Prednisolone solution for injection. 30mg / ml, 1ml # 10

The drug is used for emergency therapy in conditions requiring a rapid increase in the concentration of GCS in the body:

• shock (burn, traumatic, operational, toxic, anaphylactic, cardiogenic, blood transfusion) - with ineffectiveness of vasoconstrictor drugs, plasma-substituting drugs and other symptomatic therapy;

• allergic reactions (acute and severe forms), anaphylactoid reactions, serum sickness;

• bronchial asthma (severe form), asthmatic status;

• edema of the brain (only after confirmation of the symptoms of increased intracranial pressure by the results of magnetic resonance imaging or computed tomography), caused by a brain tumor and / or associated with surgery or radiation therapy;

• systemic connective tissue diseases: rheumatoid arthritis, systemic lupus erythematosus;

• acute hepatitis, hepatic coma;

• primary and secondary adrenal insufficiency

Intravenous (drip or jet), intramuscular injection.

Intravenous drug Prednisolone bufus is usually administered first by jet, then by drip.

The dose of the drug and the duration of treatment are set by the doctor individually, depending on the indications and severity of the disease.

In acute adrenal insufficiency, the drug is administered in an initial single dose of 90-120 mg to 180 mg, the daily dose is 300-390 mg.

In case of severe allergic reactions, the drug Prednisolone bufus is administered in a daily dose of 90-120 mg to 180 mg for 3-16 days.

In bronchial asthma, the drug Prednisolone bufus is administered depending on the severity of the disease and the effectiveness of complex treatment from 60-90 mg to 660 mg for a course of treatment from 3 to 16 days; in severe cases, the dose can be increased to 1380 mg per course of treatment or more, with a gradual dose reduction.

In case of status asthmaticus, Prednisolone bufus is administered at a dose of 510-1200 mg per day, followed by a decrease to 300 mg per day and a transition to maintenance doses.

In case of a thyrotoxic crisis, the recommended initial dose of the drug Prednisolone bufus is 90-120 mg; daily dose - 300 mg. If necessary, the daily dose can be increased to 900 mg. The duration of administration depends on the therapeutic effect, usually up to 6 days.

In shock resistant to standard therapy, the drug Prednisolone bufus is usually administered in a stream at the beginning of therapy, after which they switch to drip. If the blood pressure does not rise within 10-20 minutes, repeat the jet injection of the drug. After withdrawal from the shock state, drip administration is continued until the blood pressure stabilizes. The initial single dose is 60-150 mg in severe cases - up to 390 mg. The drug is injected again after 3-4 hours. The daily dose may be 300-1200 mg with a subsequent dose reduction.

In acute hepatic-renal failure (in acute poisoning, in the postoperative and postpartum periods, and others), the drug Prednisolone bufus is administered at 30-90 mg per day; if indicated, the daily dose can be increased to 300-1500 mg per day or more.

With rheumatoid arthritis and systemic lupus erythematosus, the drug Prednisolone bufus is administered in addition to the systemic administration of the drug at a dose of 60-120 mg per day for no more than 7-10 days.

In acute hepatitis, the drug Prednisolone bufus is administered at 60-120 mg per day for 7-10 days.

In case of poisoning with cauterizing liquids with burns of the digestive tract and upper respiratory tract, the drug Prednisolone bufus is prescribed at a dose of 60-390 mg per day for 3-18 days.

Single dose for children: children from 2 to 12 months are administered at the rate of 2-3 mg / kg of body weight; from 1 to 14 years old - 1-2 mg / kg intravenous stream or deep intramuscular injection. The intravenous solution should be injected slowly (about 3 minutes). If necessary, you can repeat the administration of the drug through

20-30 minutes.

If intravenous administration is impossible, the drug Prednisolone Bufus is administered intramuscularly in the same doses. After the relief of the acute condition, prednisolone is prescribed orally in tablets, followed by a gradual decrease in the dose.

With prolonged use of the drug, the daily dose should be reduced gradually. Long-term therapy should not be stopped suddenly!

Active substance:

Prednisolone sodium phosphate - 40.32 mg (in terms of prednisolone) - 30.00 mg

Excipients: sodium hydrogen phosphate (sodium phosphate disubstituted) - 0.91 mg disodium edetate dihydrate (Trilon B) - 0.50 mg sodium dihydrogen phosphate dihydrate (sodium phosphate monosubstituted 2-water) - 0.34 mg propylene glycol - 0.25 ml water for injection - up to 1 ml

• Hypersensitivity to prednisolone or drug components.

• In children during the period of growth, GCS should be used only for absolute indications and under the particularly careful supervision of the attending physician.

• During pregnancy (especially in the first trimester), it is used only for health reasons.

• Since glucocorticosteroids penetrate into breast milk, if it is necessary to use the drug during breastfeeding, it is recommended to stop breastfeeding.

pharmachologic effect

Prednisolone is a synthetic glucocorticoid drug. It has anti-inflammatory, anti-allergic, immunosuppressive, anti-exudative and antipruritic effects. The immunosuppressive effect is associated with inhibition of the release of cytokines from lymphocytes and macrophages. Other effects are due to the stabilization of cell membranes, a decrease in capillary permeability, and an improvement in microcirculation.
Prednisolone has a catabolic effect, increases blood glucose levels, and causes the redistribution of adipose tissue. The drug inhibits the synthesis and secretion of ACTH and, secondarily, adrenal corticosteroids.
When applied topically and locally, the therapeutic activity of prednisone is due to its anti-inflammatory, antiallergic and antiexudative (due to the vasoconstrictor effect) action.

Side effects

With short-term use of prednisolone, like other corticosteroids, side effects are rare. When using prednisolone for a long time, the following side effects may develop:

Disorders of water and electrolyte metabolism: sodium and fluid retention in the body, hypokalemia, hypokalemic alkalosis.

From the side of the cardiovascular system: increased blood pressure, circulatory failure.

On the part of the musculoskeletal system: muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, compression fracture of the spine, aseptic necrosis of the heads of the femur and humerus, pathological fractures of the long bones.

From the digestive tract: steroid ulcer with possible perforation and bleeding, pancreatitis, flatulence, ulcerative esophagitis, indigestion, nausea, increased appetite.

On the part of the skin: atrophic stripes, acne, delayed wound healing, thinning of the skin, petechiae and hematomas, erythema, excessive sweating, allergic dermatitis, urticaria, angioedema.

From the nervous system and sensory organs: increased intracranial pressure with congestive optic papilla syndrome (pseudotumor of the brain - more often in children, usually after a too rapid dose reduction, symptoms - headache, deterioration of visual acuity or double vision); convulsions, dizziness, headache, sleep disturbance, posterior subcapsular cataract, increased intraocular pressure, glaucoma; exophthalmos.

Endocrine status: secondary adrenal and hypothalamic-pituitary insufficiency (especially during stressful situations such as illness, injury, surgery); Cushing's syndrome; growth suppression in children; menstrual irregularities; decreased tolerance to carbohydrates; manifestation of latent diabetes mellitus and increased need for insulin or oral antidiabetic drugs in patients with diabetes mellitus, hirsutism.

From the side of metabolism: negative nitrogen balance as a result of protein catabolism, hyperglycemia, glucosuria.

Mental health disorders: Symptoms mimicking schizophrenia, mania, or delirious syndrome (most often occurring within the first two weeks of treatment). The most susceptible to the appearance of mental disorders are women and patients with lupus erythematosus.

Others: anaphylactic reactions and hypersensitivity reactions, obliterating endarteritis, weight gain, masking the symptoms of infectious diseases, fainting.

Interaction

Cardiac glycosides: increased risk of cardiac arrhythmias and glycoside toxicity associated with hypokalemia.

Barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutethimide accelerate the metabolism of GCS (by inducing microsomal enzymes), weaken their effect.

Antihistamines reduce the effects of prednisone.

Amphotericin B, carbonic anhydrase inhibitors: hypokalemia, left ventricular myocardial hypertrophy, circulatory failure.

Paracetamol: hypernatremia, peripheral edema, increased calcium excretion, risk of hypocalcemia and osteoporosis. Increased risk of paracetamol hepatotoxicity.

Anabolic steroids, androgens: increased risk of developing peripheral edema, acne; use with caution, especially in case of liver and heart disease.

Oral contraceptive drugs containing estrogens: an increase in the concentration of globulins that bind glucocorticosteroids in the blood serum, a slowdown in metabolism, an increase in T1 / 2, an increase in the action of prednisolone.

Anticholinergic drugs (mainly atropine) - an increase in intraocular pressure.

Anticoagulants (coumarin derivatives, indandione, heparin), streptokinase, urokinase: decrease, and in some patients, increase in effectiveness; dose should be determined based on PT; increased risk of ulceration and bleeding from the gastrointestinal tract.

Tricyclic antidepressants can exacerbate mental health problems associated with prednisolone. They should not be prescribed to treat these disorders.

Oral antidiabetic drugs, insulin: weakening the hypoglycemic effect, increasing the concentration of glucose in the blood. Possible dose adjustment of antidiabetic drugs.

Antithyroid drugs, thyroid hormones - changes in the function of the thyroid gland (it is possible to adjust the dose of these drugs or stop taking them).

Diuretic drugs: weakening of the action of diuretics (potassium-sparing), hypokalemia.

Laxatives: weakening of action, hypokalemia.

Ephedrine can accelerate the metabolism of GCS (dose adjustment of prednisolone is possible).

Immunosuppressive drugs: increased risk of infection, lymphoma, and other lymphoproliferative diseases.

Isoniazid: a decrease in the concentration of isoniazid in the blood plasma, mainly in persons with rapid acetylation (dose change is possible).

Mexiletine: accelerating the metabolism of mexiletine and decreasing its concentration in the blood serum.

Drugs that block neuromuscular conduction (depolarizing muscle relaxants): hypocalcemia associated with the use of prednisolone can increase the blockade of synapses, leading to an increase in the duration of the neuromuscular blockade.

NSAIDs, acetylsalicylic acid, alcohol: weakening the action, increasing the risk of developing peptic ulcer disease and bleeding from the gastrointestinal tract.

Drugs and food containing sodium: peripheral edema, arterial hypertension (it may be necessary to reduce sodium intake with food and drugs with a high sodium content; sometimes the use of corticosteroids requires additional sodium administration).

Vaccines containing live viruses: during the period of application of immunosuppressive doses of GCS, replication of viruses and the development of viral diseases are possible; decreased antibody production (simultaneous use is not recommended).

Other vaccines: increased risk of neurological complications and decreased antibody production.

Folic acid: increased need for this drug.

Overdose

The risk of overdose increases with prolonged use of prednisolone, especially in high doses.

Symptoms: increased blood pressure, peripheral edema, increased unwanted effects described above.

Treatment: You should temporarily stop taking the drug or reduce the dose.

Special instructions

Prednisolone is contraindicated in patients with systemic fungal infections due to the risk of increased infection. The drug can in some cases be used for fungal infections treated with amphotericin B to reduce its side effects, but in these cases it can cause circulatory failure and hypertrophy of the left ventricular myocardium, as well as severe hypokalemia. Taking the drug with meals can reduce gastrointestinal side effects.

Antacids have not been shown to be effective in preventing ulceration, gastrointestinal bleeding, or bowel perforation. With long-term treatment, sodium restriction and an increase in potassium may be necessary, as well as an increase in protein in food.

In the case of the development of steroid myopathy, if prednisolone therapy cannot be canceled, replacing it with another GCS can alleviate the symptoms.

The risk of developing osteoporosis associated with long-term use of GCS can be reduced by taking calcium and vitamin D or, if the patient's condition allows, by performing appropriate physical exercises.

In the event of psychosis or depression, you should, if possible, reduce the dose or stop taking the drug. If necessary, you can use phenothiazines or lithium compounds.

In order to alleviate some of the symptoms of GCS withdrawal syndrome (without suppressing the hypothalamus-pituitary-adrenal system), acetylsalicylic acid or other NSAIDs can be prescribed.