Active substanceAscorbic acidAscorbic acid
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  • Dosage form: & nbspsustained-release capsules
    Composition:

    Each capsule of the prolonged action contains:

    Active substance:

    Ascorbic acid - 500 mg (in the form of pellets-602.5 mg containing Excipients: sugar grits [sucrose, molasses starch], shellac, talc, tartaric acid).

    Capsule shell:

    housing - dye sunset sunset yellow (Sunset yellow FCF - FD&C Yellow 6), gelatin;

    cap - dye sunset yellow (Sunset yellow FCF - FD&C Yellow 6), titanium dioxide, gelatin.

    Description:

    Hard gelatin capsules, № 0.

    Cap: opaque orange.

    Housing: orange transparent.

    Contents of capsules: spherical granules (pellets) from white to light yellow color.

    Pharmacotherapeutic group:vitamin
    ATX: & nbsp

    A.11.G.A.01   Ascorbic acid

    Pharmacodynamics:

    Ascorbic acid is indispensable for normal functioning and the formation of connective tissue, especially for its intracellular mass and collagen. In the process of collagen synthesis, ascorbic acid participates in the hydroxylation of proline and lysine in the peptide chain. It is a part of many oxidation-reduction reactions taking place in the body and takes part in the metabolism of phenylalanine, tyrosine, folic acid, norepinephrine, histamine and some enzyme systems involved in the synthesis of lipids, proteins and hydroxylation of carnitine and serotonin. It stabilizes the integrity of the capillary wall, contributes to an increase in the absorption of iron.

    Pharmacokinetics:

    Suction: ascorbic acid Easily absorbed from the gastrointestinal tract and distributed in all tissues. In this dosage form ascorbic acid is released gradually within 8-12 hours after oral administration. Ascorbic acid is released from each granule gradually, so its concentration in the digestive tract does not increase significantly. The maximum concentrations are found in the adrenal glands, the pituitary gland and the intestinal wall. 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 unchanged form and in the form of metabolites.

    Indications:

    Treatment of vitamin C deficiency (including vitamin C vitamin deficiency) and conditions caused by vitamin C deficiency in complex therapy:

    - "catarrhal diseases", accompanied by a febrile condition to increase the body's resistance;

    - in the period of convalescence after long-term illnesses;

    - for alcohol and nicotine addiction;

    - with flaccid wounds;

    - with increased physical exertion, including athletes.
    Contraindications:

    Hypersensitivity to the drug components, hypercoagulation, thrombophlebitis, a tendency to thrombosis, diabetes mellitus, kidney stone disease, deficiency of glucose-6-phosphate dehydrogenase, pregnancy, lactation, children under 14 years.

    With prolonged use in large doses (more than 500 mg) - hyperoxalaturia, hemochromatosis, thalassemia.

    Carefully:

    Carefully - Hyperoxalaturia, renal failure, hemochromatosis, thalassemia, polycythemia, leukemia, sideroblastic anemia, sickle cell anemia, malignant neoplasms.

    Dosing and Administration:

    The drug is taken orally after a meal.

    Adults: 1 - 2 capsules per day. The maximum daily dose is 2 capsules per day. The therapeutic dose in children from 14 years is 500 mg (1 capsule) per day. The maximum daily dose is 1 capsule per day.

    Side effects:

    From the central nervous system: headache, fatigue, with prolonged use of large doses - increased central nervous system (CNS) excitability, sleep disturbance.

    From the gastrointestinal tract: irritation of the mucous membrane of the gastrointestinal tract, nausea, vomiting, diarrhea, spastic pain in the epigastric region.With prolonged use of large doses - hyperacid gastritis, ulceration of the mucous membrane of the gastrointestinal tract (GIT).

    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, moderate pollakiuria (when taking a dose of more than 600 mg per day).

    From the cardiovascular system: a decrease in the permeability of capillaries and worsening tissue trophism, hypercoagulation, 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, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia, glucosuria.

    Other: hypervitaminosis, metabolic disorders, suppression of the function of the insulin pancreas apparatus (hyperglycemia), sensation of heat, prolonged use of large doses - sodium and liquid retention, disruption of zinc and copper metabolism.

    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:

    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 (as 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 application with deferoxamine. Reduces the effectiveness of heparin, indirect anticoagulants, antibiotics. Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drink - reduce absorption and assimilation of ascorbic acid. ASA reduces the absorption of ascorbic acid by about a third. With simultaneous use with ASA, there is an increase in urinary excretion of ascorbic acid and a decrease in ASA excretion. Ascorbic acid 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. 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 adrenals and arterial pressure.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 minimum 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, transaminase activity).

    Long-term use of high doses of ascorbic acid may accelerate its metabolism, so after the drug can be withdrawn paradoxical hypovitaminosis can develop.

    Form release / dosage:

    Capsules of prolonged action 500 mg.

    Packaging:10 capsules in a blister of PVC / A1. For 1, 3 or 6 blisters in a cardboard pack together with instructions for use.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    2 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-008615/09
    Date of registration:28.10.2009
    The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic
    Manufacturer: & nbsp
    ZENTIVA, k.s. Czech Republic
    Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
    Information update date: & nbsp16.10.2014
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