Ascorbic acid solution for intravenous and intramuscular administration 50mg/ml in ampoules 2ml №10

Name:
Ascorbic acid solution din 50mgml in amp.2ml in pack No. 10×1
Description:
Transparent colorless or slightly colored liquid. One ampoule contains: active ingredient – ascorbic acid – 50 mg in 1 ml or 100 mg in 2 ml of solution; excipients: sodium bicarbonate, anhydrous sodium sulfite, water for injection. Pharmacotherapeutic group Vitamins. Vitamin C. ATX code – A11GA01. Pharmacological properties Pharmacodynamics A drug with vitamin C activity has a metabolic effect, is not formed in the human body, but comes only with food. Participates in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration; increases the body’s resistance to infections, reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. Participates in the metabolism of phenylalanine, tyrosine, folic acid, norepinephrine, histamine, iron, utilization of carbohydrates, synthesis of lipids, proteins, carnitine, immune reactions, hydroxylation of serotonin, enhances the absorption of non-heme iron. Regulates the transport of hydrogen ions in many biochemical reactions, improves the use of glucose in the tricarboxylic acid cycle, participates in the formation of tetrahydrofolic acid and tissue regeneration, the synthesis of steroid hormones, collagen, procollagen. Maintains the colloidal state of the intercellular substance and normal capillary permeability (inhibits hyaluronidase). Activates proteolytic enzymes, participates in the exchange of aromatic amino acids, pigments and cholesterol, promotes the accumulation of glycogen in the liver. Due to the activation of respiratory enzymes in the liver, it enhances its detoxification and protein-forming functions, increases the synthesis of prothrombin. It improves bile secretion, restores the exocrine function of the pancreas and the endocrine function of the thyroid. Regulates immunological reactions (activates the synthesis of antibodies, the C3 component of complement, interferon), promotes phagocytosis, increases the body’s resistance to infections. It inhibits the release and accelerates the degradation of histamine, inhibits the formation of prostaglandins and other mediators of inflammation and allergic reactions. Pharmacokinetics Communication with plasma proteins? 25%. The concentration of ascorbic acid in plasma is normally approximately 10-20 mcg / ml, body reserves are about 1.5 g when taking daily recommended doses and 2.5 g when taking 200 mg / day. Easily penetrates into leukocytes, platelets, and then? in all tissues; the highest concentration is achieved in the glandular organs, leukocytes, liver and lens of the eye; deposited in the posterior pituitary gland, adrenal cortex, ocular epithelium, intermediate cells of the seminal glands, ovaries, liver, spleen, pancreas, lungs, kidneys, intestinal wall, heart, muscles, thyroid gland; crosses the placenta. The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and in plasma. In deficient states, the concentration in leukocytes decreases later and more slowly and is considered as a better criterion for assessing deficiency than plasma concentration. It is metabolized mainly in the liver to deoxyascorbic acid and then to oxaloacetic and diketogulonic acids. It is excreted by the kidneys, with sweat, breast milk in the form of unchanged ascorbate and metabolites. With the appointment of high doses, the rate of excretion increases dramatically. Smoking and the use of ethanol accelerate the destruction of ascorbic acid (transformation into inactive metabolites), sharply reducing stocks in the body. Excreted during hemodialysis. Indications for use Treatment of hypo- and avitaminosis C (if necessary, rapid replenishment of vitamin C and the impossibility of oral administration). Clinical situations associated with the need for additional administration of ascorbic acid, incl. parenteral nutrition, diseases of the gastrointestinal tract (persistent diarrhea, resection of the small intestine, peptic ulcer, gastrectomy), Addison’s disease. Contraindications Hypersensitivity to the components of the drug. Administration of large doses? hypercoagulability, thrombophlebitis, tendency to thrombosis, diabetes mellitus, nephrolithiasis, deficiency of glucose-6-phosphate dehydrogenase. With caution Hyperoxaluria, renal failure, hemochromatosis, thalassemia, polycythemia, leukemia, sideroblastic anemia, sickle cell anemia, malignant neoplasms. Dosage and administration The solution for injection is administered intravenously or intramuscularly. For therapeutic purposes, adults are usually prescribed 50-150 mg (1-3 ml of a 50 mg / ml solution) per day, the maximum single dose is 200 mg (4 ml), the maximum daily dose is 1 g (20 ml). Therapeutic doses for children are 50-100 mg (1-2 ml) per day. The duration of treatment depends on the nature and course of the disease. Side effect From the side of the central nervous system: with a rapid on / in the introduction? dizziness, feeling tired, with prolonged use of large doses (more than 1 g)? headache, increased excitability of the central nervous system, insomnia. From the urinary system: moderate pollakiuria (when using a dose of more than 600 mg / day), with prolonged use of large doses? hyperoxaluria, nephrolithiasis (from calcium oxalate), damage to the glomerular apparatus of the kidneys. From the side of the cardiovascular system: with prolonged use of large doses? decrease in capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulability, development of microangiopathies), myocardial dystrophy. Allergic reactions: skin rash, skin hyperemia, anaphylactic shock. Laboratory indicators: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia, glucosuria, hyperglycemia. Local reactions: soreness at the injection site. Others: with prolonged use of large doses (more than 1 g)? inhibition of the function of the insular apparatus of the pancreas (hyperglycemia, glucosuria), hypervitaminosis, retention of Na + and fluid, impaired metabolism of Zn2 + and Cu2 +, with intravenous administration in large doses – the threat of abortion. Precautions Due to the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor kidney function and blood pressure. With prolonged use of large doses, inhibition of the function of the insular apparatus of the pancreas is possible, therefore, in the course of treatment, it must be regularly monitored. In patients with high iron content in the body, ascorbic acid should be used in minimal doses. The appointment of ascorbic acid to patients with rapidly proliferating and intensively metastasizing tumors can aggravate the course of the process. Ascorbic acid as a reducing agent can distort the results of various laboratory tests (blood glucose, bilirubin, activity of “liver” transaminases and lactate dehydrogenase). Use during pregnancy and lactation During pregnancy and lactation, use only if the intended benefit to the mother outweighs the potential risk to the fetus and child. Theoretically, there is a danger to the child when the mother uses high doses of ascorbic acid (it is recommended not to exceed the maximum daily requirement for ascorbic acid by the nursing mother). The minimum daily requirement for ascorbic acid in the II-III trimesters of pregnancy is about 60 mg. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid, which is taken by a pregnant woman, and then the newborn may develop a “withdrawal” syndrome. Minimum daily requirement during lactation ? 80 mg. A mother’s diet containing an adequate amount of ascorbic acid is sufficient to prevent deficiency in an infant. Influence on the ability to drive a car and work with moving mechanisms Does not affect. Interaction with other drugs Increases the concentration of benzylpenicillin and tetracyclines in the blood; at a dose of 1 g / day, it increases the bioavailability of ethinylestradiol (including that which is part of oral contraceptives). Reduces the effectiveness of heparin and indirect anticoagulants. Increases the risk of developing crystalluria in the treatment of salicylates and short-acting sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood. Increases the overall clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body. Medicines of the quinoline series, calcium chloride, salicylates, glucocorticosteroids with prolonged use deplete the reserves of ascorbic acid. With simultaneous use reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction of disulfiram and ethanol. In high doses, it increases the excretion of mexiletin by the kidneys. Barbiturates and primidone increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of antipsychotic drugs (neuroleptics)? phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants. Pharmaceutically incompatible with aminophylline, bleomycin, cefazolin, cefapirin, chlordiazepoxide, estrogens, dextrans, doxapram, erythromycin, methicillin, nafcillin, benzylpenicillin, warfarin. Overdose Symptoms of overdose occur when ascorbic acid is administered in large doses or over an extended period of time. The development of arterial hypertension, hyperglycemia, glucosuria, thromboembolic complications, nephrolithiasis is characteristic. Assistance measures include drug withdrawal and symptomatic therapy. There is no specific antidote. Upakovka1 ml or 2 ml in glass ampoules. 10 ampoules, together with the leaflet, are placed in a cardboard box (No. 10). 10 ampoules, together with the leaflet, are placed in a pack with a cardboard liner to fix the cardboard ampoules (No. 10). Storage conditions In a place protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 1 year. Do not use after the expiration date. Pharmacy dispensing conditions By prescription use for Ascorbic acid solution for intravenous and intramuscular injection 50mg/ml in ampoules 2ml №10