Elevit pronatal coated tablets №30

Description

Elevit №30 Dosage form
Film-coated tablets.

Main physical and chemical properties: grayish-yellow oval tablets, film-coated, with a dividing line.

Elevit №30 Pharmacotherapeutic group
Multivitamins with other minerals, including combinations.

ATX code A11A A03

Elevit №30 Pharmacological properties

Pharmacodynamics.

Elevit® Pronatal is a multivitamin-mineral preparation containing 12 vitamins in combination with three minerals and four microelements, specially designed to provide optimal micronutrient support for both the fetus and the expectant mother.

Vitamins are vital for the normal development and growth of the fetus and newborn, for metabolism and the formation of carbohydrates, energy, lipids, nucleic acids and proteins, as well as for the synthesis of amino acids, collagen and neurotransmitters.

Multivitamin-multimineral drugs are indicated for the prevention and correction of micronutrient nutrient deficiencies. Pregnancy and breastfeeding are periods of increased need for micronutrients, which increases the risk of micronutrient deficiencies for both mother and child. Micronutrient deficiencies pose a more serious health risk, especially during pregnancy, as they can also interfere with the normal fetal development.

The evaluation of the efficacy and safety of Elevit® Pronatal during pregnancy planning (one month before conception and up to the third month of gestation) revealed no neural tube defects compared to 6 cases in the placebo group. The difference was statistically significant and was confirmed in a subsequent pharmacoepidemiological two-cohort study in which 1 case of neural tube defect was observed in the Elevit® Pronatal group compared with 9 cases in the control group without vitamin support. In addition, both studies found that the overall rate of severe malformations (eg, urinary tract, cardiovascular, limb defects, and hypertrophic pylorostenosis) was lower in the Elevit® Pronatal group compared with the placebo group or the control group without adding vitamins accordingly. It was also found that in the Elevit® Pronatal group, nausea, vomiting and dizziness were 2 times less common than in the placebo group.

The level of folate in the erythrocytes of a pregnant woman is an indicator of the possible development of a neural tube defect in the fetus. The folate thresholds associated with the lowest risk of neural tube defects were 906 nmol / L.

The addition of Elevit® Pronatal is recommended for women when planning a pregnancy because neural tube defects occur in the first weeks after conception, even before pregnancy can be diagnosed.

Pharmacokinetics.

No pharmacokinetic studies have been performed with Elevit® Pronatal.

Indication
To prevent and correct vitamin and mineral deficiencies during pregnancy planning, during pregnancy and during breastfeeding.

Use the drug at least 1 month before fertilization to reduce the risk of neural tube defects and other congenital malformations.

To prevent the development of anemia associated with iron and folic acid deficiency during pregnancy and breastfeeding.

To reduce the frequency of nausea and vomiting in the early stages of pregnancy.

Contraindication
Hypersensitivity to any of the components of the drug, hypervitaminosis A and / or D, concomitant use with drugs containing vitamin A and / or D, treatment with vitamin A or synthetic isomers of isotretinoin and etretinate or beta-carotene (beta-carotene is considered a source of vitamin A), concomitant use of retinoids; severe renal impairment, iron and / or copper metabolism disorders, hypercalcemia, severe hypercalciuria, history of sarcoidosis, active forms of pulmonary tuberculosis, gastric and duodenal ulcers in the acute stage, hypervitaminosis E.