Name Folic acid tabl. The presence of blotches of a darker and lighter color is allowed. Composition Each tablet contains the active substance: folic acid – 1 mg; excipients: powdered sugar, potato starch, stearic acid. Pharmacotherapeutic group Antianemic agents. Folic acid and its derivatives. ATX code: B03BB01. Pharmacological properties Pharmacodynamics Vitamin B group (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, administered 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 BBB, the placenta and into breast milk. TCmax – 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 use Treatment of macrocytic (folic acid deficiency) anemia. Treatment of folic acid deficiency: a) with malabsorption syndrome (non-tropical and tropical sprue; celiac disease, subject to the impossibility of observing a gluten-free diet); b) in violation of the metabolism of folate against the background of the use of certain drugs (antiepileptics, combined oral contraceptives, cytostatics), with liver diseases and insufficient intake of folic acid (for example, alcohol dependence, malnutrition); c) with increased excretion of folic acid (for example, against the background of alcohol dependence, hemolytic anemia). In pregnant women to prevent the development of defects in the formation of the neural tube in the fetus. Contraindications Hypersensitivity to the components of the drug (LS). Pernicious anemia and other conditions associated with vitamin B12 deficiency, due to the fact that folic acid monotherapy can accelerate the onset of subacute degenerative changes in the spinal cord in this case. Taking folic acid as monotherapy for more than 3 months in such individuals leads to the development of cobalamin neuropathy. Shorter courses do not cause this complication. In the elderly, therefore, cobalamin absorption should be assessed before initiating folic acid therapy. Folate-dependent neoplasms, unless severe megaloblastic or macrocytic anemia is a complication of ongoing anticancer therapy. Dosage and administration Inside. Before eating. It is allowed to crush the tablet before taking it for children and persons who have difficulty swallowing. Adults (including the elderly): For medical folic acid deficiency, 5 mg daily for 4 months; with malabsorption – it is possible to use up to 15 mg daily. For the prevention of anemia in chronic hemolytic status: 5 mg every 1 to 7 days, depending on the exacerbations of the disease. Children with hemolytic anemia and metabolic disorders In children under the age of 4 years, it is allowed to use tablets in a pre-crushed form in the form of a powder. Doses of folic acid in children are: at the age of up to 1 year 0.5 mg / kg (? tablets per 1 kg of body weight) 1 time per day, but not more than 5 mg / day, at the age of 1 to 12 years – 2, 5 – 5 mg / day; over 12 years old – 5 – 10 mg / day 1 time per day. For the treatment of macrocytic (folic acid deficiency) anemia, the following is prescribed: for adults and children of any age, the initial dose is up to 1 mg / day (1 tablet). Daily doses of more than 1 mg do not enhance the hematological effect, and most of the excess folic acid is excreted unchanged in the urine. In resistant cases, higher doses may be required. Initial doses are used for about 14 days or until a hematological and clinical response is obtained, then they are switched to maintenance treatment. The total duration of therapy can be about 4 months. Maintenance treatment: for children under 4 years old: for infants – 0.1 mg / day, for children under 4 years old – up to 0.3 mg / day; children over 4 years old and adults – 0.5 mg (? tablets), during pregnancy and lactation – 1 mg / day, but not less than 0.1 mg / day. For established folic acid deficiency during pregnancy: 5 mg daily throughout pregnancy. For the prevention of neural tube defects in the presence of a history of malformations: 4-5 mg daily 1 month before the planned conception and for 3 months after it. In the absence of a history of neural tube defects (or other predisposing factors): 0.5 mg (? tablets) daily for 10 to 12 weeks after the last menstruation. During pregnancy, the appointment of folic acid in doses above 0.4 mg / day can be carried out only after malignant (pernicious) anemia associated with vitamin B12 deficiency has been excluded. The duration of folic acid intake is not precisely defined, sometimes a multi-month course of taking the drug is required to resume and maintain normal hematopoiesis. In the case of elimination of the main causes of vitamin deficiency, improvement of the diet or elimination of concomitant diseases, the use may be terminated ahead of schedule. With concomitant alcoholism, hemolytic anemia, chronic infectious diseases, concomitant use of anticonvulsant drugs, after removal of the stomach, malabsorption of nutrients, liver failure, cirrhosis, stress, the dose of the drug should be increased and longer treatment may be required. Side effectReactions from the immune system: rarely (from 1/1000 to 1/10000 cases) – skin rash, pruritus, urticaria, bronchospasm, erythema, hyperthermia, anaphylactic reactions (including shock). From the gastrointestinal tract: rarely (from 1/1000 to 1/10000 cases) – loss of appetite, nausea, bloating and flatulence. On the part of hematopoiesis: may mask the manifestations of B12 deficiency anemia. From the nervous system: when taken in doses of more than 15 mg / day, sleep disturbance, problems with concentration, irritability, excitability, depression, confusion are possible. In people with epilepsy, an increase in the frequency of seizures is possible. Precautions The drug is not intended for the prevention of hypo- and beriberi in children (due to the discrepancy between the daily requirement and dosage of drugs). For the prevention of hypovitaminosis B9, a balanced diet is most preferable. Foods rich in vitamin B9 – green vegetables (lettuce, spinach), tomatoes, carrots, fresh liver, legumes, beets, eggs, cheese, nuts, cereals. Folic acid is removed by hemodialysis, this should be taken into account in persons with severe renal insufficiency. During treatment, the therapeutic effect should be monitored by laboratory tests and the diagnosis should be reconsidered in the absence of the expected effect. Serum potassium and iron/ferritin levels should be monitored. Cobalamin metabolism should be established in all cases of pernicious anemia (not only during pregnancy). Folic acid should not be used routinely in patients with coronary stents. Caution should be exercised when prescribing folic acid to patients who may have folic acid-dependent tumors. Folic acid at doses above 0.1 mg daily may mask pernicious anemia by improving haematological parameters, while neurological manifestations will progress. In this regard, folic acid is not used to treat B12-deficient (pernicious), normocytic and aplastic anemia, as well as anemia refractory to therapy. 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). When using large doses of folic acid, as well as therapy for a long period, it is possible to reduce the concentration of vitamin B12 (cyanocobalamin) in the blood. Long-term use of folic acid is recommended to be combined with vitamin B12. During treatment, folic acid should be taken 2 hours after taking antacids, as well as 1 hour before or 4 hours after taking cholestyramine. 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. The drug contains sucrose, which should be taken into account in patients with congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. Use during pregnancy The drug is used according to indications during pregnancy and lactation. Daily folic acid intake in early pregnancy may prevent neural tube defects in the fetus (anencephaly, spina bifida). If the drug is started after the fourth week of pregnancy, folic acid is not effective in preventing neural tube defects. Deficiency of the vitamin or its metabolites may also be associated with spontaneous abortions and intrauterine growth retardation. LactationFolic acid is actively excreted in breast milk. The accumulation of folates in milk prevails over the needs of the mother’s body in folic acid. Folic acid levels are relatively low in colostrum, but as lactation increases, the concentration of the vitamin increases. Adverse effects have not been observed in breastfed infants whose mothers received folic acid. The total amount of folic acid in breast milk corresponds to the needs of the child, although additional doses of folic acid may be needed for children with low birth weight, those who are breastfed by mothers with folic acid deficiency (50 mcg per day), or in children with long-term infectious diarrhea. Influence on the ability to drive a car and work with moving mechanisms Does not affect. Interaction with other drugs In order to prevent the development of megaloblastic anemia in patients taking cytostatics (methotrexate) or antiepileptic drugs, the concomitant administration of folic acid is recommended. Analgesics (long-term therapy), anticonvulsants (including phenytoin and carbamazepine), estrogens, oral contraceptives increase the need for folic acid. Antacids (including Ca2+, Al3+ and Mg2+ preparations), cholestyramine, sulfonamines (including sulfasalazine) reduce the absorption of folic acid (the use of folic acid should take place 1 hour before or 4 hours after the use of cholestyramine, and antacids after 2 hours after taking folic acid). Against the background of taking folic acid, the concentration of some anticonvulsant drugs (phenytoin, phenobarbital, primidone) decreases, which can lead to an exacerbation of epilepsy and requires an increase in the dose of antiepileptic drugs. Pyrimethamine, triamterene, trimethoprim reduce the effect of folic acid (instead of it, patients using these drugs should be given calcium folinate). Sulfonamides and chloramphenicol also reduce the effect of folic acid and require higher doses. Folic acid modifies the therapeutic and toxic effects of methotrexate, leflunomide, and teriflunomide. Increases the toxic effect of fluorouracil, and therefore, this combination should be avoided. Overdose Doses of folic acid up to 4-5 mg are well tolerated. Higher doses may cause: central nervous system disorders (irritability and insomnia) and gastrointestinal tract (nausea, abdominal pain, flatulence). Special measures of assistance are not required, it is enough to stop taking the drug for 1-2 days. Upakovka10 tablets in a blister pack. 5 blister packs, together with the leaflet, are placed in a cardboard box. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 3 years. Do not use after the expiration date. Terms of dispensing from pharmacies Without a prescription. Buy Folic acid tablets 1mg No. 10×5 Price for Folic acid tablets 1 mg No. 10×5 Instructions for use for Folic acid tablets 1 mg No. 10×5
Folic acid tablets 1mg №10×5
$8.00
INN | FOLIC ACID |
---|---|
The code | 2 443 |
Barcode | 4 810 201 003 603 |
Dosage | 1mg |
Active substance | Folic acid |
Manufacturer | Borisov plant of medical preparations, Belarus |
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