Ascorbinca®-kv

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT

Composition:

Active ingredient: ascorbic acid;

orange-flavored tablets

1 tablet contains ascorbic acid (vitamin C) 25 mg;

Excipients: sugar, stearic acid, potato starch, glucose monohydrate, anhydrous citric acid, powdered food flavoring "orange";

mint-flavored tablets

1 tablet contains ascorbic acid (vitamin C) 25 mg;

Excipients: sugar, stearic acid, potato starch, glucose monohydrate, powdered food flavoring "mint";

strawberry-flavored tablets

1 tablet contains ascorbic acid (vitamin C) 25 mg;

Excipients: sugar, stearic acid, potato starch, glucose monohydrate, anhydrous citric acid, powdered food flavoring "strawberry";

lemon-flavored tablets

1 tablet contains ascorbic acid (vitamin C) 25 mg;

Excipients: sugar, stearic acid, potato starch, glucose monohydrate, anhydrous citric acid, powdered food flavoring "lemon";

tutti-frutti-flavored tablets

1 tablet contains ascorbic acid (vitamin C) 25 mg;

Excipients: sugar, stearic acid, potato starch, glucose monohydrate, anhydrous citric acid, powdered food flavoring "tutti-frutti";

melon-flavored tablets

1 tablet contains ascorbic acid (vitamin C) 25 mg;

Excipients: sugar, stearic acid, potato starch, glucose monohydrate, anhydrous citric acid, powdered food flavoring "melon";

mango-flavored tablets

1 tablet contains ascorbic acid (vitamin C) 25 mg;

Excipients: sugar, stearic acid, potato starch, glucose monohydrate, anhydrous citric acid, powdered food flavoring "mango";

banana-flavored tablets

1 tablet contains ascorbic acid (vitamin C) 25 mg;

Excipients: sugar, stearic acid, potato starch, glucose monohydrate, anhydrous citric acid, powdered food flavoring "banana".

Pharmaceutical form. Tablets.

Main physicochemical properties:

orange-flavored tablets:

flat cylindrical tablets with beveled edges, white in color, with orange flavor and odor;

mint-flavored tablets:

flat cylindrical tablets with beveled edges, white in color, with mint flavor and odor;

strawberry-flavored tablets:

flat cylindrical tablets with beveled edges, white in color, with strawberry flavor and odor;

lemon-flavored tablets:

flat cylindrical tablets with beveled edges, white in color, with lemon flavor and odor;

tutti-frutti-flavored tablets:

flat cylindrical tablets with beveled edges, white in color, with tutti-frutti flavor and odor;

melon-flavored tablets:

flat cylindrical tablets with beveled edges, white in color, with melon flavor and odor;

mango-flavored tablets:

flat cylindrical tablets with beveled edges, white in color, with mango flavor and odor;

banana-flavored tablets:

flat cylindrical tablets with beveled edges, white in color, with banana flavor and odor.

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, collagen and procollagen synthesis, and regeneration of connective and bone tissues. It improves capillary permeability. It enhances iron absorption in the intestine and participates in hemoglobin synthesis. It increases 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, 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 infestation, giardiasis, and also upon consumption of alkaline beverages, fresh fruit and vegetable juices. Maximum drug concentration in blood plasma 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 part of the pituitary gland, adrenal cortex, ocular epithelium, interstitial cells of testes, 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 oxalic and diketogulonic acids. 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 increased body requirements for vitamin C during growth, pregnancy or breastfeeding, during periods of increased physical and mental stress, 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 slowly healing infected wounds, 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. Urolithiasis – when doses exceeding 1 g per day are administered. Fructose intolerance, glucose-galactose malabsorption syndrome.

Interaction with other medicinal products and other forms of interaction.

Oral ascorbic acid enhances the absorption of penicillin, tetracycline, 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 toxicity of iron, especially in cardiac muscle, potentially leading to circulatory decompensation. Vitamin C may be administered only 2 hours after deferoxamine injection.

Prolonged use of high doses in patients treated with disulfiram suppresses the disulfiram-alcohol reaction.

High doses of the medicinal product reduce the effectiveness of tricyclic antidepressants, phenothiazine-derived neuroleptics, tubular reabsorption of amphetamine, impair renal elimination of mexiletine, and affect vitamin B₁₂ resorption.

Ascorbic acid increases total clearance of ethanol.

The medicinal product reduces toxicity of sulfonamide drugs, decreases the effectiveness of heparin and indirect anticoagulants.

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

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

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

Medicinal products of the quinoline group, calcium chloride, salicylates, and corticosteroids, when used long-term, reduce body stores of ascorbic acid.

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 blood 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.

The medicinal product should not be prescribed in high doses to patients with increased blood coagulation.

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

As a reducing agent, ascorbic acid may interfere with 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 administer the medicinal product late in the day. Due to the stimulatory effect of ascorbic acid on corticosteroid hormone production, when using high doses of the medicinal product, kidney function and arterial blood 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 carefully followed and not exceeded.

Effect on the ability to drive or operate machinery

When used at therapeutic doses, the medicinal product does not affect reaction speed.

Administration and Dosage

The medicinal product should be taken orally after meals.

For prophylactic purposes, adults and children aged 14 years and older should take 2–4 tablets (50–100 mg) daily; children aged 3 to 14 years should take 2 tablets (50 mg) daily.

Therapeutic doses:

• For adults and adolescents aged 14 years and older: 2–4 tablets (50–100 mg) 3–5 times daily.
• For children aged 3 to 7 years: 2–4 tablets (50–100 mg) 2–3 times daily.
• For children aged 7 to 10 years: 4 tablets (100 mg) 2–3 times daily.
• For children aged 10 to 14 years: 4–6 tablets (100–150 mg) 2–3 times daily.

Pregnant women, postpartum women, and women with low vitamin C levels in breast milk should take 12 tablets (300 mg) daily for 10–15 days, followed by 4 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 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 the urine.

Symptoms: Prolonged use of high doses of vitamin C may lead to suppression of the pancreatic islet apparatus function, requiring monitoring of pancreatic function. Overdose may alter renal excretion of ascorbic acid and uric acid during urine acidification, increasing the risk of precipitation of oxalate stones.

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 in doses exceeding 1 g per day – irritation of the gastrointestinal mucosa, heartburn, nausea, vomiting, diarrhea.

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

Immune system disorders: Quincke's edema, occasionally anaphylactic shock in sensitized individuals.

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 may cause hemolysis of erythrocytes, hemolytic anemia (in patients with glucose-6-phosphate dehydrogenase deficiency).

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

Metabolic and nutritional disorders: disturbances in zinc and copper metabolism.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging. 10 tablets in a blister pack.

Availability. Over-the-counter.

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of business activity.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua