Prednisol, 30 mg/ml 1 ml 3 pcs

Prednisolone is a synthetic glucocorticoid drug. It has anti-inflammatory, anti-allergic, immunosuppressive, antiexsudative and antipruritic effects. Immunosuppressive effect is associated with inhibition of cytokine release from lymphocytes and macrophages. Other effects are caused by stabilization of cell membranes, decreasing capillary permeability, and improvement of microcirculation.

Prednisolone has a catabolic effect, increases blood glucose levels, causes redistribution of adipose tissue. The drug inhibits the synthesis and secretion of ACTH and, secondary to that, corticosteroids by the adrenal glands.

When used topically and topically, the therapeutic activity of prednisolone is due to its anti-inflammatory, anti-allergic and anti-exudative (due to its vasoconstrictor effect) action.

Indications

For oral and IM administration: Rheumatism; rheumatoid arthritis; dermatomyositis; periarteritis nodosa; scleroderma; Bechterew’s disease; bronchial asthma, asthmatic status; acute and chronic allergic diseases; Addison’s disease, acute adrenal cortex insufficiency, adrenogenital syndrome; Hepatitis, hepatic coma, hypoglycemic conditions, lipoid nephrosis; agranulocytosis, various forms of leukemia, lymphogranulematosis, thrombocytopenic purpura, hemolytic anemia; minor chorea; vesicles, eczema, itching, exfoliative dermatitis, psoriasis, scabies, seborrheic dermatitis, lupus erythroderma, alopecia.

For use in ophthalmology: allergic, chronic and atypical conjunctivitis and blepharitis; corneal inflammation with intact mucosa; acute and chronic inflammation of the anterior segment of the choroid, sclera and episclera; sympathetic inflammation of the eyeball; after trauma and surgery with long-term irritation of the eyeballs.

For intra-articular administration: chronic polyarthritis, post-traumatic arthritis, osteoarthritis of large joints, rheumatic lesions of individual joints, arthrosis.

For infiltration into the tissues: epicondylitis, tendovaginitis, bursitis, scapular periarthritis, keloids, sciatica, Dupuytren’s contracture, rheumatic and similar lesions of the joints and various tissues.

Active ingredient

Composition

Active ingredient: prednisolone sodium phosphate (in recalculation on prednisolone) 25 or 30 mg;

Excipients: nicotinamide; sodium metabisulfite; disodium edetate; sodium hydroxide; water for injection.

How to take, the dosage

V/v (by trickle, then dropwise) or intramuscularly. The dose of Prednisolone and duration of treatment shall be determined by the physician individually, depending on the indication and severity of the disease.

In acute adrenal insufficiency a single dose of the drug is 100-200 mg and daily 300-400 mg.

In severe allergic reactions, Prednisolone is given in a daily dose of 100-200 mg for 3-16 days.

In bronchial asthma the drug is administered depending on the severity of the disease and the effectiveness of the complex treatment of 75 to 675 mg for a treatment course of 3 to 16 days; in severe cases the dose may be increased to 1400 mg per course of treatment or more with gradual reduction of the dose.

In asthmatic status, Prednisolone is given in a dose of 500-1200 mg per day with subsequent reduction to 300 mg per day and transition to maintenance doses.

In thyrotoxic crisis, 100 mg of the drug is administered in a daily dose of 200-300 mg; if necessary, the daily dose may be increased to 1000 mg. The duration of administration depends on the therapeutic effect, usually up to 6 days.

In case of shock resistant to standard therapy, Prednisolone is usually administered by trickle at the beginning of therapy, after which it is switched to drip administration. If BP does not increase within 10-20 minutes, the drug is repeated by trickle administration. After recovery from shock continue drip administration until BP stabilizes. The single dose is 50-150 mg (in severe cases up to 400 mg). The drug shall be repeatedly administered after 3-4 hours. The daily dose may be 300-1200 mg (with subsequent dose reduction).

In acute hepatic and renal failure (in acute poisoning, in postoperative and postpartum periods), Prednisolone is administered in 25-75 mg per day; if indicated, the daily dose may be increased to 300-1500 mg per day and higher.

In rheumatoid arthritis and systemic lupus erythematosus Prednisolone is administered in addition to systemic drug administration in a dose of 75-125 mg daily for not more than 7-10 days.

In acute hepatitis, Prednisolone is administered at 75-100 mg daily for 7-10 days.

In cauterizing fluid poisoning with burns of the digestive tract and upper respiratory tract, Prednisolone is prescribed in a dose of 75-400 mg daily for 3-18 days.

If IV administration is not possible, Prednisolone is administered in m/m in the same doses. After the acute condition is resolved, oral Prednisolone tablets are prescribed, with subsequent gradual reduction of the dose.

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

Interaction

Heart glycosides: increased risk of cardiac rhythm disturbances and glycoside toxicity associated with hypokalemia.

Antihistamines weaken the effect of prednisolone. Barbiturates, antiepileptic drugs (phenytoin, carbamazepine), rifampicin, glutethimide accelerate the metabolism of GKS (through induction of microsomal enzymes), weakening their effects.

Amphotericin B, carbohydrase inhibitors: hypokalemia, left ventricular myocardial hypertrophy, circulatory failure. Paracetamol: hypernatremia, peripheral edema, increased calcium excretion, risk of hypocalcemia and osteoporosis. Increased risk of hepatotoxicity of paracetamol. Anabolic steroids, androgens: increased risk of peripheral edema, acne; use with caution, especially in liver and heart disease.

Choline-blocking drugs (mainly atropine) – increased intraocular pressure. Anticoagulants (coumarin derivatives, indandion, heparin), streptokinase, urokinase:decreased and in some patients increased effectiveness; dose should be determined based on SP; increased risk of ulceration and GI bleeding.

Estrogen-containing oral contraceptives: increased serum glucocorticosteroid-binding globulin concentrations, slower metabolism, increased T1/2, increased effect of prednisolone. Tricyclic antidepressants may exacerbate psychiatric disorders associated with prednisolone administration. They should not be prescribed for the treatment of these disorders. Antithyroid drugs, thyroid hormones – changes in thyroid function (dose adjustment of these drugs or discontinuation of them is possible).

Diuretics: weakening of the action of diuretics (potassium-saving), hypokalemia. Oral antidiabetic drugs, insulin: weakening of hypoglycemic action, increase in blood glucose concentration. Dose adjustment of antidiabetic drugs is possible. Ephedrine may accelerate the metabolism of GCS (correction of the dose of prednisolone is possible).

Laxatives: attenuation, hypokalemia. Isoniazid: decrease of isoniazid concentration in blood plasma, mainly in persons with rapid acetylation (dosage adjustment is possible). Mexiletine: acceleration of metabolism of mexiletine and reduction of its concentration in blood serum. Immunosuppressive drugs: increased risk of infection, lymphoma and other lymphoproliferative diseases.

Drugs that block neuromuscular conduction (depolarizing myorelaxants): hypocalcemia associated with the use of prednisolone may increase synaptic blockade, leading to increased duration of neuromuscular blockade.

Drugs and food containing sodium: peripheral edema, arterial hypertension (it may be necessary to reduce sodium intake with food and medications with high sodium content; sometimes use of GCS requires additional sodium administration). NSAIDs, acetylsalicylic acid, alcohol: weakening of action, increased risk of peptic ulcer disease and GI bleeding.

Vaccines containing live viruses: during the use of immunosuppressive doses of GCS viral replication and development of viral diseases are possible; decrease in antibody production (simultaneous use is not recommended). Folic acid: increased need for this drug. Other vaccines: increased risk of neurological complications and decreased antibody production.

Special Instructions

The effectiveness of antacid drugs in preventing ulcer formation, gastrointestinal bleeding, or intestinal perforation has not been confirmed. With long-term treatment, it may be necessary to limit sodium and increase potassium, and to increase protein in the diet.

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

Taking the drug with food may reduce gastrointestinal side effects. If steroid myopathy develops, if therapy with prednisolone cannot be stopped, replacing it with another GCS may alleviate the symptoms. The risk of 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 appropriate exercise.

Acetylsalicylic acid or other NSAIDs may be prescribed to alleviate some of the symptoms of GCS withdrawal (without suppressing the hypothalamic-pituitary-adrenal system). If psychosis or depression occurs, the dose should be reduced if possible, or the drug should be discontinued. Phenothiazines or lithium compounds may be used if necessary.

Contraindications

Side effects

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

Water-electrolyte metabolism disorders: sodium and fluid retention in the body, hypokalemia, hypokalemic alkalosis.

Cardiovascular system disorders: increase in BP, circulatory failure.

Musculoskeletal system disorders: muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, spinal compression fracture, aseptic necrosis of femoral and humeral heads, pathological fractures of long bones.

Gastrointestinal organs: steroid ulcer with possible perforation and bleeding, pancreatitis, flatulence, ulcerative esophagitis, digestive disorders, nausea, increased appetite.

Skin disorders: atrophic streaks, acne, delayed wound healing, skin thinning, petechiae and bruises, erythema, increased sweating, allergic dermatitis, urticaria, angioedema.

Nervous system and sensory organs: Increased intracranial pressure with optic nipple congestion syndrome (pseudotumor of the brain – more common in children, usually after reducing the dose too quickly, symptoms are headache, worsened visual acuity or double vision); seizures, dizziness, headache, sleep disturbance, posterior subcapsular cataracts, increased intraocular pressure, glaucoma; exophthalmos.

Endocrine status: Secondary adrenal and hypothalamic-pituitary insufficiency (especially during stressful situations such as illness, trauma, surgery); Cushing’s syndrome; growth suppression in children; menstrual disorders; decreased carbohydrate tolerance; manifestation of latent diabetes and increased need for insulin or oral antidiabetic drugs in diabetic patients, hirsutism.

Metabolic side: negative nitrogen balance as a result of protein catabolism, hyperglycemia, glucosuria.

Mental disorders: symptoms mimicking schizophrenia, mania or delirium syndrome (most often appear during the first two weeks of treatment). Women and lupus erythematosus patients are most susceptible to mental disorders.

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

Overdose

The risk of overdose is increased with long-term use of prednisolone, especially in high doses.

Symptoms: increased BP, peripheral edema, increased adverse effects described above.

Treatment: The drug should be temporarily discontinued or the dose should be reduced.

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