Folacinum
Producer: Jadran Galenski Laboratorij d.d. (JSC Yadran) Croatia
Code of automatic telephone exchange: B03BB01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 5 mg folic acid.
Excipients: lactose monohydrate, cellulose microcrystallic, magnesium stearate, povidone, кросповидон.
Medicine for treatment and prevention of the inborn malformations of a fruit (IMF), folate - scarce anemias and not incubation of pregnancy. The only drug of folic acid with a dosage of 5 mg in 1 tablet. It is included in the VED list (Vital and major medicines).
Pharmacological properties:
Pharmacodynamics. Group B vitamin. In an organism it will be transformed to the tetrahydrofolic acid as a coenzyme participating in various metabolic processes and necessary for normal maturing of megaloblasts and formation of normoblasts.
At deficit of folic acid the megaloblastny type of a hemopoiesis develops. Stimulates an erythrogenesis, participates in synthesis of amino acids (including methionine, serine, glycine), nucleic acids, purines, pyrimidines, in exchange of sincaline, a histidine. At pregnancy performs protective function in relation to action of the teratogenic and damaging a fruit factors. Promotes normal maturing and functioning of a placenta.
Pharmacokinetics. After intake folic acid, connecting in a stomach to an internal factor of Kastl (a specific glycoprotein), it is well and completely soaked up in a GIT. Almost completely contacts proteins of plasma. It is deposited and metabolized in a liver with formation of tetrahydrofolic acid (in the presence of ascorbic acid under the influence of digidrofolatreduktaza enzyme). Gets through a blood-brain barrier, a placenta and into breast milk. Cmax in blood is reached in 30-60 minutes.
It is removed by kidneys as in not changed look (if the accepted dose considerably exceeds daily requirement), and in the form of metabolites. It is removed by means of a hemodialysis. 5 mg of the folic acid accepted inside are brought out of an organism in 5 hours.
Indications to use:
- treatment and prevention of deficit of folic acid, against the background of unbalanced or defective food;
- treatment and prevention of anemias, against the background of deficit of folic acid: the macrocytic hyperchromic anemia, anemia and a leukopenia caused by medicines and the ionizing radiation, megaloblastny anemia, post-resection anemia, sideroblastny anemia at advanced age, the anemias connected with diseases of a small bowel, to a spr and a sprue;
- treatment and prevention of anemias at pregnancy and feeding by a breast;
- at pregnancy, for prevention of development of defects of a neurotubule in a fruit;
- long treatment by antagonists of folic acid (a methotrexate, a combination sulfamethoxazole - Trimethoprimum), anticonvulsant drugs (Phenytoinum, Primidonum, phenobarbital).
Route of administration and doses:
It is applied inside.
- for treatment of the megaloblastny anemia caused by deficit of folic acid: on 5 mg a day within 4 months, for prevention - on 2,5 mg a day;
- for prevention and treatment of macrocytic anemia at malabsorption, inflammatory diseases of intestines and unbalanced or defective food - on 15 mg a day, to patients with a disease to a spr – on 5-15 mg a day; - for prevention of development in a fruit of defects of a neurotubule - on 2,5 mg a day within 4 weeks before alleged pregnancy and to continue reception during the I trimester of pregnancy.
Higher maintenance doses can be appointed to the patients having alcoholism, and also patients with persistent infections and accepting anticonvulsant drugs.
Features of use:
The patients who are on a hemodialysis need the increased amounts of folic acid. At prolonged use of folic acid, especially in high doses, decrease in concentration in B12 vitamin blood is possible.
Prolonged use of drug is recommended to be combined with reception of B12 vitamin (cyanocobalamine).
Ability to influence speed of response at control of motor transport or work with other mechanisms: there are no data.
Side effects:
Manifestation of allergic reactions (skin rashes, itch, erythema, bronchospasm) is possible; from a GIT: anorexia, nausea, abdominal distention, bitterness in a mouth.
Interaction with other medicines:
At simultaneous use with chloramphenicol, Neomycinum, polymyxins, tetracyclines absorption of folic acid decreases.
At simultaneous use folic acid reduces effects of contraceptives for intake, ethanol, Sulfasalazinum, Cycloserinum and a glyutetimid, a methotrexate, Phenytoinum, a primidin, chloramphenicol.
Use of folic acid can reduce the plasma level of phenobarbital, Phenytoinum or Primidonum and to cause an epileptic seizure.
Cases of decrease or change of absorption can appear at simultaneous use of a holestiramin and folic acid therefore, folic acid should be accepted in 1 hour prior to or in 4-6 hours after a holestiramin.
Contraindications:
Hypersensitivity to drug components, pernicious anemia, malignant new growths, deficit of cobalamine.
Overdose:
Cases of overdose are noted.
Storage conditions:
At a temperature not above 25 °C, in the place, unavailable to children. A period of validity - 3 years. Not to apply after the period of validity specified on packaging.
Issue conditions:
Without recipe
Packaging:
On 10 tablets in PVC / It is scarlet the blister. One, two or three blisters place together with the application instruction in a cardboard pack.