Instructions for use Askocin chewable tablets No. 100
Composition
active ingredients: ascorbic acid, sodium ascorbate, zinc oxide;
1 tablet contains 100 mg of ascorbic acid, 400 mg of sodium ascorbate in terms of ascorbic acid, 15 mg of zinc oxide in terms of zinc;
excipients: mannitol (E 421), povidone K30, crospovidone, sunset yellow FCF (E 110), ethylcellulose, aspartame (E 951), magnesium stearate, orange flavoring 844763.
Dosage form
Chewable tablets.
Main physicochemical properties: light orange, round biconvex tablets with inclusions.
Pharmacotherapeutic group
Ascorbic acid (vitamin C) preparations, combinations.
ATX code A11G B.
Pharmacological properties
Pharmacodynamics
Ascocin® is a combination drug that combines two medicines: water-soluble vitamin C - ascorbic acid and a trace element - zinc.
Mechanism of action of ascorbic acid.
Ascorbic acid (vitamin C) as an antioxidant, metabolic and redox regulating agent increases the body's adaptive capabilities, increases its resistance to infections. Supports the colloidal state of the intercellular substance and normal capillary permeability (inhibits hyaluronidase). Participates in the regulation of redox processes, in the metabolism of carbohydrates, aromatic amino acids, pigments and cholesterol, in the synthesis of steroid hormones, catecholamines, in blood clotting. Enhances collagen synthesis, stimulates regeneration processes, normalizes capillary permeability. By activating respiratory enzymes in the liver, it enhances its detoxifying and protein-forming function, increases the synthesis of collagen and prothrombin. Improves bile secretion, restores the exocrine function of the pancreas. Inhibits the release and accelerates the degradation of histamine, inhibits the formation of prostaglandins and other mediators of inflammation and anaphylaxis. Regulates immunological reactions (activates the synthesis of antibodies, C3-component of the complement system, interferon), promotes phagocytosis, increases the body's resistance to infections. Has anti-inflammatory and anti-allergic effects.
Mechanism of action of zinc.
Zinc is a structural component of biological membranes, cell receptors, proteins, and is a part of more than 200 enzymatic systems. It participates in immune and antioxidant defense reactions, hematopoiesis, amino acid synthesis, and in the storage and transmission of genetic information. Being a component of the retinol-carrying protein, zinc, together with vitamin A and vitamin C, prevents the occurrence of immunodeficiencies, stimulating the synthesis of antibodies and exerting an antiviral effect.
Zinc contributes to the growth and development of cells, the proper functioning of the immune system and ensuring an immunological response, twilight vision, taste and smell perception. It affects the maintenance of normal levels of vitamin A in the blood, prolongs the action of insulin and facilitates its accumulation. In inflammatory skin conditions, it has a preventive and therapeutic effect.
Zinc deficiency causes difficulties in concentration and memory, poor appetite and distorted taste, decreased cellular and humoral immunity, poor wound healing, night blindness, carbohydrate balance disorders, hypercholesterolemia, hypertension, mental and brain disorders, prostate hypertrophy, pregnancy disorders, growth suppression and hypogonadism in children and to a large extent dermatological disorders (senile alopecia, alopecia areata, acne). In high doses, zinc inhibits the absorption of copper. Zinc deficiency also increases the absorption of toxic cadmium.
Pharmacokinetics
For ascorbic acid.
Absorption. Ascorbic acid is absorbed mainly in the upper part of the small intestine by sodium-dependent active transport. In the presence of ascorbic acid in high concentration, its absorption also occurs by passive diffusion. With an increase in the dose of ascorbic acid taken orally, from 1 g to 12 g, the specific weight of the drug absorbed decreases (approximately from 50% to 15%). Absorption of vitamin C may be impaired in diseases of the gastrointestinal tract (gastritis, ulcers, constipation, diarrhea, helminthic invasion, giardiasis), the use of fresh fruit and vegetable juices, alkaline drinks.
Metabolism. Ascorbic acid is partially metabolized through dehydroascorbic acid to oxalic acid and other products. If ascorbic acid enters the body in excessive quantities, it is excreted from the body unchanged with urine and feces. The urine also contains a metabolite of ascorbic acid - ascorbic acid-2-sulfate. Smoking and alcohol abuse accelerate the breakdown of ascorbic acid (conversion into inactive metabolites), sharply reducing its reserves in the body. The physiological level of ascorbic acid depot in the body is approximately 1.5 g. It is deposited in the posterior pituitary gland, adrenal cortex, eye epithelium, intermediate cells of the seminiferous glands, ovaries, liver, brain, spleen, pancreas, lungs, kidneys, intestinal wall, heart, muscles, thyroid gland. From plasma, it easily penetrates into leukocytes, platelets, and almost all tissues.
Excretion. Unchanged ascorbate and metabolites are excreted by the kidneys, intestines, and sweat and enter breast milk. The half-life of ascorbic acid depends on the route of administration, amount, and rate of absorption. After oral administration of ascorbic acid at a dose of 1 g, the half-life is about 13 hours. When taking doses of ascorbic acid up to 3 g per day, its excretion from the body occurs with urine. When taking doses exceeding 3 g per day, its excretion occurs with both urine and feces (in unchanged form).
For zinc.
Absorption. Zinc is absorbed throughout the small intestine. When zinc is taken on an empty stomach and in the form of an aqueous solution, the amount of the drug absorbed reaches 41-79%. When zinc is taken with food, the amount of the drug absorbed is 10-40%.
Distribution and metabolism. The maximum concentration of zinc in blood plasma is observed 2 hours after taking the drug. In the body, zinc accumulates mainly in leukocytes and erythrocytes, as well as in muscles, bones, skin, kidneys, liver, pancreas and prostate glands, retina. 60% of zinc binds to albumins, 30-40% - to alpha-2 macroglobulin, 1% - to amino acids, mainly to histidine and cysteine.
Excretion. Zinc is excreted from the body mainly with feces (90%), to a lesser extent with urine and sweat. Calcium supplements and a diet rich in calcium (dairy products) have the ability to reduce zinc absorption by almost 50%, and caffeine and alcohol significantly remove it from the body.
Indication
As part of complex treatment for conditions and diseases caused or accompanied by zinc deficiency and ascorbic acid hypovitaminosis:
- susceptibility to colds and infectious diseases;
- diseases accompanied by decreased immunity;
- bleeding (uterine, pulmonary, nasal, radiation sickness), overdose of anticoagulants, increased permeability and fragility of blood vessels;
- liver disease (hepatitis A, chronic hepatitis, cirrhosis);
- nephropathy of pregnant women;
- dystrophies, bone fractures and wounds that do not heal for a long time;
- connective tissue disorders (rheumatoid arthritis, systemic lupus erythematosus, scleroderma);
- disorders of carbohydrate and fat metabolism;
- endocrine gland dysfunction, Addison's disease;
- hypofunction of the prostate gland;
- atherosclerosis;
- bronchial asthma.
Contraindication
- Hypersensitivity to any component of the drug.
- Tendency to thrombosis; thrombophlebitis.
- Diabetes.
- Urolithiasis, severe kidney disease, severe renal failure.
- Phenylketonuria.
- With special caution, it should be prescribed to patients with impaired iron metabolism (hemosiderosis, hemochromatosis, thalassemia).
Special safety measures.
Related to ascorbic acid.
Since vitamin C has a mild stimulating effect, it is not recommended to take this drug at the end of the day.
Due to the stimulating effect of ascorbic acid on the formation of corticosteroid hormones, when using it in large doses, monitoring of kidney function and blood pressure is required.
The drug should be used with caution in cases of increased blood clotting.
It should be prescribed with particular caution to patients:
– with glucose-6-phosphate dehydrogenase deficiency (high doses of ascorbic acid can provoke hemolytic anemia);
– with a history of nephrolithiasis (risk of hyperoxaluria and oxalate deposits in the urinary tract after taking large doses of ascorbic acid).
Long-term use of large doses of ascorbic acid may accelerate its own metabolism, which may lead to paradoxical hypovitaminosis after discontinuation of treatment. The recommended dose should not be exceeded.
Should not be used simultaneously with other drugs containing vitamin C.
The drug should be used with caution in polycythemia and leukemia.
Absorption of ascorbic acid may be altered by impaired intestinal motility, enteritis, or achilli (inhibition of gastric secretion).
It should be noted that the use of vitamin C in high doses may alter some laboratory test results (blood glucose, bilirubin, transaminases, uric acid, creatinine, inorganic phosphates). The result of the study for occult blood in the stool may be negative.
When using zinc-containing preparations, the risk of copper deficiency should be taken into account. A diet rich in fibrin (e.g. bran), phosphates (e.g. dairy products), whole grain breads and phytates reduces zinc absorption due to the formation of complexes. The interval between the consumption of the above-mentioned products and the administration of zinc preparations should be at least 2 hours.
Interaction with other medicinal products and other types of interactions
Interactions related to ascorbic acid.
When used simultaneously, ascorbic acid enhances the absorption of iron, penicillin, ethinyl estradiol from the gastrointestinal tract. A similar effect applies to aluminum, so this must be taken into account when simultaneously treating with antacids containing aluminum.
Ascorbic acid, when used simultaneously, reduces the effectiveness of heparin and anticoagulants.
Absorption of ascorbic acid is reduced with simultaneous use of oral contraceptives, consumption of fruit or vegetable juices, alkaline drinks. Simultaneous administration of vitamin C and deferoxamine increases tissue toxicity of iron, especially in the heart muscle, which can lead to decompensation of the circulatory system. Vitamin C can be taken only 2 hours after the injection of deferoxamine. Long-term administration of large doses of ascorbic acid reduces the effectiveness of disulfiram treatment.
Large doses of the drug reduce the effectiveness of tricyclic antidepressants, neuroleptics - phenothiazine derivatives, tubular reabsorption of amphetamine, and disrupt the excretion of mexiletine by the kidneys.
Ascorbic acid increases the total clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylates, tetracyclines, corticosteroids, with prolonged use, reduce the reserves of ascorbic acid in the body.
At high doses, ascorbic acid affects the resorption of vitamin B12.
Vitamin C increases the excretion of oxalates in the urine, thus increasing the risk of oxalate stone formation in the urine. Vitamin C increases the risk of crystalluria during treatment with salicylates.
Interactions related to zinc.
Tetracyclines. Zinc reduces the absorption of tetracyclines and inhibits the absorption of copper (in the case of using large doses of zinc), so the drug should be used no earlier than 2 hours after taking these drugs.
Copper preparations. High doses of zinc may inhibit copper absorption (zinc salts should be used no earlier than 2 hours after taking these preparations).
Thiazide diuretics increase urinary zinc excretion.
A diet rich in fibrin (e.g., bran), phosphates (e.g., dairy products), whole grain breads, and phytins reduces zinc absorption due to complex formation, so the interval between consuming the above-mentioned foods and taking zinc supplements should be at least 2 hours.
Folic acid slightly interferes with zinc absorption.
Large doses of iron when taken orally significantly reduce the absorption of zinc (the drug should be used no earlier than 2 hours after taking these drugs).
Penicillamine and other chelating agents reduce zinc absorption (the drug should be used no earlier than 2 hours after taking these drugs).
When using multivitamin preparations with minerals that include zinc together with Ascocin®, one should be aware of the possibility of overdose.
Quinolones: Zinc reduces the absorption of quinolone-containing antibiotics and fluoroquinolones.
Application features
The drug contains: sunset yellow FCF dye (E 110), which may cause allergic reactions; aspartame (E 951), which is a derivative of phenylalanine, which is dangerous for patients with phenylketonuria.
Use during pregnancy or breastfeeding
Pregnancy.
Since controlled studies during pregnancy and controlled animal studies have not been conducted, the drug should be used only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus.
Breast-feeding.
Ascorbic acid and zinc pass into breast milk. Therefore, during breastfeeding, the drug should be used under the supervision of a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no indication that the drug may negatively affect drivers or people who work with complex machinery.
Method of administration and doses
Ascocin® should be taken orally after meals; chew the tablet and drink it with a small amount of water. The duration of treatment depends on the nature and course of the disease.
Adults - 1 tablet once a day.
The duration of treatment is determined by the doctor depending on the nature and course of the disease.
For severe hypovitaminosis and treatment of infectious diseases, it is recommended for adults to take 1 tablet 2 times a day for 5-7 days.
Children
Ascocin® should not be used in children.
Overdose
There is no evidence that this drug can cause overdose when used as recommended.
Clinical signs and symptoms, laboratory findings, and consequences of overdose vary greatly, depending on individual susceptibility and surrounding circumstances.
Common manifestations of vitamin C and/or zinc overdose may include increased incidence of gastrointestinal upset, including diarrhea, nausea, and vomiting.
If these symptoms occur, you should stop taking the drug and consult a doctor.
Specific clinical manifestations of overdose may include:
Vitamin C.
Acute or chronic overdose of vitamin C can significantly increase serum and urinary oxalate levels. In some cases, this can lead to hyperoxaluria, calcium oxalate crystalluria, calcium oxalate deposition, kidney stone formation, tubulointerstitial nephropathy, and acute renal failure. Individuals with mild to moderate renal impairment may be susceptible to these toxic effects of vitamin C at lower doses and should consult a physician before taking the drug.
Overdose of vitamin C can lead to oxidative hemolysis or disseminated intravascular coagulation in patients with glucose-6-phosphate dehydrogenase deficiency.
Zinc.
Zinc overdose can cause irritation and erosion of the gastrointestinal mucosa, acute tubular necrosis, interstitial nephritis, copper deficiency, sideroblastic anemia, and myeloneuropathy.
If an overdose of the drug is suspected, it should be discontinued and a doctor should be consulted for treatment of clinical manifestations. Vitamin C is removed by hemodialysis.
Adverse reactions
Gastrointestinal: irritation of the digestive tract mucosa, dyspepsia, nausea, vomiting, heartburn, abdominal pain, abdominal discomfort, diarrhea, gastritis, metallic taste in the mouth.
Immune system disorders: allergic reactions, including anaphylactic reactions, anaphylactic shock; hypersensitivity reactions, including asthmatic syndrome, bronchospasm, cardiorespiratory distress, skin rashes, itching, eczema, urticaria, angioedema,
From the nervous system: increased excitability, increased fatigue, sleep disturbances, headache.
On the part of the urinary system: damage to the glomerular apparatus of the kidneys, renal failure, crystalluria, formation of urate, cystine and oxalate stones in the kidneys and urinary tract.
Skin and subcutaneous tissue disorders: rash, itching.
From the blood system: thrombocytosis, thrombosis, hemolytic anemia, hyperprothrombinemia, erythrocytopenia, neutrophilic leukocytosis; in patients with glucose-6-phosphate dehydrogenase deficiency, red blood cell hemolysis may occur; hematological disorders due to copper deficiency, including leukopenia (fever, chills, sore throat), neutropenia (ulcers in the mouth and throat), sideroblastic anemia (feeling of fatigue, weakness);
On the part of the endocrine system: damage to the insular apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the appearance of diabetes mellitus.
From the cardiovascular system: arterial hypertension, myocardial dystrophy.
Metabolic disorders: zinc and copper metabolism disorders.
Others: feeling hot.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a strip, 3 or 10 strips in a cardboard box.
Vacation category
Without a prescription.
Producer
KUSUM HEALTHCARE PVT LTD/KUSUM HEALTHCARE PVT LTD.
Location of the manufacturer and its business address
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India/SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
