SOLU-MEDROL LYOPHILISATE FOR INJECTION 1000MG BOTTLE + SOLVENT

Solu-Medrol/Solu-medrol

Composition and release form

Solu-Medrol - lyophilisate for solution for injection: 1 fl. contains methylprednisolone (as sodium succinate) 500 or 1000 mg,

excipients: monohydrate monobasic sodium phosphate; Sodium phosphate; solvent: benzyl alcohol - 9 mg; water for injection q.s. 1 ml; in a pack of cardboard 1 bottle complete with solvent in bottles.

Solu-Medrol - lyophilisate for preparation of solution for injections:

1 fl.2-capacitance contains methylprednisolone (in the form of sodium succinate) 40 mg, excipients: lactose; monobasic sodium phosphate monohydrate; Sodium phosphate; in a carton pack 1 vial two-container Act − 0-Vial.

Solu-Medrol - lyophilisate for preparation of solution for injections:

1 fl.2-capacitance contains methylprednisolone (as sodium succinate) 125 or 250 mg,

excipients: monohydrate monobasic sodium phosphate; Sodium phosphate; in a carton pack 1 vial two-container Act − 0-Vial.

pharmachologic effect

Solu-Medrol has a glucocorticoid effect.

IndicationsI

Shock (burn, traumatic, operative, toxic, cardiogenic) with the failure of other therapies. Allergic reactions (acute, severe), blood transfusion shock, anaphylactic shock, anaphylactoid reactions. Cerebral edema (incl.against the background of a brain tumor or associated with surgery, radiation therapy or head injury). Bronchial asthma (severe), asthmatic status. Systemic diseases of connective tissue (SLE, rheumatoid arthritis). Acute adrenal insufficiency. Thyrotoxic crisis. Acute hepatitis, hepatic coma. Poisoning with cauterizing liquids (reducing inflammation and preventing cicatricial contractions).

Contraindications

For short-term use for "vital" indications, the only contraindication is hypersensitivity. For intraarticular administration: previous arthroplasty, abnormal bleeding (endogenous or caused by anticoagulants), intraarticular bone fracture, infectious (septic) inflammation in the joint and periarticular infections (including a history), as well as a common infectious disease, marked periarticular osteoporosis, the absence of signs of inflammation in the joint (the so-called "dry" joint, for example, in osteoarthritis without synovitis), severe bone destruction and deformity of the joint (sharp angling joint space, ankylosis), instability of the joint as a result of arthritis, aseptic necrosis of the epiphyses of the bones forming the joint.

Side effects

The side effects listed below are typical for all corticosteroids with systemic use.

Disorders of water and electrolyte balance - sodium retention, congestive heart failure in susceptible patients, hypertension, fluid retention in the body, hypokalemia and hypokalemic alkalosis.

On the part of the cardiovascular system - myocardial rupture due to myocardial infarction, hypotension, arrhythmia.

On the part of the musculoskeletal system - steroid myopathy, muscle weakness, osteoporosis, pathological bone fractures, vertebral compression fractures, aseptic necrosis and tendon ruptures (especially the Achilles tendon).

On the part of the gastrointestinal tract - ulcers with possible perforation and bleeding, gastric bleeding, pancreatitis, esophagitis, intestinal perforation, increasing the activity of AlAT, AsAT and alkaline phosphatase in the serum.

On the part of the skin - delayed healing of wounds, petechiae and ecchymosis, thinning and increased sensitivity of the skin.

On the part of the metabolism - a negative nitrogen balance due to protein catabolism.

On the part of the nervous system - increased intracranial pressure with swelling of the optic nerve head (pseudotumor of the brain), mental disorders and convulsions.

On the part of the endocrine system, menstrual disorders, the development of Itsenko-Cushing syndrome, suppression of the function of the hypothalamic-adrenal axis, impaired glucose tolerance, the clinical manifestation of latent diabetes mellitus, an increase in insulin or oral hypoglycemizing drugs in diabetic patients, slowing growth children.

On the side of the eyes - posterior subcapsular cataract, increased intraocular pressure and exophthalmos.

On the part of the immune system - masking the clinical picture of infections, activation of latent infections, possibly the occurrence of diseases caused by opportunistic pathogens, possible hypersensitivity reactions, including anaphylaxis, as well as inhibition of reactions during skin tests. In addition, during parenteral therapy of corticosteroids, allergic reactions of the anaphylactoid type (with or without circulatory collapse), cardiac arrest, bronchospasm, prolonged hiccups when using GCS in high doses can occur.

Dosage and administration

Solu-Medrol is administered intravenously, intramuscularly, or as an intravenous infusion, but for emergency conditions, treatment is started with intravenous injection. Children should be given lower doses (but not less than 0.5 mg / kg / day), but when choosing a dose, first of all, take into account the severity of the condition and the patient's response to therapy, rather than age and body weight.

As an additional therapy in life-threatening conditions - in / in, 30 mg / kg for at least 30 minutes. Administration can be repeated every 4-6 hours for a maximum of 48 hours.

Oncological diseases in the terminal stage - to improve the quality of life - in / in 125 mg / day daily for up to 8 weeks.

Prevention of nausea and vomiting associated with Chemotherapy for cancer. With chemotherapy, characterized by a slight or moderate emetic effect, i.v. / in 250 mg for at least 5 minutes 1 hour before the administration of chemotherapy, at the beginning and after the end of the administration.To enhance the effect with the first dose of the drug Solu-Medrol, you can enter drugs chlorphenothiazine.

With chemotherapy, characterized by a pronounced emetic effect, it is in / in 250 mg for at least 5 minutes in combination with appropriate doses of Metoclopramide or butyrophenone 1 hour before the administration of chemotherapy drugs, then in / in 250 mg at the beginning and after the end of the administration.

Acute traumatic injuries of the spinal cord. Treatment must begin in the first 8 hours after injury. It is recommended intravenous bolus administration at a dose of 30 mg / kg for 15 minutes, then after a 45-minute break, a continuous infusion at a dose of 5.4 mg / kg / h is carried out for 23 hours. The drug should be administered using an infusion pump into an isolated vein.

For other indications, the initial dose of Solu-Medrol 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 IV for at least 5 minutes, a dose of more than 250 mg should be at least 30 minutes. Subsequent doses are administered intravenously or intramuscularly, and the duration of the intervals between injections depends on the patient's response to therapy and on his clinical condition.

Storage conditions and shelf life

In a dry, dark place at a temperature of no higher than 20 ° C. Shelf life - 5 years.