Folic acid (Tablets) Instructions for Use

ATC Code

B03BB01 (Folic acid)

Active Substance

Folic acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Antianemic drugs; vitamin B12 and folic acid; folic acid and its derivatives

Pharmacological Action

A B vitamin (vitamin B_c, B₉). 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. It stimulates erythropoiesis, participates in the synthesis of amino acids (including methionine, serine), nucleic acids, purines and pyrimidines, and in the metabolism of choline and histidine.

During pregnancy, it protects the body from the effects of teratogenic factors. It promotes the normal maturation and function of the placenta.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract.

Plasma protein binding is high. It is metabolized in the liver and tissues. It is excreted in bile and urine. It crosses the blood-brain barrier, placenta, and is excreted in breast milk.

Indications

Macrocytic hyperchromic anemia caused by folic acid deficiency.

As part of combination therapy for the following diseases: anemia and leukopenia caused by drugs and ionizing radiation; sprue; chronic gastroenteritis; intestinal tuberculosis.

At the planning stage and during pregnancy to prevent the development of neural tube defects in the fetus in the presence of risk factors in the mother.

Treatment of megaloblastic anemia due to folic acid deficiency or increased utilization (including during pregnancy, malabsorption syndrome).

ICD codes

Dosage Regimen

Determine dosage individually based on indication, clinical status, and formulation.

For macrocytic hyperchromic anemia due to confirmed folate deficiency, administer 1-5 mg daily for adults.

For megaloblastic anemia treatment, use up to 15 mg daily; duration depends on hematological response.

In pregnancy for neural tube defect prophylaxis, prescribe 400-800 mcg daily; initiate before conception and continue through the first trimester.

For women with a previous pregnancy affected by a neural tube defect, increase dosage to 4-5 mg daily.

For malabsorption syndromes (e.g., sprue, chronic gastroenteritis), use 3-15 mg daily.

For drug-induced folate deficiency (e.g., from anticonvulsants), administer 5-10 mg daily.

Adjust dosage in patients with severe malabsorption; parenteral administration may be required.

Do not use for treating pernicious anemia or other anemias where vitamin B12 deficiency is present or untreated.

Monitor hematological parameters and serum B12 levels during long-term therapy.

Adverse Reactions

From the digestive system rarely – anorexia, nausea, abdominal distension, flatulence, bitter taste in the mouth.

From the immune system rarely – anaphylactic reactions (including shock).

Allergic reactions rarely – erythema, rash, itching, urticaria, dyspnea.

Contraindications

Hypersensitivity to folic acid; long-term therapy of patients with untreated cobalamin deficiency (e.g., pernicious anemia, vitamin B₁₂ deficiency, vegetarianism); malignant neoplasms; pregnant women without established folic acid deficiency and/or presence of risk factors for neural tube defects in the fetus; period of breastfeeding – depending on the dosage form; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Use in pregnant women without established folic acid deficiency and/or presence of risk factors for neural tube defects in the fetus is contraindicated.

Use during pregnancy is possible if indicated in recommended doses.

Use during lactation (breastfeeding) is possible strictly according to indications, in recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the folic acid drug leaflets regarding contraindications for use during breastfeeding for specific dosage forms of folic acid.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

In pernicious anemia, folic acid should be used only in conjunction with cyanocobalamin, because Folic acid, while 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 Interactions

With simultaneous use with chloramphenicol, neomycin, polymyxins, tetracyclines, the absorption of folic acid is reduced.

With simultaneous use of analgesics (long-term therapy), anticonvulsants (including phenytoin, carbamazepine), estrogens, parenteral contraceptives, the requirement for folic acid increases.

With simultaneous use of folic acid, a decrease in the plasma concentration of phenobarbital, phenytoin, primidone is possible, and the risk of an epileptic seizure increases.

With simultaneous use of antacids (including calcium, aluminum and magnesium preparations), cholestyramine, sulfonamides (including sulfasalazine), the absorption of folic acid is reduced.

Antacids should be taken 2 hours after taking folic acid, cholestyramine – 4-6 hours before or 1 hour after taking folic acid.

With simultaneous use, methotrexate, pyrimethamine, triamterene, trimethoprim inhibit dihydrofolate reductase and reduce the effect of folic acid.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.