Cevicap - instructions for use, dose, side effects, contraindications

Ascorbic acid (vitamin C) takes part in many metabolic reactions, affects immunity, detoxification processes, cholesterol metabolism, iron absorption, conversion of folic acid into its active form - folinic acid, and also prevents peroxidation processes. Ascorbic acid takes part in the biosynthesis of collagen, elastin and proteoglycans, participates in the formation of connective tissue, which integrates and supports the intracellular structure of all tissues of the body. Collagen, which constitutes 30-40% of body proteins, is the main building component of connective tissue, is a part of the skin, endothelium of blood vessels, ligaments, tendons, bones, teeth, cornea, and intercellular substance. Affects the healing processes of wounds, diaper rash, bone fractures.

Pharmacokinetics:

After oral administration ascorbic acid well absorbed from the gastrointestinal tract.

Approximately 25% of ascorbic acid binds to plasma proteins.

Rapidly penetrates from the blood into virtually all tissues and biological fluids (including through the placental barrier and into milkbreastfeeding women).

The concentration of ascorbic acid in blood plasma - a healthy person is 0.8 - 1.5 mg / 100 ml.

Ascorbic acid reversibly oxidizes to form dehydroascorbic acid. Part is metabolized with the formation of ascorbate-2-sulfate (inactive) and oxalic acid and excreted in the urine.

Excretion of ascorbic acid is controlled by the renal threshold, which for vitamin C is 1.5 mg / 100 ml. Vitamin C, taken in excessive amounts, is quickly excreted unchanged by the kidneys.

Indications:

In the complex therapy of conditions accompanied by an increased need for vitamin C:

- "catarrhal" diseases and infectious diseases of the upper respiratory tract to increase the body's resistance;

- in the period of convalescence after the transferred diseases.

Prevention of vitamin C deficiency with:

- artificial feeding of infants;

- unbalanced and malnutrition.

Contraindications:

Hypersensitivity to the components of the drug. The introduction of large doses - hypercoagulation, thrombophlebitis, a tendency to thrombosis, diabetes mellitus, renal stone disease, a deficiency of glucose-6-phosphate dehydrogenase.

Carefully:

hyperoxaluria, oxalosis, renal failure, hemochromatosis, thalassemia, polycythemia, leukemia, sideroblastic anemia, sickle cell anemia, malignant neoplasms.

Pregnancy and lactation:

The minimum daily requirement for ascorbic acid in II-III trimesters of pregnancy - about 60 mg.

The minimum daily requirement for breastfeeding is 80 mg. A mother's diet containing an adequate amount of ascorbic acid is sufficient to prevent vitamin C deficiency in an infant (it is recommended not to exceed the maximum monthly requirement for ascorbic acid in a nursing mother).

Dosing and Administration:

Inside.

Drops can be given in one or more doses, preferably with meals. For infants it is recommended to dissolve drops with water, tea or add to food.

One drop contains 5 mg of vitamin C.

Prophylactically:

- infants and children of the first year of life: 5-6 drops (about 25-30 mg) per day;

- children from 2 to 11 years: 10 drops (about 50 mg) per day;

- adolescents from 12 to 17 years: 10 - 12 drops (about 50 -60 mg) per day.

- adults 20-30 drops (about 100-250 mg) per day.

For adults, therapeutic doses are 2-5 times higher than preventive, but not more than 1.0 g per day (depending on the indications).

Side effects:

From the central nervous system: headache, fatigue, with prolonged use of large doses - increased central nervous system excitability, sleep disturbance.

From the gastrointestinal tract: irritation of the mucous membrane of the gastrointestinal tract, nausea, vomiting, diarrhea, stomach cramps.

On the part of the endocrine system: oppression of the function of the insular apparatus pancreas (hyperglycemia, glucosuria).

From the side of the urinary system: when used in high doses - hyperoxaluria and the formation of urinary stones from calcium oxalate, damage to the glomerular apparatus of the kidneys.

From the cardiovascular system: a decrease in the permeability of capillaries and worsening trophism of tissues, thrombosis, when used in high doses - increased blood pressure, the development of microangiopathies, myocardial dystrophy.

Allergic reactions: skin rash, rarely - anaphylactic shock.

Prolonged use of high doses of ascorbic acid can lead to addiction, which can lead to symptoms of vitamin C deficiency after drug withdrawal.Laboratory Indicators: thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia.

Other: hypervitaminosis, sensation of heat, with prolonged use of large doses - sodium retention (Na⁺) and liquid.

Overdose:

When taking more than 1 g per day, heartburn, diarrhea, difficulty urinating and / or staining the urine red, hemolysis (in patients with deficiency of glucose-6-phosphate dehydrogenase) are possible.

Treatment: symptomatic, stopping the intake of vitamin C.

If any side effects occur, stop taking the medication and consult a doctor.

Interaction:

Ascorbic acid increases, the concentration in the blood of benzylpenicillin and tetracyclines; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol (as part of oral contraceptives). Improves absorption in the intestines of iron preparations (converts trivalent iron into bivalent); can increase the excretion of iron with simultaneous application with deferoxamine. Reduces the effectiveness of heparin, indirect anticoagulants. Acetylsalicylic acid, oral contraceptives, fresh juices and alkaline drink - reduce absorption and assimilation of ascorbic acid.With simultaneous use with acetylsalicylic acid, the urinary excretion of ascorbic acid increases and the excretion of acetylsalicylic acid decreases. Acetylsalicylic acid reduces the adsorption of ascorbic acid by about 30%. Ascorbic acid increases the risk of developed crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood. Increases the total clearance of ethanol, which, in turn, reduces the concentration of ascorbic acid in the body. Preparations of quinoline series, calcium chloride, salicylates, glucocorticosteroids with long-term use deplete the stores of ascorbic acid. With simultaneous use reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it may interfere with the interaction Disulfiram - ethanol. In high doses increases the renal excretion of mexiletan. Barbiturates and pyramidone increase the excretion of ascorbic acid in the urine.Reduces the therapeutic effect of neuroleptics (phenothiazine derivatives), tubular reabsorption of amphetamine and tricyclic antidepressants.

Special instructions:

Cevicap ® - a solution of vitamin C in the form of drops specially designed for children - makes it possible to take small, children's doses of ascorbic acid.

In connection with the stimulating effect of ascorbic acid on the synthesis of glucocorticosteroid hormones, it is necessary to monitor the function of the adrenal glands, arterial pressure.

With prolonged use of large doses, oppression of the insulin function of the pancreas is possible, so during treatment it must be regularly monitored. Patients with elevated iron levels in the body should use ascorbic acid in minimal doses. Assigning ascorbic acid to patients with rapidly proliferating and intensely metastatic tumors can aggravate the course of the process. Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests (blood glucose, bilirubin, transaminase activity).

Long-term use of high doses of ascorbic acid may accelerate its metabolism, so after the drug can be withdrawn paradoxical hypovitaminosis can develop.

Form release / dosage:

Drops for ingestion 100 mg / ml.

Packaging:

10 ml or 30 ml in bottles of dark glass with a polyethylene stopper and a screwed polyethylene cap with a warranty ring "first opening".

1 bottle with instructions for use in a cardboard box.

Storage conditions:

Store in a tightly closed bottle at a temperature of 15 ° C to 25 ° C.

Protect from light.

Keep out of the reach of children.

Shelf life:

2 years

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-008820/08

Date of registration:06.11.2008

The owner of the registration certificate:Medan Pharma, Joint Stock CompanyMedan Pharma, Joint Stock Company Poland

Manufacturer: & nbsp

MEDANA PHARMA, S.A. Poland

Representation: & nbspPolish Medicines Ltd.Polish Medicines Ltd.

Information update date: & nbsp15.12.2008

Illustrated instructions

Instructions

Cevicap® (Cevikap®)