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Ascozin Tablets

Ascozin Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Ascozin® is administered in habitude to cold, infectious dideases and immune deficit 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 break and wounds, which are not healed for a long period, dystrophy.
Ascozin® can be administered in complex treatment of diseases, which are accompanied with decreased immunity, connective tissue injury, impairmeny of carbohydrate metabolism and lipometabolism, dysfunction of endocrine gland, increased penetration and fragility of blood vessel, and also in hypofunction of prostate gland. The preparation can be used in atherosclerosis, bronchial asthma, connective tissues diseases (rheumatoid arthritis, systemic lupus erythematosus, and scleroderma).

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:

GIT:
nausea, vomiting, heartburn, diarrhea.

CNS:
hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue: allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs 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 concrete diseases (arthritis, bronchial astma 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 blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

Treatment:
It is symptomatic.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description

COMPOSITION:
Active substance:
Ascorbic acid; Sodium ascorbate; Zinc oxide.

1 tablet contains:
ascorbic acid 100 mg; sodium ascorbat that is equivalent to ascorbic acid 400 mg; zinc oxide that is equivalent to zinc 15 mg.
Excipients:
Manitol (Е 421), Povidone, Crosspovidone, Sunset Yellow Dye FCF (Е 110), Ethylcellulose, Aspartam (E 951), Magnesium Stearate, Orange flavor 844763.

Indications and dosage.

INDICATIONS:
Ascozin® is administered in habitude to cold, infectious dideases and immune deficit 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 break and wounds, which are not healed for a long period, dystrophy. Ascozin® can be administered in complex treatment of diseases, which are accompanied with decreased immunity, connective tissue injury, impairmeny of carbohydrate metabolism and lipometabolism, dysfunction of endocrine gland, increased penetration and fragility of blood vessel, and also in hypofunction of prostate gland. The preparation can be used in atherosclerosis, bronchial asthma, connective tissues diseases (rheumatoid arthritis, systemic lupus erythematosus, and scleroderma).

DOSAGE:
Ascozin® is used after meal;
a tablet is chewed and took with enough water.
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 treatment character and clinical course.

Side effects and drug interactions.

ADVERSE REACTIONS:
Usually the preparation is well tolerated.

During a long-term usage of high doses there can be possible follow side effects:
GIT:
nausea, vomiting, heartburn, diarrhea.

CNS:
hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.

Skin and subcutaneous tissue:
allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

Drug interactions:
Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs 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 concrete diseases (arthritis, bronchial astma 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 blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

Warnings and precautions

Pregnancy and lactation:
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 a case when the benefit for a mother overweights a potential risk for a fetus. Ascorbic acid penetrates into breast milk, therefore during lactation period the preparation must be used under the doctor's control.

Children:
Ascozin® is not administered to children.

PRECAUTIONS:
During Ascozin® administration in high doses it is necessary a control of liver function and blood pressure (due to stimulation of corticosteroid formation by vitamin C), and also pancreas gland (due to insular apparatus inhibition by the preparation).
It is administered with caution in deficit of glucose-6-phosphatdehydrogenase, kidney dysfunction (hyperoxalaturia, urolithiasis in anamnesis etc.); in urolithiasis a daily dose of vitamin C should not exceed 1 g.
The preparation can change the results of different laboratory tests (content of glucose, bilirubin in blood, activity of transaminase and lactatedehydrogenase). During a long-term treatment it is necessary a control of glucose level (especially in high dose administration).
As ascorbic acid increases iron absorption, its administration in high doses can be dangerous for patients with hemochromatosis, thalassemia, polycythemia, leukemia and sideroblastic anemia. In patients with high iron content in organism ascorbic acid should be used in minimal dose.
It is necessary to administer Ascozin® with caution to patients with progressive cancroid disease, because its administration can accelerate clinical course.

Ability to influence reaction velocity while driving or operating any other mechanisms.
There are no reports that the preparation can have a negative influence on drivers or people who work with sophisticated mechanisms.

Overdosage and Contraindications

Overdose:
Symptoms:
nausea, vomiting, intestine spasm, diarrhea;
it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

Treatment:
It is symptomatic.
> CONTRAINDICATIONS:
Hypersensitivity to ascorbic acid. Thrombophlebitis, inclination to thrombosis, pancreatic diabetes. Children age less than 18 years old.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

As antioxidant, metabolic, and redox processes regulating agent ascorbic acid (vitamin C) 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 carbohydrate metabolism, aromatic amino acid, pigments and cholesterine; in synthesis of steroid hormones, catecholamines, 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 generating functions; it enhances synthesis of collagen and prothrombin. It improves bile excretion, renews exocrinous function of pancreas. It inhibits excretion and accelerates histamine degradation, inhibits formation of prostaglandins and other inflammation and anaphylactic mediators. It regulates immunological reactions (it activates synthesis of antibody, C3-component of complement, interferon), facilitates phagocytosis, elevates organism resistance to infections. It has an anti-inflammatory and anti-allergic action.
Daily maintenance in ascorbic acid in adults is 70 – 100 mg, in pregnant women and during lactation – 100 – 120 mg, in children and adolescents due to their age – 30 – 70 mg. Vitamin C deficit in meal causes a development of C hypo- or avitaminosis as far as this vitamin is not synthesized in organism.
Zink is a structural component of biological membranes, cell receptors, proteins; it enters into compositions of more than 200 enzyme systems. It takes part in reactions of immune and anti-oxidant protection, blood formation, amino acids synthesis, in genetic information preservation and transmission. Being a component of protein, which transmits retinol, zinc together with vitamin A and vitamin C prevents immune deficit formation, stimulating antibody synthesis and causing antiviral action. It is necessary for formation of erythrocyte and other blood corpuscle. Zinc normalizes lipometabolism, provides normal function of endocrine gland, including synthesis of insulin, growth hormone, corticotropin and somatropin. It maintains sexual and reproductive functions – it is necessary for metabolism of vitamin E, which is a precursor of sexual hormones and is included into testosterone production; zinc is also important for normal prostata gland functioning. Daily maintenance in zinc is 15 mg.
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 mkg/ml. Depo level in organism is approximately 1.5 g. About 25% of it is bound with plasma proteins, deposited in posthypophysis, adrenal gland cortex, eye epithelium, perineal cells of seminal gland, ovary, liver, brain, spleen, pancreas, pulmones, kidney, intestine wall, heart, muscle, thyroid gland. It easily penetrates into leucocyte, thrombocyte and almost into all tissues from plasma. It is boitransformed 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, helminthic invasion, lambliasis), usage of fresh fruit and vegetable juice, alkaline drinking. The preparation excretion is increased during increasing of its concentration in plasma up to more 1.4 mg/100 ml. The preparation absorption is decreased when fresh fruit and vegetable juice, alkaline drinking are used. Smoking and ethyl alcohol abuse accelerates ascorbic acid decay (transformation into inactive metabolites), sharply decreasing its reserve in organism.
Absorbed in intestine zinc is distributed in tissues and included to compositions of enzyme series and biologically active substances. 90% of zinc is excreted from organism with faeces and 2 – 10 – with urine. Calcium additives and ration rich in calcium (dairy products) have an ability to reduce zinc digestion nearly by 50%, and caffeine and alcohol intensively remove it from the organism.

PHARMACEUTICAL CHARACTERISTICS:
General physic-chemical properties: Round biconvex light-orange tablets with uniformly distributed spots.

Shelf-life:
2 years.

Storage:
Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Package:
There are 10 tablets in a strip, there are 3 strips are in a carton box No. 30 (10 x 3).
There are 10 tablets in a strip, there are 10 strips are in a carton box No. 100 (10 x 10).

Conditions of supply:
Without prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575