Expiration date: 02/2025
The composition and form of issue:
Tablets. 1 tablet contains:
methylprednisolone 4 mg
16 mg
excipients: lactose monohydrate corn starch magnesium stearate gelatin talc, purified water
in dark glass bottles or containers of PE, 30 or 100 PCs. in cardboard pack 1 bottle or container.
Lyophilisate for preparation of solution for intravenous and intramuscular injection. 1 vial contains:
methylprednisolone sodium succinate (equivalent methylprednisolone) 250 mg
auxiliary substances: sodium hydroxide
solvent: water for injections
in bottles (complete with the solvent in vials of 4 ml) in cardboard pack 1 set.
Description pharmaceutical form:
Lyophilisate for preparation of solution for I/m and/in the introduction: lyophilized powder white or slightly yellowish, hygroscopic.
The solvent (water for injection): clear, colorless liquid.
Tablets 4 mg: round, flat with bevelled edge, from almost white to white with transverse dividing line on one side.
Tablets 16 mg: round, flat with bevelled edge, from almost white to white with transverse valium and applied code "ORN 346" on one side.
Method of application and dose:
The dose and duration of treatment is determined by physician individually depending on the indication and the severity of the disease.
Pills
Inside, during or immediately after a meal, squeezed small amount of liquid. The entire daily dose of the drug should be taken once or double daily dose — in a day taking into account the circadian rhythm endogenous secreta corticosteroids in the interval from 6 to 8 am. High daily dose can be divided into 2-4 doses, this morning, you should take a big dose.
The initial dose may vary from 4 to 48 mg of methylprednisolone per day depending on the nature of the disease. In less severe diseases usually sufficient use of lower doses, although individual patients may require higher doses. High doses may be required in such diseases and conditions as multiple sclerosis (200 mg/day), cerebral edema (200-1000 mg/day) and organ transplantation (up to 7 mg/kg/day). If after a reasonable period of time not received a satisfactory clinical effect, the drug should be discontinued and the patient another type of therapy.
Children dose determined by the physician based on weight or body surface. In adrenal insufficiency, the interior of 0.18 mg/kg, or 3.33 mg/m2 per day in 3 divided doses, for other indications — 0,42–1,67 mg/kg or 12.5–50 mg/m2 per day in 3 divided doses.
Chronic administration of the drug daily dose should be reduced gradually. Duration of therapy should not be discontinued abruptly!
Lyophilisate for preparation of solution for I/m or I/V administration
In/in (slow jet injection or infusion), in/m.
Preparation of the solution. The solution for injection is prepared by adding the solvent to the vial of lyophilisate immediately before use. The prepared solution contains 62.5 mg/ml methylprednisolone.
As adjunctive therapy in life-threatening conditions administered 30 mg/kg/for a period of not less than 30 min. Introduction this dose can be repeated every 4-6 h for 48 h
Pulse therapy in the treatment of diseases in which corticosteroids are effective therapy in exacerbations of the disease and/or ineffectiveness of standard therapy.
The recommended regimen
Rheumatic diseases. 1 g/day/V for 1-4 days or 1 g/month/for 6 months.
Systemic lupus erythematosus. 1 g/day/for 3 days.
Multiple sclerosis. 1 g/day/for 3 or 5 days.
Edematous state (e.g. glomerulonephritis, lupus nephritis). 30 mg/kg/a day for 4 days or 1 g/day for 3, 5 or 7 days.
The above doses should be administered for at least 30 min, the introduction can be repeated, if within a week after the treatment was not improved, or if required by the patient's condition.
Cancer in the terminal stage (to improve the quality of life). 125 mg/day I/day for up to 8 weeks.
Prevention of nausea and vomiting associated with chemotherapy for cancer diseases. During chemotherapy, characterized by small or srednevyrazhennymi gag effect, enter 250 mg in/for a period of not less than 5 min for 1 h before the chemotherapeutic drug, at the beginning of chemotherapy and after its completion. During chemotherapy, characterized by a strong gag effect, enter 250 mg in/for a period of at least 5 minutes in combination with appropriate doses of metoclopramide or a butyrophenone 1 hour before the chemotherapeutic drug, then 250 mg IV at the beginning of chemotherapy and after its completion.
In other indications initial dose of 10-500 mg in/in, depending on the nature of the disease. For a short course in severe acute conditions may require higher doses. Initial dose not exceeding 250 mg, should be entered in/for a period of at least 5 minutes, doses exceeding 250 mg administered for at least 30 min. Subsequent dose is injected in/in or/m, while the length of intervals between doses depends on the patient's response to therapy and clinical status.
Children should be administered a lower dose (but not less than 0.5 mg/kg/day), however, when the dose in the first place should take into account the severity of the condition and the patient's response to therapy, but not age and body weight.
