Vitamin C - instructions for use, dose, side effects, contraindications

Excipients: sodium hydrogen carbonate - 721.00 mg, sodium carbonate-152.00 mg, lemon acid - 1300.00 mg, sucrose - 962.00 mg, flavoring orange - 90.00 mg, riboflavin sodium phosphate - 1.00 mg, sodium saccharinate - 3.50 mg, macrogol 6000 - 80.00 mg, sodium benzoate - 20.00 mg, Povidone-K30 - 8.00 mg.

1 tablet effervescent 1000 mg contains

active substance: ascorbic acid 1000 mg;

Excipients: sodium hydrogen carbonate 821.00 mg, sodium carbonate 152.00 mg, citric acid 1030.00 mg, sorbitol 808.00 mg, lemon flavor 75.00 mg, riboflavin sodium phosphate 1.00 mg, sodium saccharinate - 5,00 mg, macrogol 6000 - 60,00 mg, sodium benzoate - 40,00 mg, povidone-K30 - 8,00 mg.

Description:

Round tablets of flat-cylindrical shape with a facet on both sides, with a rough surface, from pale yellow to yellow, with presence light orange dot inclusions.

Pharmacotherapeutic group:Vitamin

ATX: & nbsp

A.11.G.A.01 Ascorbic acid

Pharmacodynamics:

Ascorbic acid is a vitamin, it has a metabolic effect, it does not form in the human body, but comes only with food. With unbalanced and malnutrition, a person experiences a deficiency in ascorbic acid.

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, and improves the utilization of glucose in the cycle of tricarboxylic acids involved 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 activation respiratory enzymes in the liver increases its detoxication and protein function, 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 Pg and other mediators of inflammation and allergic reactions.

In low doses (150-250 mg / day inwards) improves the complexing function of deferoxamine in chronic drug intoxication Fe, 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 (stomach ulcer and duodenal ulcer, 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 with daily recommended doses and 2.5 g with 200 mg / day, the time to reach the maximum concentration after ingestion is 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:

For tablets containing 1000 mg of ascorbic acid:

Treatment of vitamin C deficiency.

For tablets containing 250 mg of ascorbic acid:

Treatment and prevention of hypo- and avitaminosis S., including those caused by a condition of increased need for ascorbic acid at:

- increased physical and mental stress;

- in the complex treatment of colds, ARVI;

- at asthenic conditions;

- in the recovery period after the diseases.

- pregnancy (especially prolific, against the background of nicotine or drug dependence).

Contraindications:

Hypersensitivity to the components of the drug.

Children under 18 years (for this dosage form).

With prolonged use in large doses (more than 500 mg): - diabetes mellitus, hyperoxaluria, nephrolithiasis, hemochromatosis, thalassemia.

Carefully:

Diabetes mellitus, deficiency of glucose-6-phosphate dehydrogenase; hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, oxalosis, 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 a "cancellation" syndrome may develop 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:

The drug is taken orally after a meal. 1 tablet is dissolved in a glass of water (200 ml). Tablets should not be swallowed, chewed and dissolve in the mouth.

Treatment of vitamin C deficiency: at 1000 mg per day.

Treatment and prevention of hypo- and avitaminosis C: 250 mg 1-2 times a day.

During pregnancy prescribe the drug at a maximum daily dose of 250 mg for 10-15 days.

Side effects:

From the central nervous system (CNS): with prolonged use of large doses (more than 1000 mg) - headache, increased excitability of the central nervous system, insomnia.

From the digestive system: irritation of the mucous membrane of the gastrointestinal tract (GIT), with prolonged use of large doses - nausea, vomiting, diarrhea, hyperacid gastritis, ulceration of the mucous membrane of the gastrointestinal tract.

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

From 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 of tissue trophism, increased blood pressure, hypercoagulation, development of microangiopathies).

Allergic reactions: skin rash, skin hyperemia.

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

Other: hypervitaminosis, metabolic disorders, sensation of heat, with prolonged use of large doses - sodium retention (Na⁺) and liquid, the disruption of the exchange of zinc, copper.

Overdose:

Symptoms: with prolonged use of large doses (more than 1000 mg per day), nausea, heartburn, diarrhea, irritation of the gastrointestinal mucosa, flatulence, abdominal pain of a spastic nature, frequent urination, nephrolithiasis, insomnia, irritability, hypoglycemia.

Treatment: symptomatic, forced diuresis. If any side effects occur, stop taking the medication and consult a doctor.

Interaction:

Increases the concentration in the blood of benzylpenicillin and tetracyclines; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol (including those included in oral contraceptives). Improves absorption in the intestine of iron preparations (converts trivalent iron into bivalent), can increase excretion of iron with simultaneous application with deferoxamine.

Reduces the effectiveness of heparin and indirect anticoagulants.

Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drink reduce the absorption and absorption of ascorbic acid.

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.

The drugs 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 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 destruction of ascorbic acid occurs (up to 30-50% in the case of 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 blood 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 minimal doses.

Currently, the effectiveness of the use of ascorbic acid for the prevention of cardiovascular diseases (CCC) and certain types of malignant tumors is not proven.

Ascorbic acid is not recommended for use with pyorrhea, infectious diseases of gums, haemorrhagic phenomena, hematuria,hemorrhage into the retina of the eye, immune system disorders, depression, not related to vitamin C deficiency.

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 and LDH).

Form release / dosage:

Tablets effervescent 250 mg, 1000 mg.

Packaging:For 20 tablets in a plastic tube, ukuporennuyu plastic cover with silica gel and control the first dissection. 1 tuba together with instructions for use in a pack of cardboard.

Storage conditions:

Store in a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Shelf life:

2 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:P N 015746/01

Date of registration:30.06.2009 / 20.09.2016

Expiration Date:Unlimited

The owner of the registration certificate:Soko Stark DOO.Soko Stark DOO. Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspAtlantic Group, AOAtlantic Group, AORussia

Information update date: & nbsp21.02.2017

Illustrated instructions

Instructions

Vitamin C (Vitamin C)