Instructions Folic acid Astra tablets 5 mg blister No. 50
Composition
active ingredient: folic acid hydrate;
1 tablet contains folic acid hydrate 5 mg;
Excipients: microcrystalline cellulose; lactose monohydrate; povidone; crospovidone; magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: flat-cylindrical tablets with beveled edges and a score, pale yellow to yellow in color. Minor orange inclusions are allowed on the surface of the tablet.
Pharmacotherapeutic group
Folic acid and its derivatives. Folic acid.
ATX code V0ZV V01.
Pharmacological properties
Pharmacodynamics.
After taking the drug, folic acid is reduced to tetrahydrofolate, which acts as 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 methionine, serine, glycine and histidine), nucleic acids, purines, pyrimidines, participates in choline metabolism. Performs a protective function against the effects of teratogenic factors. In addition, it contributes to the normal maturation and functioning of the placenta.
Folic acid plays an important role in the process of sperm maturation and can be used to treat male infertility.
Folic acid deficiency leads to the development of megaloblastic hematopoiesis - in pregnant women, this can lead to the development of congenital defects in the fetus (neural tube defects, hydrocephalus, etc.). The most serious consequence of folic acid deficiency is a decrease in the ability to repair damaged tissues.
Pharmacokinetics.
Folic acid is well absorbed from the gastrointestinal tract, mainly from the duodenum and small intestine. It is evenly distributed throughout all tissues, selectively concentrated in the cerebrospinal fluid. The highest concentration in blood plasma is reached 30–60 minutes after oral administration.
In plasma and liver it is metabolized to 5-methyltetrahydrofolate, an active substance that binds to glutamic acid and forms a coenzyme. Approximately 50% of the total folic acid supply is stored in the liver. About 70% is bound to plasma proteins. It is excreted in the urine by glomerular filtration. After taking a dose of 5 mg, it will be excreted in the urine after 5 hours.
Indication
For the treatment and prevention of anemias associated with folic acid deficiency: macrocytic anemia; anemia and leukopenia caused by drugs and ionizing radiation; megaloblastic anemia, post-resection anemia; anemia in inflammatory bowel diseases (Crohn's disease, ulcerative colitis), malabsorption syndrome (gluten enteropathy or celiac disease), sprue.
For the prevention of the development of congenital fetal defects (nerve trunk defects: hydrocephalus, brain hernias, "cleft palate", "hare lip") in women planning pregnancy and at risk. Folic acid deficiency associated with unbalanced or inadequate nutrition.
For the treatment of male infertility due to reduced spermatogenesis (oligospermia).
Contraindication
Hypersensitivity to folic acid or to other components of the drug, malignant neoplasms, pernicious anemia, untreated cobalamin deficiency.
Interaction with other medicinal products and other types of interactions
Folic acid may reduce the plasma concentrations of phenobarbital, phenytoin and primidone, thereby increasing the likelihood of epileptic seizures. Folic acid may affect the toxic and therapeutic effects of methotrexate. Antibacterial drugs, cycloserine, glutethimide, chloramphenicol and cotrimoxazole may affect folate metabolism. Ethanol and acetylsalicylic acid may increase the elimination of folic acid. With the simultaneous use of cholestyramine and folic acid, a decrease or change in absorption is possible. Therefore, the drug should be taken 1 hour before or 4-6 hours after taking cholestyramine.
Folate increases the effectiveness of lithium. Nitrous oxide can cause acute folic acid deficiency. Concomitant combination with fluorouracil should be avoided. Antacids containing aluminum or magnesium can reduce the absorption of folic acid, so patients should be advised to take antacids 2 hours after taking folic acid. Folic acid can reduce the absorption of zinc in the intestine. Folic acid deficiency can be caused by drugs such as oral contraceptives, antituberculosis drugs, folic acid antagonists such as pyrimethamine, triamterene, trimethoprim, sulfonamides, anticonvulsants, chloramphenicol, cytostatics, analgesics.
The drug cannot be used together with mineral acids, alkaline substances, and reducing agents, as folic acid is inactivated.
Application features
The drug should be prescribed with caution to patients with anemia of unknown etiology, since folic acid can interfere with the diagnosis of pernicious anemia, alleviating the hematological manifestations of the disease and allowing neurological complications to progress. In the case of pernicious anemia, the drug should be used only together with cyanocobalamin, since folic acid, stimulating hematopoiesis, does not prevent the development of neurological complications (funicular myelosis, etc.). In sprue, folic acid should be used in combination with ascorbic acid, cyanocobalamin and with hemotherapy.
Long-term use of folic acid, especially in high doses, is not recommended due to the risk of reducing blood concentrations of cyanocobalamin.
When treating with folic acid, systematic monitoring of blood conditions is necessary.
The tablets contain lactose, therefore their use is not recommended for patients with rare hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
For elderly patients, a cobalamin absorption test should be performed before starting long-term therapy.
Use during pregnancy or breastfeeding.
This medicine is not intended for healthy pregnant women. The medicine is prescribed to pregnant women with folic acid deficiency and to women at risk who are planning a pregnancy, to prevent the development of congenital defects in the fetus: neural tube defects (hydrocephalus, cerebral hernias, cleft palate, hare lip).
The drug can be used during breastfeeding in recommended doses. Folic acid passes into breast milk.
Folic acid deficiency, or impaired folate metabolism, has been associated with birth defects and some neural tube defects. Interference with folate metabolism or folic acid deficiency due to the use of certain drugs, such as anticonvulsants and antineoplastic agents, in early pregnancy has been associated with congenital anomalies. Lack of the vitamin or its metabolites may also contribute to spontaneous abortion and intrauterine growth retardation.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
When used properly, folic acid does not affect the ability to drive or operate other machinery.
Method of administration and doses
For therapeutic purposes, adults and women during breastfeeding are prescribed 2.5–5 mg (1/2–1 tablet) per day. The course of treatment is 20–30 days. It is recommended to conduct 2–3 courses with a break of 1 month. It is recommended to combine the use of the drug for a long time with the intake of vitamin B12 (cyanocobalamin).
Women planning pregnancy and at risk should be prescribed 5 mg (1 tablet) daily for 4 weeks before pregnancy and continue during the first 3 months of pregnancy to prevent the development of congenital neural tube defects in the fetus.
For the prevention of folic acid deficiency associated with unbalanced or inadequate nutrition - 2.5–5 mg (1/2–1 tablet) per day. The course of treatment is 20–30 days.
It is recommended to repeat the treatment course after 1 month.
For megaloblastic anemia, prescribe 5 mg (1 tablet) of folic acid per day for
4 months (for prevention, the recommended dose is 2.5 mg (1/2 tablet) per day).
Patients with sprue, macrocytic anemia, malabsorption, and inflammatory bowel diseases are recommended to take 5–15 mg (1–3 tablets) per day.
For celiac disease, it is recommended to take 5–15 mg per day.
For the treatment of male infertility due to reduced spermatogenesis (oligospermia), it is recommended to prescribe 5 mg (1 tablet) per day. The duration of treatment is determined individually by the doctor.
Children.
Do not use on children.
Overdose
No cases of overdose have been reported. Use in very high doses should not harm the patient.
An overdose of folic acid can mask a vitamin B12 deficiency.
Prolonged and significant excess of recommended doses can cause a dangerous accumulation of folacin crystals, leading to intoxication of the body and increased side effects.
Treatment: drug withdrawal, symptomatic therapy.
Side effects
"Folic Acid Astra" is well tolerated.
Adverse reactions are classified according to organ systems and listed by frequency: very common
(≥ 1/10) ≥ 10%; often (≥ 1/100 and <1/10) > 1% and < 10%; very rarely (≥ 1/1000 and < 1/100) > 0.1% and
< 1%; rare (≥ 1/10,000, < 1/1,000) 0.01% and < 0.1%; very rare (< 1/10,000) < 0.01%, unknown (cannot be estimated due to lack of data).
Gastrointestinal tract: rarely - anorexia, nausea, bloating, flatulence, vomiting, bitter taste in the mouth.
Immune system disorders: Rare: hypersensitivity reactions, including erythema, rash, pruritus, urticaria, dyspnea, anaphylactic reactions, including shock; hypotension.
Central nervous system: fever, night sleep disorders, convulsions.
On the part of the urinary system: hypertrophy of epithelial cells in the renal tubules and impaired function.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister; 5 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
"ASTRAPHARM" LLC.
Location of the manufacturer and address of its place of business.
Ukraine, 08132, Kyiv region, Kyiv-Svyatoshynskyi district, Vyshneve, Kyivska st., 6.
