Active substanceAscorbic acidAscorbic acid
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  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    In 1 ml of the preparation contains:

    active substance- Acid ascorbic acid - 50.0 mg or 100.0 mg

    Excipients- sodium bicarbonate, sodium metabisulphite, water for injection, saturated with carbon dioxide.

    Description:Colorless or slightly colored liquid.
    Pharmacotherapeutic group:Vitamin
    ATX: & nbsp

    A.11.G.A.01   Ascorbic acid

    Pharmacodynamics:

    Ascorbic acid is a vitamin remedy, which is not formed in the human body, but comes only with food. Participates in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood clotting, tissue regeneration; in the synthesis of steroid hormones; increases the body's resistance to infections, reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. It has pronounced antioxidant properties. Regulates hydrogen transport in many biochemical reactions, improves the use of glucose in the cycle of tricarboxylic acids, participates in the formation of tetrahydrofolic acid and tissue regeneration, the synthesis of steroid hormones, collagen, procollagen. It supports the colloidal state of the intercellular substance and the normal permeability of capillaries (oppresses 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 pancreas. Regulates immunological reactions (activates the synthesis of antibodies, 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 (Pg) and other mediators of inflammation and allergic reactions.

    Pharmacokinetics:

    Metabolised mainly in the liver in desoxyascorbic and then in oxaloacetic and diketogulonovoy acid. It is excreted by the kidneys, through the intestines, with sweat, breast milk in the form of unchanged ascorbate and metabolites.

    At the appointment of high doses, the rate of excretion increases sharply. Smoking and the use of ethanol accelerate the destruction of ascorbic acid (conversion into inactive metabolites), sharply reducing the reserves in the body. It is in hemodialysis.

    Indications:

    Applied for medical purposes in all clinical situations associated with the need for additional administration of ascorbic acid.

    The drug is prescribed:

    - with avitaminosis C (scurvy);

    - in the complex therapy for bleeding (pulmonary, uterine, caused by radiation sickness), with various intoxications and infectious diseases, alcohol and infectious delirium, Addison's disease, with an overdose of anticoagulants, flaccid wounds, various dystrophies.

    Contraindications:

    Hypersensitivity to the components of the drug. The introduction of large doses - hypercoagulation, thrombophlebitis, a tendency to thrombosis, diabetes mellitus, renal stone disease, a deficiency of glucose-6-phosphate dehydrogenase.

    Carefully:

    Hyperoxaluria, renal insufficiency, hemochromatosis, thalassemia, polycythemia, leukemia, sideroblastic anemia, sickle cell anemia, malignant neoplasms.

    Pregnancy and lactation:

    Ascorbic acid penetrates the placenta. The study of reproduction on animals revealed an unfavorable effect on the fetus, but no adequate and strictly controlled studies were performed in humans,so when parenteral administration of large doses of ascorbic acid, it is necessary to correlate the benefits to the mother and the risk to the fetus.

    Ascorbic acid penetrates into breast milk, so when parenteral administration of large doses of ascorbic acid, it is necessary to resolve the issue of stopping breastfeeding.

    Dosing and Administration:

    Apply to the doctor's prescription.

    The drug is administered intravenously and intramuscularly.

    Therapeutic doses for adults - 1-3 ml of a solution of 50 mg / ml, when poisoning is administered up to 60 ml / day.

    Treatment doses for children - 1-2 ml of 50 mg / ml solution (or 1 ml of 100 mg / ml solution).

    The duration of treatment depends on the nature and course of the disease.

    Side effects:

    From the central nervous system (CNS): with rapid intravenous injection - dizziness, a sense of fatigue; with prolonged use of large doses - increased excitability of the central nervous system, sleep disturbance.

    From the gastrointestinal tract (GIT): nausea, vomiting, diarrhea, stomach cramps.

    From the endocrine system: oppression of the insular pancreas function (hyperglycemia, glucosuria).

    From the urinary system: when used in high doses - hyperoxaluria and the formation of urinary stones from calcium oxalate, damage to the glomerular apparatus of the kidneys.

    From the cardiovascular system (SSS): decreased capillary permeability and worsening trophism of tissues, thrombosis, when used in high doses - increased blood pressure, the development of microangiopathies, myocardial dystrophy.

    Allergic reactions: skin rash, rarely anaphylactic shock.

    Laboratory indicators: thrombocytosis, hyperprotrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

    Other: hypervitaminosis, metabolic disorders, a feeling of heat, with prolonged use of large doses - sodium and liquid retention, disruption of zinc and copper metabolism.

    Overdose:

    With intravenous administration in high doses - the threat of abortion (due to estrogenemia), hemolysis of erythrocytes. If you experience any of the symptoms listed below, the drug should be discontinued.

    With prolonged use of large doses (more than 1 g) symptoms: headache; increased excitability of the central nervous system; insomnia; nausea; vomiting; diarrhea; hyperacid gastritis;ulceration of the mucous membrane of the gastrointestinal tract; oppression of the insular pancreas function (hyperglycemia, glucosuria); hyperoxaluria; nephrolithiasis (from calcium oxalate); damage to the glomerular apparatus of the kidneys; moderate pollakiuria (when taking a dose of more than 600 mg / day); a decrease in the permeability of capillaries (possibly deterioration of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies.

    Treatment: symptomatic.

    Interaction:

    Ascorbic acid increases the concentration of benzylpenicillin and tetracyclines in the blood; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol (in contraceptives for oral administration). Reduces the effectiveness of heparin, indirect coagulants, antibiotics. With simultaneous use with acetylsalicylic acid, the urinary excretion of ascorbic acid increases and the excretion of acetylsalicylic acid decreases. Ascorbic acid increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows 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 total clearance of ethanol, which, in turn, reduces the concentration of ascorbic acid in the body. Preparations of quinoline series, calcium chloride, salicylates, glucocorticosteroids with long-term use deplete the stores of ascorbic acid. With simultaneous use reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it can disrupt the interaction of disulfiram-ethanol.

    In high doses increases the renal excretion of mexiletine. Barbiturates and primidon increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of neuroleptics (phenothiazine derivatives), tubular reabsorption of amphetamine and tricyclic antidepressants.

    Special instructions:

    In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the function of the adrenal glands and arterial pressure (BP). With prolonged use of large doses, oppression of the insulin function of the pancreas is possible, so during treatment it must be regularly monitored.In patients with elevated iron levels in the body, ascorbic acid should be used in minimal doses. Assigning ascorbic acid to patients with rapidly proliferating and intensely metastatic 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, lactate dehydrogenase).

    Form release / dosage:

    Solution for intravenous and intramuscular injection 50 mg / ml and 100 mg / ml.

    Packaging:

    2 ml or 5 ml into neutral glass ampoules.

    5 ampoules in a contour mesh package made of a non-coated PVC film. 1 or 2 contour squares in a pack of cardboard.

    5, 10 ampoules in a pack of cardboard with partitions or grilles, or a paperboard separator for consumer packaging or sack paper.

    10 ampoules per box of cardboard.

    Each instruction box or bundle contains instructions for use, an ampoule knife or a scapegrator ampoule.

    When using ampoules with incisions, rupture rings, break points, an ampoule knife or an ampoule ampoule opener is not inserted.
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    For a solution of 50 mg / ml, 1 year. For a solution of 100 mg / ml 1 year 6 months. The drug should be used before the date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001493/09
    Date of registration:03.03.2009 / 24.08.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOCHEMIST, OJSC BIOCHEMIST, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp26.09.2017
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