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

auxiliary substances: citric anhydrous acid - 1.0300 g, sorbitol - 0.5000 g, sodium bicarbonate - 0.9000 g,lactose anhydrous - 0.4200 g, 'orange flavor, type Bolexo - 0.0350 g, macrogol 6000 - 0.1000 g, acesulfame potassium, - 0.0120 g, dye red charming AC - 0.0030 g.

Description:Round, smooth, marble-light pink hygroscopic tablets.

Pharmacotherapeutic group:Vitamin.

ATX: & nbsp

A.11.G.A.01 Ascorbic acid

Pharmacodynamics:

Ascorbic acid (vitamin C) is not formed in the human body, but comes only with food.

The mechanism of action of ascorbic acid has not yet been fully clarified. It has the properties of a powerful reducing agent. It affects the metabolism of connective tissue (most of all, the synthesis of collagen). It plays a very important role in the body's reaction to stress, and in the prevention of infections (it is necessary for the normal function of T-lymphocytes, normal phagocytic activity, it protects endothelial cells from apoptosis caused by cytokines and inflammatory mediators). Ascorbic acid It is necessary for the conversion of dopamine into noradrenaline, is a cofactor of the enzyme cholesterol-7-alfa hydroxylase (necessary for the metabolism of cholesterol), it increases the absorption of the iron ion in the gastrointestinal tract, and also participates in the synthesis of carnitine and neuroendocrine peptides.

Pharmacokinetics:

Absorption

Ascorbic acid is well absorbed from the gastrointestinal tract (mainly absorption occurs in the jejunum). Absorption of ascorbic acid in the gastrointestinal tract occurs rapidly and, apparently, is an active process, the amount of absorbed ascorbic acid depends on the dose. When taking high doses, absorption is incomplete, the unabsorbed part of the dose taken is excreted through the intestine in an unchanged form. The time of reaching the maximum concentration after ingestion is 2-3 hours. Diseases of the gastrointestinal tract (peptic ulcer of stomach and duodenum, constipation or diarrhea, helminthic invasion, giardiasis), consumption of fresh fruit and vegetable juices, alkaline drink reduce absorption of ascorbic acid acid in the intestine.

Distribution

Connection with plasma proteins - 25%.

Ascorbic acid easily penetrates into leukocytes, platelets, and then into all tissues; the greatest concentration is achieved in glandular organs, leukocytes, liver, lens of the eye, adrenal glands, pituitary gland and intestinal wall, penetrates the placental barrier, and also is excreted in breast milk.

Metabolism

Metabolism of ascorbic acid occurs in the liver. Most of the ascorbic acid is reversibly oxidized to dehydroascorbic acid and then metabolized to oxaloacetic acid and ascorbate-3-sulfate. Long-term use of high doses of ascorbic acid (more than two weeks of a dose of more than 500 mg and more than one week of a dose of more than 1000 mg) can accelerate its metabolism; smoking and the use of ethanol also sharply accelerate the destruction of ascorbic acid (turning it into inactive metabolites), reducing the reserves of ascorbic acid in the body.

Excretion

Ascorbic acid and its metabolites are excreted by the kidneys, through the intestine and with sweat.

Indications:- Treatment and prevention of Vitamin C hypovitaminosis.

- Infectious diseases, such as respiratory infections, including acute respiratory infections (ARI), acute respiratory viral infections (ARI) (to reduce the severity and duration of symptoms).

- States of increased need for ascorbic acid: exercise, intense physical or mental work; condition after severe injuries, burns, surgical operations, smoking.

- Slowly healing wounds and fractures, with bedsores and trophic disorders.

Contraindications:

- Hypersensitivity to ascorbic acid and excipients, the drug.

- Pregnancy.

- Lactation period.

- Children under 18 years.

- Congenital intolerance to galactose, insufficiency of lactase, glucose-galactose malabsorption (due to the content of lactose), congenital intolerance to fructose (due to the content of the drug sorbitol).

Contraindications for long-term use (more than 1-2 weeks) in large doses (more than 500 mg)

- Hyperoxapuria, oxalate nephrolithiasis.

- Metabolic disorders of iron (hemosiderosis, hemochromatosis).

- Thalassemia.

- Deficiency of glucose-6-phosphate dehydrogenase.

- Diabetes.

Carefully:

- Hyperoxalaturia, oxalate nephrolithiasis;

- Metabolic disorders of iron (hemosiderosis, hemochromatosis).

- Thalassemia.

- Sideroblastic anemia

- Sickle-cell anemia.

- Deficiency of glucose-6-phosphate dehydrogenase.

- Hypercoagulation, thrombophlebitis, propensity to thrombosis.

Pregnancy and lactation:

Dosing and Administration:

The drug is intended for admission by adults.

The drug is taken internally. Before taking the tablet, dissolve in 150 ml of water. Usual dose 1 tablet per day, usually for 2 weeks. In the treatment of hypovitaminosis, higher doses of ascorbic acid can be used up to 1000 mg per day for 1 week.

The maximum daily intake for adults is 1000 mg.

Side effects:

To indicate the incidence of unwanted adverse reactions (CPD), a

classification of the NDP of the World Health Organization: very frequent> 10%;

frequent >1 and <10%; infrequent >0,1 and <1%; rare >0.01 and <0.1%; very rare <0.01%,

unknown frequency (when, according to available data, it is not possible to estimate

frequency of development of NDP).

Immune system disorders

Infrequent: eczema, urticaria, skin rash, skin hyperemia.

Disturbances from the gastrointestinal tract (when used in high doses: several grams of ascorbic acid per day)

Infrequent: nausea, vomiting, diarrhea, irritation of the mucous membrane of the gastrointestinal tract.

Rare: with prolonged use of large doses (more than two weeks of a dose of more than 500 mg and more than one week of a dose of more than 1000 mg), hyperacid gastritis, ulceration of the mucous membrane of the gastrointestinal tract is possible.

General disorders (when used in high doses: several grams of ascorbic acid per day) Rare: weakness.

Disturbances from the blood and lymphatic system (with very high doses)

Very rare: haemolytic anemia, thrombocytosis, erythropenia, leukocytosis.

Disorders from the kidneys and urinary tract

Rare: oxalate nephrolithiasis (at very high dosages), moderate pollakiuria (when receiving a dose of 600 mg / day).

Very rare: damage to the glomerular apparatus of the kidneys, renal failure (when taking very high doses).

Disturbances from the nervous system

Unknown frequency: with prolonged use (more than 1 week), high doses (1000 mg) - headaches, irritability, insomnia.

Violations from the heart and blood vessels

Unknown frequency: during prolonged use of large doses (over two weeks dose of 500 mg or more one week dose 1000 mg) - reducing capillary permeability (possibly deteriorating trophic tissue), increased blood pressure, giperprotrombinemiya, hypercoagulation, microangiopathy development.

Disorders from the metabolism and nutrition

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

Unknown frequency: hypokalemia.

Overdose:

Symptoms of overdose: when taking ascorbic acid in a dose of more than 1 g: diarrhea, nausea, vomiting, irritation of the mucous membrane of the gastrointestinal tract, flatulence, abdominal pain of a spastic nature, frequent urination, insomnia, irritability, hypoglycemia.

When taking a very high dose: hemolytic anemia, oxalate nephrolithiasis, renal failure.

Treatment of an overdose: there is no specific treatment, symptomatic therapy, forced diuresis.

Interaction:

With iron preparations

Ascorbic acid improves absorption in the intestine of iron preparations (converts trivalent iron into bivalent).

With benzylpenicillin and tetracyclines

Ascorbic acid increases absorption and concentration in the blood of benzylpenicillin and tetracyclines.

With ethinyl estradiol

Ascorbic acid at a dose of 1 g / day increases absorption and increases bioavailability

ethinylestradiol.

With salicylates

Salicylates with prolonged use deplete the stores of ascorbic acid in the body.

Acetylsalicylic acid reduces the absorption and concentration of ascorbic acid in the blood. With the simultaneous use of ascorbic acid and acetylsalicylic acid, the excretion of ascorbic acid by the kidneys increases. Ascorbic acid increases renal reabsorption of salicylates.

With oral contraceptives

Ascorbic acid reduces the concentration of oral contraceptives in the blood. Oral contraceptives reduce absorption and absorption of ascorbic acid.

With anticoagulants

When used in high doses ascorbic acid reduces the effectiveness of anticoagulants, such as heparin, indirect anticoagulants.

With cyanocobalamin (vitamin B

Ascorbic acid disrupts the absorption of cyanocobalamin.

With oxalates

Ascorbic acid increases the excretion of oxalates by the kidneys, which increases the risk of formation of oxalate stones in the kidneys.

With fresh juices and alkaline drink

Fresh juices and alkaline drink reduce the absorption and absorption of ascorbic acid. With short-acting sulfanilamides

Ascorbic acid increases the risk of developing crystalluria in the treatment of short-acting sulfanilamides, especially in combination with salicylates.

With acids

Ascorbic acid slows the excretion of acids by the kidneys.

With drugs that have an alkaline reaction

Ascorbic acid increases the excretion of drugs that have an alkaline reaction (including alkaloids).

With ethanol

Ascorbic acid increases the overall clearance of ethanol, ethanol, in turn, reduces the concentration of ascorbic acid in the body.

Ascorbic acid with long-term use or use in high doses (more than two weeks of a dose of more than 500 mg and more than one week dose of more than 1000 mg) can disrupt the interaction of disulfiram and ethanol.

With quinolines, calcium chloride, glucocorticosteroids

Preparations of quinoline series, calcium chloride, glucocorticosteroids with prolonged use deplete the stores of ascorbic acid in the body.

With isoprenaline

Ascorbic acid reduces the positive chronotropic effect of isoprenaline.

With mexiletine

Ascorbic acid in high doses increases the renal excretion of mexiletine.

With barbiturates and primidon

Barbiturates and primidon increase the excretion of ascorbic acid in the urine.

With antipsychotic drugs (neuroleptics, which are phenothiazine derivatives).

Ascorbic acid reduces the therapeutic effect of antipsychotic drugs (neuroleptics, which are derivatives of phenothiazine).

With amphetamine and tricyclic antidepressants

Ascorbic acid reduces tubular reabsorption of amphetamine and tricyclic antidepressants.

Special instructions:

High doses of ascorbic acid increase the excretion of oxalates, contributing to the formation of calculi in the kidneys.

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 (more than two weeks, doses of more than 500 mg and more

one week dose of more than 1000 mg) may inhibit the function of the insulin apparatus of the pancreas, so during treatment it must be regularly monitored.

In patients with elevated iron levels in the body, ascorbic acid should be used in low 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 and urine glucose content, bilirubin content in the blood, activity of "hepatic" transaminases in the blood).

Long-term use of high doses of ascorbic acid (more than two weeks of a dose of more than 500 mg and more than one week of a dose of more than 1000 mg) can speed up its metabolism, so after the drug can be canceled, paradoxical hypovitaminosis may develop.

Effect on the ability to drive transp. cf. and fur:Admission CELASCON® Vitamin C, tablets effervescent, does not affect a person's ability to drive vehicles or engage in other potentially hazardous activities.

Form release / dosage:Tablets effervescent 500 mg [taste of red orange].

Packaging:For 10 or 20 tablets in a tube of polypropylene, sealed with a lid of polyethylene with a desiccant and control of the first autopsy. For 1 or 3 tubes (10 tablets), 1 tube (20 tablets) are placed in a cardboard box together with instructions for use.

Storage conditions:

In a dry, dark place at a temperature of no higher than 25 ° C, in a tightly closed container.

Keep out of the reach of children.

Shelf life:Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001388

Date of registration:20.12.2011/10.08.2015

Date of cancellation:2017-10-24

The owner of the registration certificate:Zentiva as.Zentiva as. Czech Republic

Manufacturer: & nbsp

Saneca Pharmaceuticals a.s. The Slovak Republic

Representation: & nbspZENTIVA PHARMA, LLCZENTIVA PHARMA, LLC

Information update date: & nbsp24.10.2017

Illustrated instructions

Instructions

Celascon® Vitamin C (Celaskon® Vitamin C)