Catad_pgroup Systemic corticosteroids

Metipred - instructions for use

INSTRUCTIONS
on the medical use of the drug

Registration number:

P No. 015709/01; P No. 015709/02

Tradename: Metipred

International non-proprietary name:

Methylprednisolone

Dosage form
Tablets; lyophilizate for preparation of solution for intramuscular and intravenous administration.

Compound
1 tablet contains:
Active substance: methylprednisolone - 4 or 16 mg;
Excipients: lactose monohydrate, corn starch, magnesium stearate, gelatin, talc, purified water.
1 vial contains:
Active substance: methyl prednisolone sodium succinate in terms of methyl prednisolone - 250 mg;
Excipients: sodium hydroxide. The solvent is water for injection.

Description
Lyophilisate for solution preparation for intramuscular and intravenous administration: lyophilized powder of white or slightly yellowish color, hygroscopic. The solvent (water for injection) is a clear, colorless liquid.
Tablets 4 mg: round, flat tablets with a beveled edge from almost white to white with a transverse dividing risk on one side.
Tablets 16 mg: almost white to white round, flat, beveled-edged tablets with a score line and "ORN 346" on one side.

Pharmacotherapeutic group:

Glucocorticosteroid.

ATC Code: H02AB04.

Pharmacological properties

Pharmacodynamics
Methylprednisolone is a synthetic glucocorticosteroid drug. It has anti-inflammatory, anti-allergic, immunosuppressive effects, increases the sensitivity of beta-adrenergic receptors to endogenous catecholamines.
Interacts with specific cytoplasmic receptors (glucocorticosteroid (GCS) receptors are found in all tissues, especially in the liver) to form a complex that induces the formation of proteins (including enzymes that regulate vital processes in cells.)
Protein metabolism: reduces the amount of globulins in plasma, increases the synthesis of albumin in the liver and kidneys (with an increase in the albumin / globulin ratio), reduces the synthesis and enhances protein catabolism in muscle tissue.
Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (accumulation of fat occurs mainly in the area of ​​the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.
Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract; increases the activity of glucose-6-phosphatase (increased intake of glucose from the liver into the blood); increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases (activation of gluconeogenesis); contributes to the development of hyperglycemia.
Water-electrolyte metabolism: retains sodium and water in the body, stimulates the excretion of potassium (mineralocorticoid activity), reduces the absorption of calcium from the gastrointestinal tract, reduces the mineralization of bone tissue.
The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils and mast cells; inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes (especially lysosomal) and organelle membranes. It acts on all stages of the inflammatory process: it inhibits the synthesis of prostaglandins at the level of arachidonic acid (lipocortin inhibits phospholipase A2, inhibits the liberation of arachidonic acid and inhibits the biosynthesis of endoperoxides, leukotrienes, which contribute to inflammation, allergies, etc.), the synthesis of "pro-inflammatory cytokines" (interleukin 1, tumor necrosis factor alpha, etc.); increases the resistance of the cell membrane to the action of various damaging factors.
The immunosuppressive effect is due to the involution of lymphoid tissue, inhibition of the proliferation of lymphocytes (especially T-lymphocytes), suppression of B-cell migration and the interaction of T- and B-lymphocytes, inhibition of the release of cytokines (interleukin-1, 2; interferon gamma) from lymphocytes and macrophages and decreased antibody production.
The antiallergic effect develops as a result of a decrease in the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of circulating basophils, T- and B-lymphocytes, mast cells; suppression of the development of lymphoid and connective tissue, reducing the sensitivity of effector cells to allergy mediators, inhibition of antibody formation, changes in the body's immune response.
In obstructive diseases of the respiratory tract, the action is mainly due to the inhibition of inflammatory processes, the prevention or decrease in the severity of edema of the mucous membranes, the decrease in eosinophilic infiltration of the submucosal layer of the bronchial epithelium and the deposition of circulating immune complexes in the bronchial mucosa, as well as inhibition of erosion and desquamation of the mucosa. Increases the sensitivity of beta-adrenergic receptors of small and medium-sized bronchi to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by reducing its production.
Suppresses the synthesis and secretion of adrenocorticotropic hormone (ACTH) and secondarily - the synthesis of endogenous corticosteroids.
It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.

Pharmacokinetics
When ingested, it is rapidly absorbed, absorption is more than 70%. Has a "first pass" effect.
When administered intramuscularly, absorption is complete and fairly rapid. Bioavailability with intramuscular injection - 89%.
The time to reach the maximum concentration in blood plasma (Cmax) after oral administration is 1.5 hours, with intramuscular injection - 0.5-1 hour. C max after intravenous administration at a dose of 30 mg / kg for 20 minutes, or intravenous drip at a dose of 1 g for 30-60 minutes, reaches 20 μg / ml. After intramuscular administration of 40 mg, approximately 2 hours later, Cmax is reached, which is 34 μg / ml.
Communication with plasma proteins - 62%, regardless of the administered dose (bounds only to albumin).
The plasma half-life for oral administration is approximately 3.3 hours, for parenteral administration - 2.3-4 hours and probably does not depend on the route of administration. Due to intracellular activity, a pronounced difference is revealed between the half-life of methylprednisolone from blood plasma and the half-life from the body as a whole (approximately 12-36 hours). The pharmacotherapeutic effect persists even when the level of the drug in the blood is no longer determined.
It is metabolized mainly in the liver, metabolites (ll-keto and 20-hydroxy compounds) do not have GCS activity and are excreted mainly by the kidneys (about 85% of the administered dose is found within 24 hours in the urine, and about 10% in the feces). Penetrates through the blood-brain barrier and placental barrier. Metabolites are found in breast milk.

Indications
For oral administration:

• Systemic connective tissue diseases (systemic lupus erythematosus, scleroderma, periarteritis nodosa, dermatomyositis, rheumatoid arthritis).
• Acute and chronic inflammatory diseases of the joints - gouty and psoriatic arthritis, osteoarthritis (including post-traumatic), polyarthritis (including senile), humeroscapular periarthritis, ankylosing spondylitis (Bekhterev's disease), juvenile arthritis, Still's syndrome in adults, bursitis, nonspecific tendosynovitis, synovitis and epicondylitis.
• Acute rheumatism, rheumatic carditis, chorea minor.
• Bronchial asthma, status asthmaticus.
• Acute and chronic allergic diseases - incl. allergic reactions to drugs and wheat products, serum sickness, urticaria, allergic rhinitis, Quincke's edema, drug exanthema, hay fever, etc.
• Skin diseases - pemphigus, psoriasis, eczema, atopic dermatitis (common neurodermatitis), contract dermatitis (involving a large surface of the skin), toxidermia, seborrheic dermatitis, exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome), bullous dermatitis herpetiformis, Stevens-Johnson syndrome .
• Cerebral edema (including against the background of a brain tumor or associated with surgery, radiation therapy or head trauma) after preliminary parenteral use of GCS.
• Allergic eye diseases - allergic forms of conjunctivitis.
• Inflammatory eye diseases - sympathetic ophthalmia, severe sluggish anterior and posterior uveitis, optic neuritis.
• Primary or secondary adrenal insufficiency (including condition after removal of the adrenal glands).
• Congenital adrenal hyperplasia.
• Kidney diseases of autoimmune origin (including acute glomerulonephritis).
• nephrotic syndrome.
• Subacute thyroiditis.
• Diseases of the blood and hematopoietic system - agranulocytosis, panmyelopathy, autoimmune hemolytic anemia, lympho- and myeloid leukemia, lymphogranulomatosis, thrombocytopenic purpura, secondary thrombocytopenia in adults, erythroblastopenia (erythrocyte anemia), congenital (erythroid) hypoplastic anemia.
• Interstitial lung diseases - acute alveolitis, pulmonary fibrosis, sarcoidosis II-III st.
• Tuberculous meningitis, pulmonary tuberculosis, aspiration pneumonia (in combination with specific chemotherapy).
• Berilliosis, Leffler's syndrome (not amenable to other therapy); lung cancer (in combination with cytostatics).
• Multiple sclerosis.
• Ulcerative colitis, Crohn's disease, localized enteritis.
• Hepatitis, hypoglycemic conditions.
• Prevention of transplant rejection in organ transplantation.
• Hypercalcemia against the background of oncological diseases, nausea and vomiting during cytostatic therapy.
• Myeloma.

Parenterally
Emergency therapy for conditions requiring a rapid increase in the concentration of glucocorticosteroids in the body:

• Shock conditions (burn, traumatic, surgical, toxic, cardiogenic) - with the ineffectiveness of vasoconstrictors, plasma-substituting drugs and other symptomatic therapy.
• Allergic reactions (acute severe forms), hemotransfusion shock, anaphylactic shock, anaphylactoid reactions.
• Cerebral edema (including against the background of a brain tumor or associated with surgery, radiation therapy or head trauma).
• Bronchial asthma (severe form), status asthmaticus.
• Systemic connective tissue diseases (systemic lupus erythematosus, rheumatoid arthritis).
• Acute adrenal insufficiency.
• thyrotoxic crisis.
• Acute hepatitis, hepatic coma.
• Reducing inflammation and preventing cicatricial narrowing (in case of poisoning with caustic fluids).

Contraindications
For short-term use for health reasons, the only contraindication is hypersensitivity to methylprednisolone or the components of the drug.
In children during the period of growth, corticosteroids should be used only according to absolute indications and under the most careful supervision of the attending physician.

Use during pregnancy and breastfeeding
During pregnancy (especially in the first trimester), they are used only for health reasons.
Since glucocorticosteroids pass into breast milk, if it is necessary to use the drug during breastfeeding, it is recommended to stop breastfeeding.

Dosage and administration
The dose of the drug and the duration of treatment is set by the doctor individually, depending on the indications and severity of the disease.
Tablets. The entire daily dose of the drug is recommended to be taken orally once or twice a daily dose - every other day, taking into account the circadian rhythm of endogenous secretion of glucocorticosteroids in the range from 6 to 8 a.m. Tablets should be taken during or immediately after a meal with a small amount of liquid.
The initial dose of the drug can be from 4 mg to 48 mg of methylprednisolone per day, depending on the nature of the disease. For less severe diseases, lower doses are usually sufficient, although higher doses may be required in some patients. High doses may be required for diseases and conditions such as multiple sclerosis (200 mg/day), cerebral edema (200-1000 mg/day) and organ transplantation (up to 7 mg/kg/day). If after a sufficient period of time a satisfactory clinical effect is not obtained, the drug should be discontinued and the patient should be prescribed another type of therapy.
For children, the dose is determined by the doctor, taking into account the weight or surface of the body. With adrenal insufficiency - orally 0.18 mg / kg or 3.33 mg / sq.m per day in 3 doses, for other indications - 0.42-1.67 mg / kg or 12.5-50 mg / sq. .m per day in 3 divided doses.
With prolonged use of the drug, the daily dose should be reduced gradually. Long-term therapy should not be stopped abruptly!
Parenterally the drug is administered in the form of slow intravenous jet injections or intravenous infusions, as well as intramuscular injections.
Solution preparation. The solution for injection is prepared by adding the solvent to the lyophilisate vial immediately before use. The prepared solution contains 62.5 mg/ml of methylprednisolone.
As adjunct therapy for life-threatening conditions enter 30 mg/kg of body weight in/in for at least 30 minutes. The introduction of this dose can be repeated every 4-6 hours for no more than 48 hours.
Pulse therapy in the treatment of diseases in which GCS therapy is effective, with exacerbations of the disease and / or with the ineffectiveness of standard therapy.
Recommended treatment regimens:

• Rheumatic diseases: 1 g/day IV for 1-4 days or 1 g/month IV for 6 months
• Systemic lupus erythematosus: 1 g/day IV for 3 days
• Multiple sclerosis: 1 g/day IV for 3 or 5 days
• Edematous conditions, eg, glomerulonephritis, lupus nephritis: 30 mg/kg IV every other day for 4 days or 1 g/day for 3, 5, or 7 days

The above doses should be administered over at least 30 minutes, the administration can be repeated if no improvement has been achieved within a week after the treatment, or if the patient's condition requires it.
Oncological diseases in the terminal stage - to improve the quality of life: administer 125 mg/day IV daily for up to 8 weeks.
Prevention of nausea and vomiting associated with cancer chemotherapy. In chemotherapy characterized by slight or moderate vomiting, administer 250 mg intravenously for at least 5 minutes 1 hour before the administration of the chemotherapeutic drug, at the beginning of chemotherapy, and also after its completion. In chemotherapy characterized by pronounced vomiting, administer 250 mg IV over at least 5 minutes in combination with appropriate doses of metoclopramide or butyrophenone 1 hour before the administration of the chemotherapeutic drug, then 250 mg IV at the beginning of chemotherapy and after its completion.
For other indications, the initial dose is 10-500 mg IV, depending on the nature of the disease. For a short course in severe acute conditions, higher doses may be required. An initial dose not exceeding 250 mg should be administered intravenously over at least 5 minutes; doses above 250 mg should be administered over at least 30 minutes. Subsequent doses are administered intravenously or intramuscularly, with the duration of the intervals between injections depending on the patient's response to therapy and on his clinical condition.
Children should be administered lower doses (but not less than 0.5 mg / kg / day), however, when choosing a dose, the severity of the condition and the patient's response to therapy are primarily taken into account, and not age and body weight.

Side effect
The frequency of development and severity of side effects depends on the duration of use, the size of the dose used and the possibility of observing the circadian rhythm of Metipred's appointment.
When using Metipred, the following may be noted:
From the endocrine system: decreased glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, adrenal suppression, Itsenko-Cushing syndrome (moon face, pituitary-type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, muscle weakness, striae), delayed sexual development in children.
From the digestive system: nausea, vomiting, pancreatitis, steroid ulcer of the stomach and duodenum, erosive esophagitis, gastrointestinal bleeding and perforation of the gastrointestinal tract wall, increased or decreased appetite, indigestion, flatulence, hiccups. In rare cases, an increase in the activity of "liver" transaminases and alkaline phosphatase.
From the side of the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of heart failure, changes in the electrocardiogram characteristic of hylocalemia, increased blood pressure, hypercoagulability, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle.
From the nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or restlessness, insomnia, dizziness, vertigo, cerebellar pseudotumor, headache, convulsions.
From the sense organs: posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral eye infections, trophic changes in the cornea, exophthalmos, sudden loss of vision (with parenteral administration in the head, neck, turbinates, scalp, it is possible deposition of crystals of the drug in the vessels of the eye).
From the side of metabolism: increased excretion of calcium, hypokalydemia, weight gain, negative nitrogen balance (increased protein breakdown), increased sweating.
Caused by mineralocorticoid activity: fluid and sodium retention (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).
From the musculoskeletal system: growth retardation and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely, pathological bone fractures, aseptic necrosis of the head of the humerus and femur), muscle tendon rupture, steroid myopathy, decreased muscle mass (atrophy).
From the skin and mucous membranes: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, striae, a tendency to develop pyoderma and candidiasis.
Allergic reactions: skin rash, itching, anaphylactic shock, local allergic reactions.
Local for parenteral administration: burning, numbness, pain, tingling at the injection site, infection at the injection site, rarely - necrosis of surrounding tissues, scarring at the injection site; atrophy of the skin and subcutaneous tissue with intramuscular injection (especially dangerous is the introduction into the deltoid muscle).
Others: development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccination), leukocyturia, "withdrawal" syndrome, "flushing" of blood to the head.

Overdose
It is possible to increase the side effects described above. It is necessary to reduce the dose of Metipred. Treatment is symptomatic.

Interaction with other drugs
Pharmaceutical incompatibility of methylprednisolone with other intravenously administered drugs is possible - it is recommended to administer it separately from other drugs (intravenously as a bolus, or through another dropper, as a second solution). Co-administration of methylprednisolone with:

• inducers of "liver" microsomal enzymes (phenobarbital, rifampicin, phenytoin, theophylline, rifampicin, ephedrine) leads to a decrease in its concentration (increase in metabolic rate);
• diuretics (especially "thiazide" and carbonic anhydrase inhibitors) and amphotericin B- may lead to increased excretion of potassium from the body and an increased risk of developing heart failure; carbonic anhydrase inhibitors and loop diuretics may increase the risk of osteoporosis;
• with sodium preparations- to the development of edema and increased blood pressure;
• cardiac glycosides- their tolerance worsens and the likelihood of developing ventricular extrasitolia increases (due to the hypokalemia caused);
• indirect anticoagulants- weakens (rarely enhances) their effect (dose adjustment is required);
• anticoagulants and thrombolytics- increased risk of bleeding from ulcers in the gastrointestinal tract;
• ethanol and non-steroidal anti-inflammatory drugs (NSAIDs)- the risk of erosive and ulcerative lesions in the gastrointestinal tract and the development of bleeding increases (in combination with NSAIDs in the treatment of arthritis, it is possible to reduce the dose of glucocorticosteroids due to the summation of the therapeutic effect);
• indomethacin- the risk of developing side effects of methylprednisolone increases (displacement of methylprednisolone by indomethacin from its association with albumins);
• paracetamol- increases the risk of developing hepatotoxicity (induction of liver enzymes and the formation of a toxic metabolite of paracetamol);
• acetylsalicylic acid- accelerates its excretion and reduces the concentration in the blood (with the abolition of methylprednisolone, the level of salicylates in the blood increases and the risk of side effects increases);
• insulin and oral hypoglycemic drugs, antihypertensive drugs- their effectiveness decreases;
• vitamin D- its effect on calcium absorption in the intestine is reduced;
• growth hormone- reduces the effectiveness of the latter, and with praziquantel - its concentration;
• M-anticholinergics (including antihistamines and tricyclic antidepressants) and nitrates- promotes increase in intraocular pressure;
• isoniazid and mexiletin- increases their metabolism (especially in "slow" acetylators), which leads to a decrease in their plasma concentrations. ACTH enhances the action of methylprednisolone.

Ergocalciferol and parathyroid hormone prevent the development of osteopathy caused by methylprednisolone.
Cyclosporine and ketoconazole, by slowing down the metabolism of methylprednisolone, can in some cases increase its toxicity.
The simultaneous appointment of androgens and steroid anabolic drugs with methylprednisolone contributes to the development of peripheral edema and hirsutism, the appearance of acne.
Estrogens and plural estrogen-containing contraceptives reduce the clearance of methylprednisolone, which may be accompanied by an increase in the severity of its action.
Mitotane and other inhibitors of adrenal function may necessitate an increase in the dose of methylprednisolone.
When used simultaneously with live antiviral vaccines and against the background of other types of immunizations, it increases the risk of virus activation and the development of infections.
Immunosuppressants increase the risk of developing infections and lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus.
Antipsychotics (neuroleptics) and azathioprine increase the risk of developing cataracts with methylprednisolone.
The simultaneous administration of antacids reduces the absorption of methylprednisolone.
With simultaneous use with antithyroid drugs, it decreases, and with thyroid hormones, the clearance of methylprednisolone increases.

special instructions
Store the prepared solution for parenteral administration at room temperature (15°-20°C) and use within 12 hours. If the prepared solution is stored in a refrigerator at a temperature of 2°-8°C, then it can be used within 24 hours.
During treatment with Metipred (especially long-term), it is necessary to observe an ophthalmologist, control blood pressure, the state of water and electrolyte balance, as well as peripheral blood patterns and blood glucose concentrations.
In order to reduce side effects, you can prescribe antacids, as well as increase the intake of potassium in the body (diet, potassium preparations). Food should be rich in proteins, vitamins, with limited content of fats, carbohydrates and salt.
The effect of the drug is enhanced in patients with hypothyroidism and cirrhosis of the liver. The drug may increase existing emotional instability or psychotic disorders. When indicating a history of psychosis, Metipred in high doses is prescribed under the strict supervision of a physician.
Caution should be used in acute and subacute myocardial infarction - it is possible to spread the focus of necrosis, slow the formation of scar tissue and rupture the heart muscle.
In stressful situations during maintenance treatment (for example, surgery, trauma or infectious diseases), the dose of the drug should be adjusted due to an increase in the need for glucocorticosteroids.
With sudden cancellation, especially in the case of previous use of high doses, the development of a “withdrawal” syndrome (anorexia, nausea, lethargy, generalized musculoskeletal pain, general weakness) is possible, as well as an exacerbation of the disease, for which Metipred was prescribed.
During treatment with Metipred, vaccination should not be carried out due to a decrease in its effectiveness (immune response).
When prescribing Metipred for intercurrent infections, septic conditions and tuberculosis, it is necessary to simultaneously treat with bactericidal antibiotics.
In children during long-term treatment with Metipred, careful monitoring of the dynamics of growth and development is necessary. Children who during the period of treatment were in contact with patients with measles or chickenpox are prescribed specific immunoglobulins prophylactically.
Due to the weak mineralocorticoid effect for replacement therapy in adrenal insufficiency, Metipred is used in combination with mineralocorticoids.
In patients with diabetes mellitus, the concentration of glucose in the blood should be monitored and, if necessary, the dose of hypoglycemic agents should be adjusted.
X-ray control of the osteoarticular system (spine, hand) is shown.
Metipred in patients with latent infectious diseases of the kidneys and urinary tract can cause leukocyturia, which may be of diagnostic value. Metipred increases the content of metabolites of 11- and 17-hydroxyketocorticosteroids.

Release form
Tablets of 4 or 16 mg. 10 tablets in a blister. 3 or 10 blisters, together with instructions for use, are placed in a cardboard box. 30 or 100 tablets in amber glass bottles. 1 vial, together with instructions for use, is placed in a cardboard box. 30 tablets in a plastic (polyethylene) container. 1 container, together with instructions for use, is placed in a cardboard box.
Lyophilized powder for solution for intramuscular and intravenous administration of 250 mg in vials. 1 bottle together with instructions for use is placed in a cardboard box.
Freeze dried powder for the preparation of a solution for intramuscular and intravenous administration of 250 mg in vials complete with a solvent in ampoules of 4 ml. 1 vial and 1 ampoule together with instructions for use are placed in a cardboard box.

Storage conditions
List B.
Tablets of 4 or 16 mg. At a temperature of 15 to 25 ° C, out of the reach of children.
Lyophilized powder. At a temperature of 15 - 25 ° C in a place protected from light. The reconstituted solution is stored in a refrigerator at 2 - 8°C for 24 hours.

Best before date
5 years.
Do not use after the expiry date stated on the packaging.

Conditions for dispensing from pharmacies:

on prescription.

Manufacturer
"Orion Corporation" P.Ya. 65, 02101 Espoo, Finland.
Representative office in Moscow: 113093, Moscow, st. Lyusinovskaya, 36, building 1

A fairly common reason for unsuccessful attempts to conceive a baby is a violation of the hormonal background of a woman, in which male sex hormones predominate in the body.

In order to correct this condition, doctors prescribe serious therapy with certain medications. One of these is Metipred (Methylprednisolone), which consists of a potent substance that can suppress male hormones while stimulating female hormones.

Use during pregnancy and lactation

The drug has a potent effect on many pathological processes in the body. These include such diseases:

• Connective tissue disorders;
• Inflammation in the joint tissue;
• Treatment of rheumatism, asthma, cerebral edema;

However, women are more familiar with the drug as a treatment for infertility.

There are many reasons for the lack of conception. Moreover, most often it is caused not so much by pathological changes in the internal organs, but by diseases that adversely affect reproductive function, causing problems with conception.

Metipred when planning pregnancy is able to eliminate some violations. In particular, it is prescribed for hyperandrogenism - an excess of male hormones in the female body.

We list other "opportunities" of the drug when planning pregnancy:

• Stabilization of violations of the concentration of hormones;
• Elimination of inflammation processes;
• Reduction of fibroids in the uterus;
• Increased exposure to other medications;
• Elimination of the consequences of previous non-developing pregnancies.

But since this is a drug with many side effects, the reasons for prescribing it must be very good. Before taking, be sure to consult not only with a gynecologist, but also with an endocrinologist. Sometimes Metipred is prescribed unjustifiably.

For pregnancy, Metipred is necessary to normalize hormone levels, but often the desired effect does not occur. This may be due to a number of reasons:

• genetic predisposition;
• Use before the course of therapy "Dufaston";
• Injury;
• Exacerbation of chronic pathologies;
• The appearance and growth of tumors;
• Insufficiently balanced diet.

The task of the gynecologist is to identify for what reason the stabilization of the hormonal background does not occur. He needs to compare the repeated laboratory test with the results of the tests that were carried out before the treatment. After identifying the cause, the dosage of the drug and the method of therapy is adjusted.

A sharp change in the hormonal background in infertility is no less dangerous than its violation. Therefore, if repeated laboratory diagnostics revealed such changes in the number of necessary hormones, they make a temporary break in taking the medicine.

The doctor prescribes Metipred according to the indications that we talked about above. The dosage and regimen of the drug is determined depending on the degree of hormonal imbalance.

Most often, the course of therapy does not exceed 3 months, and the daily intake of the drug is ½ tablet. However, depending on the individual characteristics of the woman, the doctor may change the treatment regimen.

While taking Metipred, when planning a pregnancy, certain recommendations must be followed. A tablet (or half a tablet, as prescribed by your doctor) should be taken once a day in the morning during or immediately after a meal.

Although in some individual cases, doctors prescribe to their patients a different dosage and a different time of admission. In this case, you need to trust your doctor.

It is important to drink it with enough water.

If, after therapy, a long-awaited event occurred, and the woman found two long-awaited strips on the test, you cannot stop taking the drug on your own! The doctor should also determine the tactics of canceling Mitepred, because a sharp destabilization of the hormonal background can cause a miscarriage.

Moreover, despite the fact that foreign medicine refused to use the drug after conception, Russian doctors also use it during pregnancy. This is due to the fact that sometimes after stopping the medication in women, a condition is fixed that threatens the course of pregnancy.

If Metipred is prescribed when planning a pregnancy, then they try to refuse other medicines. With a powerful effect on the entire body, the drug can neutralize the effects of other drugs or cause dangerous side effects.

However, when the situation requires additions to therapy, the gynecologist may consider the combined use of tablets.

Metipred and Klostilbegit are potent drugs with a different spectrum of action. If the first medicine stabilizes the hormonal background, then the second helps to stimulate ovulation. Both drugs have many contraindications, so their combined use should be justified.

Metipred and Duphaston can also play a positive role in a successful conception in a duet. During the stabilization of hormones, Dufaston prepares the uterus, strengthening its walls (endometrium).

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Once again, we recall that these drugs have a strong effect, causing many unpleasant and sometimes dangerous consequences.

Before prescribing a hormonal drug to a woman, a gynecologist needs to conduct a complete examination, not only in her field, but also in the field of endocrinology.

And then, taking into account all the results, develop an effective treatment regimen to "level" the hormonal background in order to achieve pregnancy in the future.

Metipred is appointed in the following cases:

• if the level of the male sex hormone (testosterone) is too high, which “does not allow” a woman to become pregnant, or, if pregnancy has already begun, provokes a miscarriage;
• if there is a risk of developing secondary infertility in gynecological diseases in girls at an early age (for example, uterine fibroids, which is progressing).

It is important to remember that only a doctor can prescribe such a drug and only after a comprehensive and detailed examination. He also selects the necessary dosage and regimen. Most often, the drug is taken half a tablet a day with meals or immediately after, with a small amount of water.

There is another form of release of the drug, intended for injection, but doctors prescribe it only in extremely difficult cases. Initially, the indications for prescribing the drug do not at all relate to pregnancy planning, so you will not find in the instructions how to take it in this case.

Reviews of the named drug indicate that Metipred is able to successfully equalize the hormonal background in a situation where testosterone predominates in the body of the expectant mother (a condition called hyperandrogenism in medicine).

Interaction with other drugs

With an illiterate combination of medicines, the expected result will not be, but serious complications are very likely. Therefore, experts advise to pay attention to the consequences of different drug combinations.
In this case, we are talking about such problems:

• enhancing the ulcerogenic effect of non-steroidal anti-inflammatory drugs;
• an increase in the risk of hemorrhages in the interaction of Metipred and anticoagulants;
• reducing the effect of anticoagulants;
• muscle weakness, which is possible when combined with anticholinesterase drugs;
• reducing the effectiveness of oral drugs of the glycemic group when combined with insulin and Metipred;
• strengthening the effect of active methylprednisolone when combined with inhibitors (Erythromycin, Ketoconazole, Clarithromycin);
• the ineffectiveness of a hormonal drug when it interacts with drugs that provoke the production of enzymes;
• intensive loss of potassium, which is possible when Metipred is combined with diuretics and laxatives;
• enhancing the therapeutic effect of other immunosuppressive drugs, as well as antiemetic drugs that are used in chemotherapy;
• the possibility of convulsions when combined with Cyclosporine;
• decrease in the effect of Somatropin with prolonged combination;
• the development of acute forms of myopathy when combining high doses of a hormonal agent with Doxacarium.

The risk of development and severity of side effects of the drug directly depends on how long and at what dosage it was used. By the way, long-term therapy with this drug should not be stopped suddenly: the dose is reduced gradually and under the supervision of a specialist.

The use of the described tool, as you have already seen, requires special care and accuracy. When prescribing it, do not forget to tell your doctor about all the drugs that you are currently taking.

Take, for example, the situation when the expectant mother combines Paracetomol and Metipred. Reviews of experts in this regard are extremely negative.

So, doctors say that in this case there is a risk of developing hepatotoxicity (toxic effects of drugs on the liver). A parallel intake with diuretics can provoke an increase in the risk of heart failure.

Methylprednisolone also helps to reduce the effect of anticoagulants, and when taken together with nonsteroidal drugs, it can provoke the development of ulcers in the gastrointestinal tract. The described drug reduces the effect of the introduction of insulin and means to lower blood pressure.

Despite the fact that abroad they have already refused to take the described medicine, our doctors assure that it quite often turns out to be the only way to maintain a long-awaited pregnancy.

In addition, correctly prescribed, in small doses, this drug, according to experts, is completely safe. As experience shows, many women safely endured and gave birth to healthy babies, while taking this remedy.

But if you don’t want to take risks in any way, opt for medicines with a similar effect. Naturally, with the permission of the leading specialist.

So, what are the analogues of the drug "Metipred"? These include the following drugs: Medrol, Prednol-L, Depo-Medrol, Methylprednisolone Sopharma, Solu Medrol, Urbazon and Urbazon-Depot.

But, despite the similarity, they may differ somewhat in their effect on the body, which gives doctors the opportunity, in case of poor tolerance by the patient of a particular drug, to find analogues for Metipred that are suitable for a particular situation.

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According to the instructions for the use of Metipred, the number of tablets and the duration of treatment depends on the indications and the severity of the disease. The entire daily dose must be taken orally at one time. Tablets should be taken during or immediately after a meal with a small amount of water.

The initial dose is from 4 to 48 milligrams per day. In severe diseases, the dose can be increased, with less severe - reduced.

As a rule, high doses are taken for organ transplantation (up to 7 milligrams per 1 kilogram per day), cerebral edema (from 200 to 900 milligrams per day), multiple sclerosis (200 milligrams per day).

Metipred is administered intramuscularly or as slow intravenous jet injections or intravenous infusions.

To prepare the solution, immediately before use, the solvent is added to the vial with the lyophilisate. The prepared solution contains 62.5 mg/ml of methylprednisolone.

In life-threatening conditions, Metipred 30 mg/kg is administered intravenously over at least 30 minutes (as adjunctive therapy). The introduction of the same dose can be repeated for 48 hours every 4-6 hours.

During pulse therapy in the treatment of diseases in which glucocorticosteroids are effective, exacerbations of diseases and / or ineffectiveness of standard methods of treatment, Metipred is prescribed as follows (intravenously):

• Rheumatic diseases: 1-4 days, 1000 mg per day or 6 months, 1000 mg per month;
• Multiple sclerosis: 3 or 5 days, 1000 mg per day;
• Systemic lupus erythematosus: 3 days at 1000 mg per day;
• Edematous conditions (eg, lupus nephritis, glomerulonephritis): 4 days at 30 mg / kg every other day or 3, 5 or 7 days at 1000 mg per day.

The above doses must be administered over at least 30 minutes. If no improvement is achieved within 7 days of therapy, or if the patient's condition requires it, the administration can be repeated.

In the terminal stages of oncological diseases, to improve the quality of life, 125 mg is administered intravenously daily for 2 months.

During chemotherapy, characterized by a moderate or slight emetic effect, 250 mg of Metipred is administered intravenously for at least 5 minutes.

The drug is used 1 hour before the administration of a chemotherapeutic drug, at the beginning of chemotherapy and after its completion. With a pronounced emetic effect accompanying chemotherapy, 250 mg is administered intravenously for at least 5 minutes simultaneously with the corresponding doses of butyrophenone or metoclopramide 1 hour before the administration of the chemotherapeutic drug, then 250 mg at the beginning of chemotherapy and after its completion.

The initial dose for other indications, depending on the nature of the disease, is 10-500 mg (intravenously). For short courses in acute severe conditions, higher doses may be required.

Initial doses up to 250 mg should be given over at least 5 minutes, higher doses over at least 30 minutes. The following doses can be administered intravenously or intramuscularly, the duration of the intervals between injections is determined by the patient's response to treatment and his clinical condition.

Children are prescribed lower doses (but not less than 0.5 mg / kg per day), however, first of all, when choosing a dose, it is important to consider not the body weight and age of the patient, but the severity of the condition and response to therapy.

When using the drug, it is necessary to take into account the interaction with other drugs:

1. When taken simultaneously with NSAIDs, it is possible to increase the risk of erosive and ulcerative lesions of the gastrointestinal tract.
2. When combined with barbiturates, the effectiveness of methylprednisolone may decrease.
3. With simultaneous use with phenobarbital and phenytoin, the clearance of methylprednisolone increases and its effectiveness decreases.
4. With complex use, it is possible to reduce the effect of phenytoin. With erythromycin - there is a possibility of inhibition of the metabolism of methylprednisolone. With cyclosporine - inhibition of the metabolism of methylprednisolone and cyclosporine.
5. With the combined use of methylprednisolone with oral anticoagulants, heparin increases or decreases the anticoagulant effect. With furosemide and thiazide diuretics - potentiation of hypokalemia is possible. With salicylates - it is possible to reduce the effect of salicylates.
6. With simultaneous use with insulin, metformin and glibenclamide, the effectiveness of hypoglycemic agents decreases. With itraconazole and ketoconazole, the concentration of methylprednisolone in the blood plasma increases. With methotrexate - synergism of immunosuppressive effects. With pancuronium - a decrease in neuromuscular blockade. With pyridostigmine and neostigmine - the development of a myasthenic crisis is possible. With salbutamol - an increase in the potential toxicity and effectiveness of salbutamol. With rifampicin - an increase in the clearance of methylprednisolone.

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Instructions for use

According to the instructions for use, the dose of Metipred and the duration of therapy are set individually by the doctor based on the indications and severity of the course of the disease.

• The initial dose of the drug can be from 4 mg to 48 mg of methylprednisolone per day, depending on the nature of the disease. For less severe diseases, lower doses are usually sufficient, although higher doses may be required in some patients. High doses may be required for diseases and conditions such as multiple sclerosis (200 mg/day), cerebral edema (200-1000 mg/day) and organ transplantation (up to 7 mg/kg/day). If after a sufficient period of time a satisfactory clinical effect is not obtained, the drug should be discontinued and the patient should be prescribed another type of therapy.

A high daily dose can be divided into 2-4 doses, while in the morning you should take a large dose. Tablets should be taken during or immediately after a meal with a small amount of liquid.

The instructions for use indicate that Metipred tablets are taken orally. The dose of the drug and the duration of treatment is set by the doctor individually, depending on the indications and severity of the disease.

Contraindications

• hypotension and other diseases of the cardiovascular system (including congestive heart failure);
• diabetes;
• osteoporosis;
• glaucoma;
• mental disorders;
• polio;
• nephritis;
• ulcers of the digestive tract;
• syphilis;
• individual intolerance to the active substance and lactose;
• Itsenko-Cushing's syndrome;
• acute or chronic forms of viral and bacterial diseases;
• tuberculosis (acute or latent form);
• pancreatitis;
• tendency to thrombophlebitis;
• blood clotting disorders;
• liver dysfunction;
• hypothyroidism.

In addition, Metipred should not be used by the elderly, as well as those who have an increased risk of perforation or internal bleeding.

For short-term use for health reasons, the only contraindication is a strong sensitivity to methylprednisolone or other components of the drug.

Main contraindications:

1. Lactose intolerance;
2. fungal or bacterial infections (acute or chronic);
3. Arterial hypertension (with caution);
4. Diabetes mellitus (only with the permission of a doctor);
5. Diseases of the gastrointestinal tract;
6. kidney or liver failure;
7. Pregnancy;
8. Childhood;
9. Heart disease.

The drug can be prescribed only under the close supervision of the attending physician to patients suffering from impaired liver function and hypothyroidism.

Hypersensitivity to the components of Metipred is the only contraindication for short-term therapy for health reasons.

In children during the period of growth, the drug should be used only under the close supervision of a physician and according to absolute indications.

Prices

So, a competent specialist should prescribe the named remedy, who will help not only choose the right dosage, but will also monitor the patient's health throughout the entire time of therapy.

In Russia, the price for the Metipred drug was set at 260 rubles. (when packaged 4 mg / 30 pcs.). It should be noted that you can buy it in pharmacies only with a doctor's prescription.

The price of Metipred tablets in Russia averages 260 rubles (4 mg / 30 pcs.).

You can buy the drug in Ukraine for an average of 190 hryvnia (4 mg / 30 pcs.).

The average price of METIPRED, tablets in pharmacies (Moscow) is 200 rubles.

How much does Metipred cost? The average price in pharmacies is at the level of 210 rubles.

Price in the online pharmacy site: from 177

Some facts

Metipred is manufactured by the Finnish pharmaceutical company Orion Pharma.

Main active ingredient

Methylprednisolonum.

Belonging to ICD-10 groups

This drug belongs to the following classes: J, K, M, R, T, Z.

The need for application

Metipred is prescribed for therapy:

• diseases characterized by a systemic type of inflammation of various organs and systems;
• inflammatory diseases in the joints in acute and chronic form;
• rheumatism in an acute form;
• bronchial asthma;
• allergies in chronic and acute form;
• various skin diseases;
• cerebral edema;
• eye diseases of allergic and inflammatory type;
• adrenal insufficiency;
• congenital deformation of the adrenal glands;
• autoimmune kidney disease;
• nephrotic syndrome;
• blood diseases;
• lung diseases;
• multiple sclerosis;
• ulcerative colitis, enteritis;
• hepatitis A;
• for the prevention of rejection after transplantation;
• hypercalcemia in cancer patients;
• myeloma.

Pharmacological effect

The drug is effectively used to artificially suppress the immune system and relieve inflammation.

Produced form and components

Metipred is produced as a dragee for oral administration and a concentrate for dissolution. The components of the dragee are Methylprednisolonum, Lacticum, Frumentum amylum, E572, Gelatina, Talcum, Aqua destillata. The components of the concentrate are Methylprednisolonum, Natrii hydroxidum. Solvent - Aqua destillata.

Adverse symptoms

The intake of these tablets may be accompanied by negative reactions, manifested in the form of disturbances in the endocrine system, sensations of nausea, vomiting, ulcers in the stomach and the initial sections of the small intestine, erosions, bleeding in the gastrointestinal tract, disturbances in appetite, increased gas formation, rapid and slow heartbeat, increased blood pressure, thrombosis, various hallucinations, depression, excessive nervousness, insomnia, pain in the head, involuntary contractions in the muscles, cataracts, loss of vision, decreased levels of calcium, potassium, elevated sodium levels, muscle pain, slow growth, slow wound healing, various pigmentation and rashes, allergies, numbness and tingling in the injection area, etc.

The presence of restrictions on admission. Contraindications.

Contraindicated for use in the presence of allergies or hypersensitivity to the ingredients of the drug. These tablets are prohibited for use:

• in the presence of tuberculosis or other infections caused by bacteria or viruses;
• in the presence of fungal diseases of a systemic nature.

Dosage and instructions for use

The duration of therapy and dosage for each patient is individual. The attending doctor deals with this issue after he has assessed the patient's condition and the severity of his illness.

Dragee

Dragee Metipred is used for oral administration. Reception is carried out during the period of eating or at its completion. The daily volume of the drug taken can be taken in one day, or you can take a double amount, but then the dose is taken every other day. The double dosage can be divided into two, three or four times. But a large dose is taken in the morning. The initial medication is prescribed based on the severity of the disease and is made in a volume equal to 4 to 48 milligrams per day. For the treatment of multiple sclerosis, the dose is prescribed at a dosage of 200 milligrams per day. Patients with cerebral edema should take 200 milligrams to 1 g per day. When transplanting organs, the intake is made in an amount not exceeding 7 milligrams per 1 kg of body weight per day. In the absence of the desired result, therapy is canceled and another option is prescribed. For the treatment of children, the doctor himself selects the dosage regimen based on the weight and area of ​​the patient's body. For the treatment of insufficiency in the adrenal glands, a dosage of 0.18 milligrams per 1 kg of body weight or 3.33 milligrams per 1 m2 of body area is used and it is divided into 3 times. Therapy of other diseases is carried out in a volume of 0.42 to 1.67 milligrams per 1 kg of body weight, or from 12.5 to 50 mg per 1 m2 of body area, the selected dosage is divided into 3 times. Taking this drug for a long period of time should be carried out with a gradual decrease in the amount of medication taken. It is not recommended to cancel treatment abruptly.

Dissolution concentrate.

Metipred concentrate is used for intravenous and intramuscular administration. For intravenous use, it can be made in the form of droppers or a slow jet injection. The solution for further use is prepared as follows: the solvent presented in the package is introduced into the bottle with the concentrate. Auxiliary therapy in the presence of a threat to life for the patient is carried out in a volume equal to 30 milligrams per 1 kg of weight and is administered intravenously for half an hour. This introduction can be repeated 4 or 6 times a day, but in a period not exceeding two days. Therapy for rheumatism is carried out intravenously at a dosage of 1 gram per day or 1 gram per month for a 6-month period. Treatment of lupus erythematosus in a systemic form is carried out intravenously for 3 days, 1 gram per day. Therapy for multiple sclerosis is carried out intravenously for 3 or 5 days, 1 gram per day. For edematous diseases, the dosage is 30 mg per 1 kg of weight for 4 days, or 1 gram per day on the 3rd, 5th and 7th days. Therapy of patients with oncology in the terminal form is carried out in the amount of 125 milligrams per day every day, but not more than 2 months.

Compatibility with other drugs

When combining glucocorticoids with drugs aimed at inhibiting blood clotting, the effectiveness of the latter may increase. Salicylates, indomethacin, and other non-steroidal anti-inflammatory drugs combined can cause stomach ulcers. Metipred combined with salicylates can reduce the level of the latter in the body, causing the rate of excretion by the kidneys. When interacting with this drug, drugs aimed at lowering blood sugar levels may decrease the effectiveness of the latter. Barbiturates and primidone may reduce the effectiveness of methylprednisolone. The use of carbamazepine and rifampicin reduce the effectiveness of methylprednisolone. Co-administration with drugs that slow down the activity of cytochrome P450 enzymes can provoke an increase in methylprednisolone in the body, thereby increasing side symptoms. When interacting with drugs containing estrogen, methylprednisolone may linger in the body, as a result, its effect will be enhanced. When combined with fluoroquinolones, the integrity of the tendons may be impaired. When combined with diuretics and laxatives, the level of potassium in the blood can decrease significantly. Combined reception with drugs aimed at artificial suppression of immunity can provoke an increase in their effectiveness. When combined with drugs that inhibit cholinesterase activity, in patients with rapid fatigue of striated muscles, muscle weakness only increases. The combined use of cyclosporine and methylprednisolone can provoke the occurrence of uncontrolled muscle spasms.

Therapy of diseases in mothers in position and those who breastfeed

The active ingredient Metipred tends to penetrate the placental barrier of the mother to the child. Accordingly, the appointment of this drug can be carried out only when the attending physician has weighed all the pros and cons and the benefits of its use far outweigh the possible risks. Means of this category can provoke the birth of a dead child. If a pregnant woman took such drugs, then in the future, the born baby should be monitored to identify or exclude adrenal insufficiency. If there is an opportunity for replacement therapy, then it is better to implement it. Mothers who are breastfeeding their baby should stop taking this medication or stop breastfeeding during long-term therapy with this drug.

Compatibility with alcoholic beverages

Drinking alcohol while taking Metipred is highly undesirable. This combination increases the risk of developing ulcers in the stomach or the initial section of the small intestine.

Overdose

Taking the drug in a dosage much higher than the standard one often does not cause any negative consequences, but nevertheless, if it occurs, side effects can be significantly increased. In the event of an overdose of the drug, the patient should be assisted in the form of a gradual decrease in dosage, gastric lavage and intake of enterosorbents. Other symptomatic therapy may also be required. In order to avoid overdose, the instructions for use provided by the manufacturer must be strictly followed.

Impact on transport management

During the period of therapy with this drug, it is advisable to refrain from driving vehicles and engaging in activities that require increased concentration of attention. This refusal is caused by the presence of side symptoms, represented by mental balance and mood disorders, uncontrolled muscle spasms, and headache.

Similar drugs

Analogues are: Medrol, Solu-Medrol.

How to store

Storage is possible at temperatures from +15°С to +25°С, away from light and children. Storage and use is possible for 5 years. At the end of this period, do not use the drug.

Terms of sale

The drug is sold with a prescription from a doctor.

Metipred refers to hormonal drugs.

Pharmacological action of Metipred

Metipred is a hormone from the glucocorticosteroid group. The active substance is methylprednisolone. The drug is able to interact with steroid receptors in the cytoplasm. Metipred reduces the activity of the synthesis of certain proteins and enzymes that are involved in the destruction of joints, as well as cytokines that are involved in inflammatory and immune reactions. The drug is able to reduce the tissue response to chemical thermal, immunological infectious and mechanical stimuli.

The drug helps to stabilize the hormonal background in women taking Metipred during pregnancy, if there is a problem of an excess of male hormones.

The anti-inflammatory effect of Metipred is 5 times higher than the same effect of hydrocortisone and lasts from 18 to 36 hours. The drug is partially excreted by the kidneys (about five percent), the half-life is from two to three hours.

Release form

The drug is produced in the form of: powder, depot suspension, Metipred tablets.

Indications for use Metipred

Metipred is prescribed in case of autoimmune and rheumatic diseases, allergic reactions (including anaphylactic shock), asthma, other diseases of the lower respiratory tract, in case of ulcerative nonspecific colitis, multiple sclerosis.

The drug is also recommended for patients with cerebral edema, which is caused by a neoplasm or other conditions accompanied by high intracranial pressure, patients during the recovery period after transplantation in order to prevent rejection.

Metipred is prescribed as an antiemetic during chemotherapy. Metipred during pregnancy is used if there is a threat of its interruption or congenital dysfunction of the adrenal cortex is diagnosed.

Method of application and dosage

Metipred tablets are intended for oral administration only. The drug is taken in the morning. Tablets are not recommended to be crushed or chewed, they should be swallowed whole with the necessary amount of water. Doses and duration of treatment is determined by the attending physician individually for each patient.

For adults, the initial dose is usually 8 to 96 milligrams per day. After reaching the desired therapeutic effect, the number of Metipred tablets taken during the day is reduced. For maintenance therapy, 4 to 12 milligrams of the drug once a day is sufficient.

When prescribing the drug to children, the dosage is selected individually for each child, taking into account the fact that long-term therapy can adversely affect the growth of a small patient, causing him to delay. To prevent the development of a withdrawal syndrome, the doses of the drug are gradually reduced until the complete cessation of taking Metipred.

Metipred in the form of powder lyophilized for solution for injection is used for parenteral use (intravenously or intramuscularly as infusions or injections).

In a state of shock, in order to prevent rejection of implants, the drug is administered intravenously at a dose of not more than 30 milligrams per kilogram of body weight. If the volume of the drug exceeds one milligram per kilogram, then the process of drug administration lasts from 30 to 60 minutes.

As an antiemetic, Metipred is prescribed at a dose of 250 milligrams and taken twenty minutes before the administration of cytostatics. If necessary, the introduction of Metipred according to the instructions is repeated after six hours at the same dosage - 250 milligrams.

Children's dosage - from 1 to 3 milligrams per kilogram of body weight during the day.

Depo-suspension for injection is intended for intramuscular, intravenous and intraarticular administration of the drug. The dose for adults with intramuscular injection is from 40 to 120 milligrams of the drug once every 7-28 days. Intra-articular - from 4 to 80 milligrams of the drug once every 7-35 days (the dosage depends on the size of the joint).

From 20 to 60 milligrams of the drug is injected into the site of the skin lesion, from 40 to 120 milligrams of the drug as a holding enema once within 24-48 hours.

Side effects of Metipred

Taking Metipred contributes to the following side effects: heart failure, increased blood pressure, thromboembolism, leukocytosis, nausea, ulcers on the mucous membranes of the digestive tract, indigestion, candidal lesions of the esophagus, bulimia, pancreatitis. Sometimes there is a perforation of the gallbladder, it is also possible: emotional lability, exacerbation of schizophrenia, disruption of wakefulness and sleep, increased intraocular pressure, glaucoma, cataracts, exophthalmos, thinning of the cornea and sclera.

Side effects of Metipred also provoke: fluid and sodium retention in the body, a decrease in the level of potassium in the blood, growth retardation, amenorrhea, menstrual irregularities, weight gain, hyperglycemia, hirsutism, itching, skin rash, skin atrophy, urticaria, acne, slowing down processes regeneration, proximal myopathy, osteoporosis, rupture or loss of tendon elasticity. Patients suffering from osteoporosis or an increased risk of its development should definitely consult their doctor, who may prescribe an additional intake of bisphosphonates.

In addition, the side effects of Metipred include: hypersensitivity, changes in reactions to skin tests, immunosuppression, Cushing's syndrome, relapse of tuberculosis infection. With intra-articular and intramuscular administration of the drug, a burning sensation and pain at the injection site are possible.

Abrupt withdrawal of the drug may be accompanied by an increase in body temperature, the development of pain in the muscles and joints, and adrenal insufficiency.

Contraindications

According to the instructions, Metipred is not recommended to be taken if the patient has: lactose intolerance, sensitivity to methylprednisolone. In addition, the drug is contraindicated: in chronic viral and bacterial infections, active or latent form of tuberculosis (if these diseases are not treated).

Metipred is prescribed with caution: if the patient has arterial hypertension, congestive heart failure, mental disorders, diabetes mellitus, pancreatitis, osteoporosis, glaucoma and blood clotting disorders, a tendency to thrombophlebitis. Exclusively under the close supervision of the attending physician, the drug may be prescribed to patients with impaired liver function and hypothyroidism.

During pregnancy, Metipred is prescribed only for strict indications, since there is a risk of intrauterine death of the fetus. During breastfeeding, the use of the product is also individual.

Terms and conditions of storage

Dry place, temperature not more than 25 degrees Celsius. The drug in the form of a suspension must not be frozen. The shelf life of any form of release is five years. The solution for injection in finished form is stored in the temperature range of 2-8 degrees Celsius for no more than a day.

Content

The pathological activity of the human immune system and the inflammatory processes occurring in the body can be brought under control with the help of the drug Metipred. The practice of using the drug has proven its effectiveness. An important condition for successful use is the compliance of the therapy regimen with the instructions for use.

Composition and form of release

Metipred is produced by pharmaceutical companies in two forms: tablets and lyophilisate for solution preparation. Varieties have the following characteristics:

1. The lyophilisate is a yellowish or white hygroscopic powder for intramuscular and intravenous administration. A solvent is attached to the active substance - a transparent liquid that does not have color. It is bottled in 250 mg vials, water for injection (solvent) - in ampoules (4 ml).
2. The tablets are almost white in color, have a round shape, with beveled edges, flat with a transverse separating risk (on the same side there is an engraving - ORN 346). Tablets have a dosage of 16 mg, packed in 100 or 30 pieces in containers or vials.

The composition of both dosage forms is shown in the following table:

pharmachologic effect

Instructions for use Metipred (Metypred) refers the drug to glucocorticosteroids of synthetic origin. The drug has anti-allergic, immunosuppressive and anti-inflammatory effects, reduces the intensity of antibody growth. The drug inhibits the interaction of B- and T-lymphocytes, the migration of T-cells, inhibits the proliferation of lymphocytes, increases the sensitivity of beta-adrenergic receptors to endogenous catecholamines.

The antiallergic activity of Metipred is associated with a decrease in the production of allergy mediators, inhibition of the production of antibodies, suppression of the development of lymphoid and connective tissues. In parallel, the level of B- and T-lymphocytes, basophils, and mast cells decreases. Due to the inhibition of the release of inflammatory mediators by eosinophils, the anti-inflammatory effect of the drug is manifested.

The active component of the composition stabilizes the membranes of organelles, induces the formation of lipocortins, and reduces the number of mast cells. The drug enhances protein breakdown in muscles, increases the formation of albumin by the kidneys and liver, and reduces the number of globulins in plasma. The active component is quickly and well absorbed (by 70%), combined with blood proteins by 62%. Metabolism of the drug occurs in the liver, metabolites are excreted by the kidneys, penetrate into the meninges and placenta.

Why appoint Metipred

Indications for the appointment of Metipred are due to the pharmacokinetic features of the active substance of the drug. The drug has a pronounced therapeutic effect on a number of pathological conditions and diseases:

• lung cancer;
• nephrotic syndrome;
• connective tissue pathology (nodular periarteritis, dermatomyositis, scleroderma);
• multiple sclerosis;
• congenital adrenal hyperplasia;
• hypercalcemia due to oncological diseases, vomiting and nausea during the period of cytostatic therapy;
• interstitial pathologies of the lungs (fibrosis, acute alveolitis, sarcoidosis of the third and second stages);
• berylliosis and Laffer's syndrome;
• hepatitis;
• subacute thyroiditis;
• blood pathologies and diseases of the hematopoietic system (erythroblastopenia, lymphogranulomatosis, hemolytic autoimmune anemia, hypoplastic erythroid anemia, agranulocytosis, lymphoid and myeloid leukemia, panmyelopathy, secondary thrombocytopenia in adults, thrombocytopenic purpura);
• renal pathologies of autoimmune genesis;
• ulcerative colitis;
• prevention of rejection during organ transplantation;
• conjunctivitis;
• cerebral edema due to prior parenteral use of glucocorticosteroids;
• adrenal insufficiency of secondary and primary type;
• chronic or acute allergic pathologies (drug exanthema, urticaria, hay fever, Quincke's edema);
• bronchial asthma;
• chronic or acute inflammatory processes in the joints (synovitis, bursitis, epicondylitis, juvenile arthritis, humeroscapular periarthritis, polyarthritis, gouty and psoriatic arthritis, nonspecific tendosynovitis, ankylosing spondylitis, osteoarthritis, Still's syndrome in adults);
• pulse therapy in the treatment of pathologies in which drug therapy with glucocorticosteroids is effective;
• sympathetic ophthalmia, anterior uveitis and severe sluggish neuritis, optic nerve disease;
• skin diseases (exfoliative dermatitis, eczema, pemphigus, Stevens-Johnson syndrome, seborrheic dermatitis, atopic and contact dermatitis, psoriasis toxidermia, bullous dermatitis herpetiformis).

Method of application and dosage

The dosage of Metipred and the duration of treatment is determined by the doctor on an individual basis, based on the degree of neglect of the disease and the available indications. Tablets are taken orally (washed down with water), time - with a meal or immediately after a meal. The daily volume of the drug is taken at a time. When prescribing a double dose - in a day.

If the daily dosage is very large, then it is permissible to divide the intake into 2-4 sets (take the main part in the morning). The initial dose should be within 48 mg. In the treatment of mild pathologies, it is permissible to take low doses. Regimens for the treatment of common conditions in patients taking Metipred:

• organ transplant: at the rate of 7 mg per kg;
• multiple sclerosis: 200 mg;
• cerebral edema: 200-1000 mg.

To prepare the solution, the attached solvent is added to the vial with the lyophilizate. The injection is carried out intravenously or intramuscularly, at a slow pace. In life-threatening conditions, the solution is administered intravenously at 30 mg per kg over 30 minutes. In the course of pulse therapy in the treatment of pathologies in which glucocorticosteroids are effective, and in acute diseases, Metipred is administered intravenously:

• edematous conditions: 4 days at the rate of 30 mg per kg every other day or 3, 5, 7 days, 1000 mg daily;
• systemic lupus erythematosus: 3 days - 1000 mg per day;
• multiple sclerosis: 5 or 3 days, 1000 mg per day.

In the terminal stages of cancer, 125 mg per day is administered for 2 months (to alleviate suffering). If during chemotherapy there are side effects in the form of vomiting, then Metipred is administered intravenously for five minutes. The agent is administered one hour before the injection of a chemotherapeutic drug, immediately at the beginning of chemotherapy and after completion.

The initial dosage for other indications is 10-500 mg intravenously (depending on the pathology). Doses up to 250 mg are administered for at least five minutes, high doses for at least 30 minutes. In the future, the introduction can be carried out intravenously, with a duration that is determined by the patient's response to therapy and his condition. Children are prescribed low daily doses (not less than 0.5 mg per kg of body weight).

Metipred for rheumatoid arthritis

The procedure for administering a prescribed dose in rheumatoid arthritis should take at least half an hour. If there was no improvement in a week of treatment, the course can be repeated if necessary. The course of treatment should take from one to four days at 1000 mg per day. The second option of the therapeutic course involves treatment for six months - 1000 mg per month.

With adrenal insufficiency

Due to the unexpressed mineralocorticoid action, it is recommended to use Metipred in combination with mineralocorticoids for the replacement treatment of adrenal insufficiency. The dosage is determined by the proportion - 0.18 ml per kilogram of the patient's weight. The second option for calculating the daily dose is 3.33 mg per sq. meter of body surface area. Reception of the calculated dose can be divided into three approaches.

special instructions

According to the instructions, the prepared solution is stored at room temperature for 12 hours. When stored in the refrigerator, it can be used within a day. Other special instructions:

1. To reduce side effects, patients are prescribed antacids, increase the intake of potassium into the body with food or medicine. The diet should include food rich in proteins and vitamins, with restriction of fats, salt, carbohydrates.
2. The effect of the drug is enhanced with cirrhosis of the liver, hypothyroidism. It can increase manifestations of emotional instability, psychotic disorders. If the patient has a history of psychosis, the drug is prescribed with caution.
3. During stress (after operations, injuries, infectious diseases), the dose of glucocorticosteroid increases.
4. With the sudden cancellation of high-dose therapy, a withdrawal syndrome may develop. Its signs are nausea, anorexia, general weakness, lethargy, muscle and bone pain. Possible exacerbation of the disease.
5. When treating with Metipred, vaccination is not carried out, since its effectiveness decreases.
6. Therapy of children with this remedy requires careful monitoring of growth dynamics.
7. In case of adrenal insufficiency, it is desirable to combine Metipred with mineralocorticoids.
8. If the patient has diabetes mellitus, his blood sugar level is controlled, if necessary, the dose of hypoglycemic tablets is adjusted.
9. During treatment, it is necessary to constantly monitor the musculoskeletal system with an x-ray, take pictures of the hands and spine.
10. With latent infectious diseases of the kidneys or urinary tract, taking Metipred can cause leukocyturia. Similarly, it increases the level of metabolites of oxyketocorticosteroids.

During pregnancy

The drug Metipred is prescribed in the first trimester of pregnancy only for health reasons and with caution. During lactation, it is prohibited, because the active ingredients penetrate into breast milk. With IVF (in vitro fertilization), the drug may be prescribed to regulate hormonal levels. Use is indicated only as directed by a doctor.

drug interaction

Metipred can interact with other medicines, causing negative effects. Some of them are described in the instructions:

1. The drug increases metabolism and reduces the plasma concentration of Isoniazid, Mekseliten, reduces the level of Praziquantel, reduces the effectiveness of somatotropic hormone.
2. When the drug is combined with nitrates or m-anticholinergics, intraocular pressure increases, vitamin D reduces the effect on intestinal absorption of calcium.
3. Metipred lowers the effectiveness of insulin, oral hypoglycemic agents, antihypertensive drugs, indirect anticoagulants, worsens the tolerance of cardiac glycosides (which is dangerous for the development of ventricular extrasystole), accelerates the excretion of acetylsalicylic acid.
4. The combination of the drug with Paracetamol leads to hepatotoxicity, and with ethanol, thrombolytics, anticoagulants and non-steroidal anti-inflammatory drugs - bleeding or erosion, ulcers of the gastrointestinal tract.
5. Simultaneous administration of Indomethacin increases the risk of side effects.
6. The combination of Metipred with sodium-containing agents leads to edema, increased pressure, with diuretics or Amphotericin B - increased potassium excretion from the body (which is dangerous for the development of heart failure).
7. The combination with Azathioprine, Mexiletine and neuroleptics leads to the development of cataracts.
8. The combination of the drug with immunosuppressants increases the risk of developing lymphoma, infections.

Side effects of Metipred

Depending on how long the drug was taken and at what dosage, the severity and frequency of side effects depends. Possible reactions, according to the instructions, are:

• leukocyturia, flushing of the face, withdrawal syndrome, exacerbation or development of infections;
• slow healing of wounds, a tendency to candidiasis, pyoderma, petechiae, striae;
• violation of growth and ossification in children, tendon rupture, steroid myopathy;
• hypokalemia, hypernatremia (excessive sweating, weight gain), hypocalcemia;
• sudden loss of consciousness, trophic disorders of the cornea, bacterial infections of the eyes;
• delirium, convulsions, disorientation, headache, euphoria, cerebellar pseudotumor, hallucinations, vertigo, psychosis, dizziness, paranoia, insomnia;
• muscle weakness;
• hypercoagulation, thrombosis, increased pressure, bradycardia, arrhythmia;
• hyperpigmentation, hypercholesterolemia, hypoalbuminemia;
• necrosis, necrolysis, nephrourolithiasis;
• osteoporosis, strongyloidiasis, exophthalmos, ecchymosis;
• nausea, hiccups, vomiting, pancreatitis, flatulence, steroid gastric ulcer, indigestion;
• delayed sexual development, Itsenko-Cushing's syndrome (stretch marks, muscle weakness, amenorrhea, hirsutism, dysmenorrhea, moon-shaped face, increased pressure, obesity), inhibition of the adrenal glands.

Overdose

If you take Metipred solution or tablets for a long time in high doses, an overdose may develop. Its symptoms, according to the instructions, are enhanced side effects. For treatment, you should consult a doctor, reduce the dose taken, and conduct symptomatic therapy. No specific antidotes for the drug have been found.

Contraindications

The only contraindication to the use of the drug is the individual intolerance to the components of the composition. It is used with caution in the following conditions:

• hypoalbunemia;
• pregnancy;
• closed or open angle glaucoma;
• polio;
• severe chronic kidney, heart or liver failure;
• diabetes;
• meningitis;
• hypothyroidism;
• Itsenko-Cushing's disease;
• thyrotoxicosis;
• transferred myocardial infarction;
• hyperlipidemia;
• arterial hypertension;
• immunodeficiency;
• lymphadenitis;
• post- and pre-vaccination periods;
• systemic mycosis, amoebiasis, measles, herpes simplex, chickenpox, latent or active tuberculosis, viremic phase of herpes zoster;
• duodenal or gastric ulcer, diverticulitis, intestinal anastomosis, gastritis, esophagitis, latent or acute peptic ulcer.

Terms of sale and storage

Metipred is a prescription drug that is stored at a temperature of 15-25 degrees out of the reach of children for 5 years.

Metipred's analogs

To replace the drug, you can allocate funds with a similar composition or other components, but the same effect. These include:

• Medrol - glucocorticoid tablets based on methyldprednisolone;
• Lemod is a synthetic glucocorticosteroid in the form of tablets and a lyophilisate for the preparation of a solution containing methylprednisolone.

Metipred price

In pharmacies in Moscow, you can buy both forms of the drug. Their cost depends on the type of medicine and pricing policy. Approximate prices.