch;

lactose;

sucrose.

How to take, the dosage

Ingestion. The dose may vary and should be chosen individually depending on the nature of the disease and the patient’s response to therapy. The initial dose is 4 to 48 mg/day depending on the nature of the disease. Lower doses are usually sufficient for less severe disease, although some patients may require higher doses.

Higher doses may be needed for diseases and conditions such as multiple sclerosis (200 mg/day), brain edema (200-1000 mg/day) and organ transplantation (up to 7 mg/kg/day). If a satisfactory clinical effect is not obtained after a sufficient period of time, the drug should be withdrawn and another therapy should be prescribed to the patient.

In children, the dose is determined by the physician with regard to weight or body surface area. In adrenal insufficiency, 0.18 mg/kg or 3.33 mg/m2/day in 3 doses; in other indications, 0.42-1.67 mg/kg or 12.5-50 mg/m2/day in 3 doses.

The withdrawal of the drug after long-term therapy is recommended to be carried out gradually. If a good effect is obtained during treatment, an individual maintenance dose should be selected for the patient by gradually reducing the initial dose at certain intervals until the lowest dose is found to maintain the achieved clinical effect. Keep in mind that continuous monitoring of the drug dosing regimen is necessary.

There may be situations that require dose adjustments, such as changes in clinical presentation with remission and onset of disease, individual patient responses, and distress not directly related to the underlying disease, which may require increasing the dose for a period of time and is dependent on the patient’s condition.

Alternating therapy.

Alternating therapy is a dosing regimen in which twice the daily dose of glucocorticosteroids is given in the morning every other day. The goal of this therapy is to maximize clinical benefit while minimizing some of the adverse effects such as pituitary-adrenal suppression, glucocorticosteroid withdrawal, and growth retardation in children.

Interaction

Increases toxicity of cardiac glycosides (due to the resulting hypokalemia the risk of arrhythmias increases). Accelerates excretion of ASA, reduces its concentration in the blood (when methylprednisolone is withdrawn, the concentration of salicylates in the blood increases and the risk of side effects increases).

When used simultaneously with live antiviral vaccines and against the background of other types of immunizations increases the risk of virus activation and development of infections. Increases metabolism of isoniazid, mexiletine (especially in “fast” acetylators), which leads to a decrease in their plasma concentrations. Increases the risk of hepatotoxic reactions of paracetamol (induction of “liver” enzymes and formation of toxic metabolite of paracetamol).

Enhances (with prolonged therapy) folic acid. Hypokalemia caused by GCS may increase the severity and duration of muscle block on the background of myorelaxants.

In high doses it reduces the effect of somatropin. Antacids decrease absorption of GCS. Reduces the effect of hypoglycemic drugs, increases the anticoagulant effect of coumarin derivatives. Weakens the effect of vitamin D on Ca2+ absorption in the intestinal lumen.

Ergocalciferol and parathormone prevent the development of osteopathy caused by GCS. Reduces the concentration of praziquantel in the blood. Ketoconazole reduces clearance and increases toxicity of methylprednisolone. Concomitant use with cyclosporine causes mutual inhibition of metabolism – the risk of side effects of both drugs (cases of seizures were noted when used together).

Tiazide diuretics, carbohydrate inhibitors, etc. GCS and amphotericin B increase the risk of hypokalemia, Na+-containing drugs – edema and increased BP. NSAIDs and ethanol increase the risk of gastrointestinal mucosa ulceration and bleeding, in combination with NSAIDs for arthritis treatment, the dose of GCS may be reduced due to the summation of therapeutic effect. Indomethacin, displacing methylprednisolone from binding to albumin, increases the risk of its side effects.

Amphotericin B and carboanhydrase inhibitors increase the risk of osteoporosis. The therapeutic effect of GCS is reduced under the influence of phenytoin, barbiturates, ephedrine, theophylline, rifampicin and other inducers of “hepatic” microsomal enzymes (increased metabolic rate). Mitotane and other inhibitors of adrenal cortex function may necessitate increasing the dose of GCS. Clearance of GCS is increased against the background of thyroid hormones.

Immunosuppressants increase the risk of infections and lymphoma or other lymphoproliferative disorders associated with Epstein-Barr virus. Estrogens (including oral estrogen-containing contraceptives) decrease GCS clearance, prolong T1/2 and their therapeutic and toxic effects. The appearance of hirsutism and acne is promoted by the simultaneous use of other steroid hormonal drugs – androgens, estrogens, anabolics, oral contraceptives.

Tricyclic antidepressants may increase the severity of depression caused by taking GCS (not indicated for therapy of these side effects). The risk of cataracts increases when used together with other antipsychotics. GCS, antipsychotic drugs (neuroleptics), carbutamide and azathioprine.

The simultaneous use with m-cholinoblockers (including antihistamines, tricyclic antidepressants), nitrates promotes development of increased intraocular pressure.

Special Instructions

Before treatment, the patient should be examined for possible contraindications. Clinical examination should include CPS, lung X-ray, gastric and duodenal examination; urinary system, organs of vision.

Before and during steroid therapy it is necessary to monitor general blood count, blood and urine glucose concentrations, plasma electrolytes. In case of intercurrent infections, septic conditions and tuberculosis, simultaneous antibiotic therapy is necessary. Immunization should not be carried out during treatment.

In case of sudden withdrawal, especially in case of previous use of high doses, a syndrome of “withdrawal” of GCS occurs: decreased appetite, nausea, lethargy, generalized bone and muscle pain, asthenia. After withdrawal, relative insufficiency of the adrenal cortex persists for several months.

If stressful situations occur during this period, GCS is prescribed (as indicated) for the time, if necessary – in combination with MKS. Children who have been in contact with patients with measles or chickenpox during the treatment period are prophylactically prescribed specific Ig. To reduce side effects, administration of anabolic steroids and increased K+ intake with food are justified.

In Addison’s disease, concomitant administration of barbiturates should be avoided – risk of acute adrenal insufficiency (Addison’s crisis). Administration during pregnancy in the first trimester and during lactation: administer with consideration of the expected therapeutic effect and adverse effect on the fetus and child.

In case of prolonged therapy during pregnancy – fetal growth disorder. In III trimester of pregnancy – danger of adrenal cortex atrophy in fetus, which may require substitution therapy in newborn.

In children in the period of growth, GCS should be used only with absolute indications and under close supervision of the attending physician.

Contraindications

Side effects

Metabolic disorders: sodium retention, chronic heart failure in predisposed patients, increased BP, fluid retention, potassium loss and hypokalemic alkalosis, negative nitrogen balance due to protein catabolism.

Muscular system disorders: steroid myopathy, muscle weakness, osteoporosis, pathological fractures, vertebral compression fractures, aseptic necrosis of epiphyses of tubular bones, tendon ruptures, especially of Achilles tendon.

Digestive system disorders: peptic ulcer with possible perforation and bleeding, gastric bleeding, pancreatitis, esophagitis, intestinal perforation. After GCS treatment an increase of serum ALT, ACT and ALP activity was observed. Usually these changes are insignificant, not associated with any clinical syndromes and are reversible after discontinuation of treatment.

Dermatological reactions: slow wound healing, petechiae and ecchymosis, thinning and decreased skin strength.

Nervous system disorders: increased intracranial pressure, pseudotumor of the brain, mental disorders, seizures.

Endocrine system disorders: menstrual cycle disorders, hirsutism, development of Cushing’s syndrome, suppression of pituitary-adrenal system, decreased carbohydrate tolerance, manifestation of latent diabetes, increased need for insulin or oral hypoglycemic agents in diabetic patients, growth retardation in children.

Overlooking organ: posterior subcapsular cataract, increased intraocular pressure with risk of optic nerve damage, exophthalmus.

Allergic reactions: hypersensitivity reactions, including allergic systemic reactions, possible suppression of reactions in skin tests.

Others: the eroded clinical picture in infectious diseases, activation of latent infections, the occurrence of infections caused by opportunistic pathogens, withdrawal syndrome of GCS.

Overdose

The clinical syndrome of acute drug overdose has not been described. Reports of cases of acute toxicity in GCS overdose are extremely rare.

Symptoms: frequent repeated administration (daily or several times a week) for a long time may lead to development of Cushing’s syndrome and other complications characteristic of prolonged GCS therapy.

Treatment: conduct symptomatic therapy. Methylprednisolone is excreted by dialysis. There is no specific antidote.

Pregnancy use

The use of Medrol during pregnancy is possible if the expected effect of therapy exceeds the potential risk to the fetus (adequate and strictly controlled safety studies have not been conducted).

Women of childbearing age should be warned about the potential risk to the fetus (corticosteroids pass through the placenta).

Feeding women are advised to stop either breastfeeding or using the drug, especially at high doses (corticosteroids penetrate into breast milk and can inhibit endogenous corticosteroid production, suppress growth, and cause unwanted effects in the offspring).

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