To Saul Medrolum time. and rast. for solution for infection. 1000 mg fl. + rastvo. fl. 15.6 ml No. 1 ***

Powder and solvent for injections to "Saul Medrolum" is applied to solution at indications which are provided below.

Anti-inflammatory treatment:

• rheumatic diseases: as auxiliary therapy for short-term use (to help the patient to endure a sharp episode or aggravation) in the following diseases:
  • posttraumatic osteoarthritis;
  • a synovitis in an osteoarthritis;
  • a pseudorheumatism, in particular a juvenile pseudorheumatism (in some cases there can be a need for maintenance therapy by a low dose);
  • acute and subacute bursitis;
  • epicondylitis;
  sharp nonspecific tendosinoviit
  • ;
  • acute gouty arthritis;
  • psoriasis arthritis;
  • ankylosing spondylitis;
• collagenose (system diseases of connective tissue): during aggravation or as maintenance therapy in some cases in such diseases, as:
  • system lupus erythematosus (and lupoid nephrite);
  • acute rheumatic carditis;
  • system dermatomyositis (polymiositis);
  • nodular periarteritis;
  • Gudpascher's syndrome;
• dermatological diseases:
  • bladderwort;
  • heavy multiformny erythema (Stephens-Johnson's syndrome);
  • exfoliative dermatitis;
  • bullous herpetiform dermatitis;
  • heavy seborrheal dermatitis;
  • heavy psoriasis;
  • fungoid mycosis;
  • small tortoiseshell;
• allergic states: control of serious or disabling allergic conditions which do not respond properly to the carried-out traditional treatment, in such diseases as:
  • bronchial asthma;
  • contact dermatitis;
  • atopic dermatitis;
  • serum disease;
  • seasonal or year-round allergic rhinitis;
  • reaction of hypersensitivity to medicines;
  • small tortoiseshell;
  • an acute non-infectious laryngeal edema (medicine of the first choice is epinephrine);
• ophthalmologic diseases: heavy acute and chronic allergic and inflammatory processes in an eye, in particular:
  • Herpes zoster full-time;
  • iritis, iridocyclitis;
  • chorioretinitis;
  diffusion back uveitis also horioideit
  • ;
  • optic neuritis;
  • sympathetic ophthalmia;
  • inflammation of an average segment of an eye;
  • allergic conjunctivitis;
  • allergic ulcers of edge of a cornea;
  • keratitis;
• a disease of digestive tract: critical periods in the following diseases:
  • ulcer colitis (system therapy);
  • regional enteritis (system therapy);
• respiratory diseases:
  • sarcoidosis of lungs;
  • berylliosis;
  • a fulminantny or disseminate pulmonary tuberculosis, at simultaneous use with the corresponding antitubercular chemotherapy;
  • Leffler's syndrome which is not responding to treatment by other means;
  • aspiration pneumonitis;
  • an average and severe form of the pneumonia caused by Pneumocystis carinii at patients with AIDS (as auxiliary therapy within the first 72 hours of protipnevmotsistny therapy);
  • exacerbation of a chronic obstructive disease of lungs;
• a state, followed by hypostases: for induction of a diuresis or remission in a proteinuria at a nephrotic syndrome, a proteinuria without uraemia.

Immunosuppressive treatment:

• transplantation of body: treatments of hematologic and oncological diseases.

Treatment of hematologic and oncological diseases:

• hematologic diseases:
  • acquired (autoimmune) hemolytic anemia;
  • idiopathic Werlhof's disease of adults (only intravenously; intramuscular use is contraindicated);
  • secondary thrombocytopenia of adults;
  • an eritroblastopeniye (erythrocyte anemia);
  • congenital (erythroidal) hypoplastic anemia;
• oncological diseases: palliative treatment of such diseases, as:
  • leukoses and lymphoma at adults;
  • an acute leukosis at children;
  • for improvement of quality of life of patients with an end-stage of a cancer disease.

Others:

• nervous system:
  • brain hypostasis caused by primary or metastatic tumor and/or auxiliary treatment at surgeries or radiation therapy;
  • exacerbation of multiple sclerosis;
  • an acute injury of a spinal cord (treatment needs to be begun in the first 8 hours after an injury);
• tubercular meningitis with blockade of subarachnoid space or threat of blockade, at simultaneous use of the corresponding antitubercular chemotherapy;
• a trichinosis with damage of nervous system or myocardium;
• prevention of nausea and vomiting, connected with chemotherapy concerning a malignant new growth.

Endocrine disorders:

• primary or secondary insufficiency of bark of adrenal glands;
• acute insufficiency of bark of adrenal glands (at these indications medicaments of the choice are the hydrocortisone or a cortisone; under certain circumstances it is possible to apply synthetic analogs in a combination from mineralokortikoida);
• treatment of shock states: shock owing to insufficiency of bark of adrenal glands or shock which does not respond to traditional treatment in case of the confirmed or expected insufficiency of bark of adrenal glands (in general medicament of the choice is the hydrocortisone); if mineralokortikoidny effects are undesirable, can be preferred as Methylprednisolonum;
• before surgical intervention and in case of a severe injury or a disease at patients from the bark of adrenal glands established by insufficiency or in the presence of doubts concerning a reserve of bark of adrenal glands;
• congenital adrenal hyperplasia;
• not purulent thyroiditis;
• hypercalcemia connected with a malignant new growth.

Structure

Active ingredient - methylprednisolone (1 bottle contains 1000 mg of Methylprednisolonum in the form of succinate sodium Methylprednisolonum).

Excipients: sodium dihydrophosphate, monohydrate; sodium phosphate anhydrous.

Solvent: benzyl alcohol (9 mg/ml), water for injections.

Contraindication

• system fungal infections;
• hypersensitivity to Methylprednisolonum or to any of the excipients specified in the section "Structure".

Route of administration

Solution of Methylprednisolonum of sodium of succinate can be entered by means of an intravenous or intramuscular injection or by infusion. When rendering primary emergency aid preference is given to use in the form of an intravenous injection. The dose for babies and children can be reduced, however more it is necessary to be guided by weight of a state and the response of the patient to treatment, but not its age or body weight. The dose has to make not less than 0.5 mg/kg of body weight each 24 hours.

At an idiopathic Werlhof's disease of adults medicament is used only intravenously (intramuscular use is contraindicated).

Auxiliary therapy at states, life-threatening

Recommended dose makes 30 mg/kg of body weight at introduction in/in within not less than 30 minutes. This dose can be entered repeatedly in the conditions of a hospital each 4-6 hours within 48 hours depending on clinical need.

Pulse therapy in case of very serious aggravation and/or inefficiency of standard therapy, in particular, non-steroidal anti-inflammatory drugs, salts of gold and Penicillaminum

Pseudorheumatism: 1 g/day within 1, 2nd, 3rd or 4th days or 1 g/month intravenously within 6 months. As use of high doses of corticosteroids can lead to aritmogenny action, this therapy has to be limited to hospital conditions where there are an electrocardiograph and a defibrillator. The dose should be entered within not less than 30 minutes, and its introduction can be carried out repeatedly if within one week after therapy the reduction of symptoms is not observed or it demands a condition of the patient.

Prevention of nausea and vomiting, connected with chemotherapy concerning a malignant new growth

Chemotherapy which causes light or moderate emetogenny effect: administration of medicament to "Saul Medrolum" in a dose of 250 mg within not less than 5 minutes in one hour prior to carrying out chemotherapy, at the beginning of chemotherapy and after the termination of chemotherapy (with the first dose of medicament "Saul Medrolum" can apply to strengthening of effect chlorinated fenotiazin).

Chemotherapy which causes the significant emetogenny effect: administration of medicament to "Saul Medrolum" in a dose of 250 mg within not less than 5 minutes with the corresponding doses of Metoclopramidum or phenyl propyl ketone in one hour prior to carrying out chemotherapy, and then - medicament to "Saul Medrolum" in a dose of 250 mg at the beginning of therapy and after the termination of chemotherapy.

Acute injury of a spinal cord

in the first 8 hours after an injury.

If treatment began to be carried out within 3 hours after an injury: enter Methylprednisolonum in a dose of 30 mg/kg of body weight bolyusno within 15 minutes under constant medical observation. After a bolyusny injection take a break of 45 minutes then carry out continuous infusion of medicament in a dose of 5.4 mg/kg of body weight an hour within 23 hours.

If treatment began to be carried out within 3-8 hours after an injury: enter Methylprednisolonum in a dose of 30 mg/kg of body weight bolyusno within 15 minutes under constant medical observation. After a bolyusny injection take a break of 45 minutes then carry out continuous infusion of medicament in a dose of 5.4 mg/kg of body weight an hour within 47 hours.

).

only for this indication under control of the ECG and with a possibility of use of a defibrillator. Bolyusny introduction of high doses of Methylprednisolonum (doses of 500 mg within less than 10 minutes) can lead to developing of arrhythmias, vascular collapse and cardiac arrest.

At other indications

Initial dose makes from 10 to 500 mg depending on a clinical condition of the patient and a type of a disease. High doses can be required in case of short-term treatment of serious acute conditions, including bronchial asthma, a serum disease, urtikarny transfusion reactions and exacerbations of multiple sclerosis. Inclusive it is necessary to enter an initial dose to 250 mg not less than 5 minutes, and the doses exceeding 250 mg should be entered within not less than 30 minutes. The subsequent doses can be entered intravenously or intramusculary with intervals which depend on the answer of the patient and his clinical state. Therapy by corticosteroids is performed as auxiliary and does not replace traditional therapy.

Dose needs to be reduced or cancelled gradually if the medicament was administered more than several days. If in a chronic disease there is a spontaneous remission, treatment needs to be stopped. During long therapy it is necessary to carry out periodically ordinary laboratory researches, in particular the analysis of urine, determination of level of sugar in blood in 2 hours after a meal and also to control indicators of arterial blood pressure and body weight, to carry out a X-ray analysis of bodies of a thorax. At patients with ulcers in the anamnesis or the profound dyspepsia it is desirable to carry out a X-ray analysis of upper parts of a GIT. In case of the sudden termination of long-term treatment it is also necessary to make medical observation. For introduction in the form of intravenous (or intramuscular) injections prepare solution according to the instruction.

Feature of use

Pregnant

in the absence of adequate researches of effect of medicament on the reproductive system of the person and pre-natal development of a fruit, sodium Methylprednisolonum succinate should be applied during pregnancy only after careful estimation of a ratio advantage/risk to mother and a fruit. If long-term treatment by corticosteroids has to be stopped during pregnancy (as well as other long methods of treatment), it has to occur gradually. However in certain cases (for example, replacement therapy of insufficiency of adrenal glands) continuation of treatment or even increase in a dose can be required.

Corticosteroids, including Prednisolonum, get into breast milk. This medicine should be applied during feeding by a breast only after careful estimation of a ratio advantage/risk to mother and the baby. Benzyl alcohol can get through a placental barrier.

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At the children receiving long daily therapy by fractional doses of glucocorticoids the growth inhibition can be noted, and use of such mode should be limited to the most serious to indications.

Drivers

Though the disorder of vision belongs to rare side reactions, patients who run vehicles and/or work with other mechanisms, it is necessary to be careful.

Overdose

does not exist a clinical syndrome of acute overdose of Methylprednisolonum of sodium of succinate. The chronic overdose causes characteristic symptoms of a syndrome of Cushing. Methylprednisolonum is removed by dialysis.

Side effects

system side reactions. In spite of the fact that they seldom arise at very short-term therapy, it is always necessary to watch them carefully. It is a part of supervision at any corticosteroid therapy and concerns not only specific drug. Possible side reactions on glucocorticoids, in particular Methylprednisolonum are provided below.

Infection and invasion: masking of infections, activation of latent infections, opportunistic infections, peritonitis. Peritonitis can be the main sign or a symptom of disturbances from digestive tract, such as perforation, obstruction or pancreatitis.

from the immune system: reactions of hypersensitivity (including an anaphylaxis, with disturbance of blood circulation or without it, cardiac arrest, a bronchospasm).

Endocrine disorders: development of a cushingoid state, oppression of a hypophysial and adrenocortical axis.

Disbolism, metabolism: a metabolic acidosis, a sodium delay, a liquid delay, a gipokaliyemichesky alkalosis, manifestations of latent diabetes, increase in need for insulin or oral antidiabetic means at patients with diabetes. In comparison with a cortisone or a hydrocortisone the mineralokortikoidny effects happen less often when using such synthetic derivatives as Methylprednisolonum. Restriction in the use of salt and additional intake of potassium can be required. Epidural lipomatoz, lipomatoz (frequency is unknown).

from the system of a hemopoiesis and lymphatic system: a leukocytosis (frequency is unknown).

Mental disorders: mental disorders from euphoric mood, insomnia, differences of mood, changes of the personality and a heavy depression before outright psychotic manifestations.

from nervous system: the increased intracranial pressure with a papilledema (benign intracranial hypertensia), spasms, dizziness.

from an organ of sight: back subkapsulyarny cataract, exophthalmos. Horioretinopatiya, indistinct sight - frequency is unknown. Prolonged use of glucocorticoids can cause development of glaucoma, including with injury of optic nerves and contribute to the development of the consecutive eye infections caused by fungi or viruses. Glucocorticoids should be applied with care to patients with herpes simplex full-time because of a possibility of development of perforation of a cornea.

from heart: stagnant heart failure at predisposed patients, a rupture of a myocardium after a myocardial infarction, arrhythmia.

messages about cardiac arrhythmia and/or vascular collapse and/or cardiac arrest after fast input of high intravenous doses of Methylprednisolonum of sodium of succinate (more than 0.5 g within less than 10 minutes) Are available. It was reported about bradycardia in time or after introduction of high doses of Methylprednisolonum of sodium of succinate which can not depend on speed or duration of infusion. After introduction of high doses of glucocorticoids it was also reported about tachycardia.

Vascular disorders: arterial hypertension, arterial hypotension, petechias. The Trombotichesky phenomena (frequency is unknown).

from the respiratory system, bodies of a thorax and mediastinum: a constant hiccups at use of high doses of corticosteroids.

Gastrointestinal disorders: an ulcer with a possibility of further perforation and bleeding, gastric bleeding, pancreatitis, an esophagitis, perforation of intestines, vomiting.

from a gepatobiliarny system: hepatitis (it was reported at intravenous use), increase in level of enzymes of a liver in blood serum (for example ALT, nuclear heating plant. Frequency of these phenomena is unknown).

from skin and hypodermic fabric: ecchymomas, thinning of skin. Repeated local subcutaneous injections can lead to a local atrophy of skin.

from a musculoskeletal system and connective tissue: steroid myopathy, muscle weakness, osteoporosis, aseptic necrosis.

Disorder of a reproductive system and mammary glands: disturbance of a menstrual cycle.

Injury, poisoning and a complication after the procedures: pathological fractures, compression spinal fracture, rupture of sinews (mainly Achilles tendon).

Interaction

Compatibility and stability of solutions of Methylprednisolonum of sodium of succinate for intravenous administration and their mixes with other intravenous medicines depends on pH of mix, concentration, time, temperature and actually ability of Methylprednisolonum to be dissolved. Therefore in order to avoid problems with compatibility and stability it is recommended if it is possible, to enter a bolyusny injection succinate sodium Methylprednisolonum solutions separately from other medicines as or through a system for intravenous administration, or by means of the piggy-back system.

to Store

at a temperature not above 25 °C, out of children's reach.

Prepared solution can be stored at the room temperature no more than 12 hours.

Expiration date - 5 years.