Medrolum

Medrolum – a glucocorticosteroid (GKS) for intake.

Form of release and structure

Dosage form – tablets: an elliptic form, white color, on one party two notches (cross-wise), are applied on another – a logo engraving, on 4 mg (on 10 pieces in blisters, in a cardboard pack of 1, 3 or 10 blisters; on 30 pieces in glass bottles of dark color, in a cardboard pack 1 bottle); on 16 mg (in a blister strip packaging on 10 pieces, in a cardboard pack of 5 packagings, or on 14 pieces, in a cardboard pack 1 packaging; on 50 pieces in glass bottles of dark color, in a cardboard pack 1 bottle); on 32 mg (on 20 or 50 pieces in glass bottles of dark color, in a cardboard pack 1 bottle).

Active agent of Medrolum – Methylprednisolonum, in 1 tablet with an engraving:

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

Auxiliary components of tablets with a text:

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

Indications to use

• Aspiration pneumonitis, the symptomatic sarcoidosis disseminated or fulminant pulmonary tuberculosis (as a part of the corresponding antitubercular chemotherapy), Leffler's syndrome (in the absence of effect of therapy by other drugs), a berylliosis;
• Combination therapy of tubercular meningitis with the subarachnoidal block or at threat of the block;
• Endocrine pathologies: an inborn adrenal struma, primary and secondary adrenal insufficiency, a subacute and chronic thyroiditis, a hypercalcemia against the background of malignant new growths;
• Idiopathic Werlhof's disease and secondary thrombocytopenia (at adult patients), autoimmune hemolitic anemia, inborn hypoplastic anemia, erythrocyte anemia;
• Treatment of acute forms of general diseases of connecting fabric at a rheumatic carditis, a system dermatomyositis (polymiositis), a system lupus erythematosus, a rheumatic polimialgiya, giant-cell arteritis (it is in some cases shown as a maintenance therapy);
• Skin pathologies: pemphigus, heavy multiformny erythema (Stephens-Johnson's syndrome), herpetiform violent dermatitis, fungoid mycosis, exfoliative dermatitis, heavy seborrheal dermatitis, heavy psoriasis;
• Additional (short-term) therapy of diseases of a musculoskeletal system, including rheumatic pathologies: at an aggravation or acute forms of psoriasis arthritis, a pseudorheumatism (including a juvenile pseudorheumatism), an ankylosing spondylitis, a bursitis, a nonspecific tendosinovit, gouty arthritis, a posttraumatic osteoarthritis, an epicondylitis, a synovitis at an osteoarthritis;
• Treatment of serious (disabling) conditions (in case of inefficiency of usual therapy) at seasonal or year-round allergic rhinitis, reactions of hypersensitivity to medicines, a serum disease, contact dermatitis, atopic dermatitis, bronchial asthma;
• The chronic and heavy acute inflammatory and allergic processes connected with diseases of eyes: keratitis, optic neuritis, chorioretinitis, iritis and iridocyclitis, allergic regional helcomas, inflammation of a front segment of an eye, allergic conjunctivitis, sympathetic ophthalmia, diffusion back uveitis and choroiditis;
• Palliative therapy at oncological diseases: adults have leukoses and lymphoma, children have acute leukoses;
• Stimulation of a diuresis and achievement of remission of a proteinuria at patients with nephrotic a syndrome without uraemia, against the background of a system lupus erythematosus or idiopathic type;
• Acute forms of ulcer colitis and regional enteritis (for removal of the patient from a critical state);
• Trichinosis with defeat of a nervous system or a myocardium;
• Brain hypostasis against the background of a brain tumor, an exacerbation of multiple sclerosis;
• As a part of complex therapy at organ transplantation.

Contraindications

• Breastfeeding period;
• Hypersensitivity to drug components.

With care it is necessary to appoint drug sick with an esophagitis, a peptic ulcer of a stomach and duodenum, gastritis, an intestinal anastomosis (in the next anamnesis), a latent or acute round ulcer, a diverticulitis, nonspecific ulcer colitis (at threat of perforation or abscess), a lipidemia, a diabetes mellitus and predisposition to it, osteoporosis, a myasthenia, a hypothyroidism, acute psychosis, a hyperthyroidism, a subacute and acute myocardial infarction, arterial hypertension, the congestive heart failure expressed by a renal failure or a liver (especially against the background of the accompanying hypoalbuminemia), an open angle glaucoma; at a herpes simplex (an eye form), HIV infection (AIDS), measles, chicken pox, a strongyloidosis.

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

Appointment at system fungal infections is not recommended.

During pregnancy use of drug is admissible only according to absolute indications.

Route of administration and dosage

Pill is taken inside.

The mode of dosing is appointed by the doctor on the basis of clinical indications.

Selection of a dose needs to be made individually, considering reaction of the patient to therapy.

The recommended daily dosing:

• Adults: an initial dose – 4-48 mg, make further correction depending on the nature of a disease and a condition of the patient. So at multiple sclerosis the dose can make 200 mg, wet brain – 200-1000 mg, organs transplantation – of calculation to 7 mg on 1 kg of body weight a day. In the absence of therapeutic effect as a result of the sufficient period of reception of Medrolum drug should be replaced with other means;
• Children: the dose is defined with the surface area of a body or the child's weight, so for treatment of insufficiency of adrenal glands the dose can make 3,33 mg on 1 ^sq.m or 0,18 mg on 1 kg a day, for other indications – 12,5-50 mg on 1 ^sq.m or on 0,42-1,67 mg on 1 kg a day. The daily dose is evenly distributed on 3 receptions.

Drug withdrawal after prolonged use should be carried out gradually.

At positive dynamics of treatment, gradually reducing an initial dose, the patient should pick up the lowest maintenance dose which will allow to keep the reached clinical effect.

Use of drug needs to be accompanied with constant control of the mode of dosing. Dose adjustment can be required at change of a clinical state in case of an exacerbation of a disease, approach of remission, individual reaction of the patient to drug or against the background of the stressful situations which are directly not connected with a disease.

Use of Medrolum is shown with use of a method of alternating therapy at which the doubled daily dose is accepted 1 time in the morning every other day. This method of treatment allows to reach the maximum clinical effect at long reception and it is essential to reduce the side effects of drug connected with delay of growth at children, suppression of pituitary and adrenal system, GKS withdrawal.

Side effects

• Alimentary system: gastric bleeding, a round ulcer (with risk of a perforation and bleeding), pancreatitis, perforation of a gut, an esophagitis, increase in activity of alaninaminotranspherase, aspartate aminotransferase and an alkaline phosphatase in blood serum (usually changes have passing and insignificant character);
• Metabolism: chronic heart failure at predisposed patients, a sodium delay, increase in arterial pressure, potassium loss, a gipokaliyemichesky alkalosis, a liquid delay in an organism, negative nitrogenous balance against the background of a catabolism of proteins;
• Endocrine system: development of a syndrome of Cushing, a hirsutism, suppression of pituitary and adrenal system, decrease in tolerance to carbohydrates, emergence of a latent diabetes mellitus, at patients with a diabetes mellitus increase in need for peroral hypoglycemic means or insulin, disturbances of a menstrual cycle; children have growth delay;
• Musculoskeletal system: muscular weakness, a steroid myopathy, osteoporosis, ruptures of sinews (is more often than an Achilles tendon), compression fractures of vertebras, pathological changes, an aseptic necrosis of an epiphysis of tubular bones;
• Nervous system: increase in intracranial pressure, mental disorders, pseudoneoplasm of a brain, spasm;
• Organ of sight: increase in intraocular pressure with risk of injury of an optic nerve, a back subkapsulyarny cataract, an exophthalmos;
• Allergic reactions: hypersensitivity reactions, including allergic system reactions, perhaps, suppression of reactions at skin tests;
• Dermatological reactions: petechias and ecchymomas, delay of processes of healing of wounds, decrease in durability and thinning of skin;
• Others: activation of latent infections, distortion of a clinical picture at infectious pathologies, developing of opportunistic infections, GKS withdrawal.

Special instructions

Considering a high risk of development of complications at glucocorticoid therapy, it is necessary to appoint Medrolum in the lowest doses providing clinical effect. In case of correction of the mode of therapy the dose of drug is reduced gradually.

Use of drug can exponentiate development of mental disorders, including sleeplessness, euphoria, a depression, acute psychotic manifestations, or to increase the available emotional instability of the patient. Or after it increase in a dose of drug is shown to patients, inclined to psychotic reactions, in the period of a stress.

During administration of drug in the dose having immunodepressive effect, the patient cannot enter live or live attenuated vaccines, introduction of the killed or the inactivated vaccines is shown, at the same time reaction to their introduction can be reduced. If the dose does not possess an immunodepressive effect, immunization can be carried out according to the corresponding indications.

Action of Medrolum can erase a clinical picture of some infections or cause development of new. During administration of drug the organism can lose resistance to infections or ability to localization of infectious process.

The risk of development of infectious complications increases in proportion to increase in the accepted dose of drug both at monotherapy, and at a combination with other immunodepressants. The infections caused by pathogenic microorganisms (viruses, mushrooms, bacteria, helminths or protozoa), can proceed in an easy and severe form, up to a lethal outcome.

At active tuberculosis use is shown at treatment of the disseminated and fulminant tuberculosis, in a combination with the corresponding antitubercular chemotherapy. At appointment to patients to positive tuberkulinovy tests or latent tuberculosis there can be a process reactivation therefore treatment should be accompanied with strict medical control. Long reception of Methylprednisolonum at such patients should be carried out with co-administration of the corresponding preventive treatment.

With care it is necessary to apply at treatment of a herpes simplex of eyes because of risk of perforation of a cornea.

Long therapy by drug can promote accession of a consecutive eye viral or fungal infection, cause development of allergic reactions, developing of a back subkapsulyarny cataract, glaucoma with possible damage of an optic nerve.

High doses of Methylprednisolonum can become the reason of increase in arterial pressure, excretion of potassium, a delay of ions of sodium and water. During treatment the patient should limit consumption of table salt and to appoint potassium administration of drugs.

Medrolum increases calcium removal.

Frequent side effect of long use of high doses of drug is osteoporosis.

The long daily mode of dosing with administration of drug several times in days at treatment of children has to be applied only according to absolute indications as can cause a growth inhibition of the child. Alternating therapy allows to minimize or avoid this undesirable effect.

The gradual dose decline of drug allows to minimize manifestations of secondary insufficiency of bark of adrenal glands. This type of pathology can be observed after the end of treatment within several months therefore at emergence of any stressful situations during the specified period repeated purpose of Medrolum is necessary. Due to the possible disturbance of secretion of mineralokortikoid the accompanying purpose of mineralokortikoid and/or electrolytes is shown.

More expressed action of glucocorticosteroids is noted at patients with cirrhosis and a hypothyroidism.

Therapy can mask signs of a round ulcer therefore without the expressed pains the patient can have a bleeding or perforation.

Against the background of therapy cases of development in patients of sarcoma of Kaposha are noted, at drug withdrawal approach of clinical remission is possible.

The negative impact on reproductive function, mutagen and cancerogenic effect of drug is not established.

Medicinal interaction

Use of Medrolum in a combination with other medicines is possible only on doctor's orders.

Terms and storage conditions

To store at a temperature of 20-25 °C. To protect from children.

Period of validity – 5 years.