ASCORBIC ACID

INSTRUCTION for medical use of the medicinal product ASCORBIC ACID (ASCORBIC ACID)

Composition:

Active substance: 1 dragee contains ascorbic acid (vitamin C) 50 mg;

Excipients: sugar, starch syrup, talc, yellow wax, light mineral oil, "orange flavor" flavoring, quinoline yellow dye (E 104).

Pharmaceutical form. Dragees.

Main physicochemical properties: yellow-colored dragees. The dragees should have a spherical shape. The surface of the dragee should be uniformly colored.

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, affects the metabolism of aromatic amino acids, thyroxine metabolism, biosynthesis of catecholamines, steroid hormones and insulin. It 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 non-specific resistance of the body and has antidotal properties. Vitamin C deficiency in the diet leads to the development of hypovitaminosis and avitaminosis C, as 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 dyskinesia, enteritis, achylia, helminthic invasion, giardiasis, as well as when consuming 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 lobe, adrenal cortex, ocular epithelium, interstitial cells of testes, ovaries, liver, brain, spleen, pancreas, lungs, kidneys, intestinal wall, heart, muscles, and thyroid gland. It is mainly metabolized in the liver into dehydroascorbic acid, and further into oxalic acid and diketogulonic acid. Unchanged ascorbate and metabolites are excreted in urine and feces; they also pass 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 the increased body demand for vitamin C during growth, pregnancy or breastfeeding, under conditions of increased physical and mental stress, during infectious diseases and intoxications, hemorrhagic diatheses, as part of combined therapy for bleeding (nasal, pulmonary, uterine), radiation sickness, Addison's disease, anticoagulant overdose, soft tissue injuries and infected wounds with slow healing, bone fractures.

Contraindications.

Hypersensitivity to ascorbic acid or to 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.

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 antacids containing aluminum.

Concomitant use of vitamin C and deferoxamine increases tissue iron toxicity, especially in the myocardium, potentially leading to circulatory decompensation. Vitamin C may be administered only 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, decrease tubular reabsorption of amphetamines, interfere with renal excretion of mexiletine, and affect vitamin B12 resorption.

Ascorbic acid increases total clearance of ethanol. When ascorbic acid is used in high doses together with alcohol consumption, disulfiram-like reactions may develop.

The drug reduces the toxicity of sulfonamide medicinal products and decreases the effectiveness of heparin and indirect anticoagulants.

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

Acetylsalicylic acid (aspirin) may reduce the absorption of ascorbic acid.

Concomitant use of salicylates and ascorbic acid may increase renal excretion of ascorbic acid.

Medicinal products of the quinoline series, calcium chloride, salicylates, and corticosteroids reduce the body's ascorbic acid reserves when used long-term.

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

Special precautions for use.

When using high doses or prolonged administration of the medicinal product, it is necessary to monitor kidney function, arterial pressure, and pancreatic function. The medicinal product 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.

Large doses of the medicinal product should not be prescribed to patients with increased blood coagulation.

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 levels in the body should use the medicinal product at minimal doses.

Concurrent use of the medicinal product with alkaline drinks reduces the absorption of ascorbic acid; therefore, it should not be taken with alkaline mineral water. Absorption of ascorbic acid may also be impaired in intestinal dyskinesia, enteritis, and achylia.

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

As a reducing agent, ascorbic acid may affect laboratory test results, for example, in determining blood levels of glucose, bilirubin, and activities of transaminases and lactate dehydrogenase.

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

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

The product 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.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Dosage and Administration.

The medicinal product 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 3 to 14 years should take 1 tablet (50 mg) daily.

Therapeutic doses for children aged 14 years and older and adults are 1–2 tablets (50–100 mg) 3–5 times daily; for children aged 3 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 levels of vitamin C in breast milk should take 6 tablets (300 mg) daily for 10–15 days, followed by prophylactic dosing of 2 tablets (100 mg) daily throughout the entire breastfeeding period.

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

Children.

The medicinal product is indicated for children aged 3 years and older.

Overdose.

Ascorbic acid is well tolerated. It is a water-soluble vitamin, and any excess is excreted in urine.

Symptoms. Prolonged administration of high doses of vitamin C may lead to suppression of the endocrine function 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 medicinal product may cause vomiting, nausea, or diarrhea, which resolve after discontinuation of the drug.

Treatment. Symptomatic therapy.

Adverse reactions.

Gastrointestinal disorders: when administered at doses exceeding 1 g per day – gastrointestinal mucosa irritation, heartburn, nausea, vomiting, diarrhea.

Renal and urinary system disorders: glomerular apparatus damage, crystalluria, formation of urate, cystine and/or oxalate calculi in kidneys and urinary tract, renal failure.

Immune system disorders: angioedema (Quincke's edema), occasionally anaphylactic shock in case of sensitization.

Skin and subcutaneous tissue disorders: skin rashes, pruritus, urticaria, eczema.

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

Cardiovascular system disorders: arterial hypertension, myocardial dystrophy.

Blood and lymphatic system disorders: thrombocytosis, hyperprothrombinemia, thrombosis, erythrocytopenia, neutrophilic leukocytosis; in patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis of erythrocytes and hemolytic anemia may occur.

Nervous system disorders: increased excitability, sleep disturbances, headache, sensation of heat, fatigue.

Metabolic and nutritional disorders: 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.

50 dragees in blisters.

160 dragees in containers (bottles).

160 dragees in a container (bottle); 1 container (bottle) per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of its business activity.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua