Folic acid (Folic acid). Folic acid - instructions for use

Trade name of the drug:

International non-proprietary name:

Dosage form:

Compound:

Description:

Pharmacotherapeutic group:

ATX code:

Pharmacological properties

Pharmacodynamics

Vitamin B group (vitamin Bs, vitamin B 9) can be synthesized by the intestinal microflora. In the body, folic acid is reduced to tetrahydrofolic acid, which is a coenzyme that serves as an acceptor of one-carbon radicals. Participates in the synthesis of purine and pyrimidine bases, the metabolism of certain amino acids (for example, the interconversion of serine and glycine), the biosynthesis of the methyl radical of methionine and the degradation of histidine, as well as in the maturation of rapidly proliferating tissues, especially blood and the gastrointestinal tract. Folic acid deficiency leads to megaloblastic anemia; with folic acid deficiency in the first trimester of pregnancy, the development of the nervous system of the fetus is disrupted.

Pharmacokinetics
Folic acid is well and completely absorbed in the gastrointestinal tract, mainly in the proximal small intestine. It is restored in the lumen of the gastrointestinal tract, circulates in the blood mainly in the form of 5-methyltetrahydrofolic acid. The time to reach maximum plasma concentration is 30-60 minutes.
Intensively binds to plasma proteins. Penetrates through the blood-brain barrier, placenta and breast milk.
It is deposited and metabolized in the liver.
Excreted by the kidneys mainly as metabolites; if the dose taken significantly exceeds the daily requirement for folic acid, then it is excreted unchanged. Removed by hemodialysis.

Indications for use

• Treatment and prevention of anemia due to folic acid deficiency, including insufficient dietary intake, malabsorption, increased need (including pregnancy, lactation, hemolytic anemia, hyperthyroidism, exfoliative dermatitis or chronic infections).
• Prevention of folic acid deficiency during pregnancy and lactation.

Contraindications

Folate-dependent malignancies, the use of dihydrofolate reductase inhibitors (eg, methotrexate).

Use during pregnancy and during breastfeeding

Dosage and administration

Side effect

allergic reactions: rash, itching, erythema, bronchospasm, hyperthermia, anaphylactic reactions.
From the gastrointestinal tract: anorexia, nausea, bloating, bitter taste in the mouth, diarrhea.
From the side of the nervous system: irritability, sleep disturbance.
Others: with prolonged use, the development of hypovitaminosis B 12 is possible.

Overdose

Interaction with other drugs

special instructions

Influence on the ability to drive vehicles and mechanisms

Folic acid intake does not affect the ability to drive vehicles and engage in potentially hazardous activities that require increased concentration and psychomotor speed.

Release form

Storage conditions

Best before date

Holiday conditions

Manufacturer

Legal address:
445351, Russia, Samara region, Zhigulevsk, st. Pesochna, 11

Address of the place of production (address for correspondence, including for receiving claims):
445351, Russia, Samara region, Zhigulevsk, st. Gidrostroiteley, d. 6

Flat-cylindrical tablets, with a bevel, from pale yellow to yellow. Minor blotches of yellow are allowed.

Active ingredients

Brand

Release form

Tablets

Pharmacological effect

Vitamin B group (vitamin Bc, vitamin B9) can be synthesized by the intestinal microflora. In the body, folic acid is reduced to tetrahydrofolic acid, which is a coenzyme involved in various metabolic processes. It is necessary for the normal maturation of megaloblasts and the formation of normoblasts. Participates in the synthesis of amino acids (including glycine, methionine), nucleic acids, purines, pyrimidines, in the metabolism of choline, histidine.

Contraindications

Hypersensitivity to the components of the drug, B12 deficiency anemia, sucrase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, children under 3 years of age.

Use during pregnancy and lactation

Given that folic acid deficiency is especially dangerous in the first weeks of pregnancy, this vitamin is recommended to be taken in preparation for pregnancy, as well as during the entire period of bearing a baby, 1 mg daily. For therapeutic purposes, the dose can be increased to 5 mg per day. High doses of folic acid in the period of preparation for pregnancy and in the first third of it are also prescribed to women who have already had cases of the birth of children with folate-dependent malformations.

Dosage and administration

inside. Folic deficiency anemia: adults and children of any age, the initial dose is 1 mg / day. At high doses, resistance may occur. Maintenance treatment: for newborns - 0.1 mg / day, for children under 4 years old - 0.3 mg / day, for children over 4 years old and adults - 0.4 mg / day, during pregnancy and lactation - 0.8 mg / day, but not less than 0.1 mg / day. With hypo- and avitaminosis of folic acid (depending on the severity of avitaminosis), adults - up to 5 mg / day, children - in smaller doses, depending on age. The course of treatment is 20 - 30 days. With concomitant alcoholism, hemolytic anemia, chronic infectious diseases, after gastrectomy, malabsorption syndrome, with liver failure, cirrhosis, stress, the dose of the drug should be increased to 5 mg / day.

Side effects

Allergic reactions - skin rash, pruritus, bronchospasm, erythema, hyperthermia.

Overdose

Doses of folic acid up to 4-5 mg are well tolerated. Higher doses may cause central nervous system and gastrointestinal disturbances.

Interaction with other drugs

Anticonvulsants (including phenytoin and carbamazepine), estrogens, oral contraceptives increase the need for folic acid. Antacids (including calcium, aluminum and magnesium preparations), cholestyramine, sulfonamides (including sulfasalazine) reduce the absorption of folic acid. Methotrexate, pyrimethamine, triamterene, trimethoprim inhibit dihydrofolate reductase and reduce the effect of folic acid (calcium folinate should be given instead to patients using these drugs).

special instructions

For the prevention of hypovitaminosis of folic acid, a balanced diet is most preferable. Foods rich in folic acid - green vegetables (lettuce, spinach), tomatoes, carrots, fresh liver, legumes, beets, eggs, cheese, nuts, cereals. Folic acid is not used to treat B12-deficient, normocytic and aplastic anemia. With B12 - deficiency anemia, folic acid, improving hematological parameters, masks neurological complications. Until B12 deficiency anemia is ruled out, the appointment of folic acid in doses exceeding 0.1 mg / day is not recommended (with the exception of pregnancy and lactation).

Brand name: Folic acid

International non-proprietary name:

folic acid

Dosage form:

tablets

Folic acid composition:

1 tablet contains:

active substance:

folic acid - 0.001 g

Excipients:

lactose (milk sugar), stearic acid, potato starch, talc.

Description: tablets from light yellow to yellow, flat-cylindrical with a chamfer. Slight marbling is allowed.

Pharmacotherapeutic group:

ATX code:

Pharmacological properties

Pharmacodynamics:

Vitamin B group (vitamin Bc, vitamin B9) can be synthesized by the intestinal microflora. In the body, folic acid is reduced to tetrahydrofolic acid, which is a coenzyme involved in various metabolic processes. It is necessary for the normal maturation of megaloblasts and the formation of normoblasts. Stimulates erythropoiesis, participates in the synthesis of amino acids (including glycine, methionine), nucleic acids, purines, pyrimidines, in the metabolism of choline, histidine.

Pharmacokinetics:

Folic acid, prescribed as a drug, is well and completely absorbed in the gastrointestinal tract, mainly in the upper duodenum (even in the presence of malabsorption syndrome on the background of tropical sprue, at the same time, food folates are poorly absorbed in malabsorption syndrome). Intensively binds to plasma proteins.

Penetrates through the blood-brain and placental barriers and passes into breast milk.

Time to reach maximum plasma concentration (TC m ah) is 30-60 minutes.

It is deposited and metabolized in the liver with the formation of tetrahydrofolic acid (in the presence of ascorbic acid under the action of dihydrofolate reductase).

Excreted by the kidneys mainly as metabolites; if the accepted dose significantly exceeds the daily requirement for folic acid, then it is excreted unchanged.

Excreted by hemodialysis.

Folic acid indications for use

Treatment of megaloblastic anemia due to folic acid deficiency. Prevention and treatment of folic acid deficiency in tropical and non-tropical sprue, malnutrition.

Contraindications

Hypersensitivity to the components that make up the drug; childhood; B12 deficiency anemia.

Use during pregnancy and lactation

Folic acid method of administration and dosage

The drug is used orally, after eating 1 mg / day. At high doses, resistance may occur.

The course of treatment is 20-30 days.

Side effect

Allergic reactions - skin rash, pruritus, bronchospasm, erythema, hyperthermia.

Overdose

Data on overdose are not available.

Interaction with other drugs

Anticonvulsants (including phenytoin and carbamazepine), estrogens, oral contraceptives increase the need for folic acid. Folic acid reduces the effectiveness of phenytoin.

Antacids (including calcium, aluminum and magnesium preparations), cholestyramine, sulfonamides (including sulfasalazine) reduce the absorption of folic acid.

Methotrexate, pyrimethamine, triamterene, trimethoprim inhibit dihydrofolate reductase and reduce the effect of folic acid (calcium folinate should be given instead to patients using these drugs).

special instructions

Folic acid is not used to treat B12-deficient (pernicious), normocytic and aplastic anemia. With pernicious (B12-deficient) anemia, folic acid, improving hematological parameters, masks neurological manifestations. Until pernicious anemia is excluded, the appointment of folic acid in doses exceeding 0.1 mg / day is not recommended (with the exception of pregnancy and lactation).

Patients on hemodialysis require increased amounts of folic acid (up to 5 mg/day).

During treatment, antacids should be used 2 hours after taking folic acid, cholestyramine - 4-6 hours before or 1 hour after taking folic acid. It should be borne in mind that antibiotics can distort (deliberately underestimate) the results of microbiological assessment of the concentration of folic acid in plasma and erythrocytes.

Composition and form of release
tablets 1 mg, 50 pcs. packaged

pharmachologic effect
Replenishes folic acid deficiency, stimulates erythropoiesis.

Folic acid - folacin, water-soluble folate, vitamin B9. In the body, it is converted into tetrahydrofolic acid, which is necessary for the maturation of megaloblasts and their transformation into normoblasts. With its deficiency, a megaloblastic type of hematopoiesis develops. It occupies an important place in the metabolism of purines and pyrimidines, the synthesis of nucleic acids, the metabolism of amino acids (glycine, methionine and histidine). After ingestion, folic acid, combining in the stomach with the internal factor of Castle (a specific glycoprotein), is absorbed in the upper part of the duodenum. Almost completely bound to plasma proteins. It undergoes activation in the liver under the influence of the enzyme dihydrofolate reductase, turning into tetrahydrofolic acid. Cmax in the blood is reached in 30-60 minutes. It is excreted by the kidneys both unchanged and as metabolites.

Indications
Megaloblastic anemia, sprue, drug and radiation anemia and leukopenia, post-resection anemia, chronic gastroenteritis, intestinal tuberculosis, folic acid deficiency.
Prevention of folic acid deficiency in the body (including during pregnancy and lactation).

Contraindications
Hypersensitivity to folic acid.
Folic acid can be used during pregnancy and lactation at the recommended doses.

Dosage and administration
For medicinal purposes adults - 5 mg / day; children - in smaller doses depending on age. The course of treatment is 20-30 days.
To prevent folic acid deficiency in the body is used in doses of 20-50 mcg / day.

The daily requirement for folic acid is for children 1-6 months - 25 mcg, 6-12 months - 35 mcg, 1-3 years - 50 mcg, 4-6 years - 75 mcg, 7-10 years - 100 mcg, 11- 14 years - 150 mcg, 15 years and older - 200 mcg.
During pregnancy- 400 mcg / day, during lactation - 300 mcg / day.

Side effect
Allergic reactions: bronchospasm, erythema, fever, skin rashes.

special instructions
In pernicious anemia, folic acid should only be used in conjunction with cyanocobalamin, since folic acid, by stimulating hematopoiesis, does not prevent the development of neurological complications (including funicular myelosis). Long-term use of folic acid (especially in high doses) is not recommended due to the risk of reducing the concentration of cyanocobalamin in the blood.

drug interaction
With simultaneous use with chloramphenicol, neomycin, polymyxins, tetracyclines, the absorption of folic acid decreases.
With simultaneous use, folic acid reduces the effects of phenytoin, primidone, PAS, sulfasalazine, hormonal contraceptives for oral administration, chloramphenicol.
Folic acid increases the metabolism of phenytoin.

Storage conditions
In a dry, dark place, at a temperature not exceeding 25 ° C

Best before date: 3 years.

Compound

Description of the dosage form

Flat-cylindrical tablets with a chamfer, from pale yellow to yellow. Minor blotches of yellow are allowed.

pharmachologic effect

Pharmacodynamics

Vitamin B group (vitamin B c, vitamin B 9) can be synthesized and is necessary for the normal maturation of megaloblasts and the formation of normoblasts. Participates in the synthesis of amino acids (including glycine, methionine), nucleic acids, purines, pyrimidines, in the metabolism of choline, histidine.

Pharmacokinetics

Folic acid is well and completely absorbed in the gastrointestinal tract, mainly in the upper duodenum (even in the presence of malabsorption syndrome against the background of tropical sprue).

Intensively binds to plasma proteins. Penetrates through the BBB, the placenta, and also into breast milk. T max - 30-60 min. It is deposited and metabolized in the liver with the formation of tetrahydrofolic acid (in the presence of ascorbic acid under the action of dihydrofolate reductase).

Excreted by the kidneys mainly as metabolites. If the accepted dose significantly exceeds the daily requirement for folic acid, then it is excreted unchanged.

Excreted by hemodialysis.

Indications for Folic acid

folate deficiency anemia;

hypo- and avitaminosis of folic acid (including with tropical sprue, celiac disease, malnutrition).

Contraindications

hypersensitivity to the components of the drug;

B 12 - deficiency anemia;

sucrase deficiency;

isomaltase deficiency;

fructose intolerance;

glucose-galactose malabsorption;

children's age (up to 3 years).

Carefully: folate deficiency anemia with cyanocobalamin deficiency.

Use during pregnancy and lactation

Considering that folic acid deficiency is especially dangerous in the first weeks of pregnancy, this vitamin is recommended to be taken in preparation for pregnancy, as well as during the entire period of gestation, 1 mg daily.

The dose and degree of risk cannot be determined independently, only the attending physician should do this.

Side effects

Allergic reactions - skin rash, pruritus, bronchospasm, erythema, hyperthermia.

Interaction

Anticonvulsants (including phenytoin and carbamazepine), estrogens, oral contraceptives increase the need for folic acid.

Antacids (including calcium, aluminum and magnesium preparations), cholestyramine, sulfonamides (including sulfasalazine) reduce the absorption of folic acid.

Methotrexate, pyrimethamine, triamterene, trimethoprim inhibit dihydrofolate reductase and reduce the effect of folic acid (calcium folinate should be given instead to patients using these drugs).

There is no unequivocal information regarding zinc preparations: some studies show that folate inhibits zinc absorption, others refute these data.

Dosage and administration

inside.

Folate deficiency anemia: adults and children of any age, the initial dose is 1 mg / day. At high doses, resistance may occur.

Supportive care: for newborns - 0.1 mg / day; for children under 4 years old - 0.3 mg / day; for children over 4 years old and adults - 0.4 mg / day; during pregnancy and lactation - from 0.1 to 0.8 mg / day.

With hypo- and avitaminosis of folic acid (depending on the severity of avitaminosis): adults - up to 5 mg / day; children - in smaller doses depending on age. The course of treatment is 20-30 days.

With concomitant alcoholism, hemolytic anemia, chronic infectious diseases, after gastrectomy, malabsorption syndrome, with liver failure, cirrhosis, stress, the dose of the drug should be increased to 5 mg / day.

Overdose

Doses of folic acid up to 4-5 mg are well tolerated. Higher doses may cause CNS and GI disturbances.

special instructions

For the prevention of hypovitaminosis of folic acid, a balanced diet is most preferable. Foods rich in folic acid: green vegetables (lettuce, spinach), tomatoes, carrots, fresh liver, legumes, beets, eggs, cheese, nuts, cereals.

Folic acid is not used to treat B12 deficiency, normocytic and aplastic anemia. With B 12 -deficiency anemia, folic acid, improving hematological parameters, masks neurological complications. Until B12-deficiency anemia has been ruled out, the administration of folic acid in doses exceeding 0.1 mg / day is not recommended (with the exception of pregnancy and lactation).

It should be borne in mind that patients on hemodialysis need increased amounts of folic acid.

During treatment, antacids should be used 2 hours after taking folic acid, cholestyramine - 4-6 hours before or 1 hour after taking folic acid. It should be borne in mind that antibiotics can distort (deliberately underestimate) the results of microbiological assessment of the concentration of folic acid in plasma and erythrocytes. When using large doses of folic acid, as well as during therapy for a long period, a decrease in the concentration of vitamin B 12 (cyanocobalamin) is possible.