Ascorbic acid
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ASCORBIC ACID
Composition:
Active substance: ascorbic acid;
1 tablet contains ascorbic acid – 50 mg;
Excipients: glucose monohydrate; confectioner's sugar; calcium stearate; potato starch; anhydrous colloidal silicon dioxide; talc; orange flavor 526 natural; "Yellow Sunset FCF" (E110).
Pharmaceutical form. Chewable tablets.
Main physicochemical characteristics: whole, regular, round cylindrical tablets ranging from light yellow to orange in color with speckles, with flat upper and lower surfaces and beveled edges, featuring a score line.
Pharmacotherapeutic group.
Ascorbic acid preparations (vitamin C). Ascorbic acid. ATC code A11G A01.
Pharmacological properties.
Pharmacodynamics.
Ascorbic acid participates in redox reactions, metabolism of carbohydrates, thyroxine, iron, conversion of folic acid to folinic acid, blood coagulation, formation of steroid hormones, collagen and procollagen, tissue regeneration, regulation of capillary permeability, synthesis of lipids and proteins, and cellular respiration processes.
Vitamin C enhances the body's resistance to infections and adverse environmental influences.
Ascorbic acid has antidotal properties. It promotes iron absorption in the intestine and participates in hemoglobin synthesis.
Pharmacokinetics.
After oral administration, ascorbic acid is rapidly absorbed in the small intestine; its maximum plasma concentration is reached within 4–7 hours. From plasma, it penetrates primarily into blood components (leukocytes, platelets, erythrocytes), then into all tissues. Protein binding in blood plasma is approximately 25%.
Ascorbic acid is reversibly oxidized to form dehydroascorbic acid; part of it is metabolized to ascorbate-2-sulfate and oxalic acid, which are excreted in urine. Excess ascorbic acid is excreted unchanged in urine.
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 the components of the drug, thrombosis, predisposition to thrombosis, thrombophlebitis, diabetes mellitus, severe kidney diseases, urolithiasis (when administered at doses exceeding 1 g per day), fructose intolerance.
Special precautions.
Since ascorbic acid has a mild stimulating effect, it is not recommended to take the drug late in the day. Due to the stimulating effect of ascorbic acid on corticosteroid hormone production, renal function and arterial blood pressure should be monitored when using high doses.
Interaction with other medicinal products and other types of interactions.
The drug reduces the toxicity of sulfonamide agents, decreases the effect of heparin and indirect anticoagulants, promotes iron absorption, enhances the absorption of penicillin and tetracycline, and intensifies the adverse effects of salicylates (increasing the risk of crystalluria).
Absorption of ascorbic acid is reduced when used concomitantly with oral contraceptives, fruit or vegetable juices, and alkaline drinks.
Concomitant use of vitamin C and deferoxamine increases tissue iron toxicity, especially in the myocardium, which may lead to circulatory decompensation. Vitamin C may be taken 2 hours after deferoxamine injection.
Prolonged use of high doses in patients undergoing disulfiram treatment inhibits the disulfiram–alcohol reaction.
High doses of the drug reduce the effectiveness of tricyclic antidepressants, phenothiazine-derived neuroleptics, tubular reabsorption of amphetamines, and increase renal excretion of mexiletine. Ascorbic acid increases the total clearance of ethanol.
Quinoline derivatives, calcium chloride, salicylates, and corticosteroids reduce ascorbic acid reserves in the body when used long-term.
Vitamin C enhances aluminum absorption in the intestine, which should be considered during concomitant treatment with aluminum-containing antacids. When used in high doses, ascorbic acid affects vitamin B12 resorption. Vitamin C increases oxalate excretion in urine, thereby increasing the risk of urinary oxalate stone formation.
Acetylsalicylic acid (aspirin) may reduce the absorption of ascorbic acid.
Special precautions for use
When taking high doses or using the drug for a prolonged period, renal 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, 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.
Concurrent use of the drug with alkaline beverages reduces the absorption of ascorbic acid; therefore, it should not be taken with alkaline mineral water.
Absorption of ascorbic acid may be impaired in intestinal dyskinesia, enteritis, and achylia.
Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency.
As a reducing agent, ascorbic acid may interfere with various laboratory tests, for example, blood glucose, bilirubin, transaminase activity, and lactate dehydrogenase activity.
Ascorbic acid should be used with caution in patients with progressive malignant disease, as its use may complicate the course of the disease.
The drug may be harmful to teeth.
Use during pregnancy or breastfeeding
Vitamin C deficiency in the diet of pregnant women may be dangerous for the fetus. However, high-dose vitamin C supplementation may also negatively affect fetal development. Therefore, ascorbic acid should be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus.
Ascorbic acid passes into breast milk; therefore, during breastfeeding, vitamin C should be taken only under medical supervision.
Ability to influence reaction rate while driving or operating machinery
The drug does not affect reaction speed when driving or operating machinery at therapeutic doses.
Dosage and Administration
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 are as follows:
- For adults and adolescents aged 14 years and older: 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 to 10 years: 2 tablets (100 mg) 2–3 times daily.
- For children aged 10 to 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 pancreatic islets, requiring monitoring of pancreatic function. Overdose may alter renal excretion of ascorbic acid and uric acid, particularly during urine acidification, increasing the risk of precipitation of oxalate calculi.
Administration of high doses may cause vomiting, nausea, or diarrhea, which resolve after discontinuation of the drug.
Treatment: symptomatic.
Side effects.
Gastrointestinal tract: when administered in doses exceeding 1 g per day – irritation of the gastrointestinal mucosa, heartburn, nausea, vomiting, diarrhea.
Urinary system: kidney glomerular apparatus damage, crystalluria, formation of urate, cystine and/or oxalate calculi in kidneys and urinary tract, renal failure.
Allergic reactions: skin rashes, eczema, pruritus, Quincke's edema, urticaria; rarely – anaphylactic shock in case of sensitization.
Endocrine system: with prolonged use in high doses – damage to the islet apparatus of the pancreas (hyperglycemia, glucosuria), impaired glycogen synthesis up to the development of diabetes mellitus.
Nervous system: headache, sensation of warmth, increased excitability, sleep disturbances, fatigue.
Cardiovascular system: arterial hypertension, myocardial dystrophy.
Blood and lymphatic system: thrombocytosis, erythrocytopenia, thrombosis, neutrophilic leukocytosis, hyperprothrombinemia; in patients with glucose-6-phosphate dehydrogenase deficiency of blood cells may cause hemolysis of erythrocytes, hemolytic anemia.
Metabolic system: disturbances in zinc and copper metabolism.
Shelf life. 3 years.
Storage conditions.
Store in original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 tablets per blister;
10 tablets per blister; 5 blisters per cardboard pack.
Prescription status. Over-the-counter.
Manufacturer.
JSC "Lubnypharm".
Manufacturer's address and place of business.
16 Barvinkova St., Lubny, Poltava region, 37500, Ukraine.
INSTRUCTION
for medical use of medicinal product
ASCORBIC ACID
Composition:
Active substance: ascorbic acid;
1 tablet contains ascorbic acid – 50 mg;
Excipients: glucose monohydrate; confectionery sugar; calcium stearate; potato starch; colloidal anhydrous silicon dioxide; talc; orange flavor 526 natural; «Sunset Yellow FCF» (E110).
Pharmaceutical form. Chewable tablets.
Main physicochemical properties: intact, regular, cylindrical tablets of light yellow to orange color with specks, with flat upper and lower surfaces and beveled edges, marked with a score line for division.
Pharmacotherapeutic group.
Ascorbic acid preparations (vitamin C). Ascorbic acid. ATC code A11G A01.
Pharmacological properties.
Pharmacodynamics.
Ascorbic acid participates in redox reactions, carbohydrate metabolism, thyroxine and iron metabolism, conversion of folic acid into folinic acid, blood coagulation, synthesis of steroid hormones, collagen and procollagen, tissue regeneration, regulation of capillary permeability, synthesis of lipids and proteins, and cellular respiration processes.
Vitamin C enhances the body's resistance to infections and adverse environmental influences.
Ascorbic acid has antidotal properties. It promotes iron absorption in the intestine and participates in hemoglobin synthesis.
Pharmacokinetics.
After oral administration, ascorbic acid is rapidly absorbed in the small intestine; its maximum plasma concentration is reached within 4–7 hours. From blood plasma, it penetrates primarily into blood cells (leukocytes, thrombocytes, erythrocytes), then into all tissues. Protein binding in plasma is about 25%.
Ascorbic acid is reversibly oxidized to dehydroascorbic acid; part is metabolized into ascorbate-2-sulfate and oxalic acid, which is excreted in urine. Excess ascorbic acid is excreted unchanged in urine.
Clinical characteristics.
Indications.
Prevention and treatment of vitamin C deficiency.
Meeting increased body requirements for vitamin C during growth, pregnancy or breastfeeding; during periods 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, soft tissue injuries and infected wounds with slow healing, bone fractures.
Contraindications.
Hypersensitivity to the components of the drug, thrombosis, tendency to thrombosis, thrombophlebitis, diabetes mellitus, severe kidney diseases, urolithiasis (when administered in doses exceeding 1 g per day), fructose intolerance.
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. The drug reduces the toxicity of sulfonamide preparations, decreases the effect of heparin and indirect anticoagulants, promotes iron absorption, enhances the absorption of penicillin and tetracyclines, and increases the side effects of salicylates (risk of crystalluria).
Absorption of ascorbic acid is reduced when taken simultaneously with oral contraceptives, fruit or vegetable juices, or alkaline drinks.
Concurrent administration of vitamin C and deferoxamine increases tissue iron toxicity, especially in the myocardium, which may lead to circulatory decompensation. It may be taken 2 hours after deferoxamine injection.
Long-term intake of high doses by patients treated with disulfiram inhibits the disulfiram-alcohol reaction.
High doses of the drug reduce the efficacy of tricyclic antidepressants, phenothiazine derivative neuroleptics, tubular reabsorption of amphetamine, and increase renal excretion of mexiletine. Ascorbic acid increases total ethanol clearance. Quinoline derivatives, calcium chloride, salicylates, and corticosteroids, when used long-term, reduce ascorbic acid stores in the body.
Vitamin C enhances intestinal absorption of aluminum, which should be considered when co-administering antacids containing aluminum. High-dose ascorbic acid affects vitamin B12 resorption. Vitamin C increases oxalate excretion in urine, thus increasing the risk of urinary oxalate stone formation.
Acetylsalicylic acid (aspirin) may reduce ascorbic acid absorption.
Special instructions.
When taking high doses or prolonged treatment, kidney function, arterial pressure, and pancreatic function should be monitored. 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.
The drug should not be prescribed in doses exceeding recommended levels to patients with increased blood coagulability.
Since ascorbic acid enhances iron absorption, its use in high doses may be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia. Patients with high iron levels in the body should take the drug in minimal doses.
Concurrent use of the drug with alkaline drinks reduces ascorbic acid absorption; therefore, it should not be taken with alkaline mineral water.
Absorption of ascorbic acid may be impaired in intestinal dyskinesia, enteritis, and achylia.
Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency.
As a reducing agent, ascorbic acid may affect the results of various laboratory tests, e.g., blood glucose, bilirubin, transaminase activity, lactate dehydrogenase activity.
Use 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.
Vitamin C deficiency in pregnant women's diet may be hazardous to the fetus; however, high-dose administration may also negatively affect fetal development. Therefore, ascorbic acid should be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus.
Ascorbic acid passes into breast milk; therefore, vitamin C intake during breastfeeding should be under medical supervision.
Ability to affect reaction rate while driving or operating machinery.
The drug does not affect reaction speed at therapeutic doses when driving or operating machinery.
Administration and dosage.
The drug is taken orally, after meals.
For adults and children aged 14 years and older, the preventive dose is 1–2 tablets (50–100 mg) daily; for children aged 4 to 14 years – 1 tablet (50 mg) daily.
Therapeutic doses: for children aged 14 years and adults – 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 to 10 years – 2 tablets (100 mg) 2–3 times daily; for children aged 10 to 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 throughout the breastfeeding period for prevention.
Duration of treatment depends on the nature and course of the disease and is determined individually by a physician.
Children.
The drug is indicated for children aged 4 years and older.
Overdose.
Ascorbic acid is well tolerated. Being a water-soluble vitamin, excess amounts are excreted in urine. However, prolonged use of high-dose vitamin C may suppress pancreatic islet function, requiring monitoring of pancreatic status. Overdose may lead to changes in renal excretion of ascorbic and uric acids under acidic urine conditions, increasing the risk of oxalate crystal precipitation.
High-dose administration may cause vomiting, nausea, or diarrhea, which resolve after discontinuation.
Treatment: symptomatic.
Side effects.
Gastrointestinal tract: when administered in doses exceeding 1 g per day – irritation of the gastrointestinal mucosa, heartburn, nausea, vomiting, diarrhea.
Urinary system: kidney glomerular apparatus damage, crystalluria, formation of urate, cystine and/or oxalate calculi in kidneys and urinary tract, renal failure.
Allergic reactions: skin rash, eczema, pruritus, Quincke's edema, urticaria; rarely – anaphylactic shock in case of sensitization.
Endocrine system: with prolonged use in high doses – damage to the islet apparatus of the pancreas (hyperglycemia, glucosuria), impaired glycogen synthesis up to the development of diabetes mellitus.
Nervous system: headache, sensation of warmth, increased excitability, sleep disturbances, fatigue.
Cardiovascular system: arterial hypertension, myocardial dystrophy.
Blood and lymphatic system: thrombocytosis, erythrocytopenia, thrombosis, neutrophilic leukocytosis, hyperprothrombinemia; in patients with glucose-6-phosphate dehydrogenase deficiency of blood cells may cause hemolysis of erythrocytes, hemolytic anemia.
Metabolism: disturbances in zinc and copper metabolism.
Shelf life. 3 years.
Storage conditions.
Store in original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 tablets per blister;
10 tablets per blister; 5 blisters per cardboard pack.
Prescription status. Over-the-counter.
Manufacturer.
JSC "Lubnypharm".
Manufacturer's address and place of business.
16 Barvinkova St., Lubny, Poltava region, 37500, Ukraine.