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:



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.

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.

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.

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.

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.