Folic acid - instructions for use, dose, side effects, contraindications

auxiliary substances: lactose monohydrate - 93.00 mg, copovidone - 5.00 mg, silicon dioxide colloid (aerosil) - 0.50 mg, magnesium stearate - 0.50 mg;

shell of Opadrai II 85F220058 - 4.00 mg: polyvinyl alcohol partially

hydrolyzed - 40.00%, macrogol-3350 - 20.20%, talc - 14.80%, titanium dioxide E 171 - 6.40%, lacquer aluminum based on the dye quinoline yellow E 104 - 17.57%, lacquer aluminum based on dye solar sunset yellow E 110 - 1.00%, aluminum lacquer based on indigo carmine E 132 - 0.03%.

Description:

Round biconvex tablets, covered with a film coating of dark yellow color. On the cross-section the nucleus is light yellow with inclusions.

Pharmacotherapeutic group:vitamin

ATX: & nbsp

B.03.B.B Folic acid and its derivatives

B.03.B.B.01 Folic acid

Pharmacodynamics:

Vitamin B (vitamin B, vitamin 13) can be synthesized by the intestinal microflora. In organism 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 porphoblasts. Stimulates erythropoiesis, participates in the synthesis of amino acids (including glycine, methionine), nucleic acids, purines, nirimidines, in the exchange of choline, histidine.

Pharmacokinetics:

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

Penetrates through the blood-brain and placental barrier and penetrates into breast milk.

The time to reach the maximum concentration in the blood plasma (TCata) is 30 - 60 minutes.

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

It is excreted by the kidneys mainly in the form of metabolites; if the taken dose significantly exceeds the daily requirement for folic acid, then it is output in unchanged form.

It is excreted by hemodialysis.

Indications:

Treatment of megaloblastic anemia, caused by a deficiency of folic acid. Prevention and treatment of folic acid deficiency in tropical and nestropic sir, malnutrition.

Contraindications:

Hypersensitivity to the components that make up the drug; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; children's age till 18 years; B12-deficiency (pernicious) anemia.

Pregnancy and lactation:

In this dosage, the drug can be recommended during pregnancy. It is not recommended to use the drug in this dosage during the period of breastfeeding,as folic acid penetrates into breast milk.

Dosing and Administration:

The drug is taken orally, after eating 1 mg / day. When using large doses, resistance may occur.

The course of treatment is 20-30 days.

Side effects:

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

Overdose:

Symptoms: There are no reports of an overdose of folic acid in humans. Treatment: In case of an overdose, it is recommended to cancel the drug, wash the stomach, take activated charcoal, if necessary - symptomatic therapy.

Interaction:

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

Folic acid reduces the effectiveness of phenytoin.

Antacids (including preparations of calcium, aluminum and magnesium), colestramine, sulfopamides (including sulfasalazine) reduce the absorption of folic acid. Methotrexate, irinstamine, triamterene, trimethoprim inhibit dihydrofolaggracductase and reduce the effect of folic acid (instead, patients using these drugs should be prescribed calcium folinate).

Special instructions:

Folic acid is not used for the treatment of pernicious, normocytic and aplastic anemia. With pernicious anemia folic acid, improving hematologic indices, masks neurological manifestations. While pernicious anemia is excluded, administration of folic acid in doses exceeding 0.1 mg / day is recommended (except for pregnancy and lactation).

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

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

With the use of folic acid, as well as therapy over a long period, a decrease in the concentration of cnaiocobalamin is possible.

Effect on the ability to drive transp. cf. and fur:

The drug does not affect the performance of potentially hazardous activities,requiring the increased concentration of attention and speed of psychomotor reactions (driving and other vehicles, working with moving mechanisms, the work of the dispatcher and operator).

Form release / dosage:

Tablets, film-coated, I mg.

Packaging:

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 5 contour packagings together with the instruction for use are put in a cardboard pack.

Storage conditions:

In a protected spotlight at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002991

Date of registration:12.05.2012

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Folic acid (Folic acid)