Composition, form of production and packaging
? Tablets 1 tab.
potassium iodide 262 Ојg
in t.ch. iodine 200 Ојg
folic acid 0.4 mg
cyanocobalamin (Vit B 12 ) 0.002 mg
28 pcs. - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Folic acid belongs to the group B vitamins. In the body, folic acid is reduced to tetrahydrofolic acid, which participates in the synthesis of purines and pyrimidines, the exchange of choline, and as a whole in the metabolism of nucleic acids and proteins. This plays an important role in the formation of the central nervous system, which develops in humans on the 15-28th day after fertilization. Deficiency of folic acid causes the development of neural tube defects in the fetus.
Vitamin B and inside the cell exist in the form of two active coenzymes: methylcobalamin and adenosylcobalamin. Methylcobalamin is necessary for the work of methionine synthetase, which is involved in the metabolism of folic acid. This interaction of folic acid with cobalamin is necessary for the normal synthesis of purines and pyrimidines, and therefore DNA. With a deficiency of vitamin B 12 or folic acid, the reduced synthesis of methionine and S-adenosylmethionine disrupts many methylation reactions, the synthesis of proteins and polyamines.
Pharmacological action of the drug Jodilife is that its use allows you to overcome the metabolic blockade, which is observed in children with neural tube defects.
The specific nature of this metabolic blockade is the metabolism of the essential amino acid methionine, in which folic acid and vitamin B 12 are key elements, as they are responsible for the re-methylation of homocysteine ​​in methionine.
400 micrograms of folic acid is the minimum effective daily dose recommended by the Centers for Disease Prevention (US, UK and Australia) by healthy women as an additional daily intake to prevent the development of neural tube defects in the fetus. The recommended daily intake of vitamin B12 is 2 Ојg.
Iodine is the main element for the synthesis of thyroid hormones, thyroxine (T 4 ) and triiodothyronine (T 3 ) (the mass fraction of iodine in which is 65% and 59%, respectively). Thyroid hormones are necessary at all stages of life for the normal functioning of the central nervous system. Iodine is not only the main substrate of the thyroid gland used in the synthesis of iodine-containing thyroid hormones, but also directly affects the brain cells of the embryo.
PHARMACOKINETICS
Folic acid is rapidly absorbed in the jejunum, subject to reduction and methylation to 5-methyltetrahydrofolate. C max in plasma is observed after 30-60 min.
Intensively binds to plasma proteins. Penetrates through the blood-brain barrier, into the placenta and breast milk. It is excreted by the kidneys mainly in the form of metabolites. Vitamin B 12 can be absorbed after its interaction in the stomach with the internal Factor of the Castle, a glycoprotein that is secreted by parietal cells of the stomach. C max in plasma is observed after 8-12 hours. As in the case of folic acid, vitamin B 12 undergoes significant enterohepatic recirculation.
The average T 1/2 of vitamin B 12 is about 6 days. Part of the administered dose is excreted by the kidneys during the first 8 hours, although most of it is excreted with bile. 25% is excreted through the intestine. In addition, vitamin B12 penetrates the placenta and is present in human milk.
Vitamin B 12 is largely bound to plasma proteins, excess accumulates in the liver.
Iodine has a good absorption. It is believed that the coefficient of intestinal absorption of iodine after taking water-soluble iodine salts (eg, potassium iodide) is 100%.The mechanism of intestinal absorption of iodine is not known.
After completion of the absorption process, iodine rapidly spreads through the intercellular fluid. Iodine penetrates the placental barrier and is present in breast milk.Iodine is transported to other tissues (except thyroid tissue): the milk / salivary glands and the intestinal mucosa.
The main part of iodine is excreted by the kidneys and a small amount with saliva, milk, sweat, bile and through the intestine.
INDICATIONS
- prevention of deficiency of iodine, folic acid and vitamin B12 (cyanocobalamin) in women of childbearing age at the stage of pregnancy planning (at least 1 month before conception);
- Prevention of neural tube defects in the fetus in the first trimester of pregnancy.
DOSING MODE
1 tablet a day, before meals.
The course of preventive treatment in women of childbearing age at the stage of pregnancy planning is at least 1 month before conception and during the first trimester of pregnancy. Repeated courses on the recommendation of a doctor.
SIDE EFFECT
Disorders from the digestive tract: diarrhea, nausea, vomiting, bloating and pain in the abdominal cavity, flatulence, metallic taste in the mouth and increased salivation.
Disorders from the endocrine system: goiter, hyperthyroidism and hypothyroidism.
Disorders from the cardiovascular system: vasculitis, periarthritis with fatal outcome.
Immune system disorders: edema (including facial edema and glottis).
Disturbances from the skin: itching, rashes and erythema, urticaria, exanthema and angioedema.
Disorders from the blood and lymphatic systems: thrombocytopenic purpura.
Other disorders: hypersensitivity, general malaise, signs and symptoms similar to serum sickness: fever, joint pain, lymphatic cyst formation and eosinophilia.
CONTRAINDICATIONS
- lactation period;
- childhood;
- increased individual sensitivity to the components of the drug.
The preparation contains lactose. Patients with hereditary intolerance to galactose, deficiency of lactase or impaired absorption of glucose or galactose, the drug is contraindicated.
With a daily dose of more than 150 mg / day potassium iodide is contraindicated in patients with acute bronchitis, marked and latent hyperthyroidism.
With caution: hypokomplementemic vasculitis, goiter or autoimmune thyroiditis, kidney disease, chronic hyperkalemia, active tuberculosis, epilepsy.
PREGNANCY AND LACTATION
The drug is recommended for use during pregnancy.
The components of the drug penetrate into breast milk. Since there is currently no data on the use of the drug during this period, the drug is not recommended for use during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in kidney disease.
APPLICATION FOR CHILDREN
Contraindicated in childhood.
SPECIAL INSTRUCTIONS
It should be borne in mind that antibiotics can distort (give underestimated results) the results of analysis of the concentration of folic acid plasma and erythrocytes. In view of the influence of iodides on the thyroid gland, taking these medications can lead to a distortion of the results of thyroid function tests. Do not take a double dose of the drug if you missed the next appointment. The use of the drug does not affect the performance of potentially hazardous activities requiring special attention and quick reactions (vehicle management, working with moving mechanisms, dispatcher and operator work, etc.).
OVERDOSE
In case of overdose or accidental ingestion, immediately consult a doctor.
Symptoms of overdose: metallic taste in the mouth, increased sensitivity of teeth and gums, increased salivation, irritation of the mucous membrane of the nasal cavity, sneezing, swelling of the eyelids (symptoms known as "iodism").
In addition, with an overdose of the drug, severe headache, cough, pulmonary edema, impaired parotid and submandibular gland function, inflammation of the pharynx, larynx and tonsils, a mild skin rash at the seborrheal sites, and disorders of the gastrointestinal tract (diarrhea).
In case of an overdose, stop taking the drug and consult a doctor. Treatment is symptomatic.
DRUG INTERACTION
The drug Jodilife should not be taken in combination with methotrexate, pyrimethamine, triamterene, trimethoprim, because they act as antagonists of folic acid, inhibiting tetrahydrofolate reductase.
Taking the drug Jodilife in combination with antiepileptic drugs from the hydantoin group (phenytoin) can reduce the effect of the latter.
Analgesics (with prolonged therapy), estrogens and oral contraceptives increase the need for folic acid.
Antacids (including preparations of calcium, aluminum and magnesium), colestyramine, sulfonamides (including sulfasalazine) reduce the absorption of folic acid.
The simultaneous use of the drug with potassium-sparing diuretics can lead to a decrease in the elimination of potassium by the kidneys, as a result of which there will be a chance of severe chronic hyperkalemia.
Concomitant intake of lithium and potassium salts can lead to hypothyroidism.
Simultaneous use with antithyroid drugs can lead to increased hypothyroidism.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
At a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 3 years.
