Brand name Ascorbic acid

Form tablets, coated

Active substance / Dosage

ascorbic acid · 50 mg

Prescription type over-the-counter (OTC)

ATC code

A11GA01

Registration number UA/2983/01/01

Manufacturer PJSC "Tekhnolog"

Table of Contents

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ASCORBIC ACID
Composition:
Pharmacological properties.
Clinical characteristics.
Special precautions for use.
Administration and Dosage
Side effects.

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ASCORBIC ACID

Composition:

Active substance: ascorbic acid;

1 tablet contains 50 mg of ascorbic acid;

Excipients: starch syrup, white sugar, yellow wax, mineral oil, talc, orange flavoring (containing propylene glycol).

Pharmaceutical form. 50 mg tablets.

Main physico-chemical properties: white or white with a yellowish tinge colored pellets. They should have a spherical shape.

Pharmacotherapeutic group. Simple ascorbic acid (vitamin C) preparations. Ascorbic acid (vitamin C). ATC code A11G A01.

Pharmacological properties.

Pharmacodynamics.

Ascorbic acid (vitamin C) has pronounced reducing properties. It belongs to the group of water-soluble vitamins. It participates in redox reactions, regulation of carbohydrate metabolism, influences the metabolism of aromatic amino acids, thyroxine metabolism, biosynthesis of catecholamines, steroid hormones and insulin, and is essential for blood coagulation, synthesis of collagen and procollagen, and regeneration of connective and bone tissue. It improves capillary permeability. It promotes iron absorption in the intestine and participates in hemoglobin synthesis. It enhances the body's nonspecific resistance and has antidotal properties. Vitamin C deficiency in the diet leads to the development of hypovitaminosis and avitaminosis C, since this vitamin is not synthesized in the body.

Pharmacokinetics.

Absorption of ascorbic acid occurs predominantly in the small intestine. The absorption process may be impaired in intestinal dyskinesias, enteritis, achylia, helminthic infestations, giardiasis, as well as with consumption of alkaline beverages, fresh fruit and vegetable juices. Maximum plasma concentration of the drug after oral administration is reached within 4 hours. It readily penetrates into leukocytes and platelets, and then into all tissues; it accumulates in the posterior pituitary, adrenal cortex, ocular epithelium, interstitial cells of the testes, ovaries, liver, brain, spleen, pancreas, lungs, kidneys, intestinal wall, heart, muscles, and thyroid gland. It is predominantly metabolized in the liver to dehydroascorbic acid, and further to oxalic acid and diketogulonic acid. Unchanged ascorbate and metabolites are excreted in urine, feces, and are secreted into breast milk. When high doses are administered, and plasma concentration exceeds 1.4 mg/dL, excretion is markedly enhanced, and increased excretion may persist after discontinuation of the drug.

Clinical characteristics.

Indications.

Prevention and treatment of vitamin C deficiency.

Meeting increased bodily requirements for vitamin C during periods of growth, pregnancy, or breastfeeding; during increased physical and mental stress, infectious diseases and intoxications, hemorrhagic diatheses, as part of combined therapy for bleeding (nasal, pulmonary, uterine); in radiation sickness, Addison's disease, anticoagulant overdose, soft tissue injuries, slowly healing infected wounds, and bone fractures.

Contraindications.

Hypersensitivity to ascorbic acid or to any of the excipients of the medicinal product. Thrombosis, predisposition to thrombosis, thrombophlebitis, diabetes mellitus, severe kidney diseases. Nephrolithiasis – when doses exceeding 1 g per day are administered. Fructose intolerance, glucose-galactose malabsorption syndrome.

Special precautions.

Since ascorbic acid has a mild stimulating effect, it is not recommended to take the medication late in the day. Due to the stimulatory effect of ascorbic acid on corticosteroid hormone production, kidney function and arterial blood pressure should be monitored when high doses are used.

Interaction with other medicinal products and other types of interactions.

Oral ascorbic acid enhances the absorption of penicillin, tetracyclines, and iron; promotes intestinal absorption of aluminum, which should be considered during concomitant treatment with aluminum-containing antacids.

Concomitant use of vitamin C and deferoxamine increases tissue iron toxicity, especially in the myocardium, potentially leading to circulatory decompensation. Vitamin C may be taken only 2 hours after deferoxamine injection.

Prolonged intake of high doses by patients undergoing disulfiram treatment inhibits the disulfiram-alcohol reaction.

High doses of the drug reduce the efficacy of tricyclic antidepressants, phenothiazine-derived neuroleptics, tubular reabsorption of amphetamine, impair renal excretion of mexiletine, and affect vitamin B12 resorption.

Ascorbic acid increases the total clearance of ethanol.

The drug reduces the toxicity of sulfonamide preparations and decreases the efficacy of heparin and indirect anticoagulants.

Vitamin C enhances oxalate excretion in urine, thereby increasing the risk of urinary oxalate stone formation, and increases the risk of crystalluria during salicylate therapy.

Acetylsalicylic acid (aspirin) may reduce the absorption of ascorbic acid. Concurrent use of salicylates with ascorbic acid may increase renal excretion of ascorbic acid.

Quinoline derivatives, calcium chloride, salicylates, and corticosteroids, when used long-term, reduce ascorbic acid stores in the body.

Absorption of ascorbic acid is reduced when used concomitantly with oral contraceptives, and with consumption of fruit or vegetable juices and alkaline drinks.

Special precautions for use.

When taking high doses or using the drug for prolonged periods, kidney function, arterial blood pressure, and pancreatic function should be monitored. The drug should be used with caution in patients with a history of kidney disease.

In patients with urolithiasis (kidney stones), the daily dose of ascorbic acid should not exceed 1 g.

High doses of the drug should not be prescribed to patients with increased blood coagulation.

Since ascorbic acid enhances iron absorption, its use in high doses may be hazardous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, or sideroblastic anemia. Patients with high iron levels in the body should receive the drug in minimal doses.

Concomitant intake of the drug with alkaline drinks reduces the absorption of ascorbic acid; therefore, the tablets should not be taken with alkaline mineral water. Moreover, absorption of ascorbic acid may be impaired in intestinal dyskinesia, enteritis, and achylia.

Use with caution in the treatment of patients with glucose-6-phosphate dehydrogenase deficiency.

Ascorbic acid, being a reducing agent, may interfere with laboratory test results, for example, in determining blood levels of glucose, bilirubin, and activities of transaminases, lactate dehydrogenase, etc.

Ascorbic acid should be used with caution in patients with progressive malignant diseases, as its use may complicate the course of the disease.

The drug may be harmful to teeth.

Use during pregnancy or breastfeeding.

The medicinal product may be used during pregnancy or breastfeeding when the potential benefit to the mother outweighs the possible risk to the fetus, according to dosage recommendations and under medical supervision. Recommended doses should be strictly followed, and overdosing should be avoided.

Ability to influence reaction rate while driving or operating machinery.

Has no effect at therapeutic doses.

Administration and Dosage

The drug should be taken orally after meals.

For prophylactic purposes, adults and children aged 14 years and older should take 1–2 tablets (50–100 mg) daily. Children aged 4 to 14 years should take 1 tablet (50 mg) daily.

Therapeutic doses for adults and adolescents aged 14 years and older are 1–2 tablets (50–100 mg) 3–5 times daily. For children aged 4 to 7 years: 1–2 tablets (50–100 mg) 2–3 times daily. For children aged 7–10 years: 2 tablets (100 mg) 2–3 times daily. For children aged 10–14 years: 2–3 tablets (100–150 mg) 2–3 times daily.

Pregnant women, postpartum women, and women with low vitamin C levels in breast milk should take 6 tablets (300 mg) daily for 10–15 days, followed by 2 tablets (100 mg) daily for prophylaxis throughout the entire breastfeeding period.

The duration of treatment depends on the nature and course of the disease and is determined individually by the physician.

Children

The drug is indicated for children aged 4 years and older.

Overdose

Ascorbic acid is well tolerated. It is a water-soluble vitamin, and excess amounts are excreted in urine. However, prolonged use of high doses of vitamin C may suppress the function of the islet apparatus of the pancreas, requiring monitoring of pancreatic status. Overdose may alter renal excretion of ascorbic and uric acids during urine acidification, increasing the risk of precipitation of oxalate calculi.

Administration of high doses of the drug may cause vomiting, nausea, or diarrhea, which resolve after discontinuation of the drug. Treatment is symptomatic.

Side effects.

Gastrointestinal tract: when administered at doses exceeding 1 g per day – irritation of the gastrointestinal mucosa, heartburn, nausea, vomiting, diarrhea;

Renal and urinary tract: damage to the glomerular apparatus of kidneys, crystalluria, formation of urate, cystine and/or oxalate calculi in the kidneys and urinary tract, renal failure;

Immune system: Quincke's edema, occasionally anaphylactic shock in case of sensitization;

Skin and subcutaneous tissue: skin rashes, pruritus, urticaria, eczema;

Endocrine system: damage to the islet apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the development of diabetes mellitus;

Cardiovascular system: arterial hypertension, myocardial dystrophy;

Blood and lymphatic system: thrombocytosis, hyperprothrombinemia, thrombus formation, erythrocytopenia, neutrophilic leukocytosis; in patients with glucose-6-phosphate dehydrogenase deficiency may cause hemolysis of erythrocytes, hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency);

Nervous system: increased excitability, sleep disturbances, headache, sensation of warmth, fatigue;

Metabolic system: disturbances in zinc and copper metabolism.

Shelf life. 1 year 6 months.

Storage conditions.

Store in original packaging at a temperature not exceeding 25°C.

Packaging.

50 dragees per container; 1 container per cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

PJSC "Tekhnolog".

Manufacturer’s location and address of operations.

8 Stara Prorezna St., Uman, Cherkasy region, 20300, Ukraine.

INSTRUCTION
for medical use of medicinal product

ASCORBIC ACID
(ASCORBIC ACID)

Composition:

Active ingredient: ascorbic acid;

1 dragee contains 50 mg of ascorbic acid;

Excipients: starch syrup, white sugar, yellow wax, mineral oil, talc, orange flavor (containing propylene glycol).

Pharmaceutical form. 50 mg dragees.

Main physicochemical properties: white or whitish-yellow dragees. Externally, they should have a spherical shape.

Pharmacotherapeutic group. Simple ascorbic acid preparations (vitamin C). Ascorbic acid (vitamin C). ATC code A11G A01.

Pharmacological properties.

Pharmacodynamics.

Ascorbic acid (vitamin C) has pronounced reducing properties. It belongs to the group of water-soluble vitamins. It participates in redox reactions, regulation of carbohydrate metabolism, influences the metabolism of aromatic amino acids, thyroxine metabolism, biosynthesis of catecholamines, steroid hormones and insulin, is necessary for blood coagulation, synthesis of collagen and procollagen, regeneration of connective and bone tissue. Improves capillary permeability. Promotes iron absorption in the intestine and participates in hemoglobin synthesis. Enhances non-specific resistance of the body and has antidotal properties. Dietary deficiency of vitamin C leads to the development of hypovitaminosis and avitaminosis C, as this vitamin is not synthesized in the body.

Pharmacokinetics.
Absorption of ascorbic acid occurs mainly in the small intestine. The absorption process may be impaired in intestinal dyskinesia, enteritis, achylia, helminthic infestation, giardiasis, as well as when consuming alkaline drinks, fresh fruit and vegetable juices. Maximum plasma concentration after oral administration is reached within 4 hours. It readily penetrates leukocytes and platelets, and then into all tissues; accumulates in the posterior pituitary, adrenal cortex, ocular epithelium, seminiferous tubule cells, ovaries, liver, brain, spleen, pancreas, lungs, kidneys, intestinal wall, heart, muscles, and thyroid gland. It is metabolized mainly in the liver into dehydroascorbic acid, and further into oxalacetic and diketogulonic acids. Unchanged ascorbate and metabolites are excreted in urine, feces, and pass into breast milk. When high doses are administered and plasma concentration exceeds 1.4 mg/dL, excretion sharply increases, and increased excretion may persist after discontinuation.

Clinical characteristics.

Indications.

Prevention and treatment of vitamin C deficiency.

To meet increased body requirements for vitamin C during growth, pregnancy or breastfeeding; under conditions of high physical and mental stress, infectious diseases and intoxications, hemorrhagic diatheses, in complex therapy of bleeding (nasal, pulmonary, uterine); in radiation sickness, Addison's disease, anticoagulant overdose, muscle tissue injuries and infected wounds with slow healing, bone fractures.

Contraindications.

Hypersensitivity to ascorbic acid or any of the excipients of the medicinal product. Thrombosis, tendency to thrombosis, thrombophlebitis, diabetes mellitus, severe kidney diseases. Urolithiasis – when doses exceeding 1 g per day are used. Fructose intolerance, glucose-galactose malabsorption syndrome.

Special precautions.

Since ascorbic acid has a mild stimulating effect, it is not recommended to take the drug at the end of the day. Due to the stimulating effect of ascorbic acid on corticosteroid hormone production, when used in high doses, kidney function and arterial pressure should be monitored.

Interaction with other medicinal products and other types of interactions.

Oral ascorbic acid increases the absorption of penicillin, tetracycline, and iron; promotes intestinal absorption of aluminum, which should be considered during concomitant treatment with antacids containing aluminum.

Simultaneous intake of vitamin C and deferoxamine increases tissue toxicity of iron, especially in the myocardium, which may lead to circulatory system decompensation. Vitamin C should be taken only 2 hours after deferoxamine injection.

Long-term intake of high doses by patients undergoing disulfiram therapy inhibits the disulfiram-alcohol reaction.

High doses of the drug reduce the efficacy of tricyclic antidepressants, phenothiazine derivative neuroleptics, reduce tubular reabsorption of amphetamine, impair renal excretion of mexiletine, and affect vitamin B12 resorption.

Ascorbic acid increases total clearance of ethanol.

The drug reduces the toxicity of sulfonamide drugs, decreases the efficacy of heparin and indirect anticoagulants.

Vitamin C increases oxalate excretion in urine, thereby increasing the risk of urinary oxalate stone formation, and increases the risk of crystalluria during salicylate therapy.

Acetylsalicylic acid (aspirin) may reduce the absorption of ascorbic acid. Concurrent use of salicylates with ascorbic acid may increase renal excretion of ascorbic acid.

Quinoline derivatives, calcium chloride, salicylates, corticosteroids with prolonged use reduce ascorbic acid reserves in the body.

Absorption of ascorbic acid is reduced when taken concomitantly with oral contraceptives, fruit or vegetable juices, and alkaline drinks.

Special instructions.

When taking high doses or prolonged use of the drug, kidney function and arterial pressure should be monitored, as well as pancreatic function. Use with caution in patients with a history of kidney disease.

In patients with urolithiasis, the daily dose of ascorbic acid should not exceed 1 g.

High doses of the drug should not be prescribed to patients with increased blood coagulability.

Since ascorbic acid enhances iron absorption, its use in high doses may be dangerous for patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia. Patients with high iron content in the body should use the drug in minimal doses.

Concurrent intake with alkaline drinks reduces absorption of ascorbic acid; therefore, dragees should not be taken with alkaline mineral water. Also, absorption of ascorbic acid may be impaired in intestinal dyskinesia, enteritis, and achylia.

Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency.

Ascorbic acid, as a reducing agent, may affect laboratory test results, for example, blood glucose, bilirubin, transaminase activity, lactate dehydrogenase activity, etc.

Use ascorbic acid with caution in patients with progressive oncological disease, as its use may complicate the course of the disease.

The drug may be harmful to teeth.

Use during pregnancy or breastfeeding.

The medicinal product may be used during pregnancy or breastfeeding when the potential benefit to the mother outweighs the possible risk to the fetus, according to dosage recommendations and under medical supervision. Recommended doses should be strictly followed and not exceeded.

Effect on ability to drive or operate machinery.

Does not affect reaction speed at therapeutic doses.

Administration and dosage.

The drug should be taken orally, after meals.

For adults and children aged 14 years and older for prophylaxis: 1–2 dragees (50–100 mg) daily; for children aged 4 to 14 years: 1 dragee (50 mg) daily.

Therapeutic doses: for children aged 14 years and adults – 1–2 dragees (50–100 mg) 3–5 times daily; for children aged 4 to 7 years – 1–2 dragees (50–100 mg) 2–3 times daily; for children aged 7–10 years – 2 dragees (100 mg) 2–3 times daily; for children aged 10–14 years – 2–3 dragees (100–150 mg) 2–3 times daily.

Pregnant women, postpartum women, and women with low vitamin C levels in breast milk should take 6 dragees (300 mg) daily for 10–15 days, followed by 2 dragees (100 mg) daily for prophylaxis throughout the breastfeeding period.

Duration of treatment depends on the nature and course of the disease and is determined individually by the physician.

Children.

The drug is indicated for children over 4 years of age.

Overdose.

Ascorbic acid is well tolerated. It is a water-soluble vitamin, and excess amounts are excreted in urine. However, prolonged use of high doses of vitamin C may suppress the function of the pancreatic islet apparatus, requiring monitoring of its condition. Overdose may lead to changes in renal excretion of ascorbic and uric acids during urine acidification, with a risk of oxalate calculus precipitation.

High-dose administration may cause vomiting, nausea, or diarrhea, which resolve after discontinuation. Treatment is symptomatic.

Side effects.