Ascorbic acid, sodium ascorbate, zinc oxide.
Each chewable tablet contains: Ascorbic Acid USP 100 mg.
Sodium Ascorbate USP 450 mg (Equivalent to Ascorbic Acid 400 mg).
Zinc Oxide BP 18.67 mg (Equivalent to Zinc 15 mg).
Excipients/Inactive Ingredients: Mannitol, PVP K-30, Crospovidone, Lake Sunset Yellow, Ethyl cellulose, Isopropyl alcohol, Aspartame, Magnesium stearate & Orange flavour 844763.
Pharmacotherapeutic Group: Ascorbic acid (Vitamin C), combinations. ATC code: А11GB.
Pharmacology: Pharmacodynamics: Ascorbic acid: Ascorbic acid (vitamin C) as antioxidant, metabolic and redox processes regulating agent, increases adaptive capacity of organism, enhances its resistance to infections. It maintains colloidal condition of intercellular substance and normal capillary penetration (it inhibits hyaluronidase). It participates in regulation of redox processes, in metabolism of carbohydrates, aromatic amino acid, pigments and cholesterol; in synthesis of steroid hormones, catecholamine, and in blood coagulation. It enhances collagen synthesis, stimulates regeneration processes, and normalizes capillary penetration. Due to activation of respiratory ferments in liver it enhances its detoxification and protein building functions; it enhances synthesis of collagen and prothrombin. It improves bile excretion, renews exocrine function of pancreas. It inhibits excretion and accelerates histamine degradation, inhibits formation of prostaglandins and other inflammatory and anaphylactic mediators. It regulates immunological reactions (it activates synthesis of antibody, C3-component of complement, interferon), facilitates phagocytosis, elevates body resistance to infections. It has an anti-inflammatory and anti-allergic action.
Daily maintenance dose of ascorbic acid in adults is 70-100 mg, in pregnant women and during lactation is 100-120 mg, in children and adolescents is 30-70 mg. Vitamin C deficient meal causes development of Vitamin C hypo or avitaminosis as this vitamin is not synthesized in organism.
Zinc: Zinc is a structural component of biological membranes, cell receptors, proteins; it takes part in more than 200 enzymatic reactions. It takes part in reactions of immune and anti-oxidant process, blood formation, amino acids synthesis, in genetic preservation and transmission. Being a component of protein, which transmits retinol, zinc together with vitamin A and vitamin C prevents immune deficit conditions, stimulates antibody synthesis and has antiviral action. It is necessary for formation of erythrocyte and other blood corpuscle. Zinc normalizes lipid metabolism, provides normal function for endocrine gland, including synthesis of insulin, growth hormone, corticotropins and somatotropins. It maintains sexual and reproductive functions – it is necessary for metabolism of vitamin E, which is a precursor of sexual hormones and takes part in testosterone production; zinc is also important for normal prostate gland functioning. Daily maintenance dose of zinc is 15 mg.
Pharmacokinetics: Ascorbic acid: Ascorbic acid is actively absorbed in small intestine. Maximal plasma concentration after oral intake is reached in 4 hours. Normal endogenous plasma concentration is approximately 10-20 mcg/ml. Body store is approximately 1.5 g. About 25% of it is bound with plasma proteins, deposited in post hypophysis, adrenal gland cortex, eye epithelium, perineal cells of seminal gland, ovary, liver, brain, spleen, pancreas, lungs, kidney, intestinal wall, heart, muscle, thyroid gland. It easily penetrates into leucocyte, thrombocyte and almost into all tissues from plasma. It is bio-transformed in liver into deoxyascorbic acid, then in oxaloacetic acid and diketogulonic acid. Unchanged ascorbate and metabolites are excreted through kidney, intestine and also with sweat and breast milk. Vitamin C absorption can be impaired in gastro-intestinal tract diseases (gastritis, ulcer, constipation, diarrhea, helminthiasis, lambliasis), usage of fresh fruit and vegetable juice, alkaline drinks. Excretion is increased if its concentration in plasma exceeds 1.4 mg/100 ml. Smoking and ethyl alcohol abuse accelerates ascorbic acid decay (transformation into inactive metabolites), sharply decreasing its reserve in body.
Zinc: Absorbed in intestine, zinc is distributed to tissues and becomes part of enzymes and biologically active substances. 90% of zinc is excreted with faeces and 2-10% with urine. Addition of calcium and calcium rich products (dairy products) reduces zinc absorption nearly by 50% and caffeine and alcohol intensively removes it from the body.
Ascozin is indicated in patients prone to cold, infectious diseases and immunodeficiency diseases, hypo and avitaminosis of vitamin C, hemorrhage (metrorrhagia, bronchial, nasal, hemorrhage in radiation sickness), hepatic diseases (hepatitis A, chronic hepatitis, cirrhosis), nephropathy of pregnancy, Addison's disease, anticoagulant overdose, bone fracture and wounds, which are not healing for a long periods, dystrophy. Ascozin can be administered in complex treatment of diseases, which are accompanied with decreased immunity, connective tissue injury, impairment of carbohydrate and lipid metabolism, dysfunction of endocrine gland, increased permeability and fragility of blood vessel, and also in hypofunction of prostate gland. Ascozin can be used in atherosclerosis, bronchial asthma and connective tissue diseases (rheumatoid arthritis, systemic lupus erythematosus, and scleroderma).
Dosage: For adults it is administered 1 tablet once a day. In severe avitaminosis and infectious disease treatment it can be used 1 tablet twice a day for a short term (during 5-7 days). The treatment course depends on the nature and duration of disease.
Method of administration: Oral.
Ascozin is taken after meal; a tablet is chewed and taken with enough water.
Symptoms: nausea, vomiting, intestinal spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyper excitability of CNS, sleep disturbance.
Treatment: It is symptomatic.
Ascozin tablets are contraindicated in case of; Hypersensitivity to ascorbic acid; Thrombophlebitis; Inclination to thrombosis; Diabetes; Children less than 18 years old.
Increased intake of ascorbic acid over a prolonged period may result in an increase in renal clearance and thereafter deficiency may result if it is withdrawn too rapidly.
Effects on Ability to Drive and Use Machines: There are no reports that the preparation can have a negative influence on drivers or people who work with sophisticated mechanisms.
Vitamin C long-term administration in high dose during pregnancy can cause a negative influence on fetus development. Use during pregnancy may be possible only in case when the benefit for a mother overweighs a potential risk for a fetus. Ascorbic acid penetrates into breast milk, therefore during lactation period the preparation must be used under medical supervision.
Usually the preparation is well tolerated. During long-term use of high doses there can be following possible side effects:
Gastrointestinal disorders: Nausea, vomiting, heartburn, diarrhea.
Nervous system disorders: Hyper excitability, headache.
Renal and urinary disorders: Formation of uric acid, cysteine or oxalate concretions.
Skin and subcutaneous tissue disorders: Allergic reactions.
Blood and lymphatic system disorders: It can cause hemolysis in patients with insufficiency of glucose-6-phosphate dehydrogenase (G6PD).
Ascorbic acid increases salicylates (increases a risk of crystalluria), ethinylestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases concentration of oral contraceptives in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron absorption in intestine. It increases general clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylate, corticosteroid decrease vitamin C reserve when used for a long term. Corticosteroids (cortisone and prednisolone), which are administered in chronic diseases (arthritis, bronchial asthma etc.), also reduce vitamin C and zinc levels.
Concurrent usage of ascorbic acid and deferoxamine enhances tissue toxicity of iron, especially in cardiac muscle that can cause decompensation of circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term use of high doses in patients, who are treated by disulfiram, inhibits disulfiram-alcohol reaction.
High doses of Ascorbic acid decreases efficacy of tricyclic depressants.
Store below 30°C in cool and dry place.
Shelf-Life: 24 months.
A11G - ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS ; Used as dietary supplements.
Chewable tab (light orange, uniformly spotted, circular, biconvex, uncoated, plain on both sides) x 10's, 3 x 10's, 10 x 10's.
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