Composition
1 effervescent tablet 250 mg contains the Active ingredient:
ascorbic acid 250.00 mg;
excipients:
sodium bicarbonate – 721.00 mg,
sodium carbonate 152.00 mg,
citric acid 1300.00 mg,
sucrose 962.00 mg,
orange flavor – 90.00 mg,
Riboflavin sodium phosphate 1.00 mg,
sodium saccharin – 3.50 mg,
macrogol 6000 – 80.00 mg
sodium benzoate – 20.00 mg,
povidone-To 30 – 8.00 mg.
Pharmacological properties
pharmacodynamic properties
Ascorbic acid is a vitamin that has a metabolic effect,
is not formed in the human body, but comes only from food.
With an unbalanced and inadequate diet, a person experiences a deficiency in ascorbic acid.
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. It participates in the metabolism of phenylalanine, tyrosine, folic acid, norepinephrine, histamine,
Fe, utilization of carbohydrates, synthesis of lipids, proteins, carnitine, immune reactions, serotonin hydroxylation, increases the absorption of non-heme Fe. It has antiplatelet and pronounced antioxidant properties. Regulates the transport of H+ 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 colloidal state of 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. Improves bile secretion, restores the external secretory function of the pancreas and the endocrine function of the thyroid gland. Regulates immunological reactions (activates the synthesis of antibodies, C3-component complement, interferon),
promotes phagocytosis, increases the body’s resistance to infections.
Inhibits the release and accelerates the degradation of histamine, inhibits the formation of Pg, etc. mediators of inflammation and allergic reactions. In low doses (150-250 mg/day orally), it improves the complexing function of deferoxamine in chronic intoxication with Fe preparations, which leads to increased excretion of the latter.
Pharmacokinetics
It is absorbed in the gastrointestinal tract (mainly in the jejunum).
With an increase in the dose to 200 mg, up to 140 mg is absorbed (70%); with a further increase in the dose, absorption decreases (50-20%).
Binding to plasma proteins is 25%. Diseases of the gastrointestinal tract (peptic ulcer of the stomach and duodenum 12, constipation or diarrhea, helminthic invasion, giardiasis), the use of fresh fruit and vegetable juices, alkaline drinks reduce the absorption of ascorbate in the intestines.
The concentration of ascorbic acid in plasma in normal amounts to approximately 10-20 mg/ml stocks in the body – about 1.5 g when you receive the daily recommended doses and 2.5 g while taking 200 mg/day, the time to maximum concentration after ingestion 4 hours Easily penetrates into white blood cells, platelets, and then all tissues;
the highest concentrations are reached in glandular organs, white blood cells, liver and lens of the eye;
deposited in the posterior lobe of the pituitary gland, the adrenal cortex, ocular epithelium, interstitial cells of the seminal glands, ovaries, liver, spleen, pancreas, lung, kidney, gut, heart, muscle, thyroid gland; crosses the placenta.
The concentration of ascorbic acid in white blood cells and platelets is higher than in red blood cells and in plasma.
In deficient states, the concentration in white blood cells decreases later and more slowly and is considered as a better criterion for assessing the deficit than the concentration in plasma. It is mainly metabolized in the liver to deoxyascorbic acid and then to oxaloacetic acid and diketogulonic acid. It is excreted by the kidneys, through the intestines, with sweat, breast milk in the form of unchanged ascorbate and metabolites. When high doses are administered, the rate of elimination increases dramatically.
Smoking and drinking ethanol accelerate the breakdown of ascorbic acid (conversion to inactive metabolites), dramatically reducing the body’s reserves. It is excreted during hemodialysis.
Indications
Treatment and prevention of hypo-and avitaminosis of the Liver, including those caused by the state of increased need for ascorbic acid in patients with:
– increased physical and mental stress;
– in the complex therapy of colds, acute respiratory viral infections;
– in asthenic conditions;
– during recovery from previous illnesses.
– pregnancy (especially multiple pregnancies, on the background of nicotine or drug addiction).
Use during pregnancy and lactation
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 the high doses of ascorbic acid that a pregnant woman takes, and then the newborn may develop a “withdrawal”syndrome.
The minimum daily requirement during lactation is 80 mg.
A mother’s diet containing an adequate amount of ascorbic acid is sufficient to prevent deficiency in an infant.
Theoretically, there is a danger for the child when the mother uses high doses of ascorbic acid (it is recommended that the nursing mother does not exceed the daily requirement for ascorbic acid).
Contraindications
Hypersensitivity to the components of the drug.
Children under 18 years of age (for this dosage form).
With prolonged use in large doses (more than 500 mg):
– diabetes mellitus,
– hyperoxaluria,
– nephrolithiasis,
– hemochromatosis,
– thalassemia.
With caution
Diabetes mellitus,
glucose-6-phosphate dehydrogenase deficiency;
hemochromatosis,
sideroblastic anemia,
thalassemia,
hyperoxaluria,
oxalosis,
kidney stone disease.
Side effects
Central nervous system (CNS)disorders:
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:
inhibition of the function of the insular apparatus of the pancreas (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 high doses-a decrease in capillary permeability (possible deterioration of tissue trophism, increased blood pressure, hypercoagulation, the development of microangiopathies).
Allergic reactions:
skin rash, hyperemia of the skin.
Laboratory parameters:
thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.
Other services:
hypervitaminosis, metabolic disorders, feeling hot, with prolonged use of large doses-sodium (Na+) and fluid retention,
impaired metabolism of zinc, copper.
Interaction
Increases the concentration of benzylpenicillin and tetracyclines in the blood;
at a dose of 1 g/day, it increases the bioavailability of ethinyl estradiol (including that included in oral contraceptives).
Improves intestinal absorption of iron preparations (converts trivalent iron to bivalent),
may increase iron excretion when used simultaneously with deferoxamine.
Reduces the effectiveness of heparin and indirect anticoagulants.
Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drinks reduce the absorption and absorption of ascorbic acid.
When used concomitantly with ASA, the 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 crystalluria during treatment with short-acting salicylates and 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 total clearance of ethanol, which, in turn, reduces the concentration of ascorbic acid in the body.
Quinoline-type drugs, calcium chloride, salicylates,
and glucocorticosteroids deplete ascorbic acid reserves with prolonged use.
When used concomitantly, it reduces the chronotropic effect of isoprenaline.
With prolonged use or use in high doses, the disulfiram-ethanol interaction may be disrupted.
In high doses, it increases the excretion of mexiletine 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.
How to take it, course of administration and dosage
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 or absorbed in the oral cavity.
Treatment of vitamin C deficiency:Â 1000 mg per day.
Treatment and prevention of hypo-and beriberi C:Â 250 mg 1-2 times a day.
During pregnancy, the drug is prescribed in a maximum daily dose of 250 mg for 10-15 days.
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 are possible.
Treatment:Â symptomatic, forced diuresis.
If any side effects occur, you should stop taking the drug and consult a doctor.
Special instructions
Foods rich in ascorbic acid:
citrus fruits, herbs, and vegetables (peppers, broccoli, cabbage, tomatoes, and potatoes).
When storing food (including long-term freezing, drying, salting, marinating),
cooking (especially in copper dishes), chopping vegetables and fruits in salads, making mashed potatoes, ascorbic acid is partially destroyed (up to 30-50% during temperature treatment). Due to the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the function of the adrenal glands and blood pressure. With prolonged use of large doses, the function of the pancreatic insular apparatus may be inhibited,
so it should be regularly monitored during treatment.
In patients with high iron content in the body, ascorbic acid should be used in minimal doses.
Currently, the effectiveness of the use of ascorbic acid for the prevention of diseases of the cardiovascular system (CVS) and some types of malignant tumors is considered unproven.
Ascorbic acid is not recommended for use in cases of pyorrhea, infectious gum diseases, hemorrhagic phenomena,
hematuria, retinal hemorrhage, immune system disorders, depression that is not associated with vitamin C deficiency.
Prescribing ascorbic acid to patients with rapidly proliferating and intensely metastatic tumors may worsen 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 of production
Effervescent tablets.
Storage conditions
Store in a dry place, protected from light, at a temperature of 15 to 25 ° C. Keep out of reach of children!
Shelf
life is 2 years. Do not use after the expiration date indicated on the package.
Active ingredient
Ascorbic Acid
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Side effects of Vitamin C, effervescent pills 250mg, 20pcs.
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