Metipred powder for solution for injections 250 mg. №1 vial

Description

Metipred composition
active substance: methylprednisolone;
1 bottle contains methylprednisolone sodium succinate 331.5 mg or 1326 mg, equivalent to 250 mg or 1000 mg of methylprednisolone;
excipients: sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate anhydrous, sodium hydroxide (for pH correction).

Dosage form
Powder for solution for injection.

Pharmacological properties
A hormonal preparation containing methylprednisolone. Responsible for the synthesis of enzymes and proteins, prevents the destruction of joints and cytokines, which are involved in immune and inflammatory processes.
It is most effective in anti-inflammatory processes – its effect is 5 times more powerful than hydrocortisone.
Metipred regulates and influences metabolic processes in the body – lipid, protein, carbohydrate and calcium.
With prolonged use, it can cause atrophy of the muscles and adrenal cortex.
The drug is well absorbed in the digestive tract of the body. Begins to act 8 hours after ingestion.

Indications
The drug Metipred is prescribed for insufficient production of hormones by the adrenal glands, genetic proliferation of adrenal tissue (hyperplasia), inflammation of the thyroid gland, and various forms of autoimmune diseases (anemia, leukemia).
The drug is taken in severe, specific forms of erythremia, psoriasis, dermatitis.
Copes well with severe forms of allergies, anaphylactic shock.
It is prescribed for the treatment of severe acute, chronic inflammatory processes in the tissues of the body – with tuberculosis in combination with chemotherapy.
With severe forms of rheumatism, arthritis, lower respiratory tract diseases, asthma.
It is prescribed for postoperative cerebral edema or due to tumors. And also in other conditions that are characterized by increased intracranial pressure.
With ulcerative colitis, Crohn’s disease, multiple sclerosis.
Metipred can be used in the postoperative period during organ transplantation to prevent transplant rejection, in patients undergoing chemotherapy as an antiemetic.

Contraindications
In case of an allergic reaction to methylprednisalone, lactose.
Not indicated for acute or chronic viral or bacterial infectious diseases.
With a latent or active form of tuberculosis, if other treatment is not carried out in parallel.
Arterial hypertension, congestive heart failure, mental disorders, diabetes mellitus, pancreatitis, old age – these are all reasons for careful use of the drug or an obstacle to not prescribing it.
Diseases of the stomach or intestines where there is a risk of bleeding opening or perforation.
Carefully weigh the risks when prescribing the drug to individuals with glaucoma, thrombophlebitis, diabetes mellitus in the family, fragility of bones and poor blood clotting.
For patients suffering from functional disorders of the liver and with hypothyroidism, the drug can be prescribed only under scrupulous medical supervision.

Children
The drug is used in pediatric practice.

Application during pregnancy and lactation
When using metipred by a pregnant woman, the high risks of a stillborn child and fetal growth arrest should be taken into account.
If a woman was taking the drug, became pregnant, the dose should be gradually reduced and the medication should be “nil”. You cannot abruptly stop taking the drug.
When breastfeeding a child, taking the drug is contraindicated; in extreme cases, breastfeeding should be canceled.

Method of administration and dosage
Methylprednisolone sodium succinate solution can be administered by intravenous or intramuscular injection, or by intravenous infusion. In primary emergency care, intravenous injection is preferred. The dose for children, in particular infants, can be reduced, but more should be guided by the severity of the condition and the patient’s response to treatment, rather than his age or body weight. The dose should be at least 0.5 mg / kg body weight every 24 hours.

• For idiopathic thrombocytopenic purpura in adults, Metipred is administered intravenously only (intramuscular administration is contraindicated).
  Adjunctive therapy for life-threatening conditions – the recommended dose is 30 mg / kg bw given intravenously over at least 30 minutes. This dose can be re-administered in a hospital setting every 4-6 hours for 48 hours depending on clinical need.
• Rheumatoid arthritis: 1 g / day intravenously for 1, 2, 3 or 4 days or 1 g / month intravenously for 6 months.
• Prevention of nausea and vomiting associated with chemotherapy for malignant neoplasm.
  Chemotherapy that produces a mild to moderate emetogenic effect: administration of Metypred at a dose of 250 mg intravenously for at least 5 minutes one hour before chemotherapy, at the beginning of chemotherapy, and at the end of chemotherapy. To enhance the effect with the first dose of Metypred, chlorinated phenothiazine can also be used.
• Acute spinal cord injury. Treatment should be started within the first eight hours after injury.
  If the treatment was started within 3 hours after the injury: methylprednisolone is administered at a dose of 30 mg / kg of body weight as an intravenous bolus for 15 minutes under constant medical supervision. After the bolus injection, take a break for 45 minutes, after which the drug is continuously infused at a dose of 5.4 mg / kg of body weight per hour for 23 hours.
  If the treatment was started within 3-8 hours after the injury: methylprednisolone is administered at a dose of 30 mg / kg of body weight intravenously bolus for 15 minutes under constant medical supervision. After the bolus injection, a break is made for 45 minutes, after which a continuous infusion of the drug is carried out at a dose of 5.4 mg / kg of body weight per hour for 47 hours. For the infusion pump, it is desirable to select a different site for intravenous administration than for the bolus injection.
• For other indications
  The starting dose of Metipred is between 10 mg and 500 mg, depending on the patient’s clinical condition and type of disease. Large doses may be required in the case of short-term treatment of severe acute conditions, in particular bronchial asthma, serum sickness, urticarial transfusion reactions and exacerbations of multiple sclerosis. An initial dose of up to and including 250 mg should be administered intravenously over at least 5 minutes, and doses that exceed 250 mg should be administered over at least 30 minutes. The following doses can be administered intravenously or intramuscularly at intervals that depend on the patient’s response and clinical condition. Corticosteroid therapy is used as an adjunct and does not replace conventional therapy.
• Pneumocystis carinii pneumonia in patients with AIDS: The recommended dose of the drug is 40 mg intravenously every 6-12 hours with a gradual dose reduction for a maximum of 21 days or until treatment for Pneumocystis infection is discontinued. Treatment should be started within 72 hours of starting treatment for Pneumocystis infection.

Solution preparation
For intravenous (or intramuscular) injection, a reconstituted solution is first prepared by adding water for injection with a syringe to the powder vial. The resulting Metipred solution is visually inspected for particulate matter and discoloration.
Therapy can be started by administering a solution of methylprednisolone sodium succinate for at least 5 minutes (doses up to and including 250 mg) and for at least 30 minutes (doses exceeding 250 mg).

Overdose
Overdose data have been reported. With prolonged use of the drug, it is possible to suppress the function of the adrenal glands.
When such a symptom appears, the dose of the drug is gradually reduced.

Side effects
Long-term treatment with the drug in childhood can lead to growth retardation.
Possible withdrawal syndrome – to avoid this, you should gradually reduce the dose of the drug.
The drug sometimes negatively affects cardiovascular (increased blood pressure, heart failure, leukocytosis), gastrointestinal (bulimia, mucosal lesions, ulcers, nausea), nervous (sleep disturbances, the appearance of gaucoma, exacerbation of schizophrenia, increased intraocular pressure), musculoskeletal motor (osteoporosis, myopathy, tendon dysfunctions) systems.
Possible water retention in the body, menstrual irregularities, weight gain, amenorrhea, rash, itching, allergic reactions.
With injections, a burning sensation and pain at the injection site are possible.
Abrupt withdrawal of the drug can cause high fever, pain in muscles and joints.

Shelf life
5 years.

Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.