Active substanceAscorbic acidAscorbic acid
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  • Dosage form: & nbspchewing tablets
    Composition:

    one tablet contains:

    active substance: ascorbic acid 0.5 g

    Excipients: dextrate, mannitol, crospovidone (polyplasdone XL-10), aspartame, magnesium stearate, talc, riboflavin, flavor ("orange")

    Description:tablets of light yellow color, flat-cylindrical with a bevel, without risks, with a characteristic orange odor.Insignificant surface roughness is allowed.
    Pharmacotherapeutic group:vitamin
    ATX: & nbsp

    A.11.G.A.01   Ascorbic acid

    Pharmacodynamics:

    A vitamin remedy, has a metabolic effect, 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; 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, Fe, the utilization of carbohydrates, the synthesis of lipids, proteins, carnitine, immune reactions, hydroxylation of serotonin, enhances the absorption of non-hemin Fe.

    It has antiplatelet and pronounced antioxidant properties. Regulates the transport of H + 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 intensifies 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-complement component, interferon), promotes phagocytosis, increases the body's resistance to infections.

    It inhibits the release and accelerates the degradation of histamine, inhibits the formation Pg and other mediators of inflammation and allergic reactions.

    In low doses (150-250 mg / day inwards) improves the complexing function of deferoxamine with chronic intoxication with iron preparations, which leads to increased excretion of the latter.

    Pharmacokinetics:

    Absorbed in the gastrointestinal tract (GIT), mainly in the jejunum.With an increase in the dose up to 200 mg, up to 140 mg (70%) is absorbed; with a further increase in the dose, the absorption decreases (50-20%). Connection with plasma proteins - 25%. Diseases of the gastrointestinal tract (peptic ulcer of stomach and duodenum, constipation or diarrhea, helminthic invasion, giardiasis), the use of fresh fruit and vegetable juices, alkaline drink reduce the absorption of ascorbate in the intestine.

    The concentration of ascorbic acid in the plasma is normally about 10-20 μg / ml, the reserves in the body are about 1.5 g when taking daily recommended doses and 2.5 g when taking 200 mg / day. TSmah after intake of 4 hours.

    Easily penetrates into leukocytes, platelets, and then into all tissues; the greatest concentration is achieved in glandular organs, leukocytes, liver and lens of the eye; deposited in the posterior lobe of the pituitary gland, adrenal cortex, ocular epithelium, interstitial cells of the seminal glands, ovaries, liver, spleen, pancreas, lungs, kidneys, intestinal wall, heart, muscles, thyroid gland; penetrates the placenta. The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and in plasma. With deficient states, the concentration in leukocytes decreases later and more slowly and is considered as the best criterion for assessing the deficit than the concentration in the plasma.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:

    Treatment of hypo- and avitaminosis C

    Contraindications:

    Hypersensitivity.

    Children under 18 years (for this dosage form)

    With prolonged use in large doses (more than 500 mg) - diabetes mellitus, hyperoxaluride, nephrolithiasis, hemochromatosis, thalassemia, deficiency of glucose-6-phosphate dehydrogenase

    Carefully:diabetes mellitus, deficiency of glucose-6-phosphate dehydrogenase; hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, nephrolithiasis.
    Pregnancy and lactation:

    The minimum daily requirement for ascorbic acid in II-III trimesters of pregnancy - 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 development of the "cancellation" syndrome is possible in a newborn.

    The minimum daily requirement for lactation is 80 mg. A mother's diet containing an adequate amount of ascorbic acid is sufficient to prevent a deficiency in an infant. Theoretically, there is a danger to the child when the mother uses high doses of ascorbic acid (it is recommended not to exceed the daily need for ascorbic acid by the lactating mother).

    Dosing and Administration:

    Inside, after eating. To chew the tablet.

    The drug is recommended for use in adults.

    With a therapeutic purpose: 1 tablet 1-2 times a day for 14 days. Break between treatment courses for at least 1 month.

    Side effects:

    From the central nervous system: at long application of the big doses (more than 1000 mg) - a headache, the raised excitability, disturbance of a dream.

    From the gastrointestinal tract: when taken orally - irritation of the mucous membrane of the gastrointestinal tract, with prolonged use of large doses - nausea, vomiting, diarrhea, hyperacid gastritis, ulceration of the mucous membrane of the gastrointestinal tract.

    From the side of the urinary system, moderate pollakiuria (when taking 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 cardiovascular system: with prolonged use of large doses - a decrease in the permeability of capillaries (possibly worsening trophic tissue, increased blood pressure, hypercoagulation, development of microangiopathies;

    Allergic reactions: skin rash, skin hyperemia;

    Laboratory indicators: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia, glucosuria;

    Other: oppression of the insular pancreas function (hyperglycemia, glucosuria).

    Overdose:

    Symptoms: diarrhea, nausea, irritation of the mucous membrane of the gastrointestinal tract, flatulence, abdominal pain of a spastic nature, frequent urination, nephrolithiasis, insomnia, irritability, hypoglycemia.

    Treatment: symptomatic, forced diuresis.

    Interaction:

    Increases the concentration in the blood of benzylpenicillin and tetracyclines; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol (incl.which is part of oral contraceptives).

    Improves absorption in the intestines of iron preparations (converts trivalent iron into bivalent); can increase the excretion of iron with simultaneous use with deferoxamine.

    Reduces the effectiveness of heparin and indirect anticoagulants. Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drink reduce absorption and absorption.

    With simultaneous application with ASA, urinary excretion of ascorbic acid increases and the excretion of ASA decreases.

    ASA reduces the absorption of ascorbic acid by about 30%. Increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, 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.

    Drugs of quinoline series, CaCl2, 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 excretion of mexiletine by the kidneys.

    Barbiturates and primidon 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.

    Special instructions:

    Foods rich in ascorbic acid: citrus fruits, greens, vegetables (peppers, broccoli, cabbage, tomatoes, potatoes). When storing products (including prolonged freezing, drying, pickling, pickling), cooking (especially in copper vessels), chopping vegetables and fruits in salads, preparing purees, partial degradation of ascorbic acid occurs (up to 30-50% with temperature treatment) .

    In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the function of the adrenals and arterial pressure.

    With long-term use of large doses of ascorbic acid, 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.

    Ascorbic acid as a reducing agent can distort the results of various laboratory tests (blood glucose, bilirubin, activity of "liver" transaminases and LDH).

    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.

    Effect on the ability to drive transp. cf. and fur:
    Form release / dosage:Tablets chewing 500 mg.
    Packaging:For 10 tablets in a plastic case or 2, 4, 5, 6, 8 tablets in a planar cell package or 2, 4, 5, 6, 8 tablets in a contiguous, cell-free package.

    For 1, 2 plastic cases or 3, 5, 6, 10, 15, 20 contour packs with instructions for use are placed in a pack of cardboard.
    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.Keep out of the reach of children.

    Shelf life:

    1 YEAR.

    Do not use at the expiration date indicated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-006776/09
    Date of registration:25.08.2009
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp04.05.2010
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