methylprednisolone | Metipred tablets 4 mg, 30 pcs.

Release form

Tablets.

Packing

30 pcs

Indications

systemic diseases of the connective tissue (SLE, scleroderma, periarteritis nodosa, dermatomyositis, rheumatoid arthritis)

acute and chronic inflammatory joint diseases - gouty and psoriatic arthritis, osteoarthritis (including post-traumatic) senile), shoulder-shoulder periarthritis, ankylosing spondylitis (ankylosing spondylitis), juvenile arthritis, Still's syndrome in adults, bursitis, nonspecific tendosynovitis, synovitis and epicondylitis

acute rheumatism, rheumatic fever cue cardit minor chorea

bronchial asthma, asthmatic status

acute and chronic allergic diseases (including allergic reactions to drugs and food products, serum sickness, urticaria, allergic rhinitis, Quincke's edema, drug exanthema, hay fever)

skin diseases - pemphigus , psoriasis, eczema, atopic dermatitis (widespread neurodermatitis), contract dermatitis (with damage to a large surface of the skin), toxidermia, seborrheic dermatitis, exfoliative dermatitis, toxic epidermal non rabbit (Lyell's syndrome), bullous herpetiform dermatitis, Stevens-Johnson syndrome

cerebral edema (including against the background of a brain tumor or associated with surgical intervention, radiation therapy or head injury) after prior parenteral administration 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 (adrenal gland after removal of the adrenal gland)

congenital adrenal hyperplasia

autoimmune kidney disease of the kidney (including acute glomerulonephritis)

nephrotic

syndrome subacute thyroiditis

diseases of the blood and hematopoietic system - agranulocytosis, panmielopatiya, autoimmune hemolytic anemia, lymphoid and myeloid leukemias, limfogranulomatoz, thrombocytopenic purpura, secondary thrombocytopenia in adults, erythroblastopenia (erythrocytic anemia), congenital (erythroid) hypoplastic anemia

interstitial lung diseases - acute alveolitis, pulmonary fibrosis, stage II-III sarcoidosis

tuberculous meningitis, pulmonary tuberculosis, aspiration pneumonia (in combination with specific not amenable to other therapy)

lung cancer (in combination with cytostatics)

multiple sclerosis

ulcerative colitis, Crohn's disease, local enteritis

hepatitis

hypoglycemic conditions

p ofilaktika transplant rejection reactions in organ transplants

hypercalcemia amid cancer, nausea and vomiting during cytostatic therapy

myeloma.

Contraindications

For short-term use for life, the only contraindication is hypersensitivity to methylprednisolone or the components of the drug.

In children during the period of GCS growth, it should be used only according to absolute indications and with careful medical supervision.

With caution, the drug should be prescribed for the following diseases and conditions: gastrointestinal diseases - peptic ulcer of the stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, recently created intestinal anastomosis, ulceration with the threat of perforation or abscess, diverticulitis

diseases viral, fungal or bacterial nature (currently or recently transferred, including recent contact with the patient) - herpes simplex, herpes zoster herpes (viremic phase ), chickenpox, measles, amoebiasis, strongyloidosis, systemic mycosis active and latent tuberculosis (use in severe infectious diseases is permissible only against the background of specific therapy)

pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after vaccination BCG immunodeficiency states (including AIDS or HIV infection)

diseases of the cardiovascular system (including recent myocardial infarction - in patients with acute and subacute myocardial infarction, the spread of the focus of necrosis, slowing down the formation of scar tissue and, as a result, rupture of the heart muscle), severe chronic heart failure, arterial hypertension, hyperlipidemia

endocrine diseases - diabetes mellitus (including impaired carbohydrate tolerance), thyrotoxicosis, hypothyroidism, disease tsenko-Kyshinga, obesity (III-IV degree)

severe chronic kidney and / or liver failure, nefrourolitiaz

hypoalbuminemia and conditions predisposing to its occurrence

systemic osteoporosis, myasthenia gravis, acute psychosis, polio (except for the form of bulbar encephalitis), open-angle and angle-closure glaucoma

pregnancy.

Use during pregnancy and lactation

During pregnancy (especially in the first trimester), the drug should be used only for health reasons.

Since corticosteroids pass into breast milk, if it is necessary to use the drug during lactation (breastfeeding), breastfeeding is recommended to be discontinued.

Composition

1 tablet contains:

Active ingredient: methylprednisolone 4 mg

Excipients: lactose monohydrate starch corn magnesium stearate gelatin talc purified water.

Dosage and administration

Inside, during or immediately after a meal, with a small amount of liquid. The entire daily dose of the drug is recommended to be taken once or double the daily dose - every other day, taking into account the circadian rhythm of endogenous secretion of corticosteroids in the range from 6 to 8 hours in the morning. A high daily dose can be divided into 2–4 doses, while a large dose should be taken in the morning.

The initial dose of the drug can be from 4 to 48 mg of methylprednisolone per day, depending on the nature of the disease. In less severe diseases, the use of lower doses is usually sufficient, although individual patients may require higher doses. 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 a different type of therapy should be prescribed to the patient.

For children, the dose is determined by the doctor based on weight or body surface. In case of adrenal insufficiency - inside 0.18 mg / kg or 3.33 mg / m2 per day in 3 doses, with other indications - 0.42-1.67 mg / kg or 12.5-50 mg / m2 per day in 3 doses.

With prolonged use of the drug, the daily dose should be reduced gradually. Long-term therapy should not be stopped suddenly!

Side effects of

From the endocrine system: decreased glucose tolerance, steroid diabetes mellitus, manifestation of latent diabetes mellitus, inhibition of adrenal gland function, Itsenko-Cushing's syndrome (moon-shaped face, pituitary-type obesity, hypertension, dysmenorrhea, dysmenorrhea, 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, gastrointestinal wall perforation, impaired digestion, digestion, flatulence, hiccups rarely - increased activity of hepatic transaminases and alkaline phosphatase.

On the part of the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest) in predisposed patients, the development or increased severity of heart failure, ECG changes characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis in patients with acute and subacute myocardial infarction are possible the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.

From the side of the central nervous system and peripheral nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness, anxiety, insomnia, dizziness, vertigo, cerebellum pseudotumor, headache, convulsion.

From the sensory organs: posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral infections of the eyes, trophic changes in the cornea, exophthalmos, sudden loss of vision (with parenteral administration in the head, neck, nasal concha, scalp may deposit crystals of the drug in the vessels of the eye).

Metabolism: increased calcium excretion, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating due to mineralocorticoid activity - fluid and sodium retention (peripheral edema), hypernatremia, hypokalemia syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the musculoskeletal system: growth retardation and processes of ossification in children (premature closure of the pineal gland), osteoporosis (very rarely pathological bone fractures, aseptic necrosis of the head of the humerus and femur), rupture of tendons of the muscles, steroid myopathy, decreased muscle masses (atrophy).

Dermatological reactions: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, striae, tendency to develop pyoderma and candidiasis.

Allergic reactions: skin rash, itching, anaphylactic shock, local allergic reactions.

Local reactions with parenteral administration: burning, numbness, pain, tingling at the injection site, infection of the injection site rarely - necrosis of surrounding tissues, scarring at the injection site, atrophy of the skin and subcutaneous tissue with i / m administration (introduction into the deltoid muscle is especially dangerous).

Other: the development or exacerbation of infections (the use of immunosuppressants and vaccination contribute to this side effect), leukocyturia, withdrawal syndrome, flushing of the head.

Drug Interaction

Concurrent administration of methylprednisolone: ​​with inducers of hepatic microsomal enzymes (phenobarbital, rifampicin, phenytoin, theophylline, ephedrine) leads to a decrease in its concentration (increase in metabolic rate)

with diuretics (especially thiazide-like and carbonic anhydrase inhibitors) and amphotericin B leads to increased excretion of potassium and increase the risk of cardiac insufficiency and sodium-containing drugs contributes to the development of edema and increased blood pressure

with cardiac glycosides leads to a decrease in their tolerability and increase the likelihood of development of ventricular эkstrasytolyy eat (because of the v z vaemoy hypokalemia)

with anticoagulants nepryam my promotes oslablenyyu (less frequently GAIN) s action (Requires correction doz )

with anticoagulants and thrombolytics lead for the development of risk Increase krovotechenyy IZ ulcers in the digestive tract with

ethanol and NSAIDs increases the risk of erosive-ulcerative lesions in the gastrointestinal tract and the development of bleeding (in combination with NSAIDs in the treatment of arthritis may reduce the dose of ACS due to the summation of therapeutic effect)

with indomethacin increases the risk of side effects with albumin)

with paracetamol increases the risk of hepatotoxicity (induction of liver enzymes and the formation of a toxic metabolite of paracetamol)

with acetyls lycic acid accelerates its excretion and lowers blood concentration (when methylprednisolone is withdrawn, the level of salicylates in the blood increases and the risk of side effects increases)

with insulin and oral hypoglycemic drugs, antipyretic drugs decreases their effectiveness

with vitamin D decreases its effect on calcium absorption in the intestines

with STG decreases the effectiveness of the last

with praziquantel decreases the concentration of the last

with m-holinoblocator drugs (including antihistamines) isoniazid and mexiletine increase 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, in slowing down the metabolism of methylprednisolone, can in some cases increase its toxicity.

The simultaneous administration of androgens and steroid anabolic drugs with methylprednisolone contributes to the development of peripheral edema, hirsutism and the appearance of acne.

Estrogens and oral 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 cortex function may necessitate an increase in the dose of methylprednisolone.

When used with live antiviral vaccines and other immunizations, increases the risk of virus activation and infection.

Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus.

Antipsychotics (neuroleptics) and azathioprine increase the risk of cataracts with methylprednisolone.

Concurrent administration of antacids reduces the absorption of methylprednisolone.

When used with antithyroid drugs, it decreases, and with thyroid hormones, the clearance of methylprednisolone increases.

Pharmaceutical Interaction

Pharmaceutical incompatibility of methylprednisolone with other injectable drugs is possible. It is recommended to enter it separately from other preparations (in / in bolus, or through another dropper, as the second solution).

Overdose

Symptoms: the side effects described above may be aggravated.

Treatment: symptomatic. The dose of Metipred should be reduced.

Storage conditions

At a temperature of 15 ° to 25 РC.

Expiration

5 Chron

Deystvuyuschee substances

methylprednisolone

dosage form

dosage form

tablets

Orion Corporation, Finland