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Folic Acid
Overview
What is Folic Acid?
Folic acid, N-[-[[(2-Amino-4-hydroxy-6-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to -aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool dry place protected from light.
The structural formula is as follows:
The molecular formula is CHNO, and the molecular weight is 441.41. Each tablet for oral administration contains folic acid 1 mg. Inactive Ingredients: Anhydrous Lactose, Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Stearate.
What does Folic Acid look like?
What are the available doses of Folic Acid?
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What should I talk to my health care provider before I take Folic Acid?
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How should I use Folic Acid?
Folic acid is effective in the treatment of megaloblastic anemias due to deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B deficiency has been ruled out or is being adequately treated with cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine.
The usual therapeutic dosage in adults and children (regardless of age) is up to 1 mg daily. Resistant cases may require larger doses.
When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, e.g., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of maintenance level made if relapse appears imminent.
In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.
What interacts with Folic Acid?
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What are the warnings of Folic Acid?
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What are the precautions of Folic Acid?
General:
There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
Drug Interactions:
False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Pregnancy - Teratogenic Effects - Pregnancy Category A.
Studies in pregnant women have not shown that folic acid increases the risk of abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, folic acid should be used during pregnancy only if clearly needed.
Nursing Mothers:
What are the side effects of Folic Acid?
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Folic acid is relatively nontoxic in man. Rare instances of allergic responses to folic acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg of folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgement. Decreased vitamin B serum levels may occur in patients receiving prolonged folic acid therapy.
In an uncontrolled study, orally administered folic acid was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or phenytoin. Another investigator reported decreased phenytoin serum levels in folate-deficient patients receiving phenytoin who were treated with 5 mg or 15 mg of folic acid daily.
What should I look out for while using Folic Acid?
Folic acid is contraindicated in patients who have shown previous intolerance to the drug.
Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B is deficient.
What might happen if I take too much Folic Acid?
Except during pregnancy and lactation, folic acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 mg of folic acid daily who are inadequately treated with vitamin B may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B deficiency will progress. Doses of folic acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin preparations; if therapeutic amounts are necessary, folic acid should be given separately.
How should I store and handle Folic Acid?
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.Dispense in a tight, light-resistant container.Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.Dispense in a tight, light-resistant container.Folic Acid Tablets USP 1 mg; Yellow, round, scored, compressed tablet imprinted "West-ward 248".They are supplied by as follows:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyFolic Acid Tablets USP 1 mg; Yellow, round, scored, compressed tablet imprinted "West-ward 248".They are supplied by as follows:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyFolic Acid Tablets USP 1 mg; Yellow, round, scored, compressed tablet imprinted "West-ward 248".They are supplied by as follows:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyFolic Acid Tablets USP 1 mg; Yellow, round, scored, compressed tablet imprinted "West-ward 248".They are supplied by as follows:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyFolic Acid Tablets USP 1 mg; Yellow, round, scored, compressed tablet imprinted "West-ward 248".They are supplied by as follows:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyFolic Acid Tablets USP 1 mg; Yellow, round, scored, compressed tablet imprinted "West-ward 248".They are supplied by as follows:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central PharmacyFolic Acid Tablets USP 1 mg; Yellow, round, scored, compressed tablet imprinted "West-ward 248".They are supplied by as follows:Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Manufactured by: Eatontown, NJ 07724This Product was Repackaged By:State of Florida DOH Central Pharmacy
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Folic acid acts on megaloblastic bone marrow to produce a normoblastic marrow.
In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Impairment of thymidylate synthesis in patients with folic acid deficiency is thought to account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic and macrocytic anemias.
Folic acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Naturally occurring conjugated folates are reduced enzymatically to folic acid in the gastrointestinal tract prior to absorption. Folic acid appears in the plasma approximately 15 to 30 minutes after an oral dose; peak levels are generally reached within 1 hour. After intravenous administration, the drug is rapidly cleared from the plasma. Cerebrospinal fluid levels are several times greater than serum levels of the drug. Folic acid is metabolized in the liver to 7,8-dihydrofolic acid and eventually to 5,6,7,8-tetrahydrofolic acid with the aid of reduced diphosphopyridine nucleotide (DPNH) and folate reductases. Tetrahydrofolic acid is linked in the N or N positions with formyl, hydroxymethyl, methyl, or formimino groups. N formyltetrahydrofolic acid is leucovorin. Tetrahydrofolic acid derivatives are distributed to all body tissues but are stored primarily in the liver. Normal serum levels of total folate have been reported to be 5 to 15 ng/mL; normal cerebrospinal fluid levels are approximately 16 to 21 ng/mL. Normal erythrocyte folate levels have been reported to range from 175 to 316 ng/mL. In general, folate serum levels below 5 ng/mL indicate folate deficiency, and levels below 2 ng/mL usually result in megaloblastic anemia.
After a single oral dose of 100 μg of folic acid in a limited number of normal adults, only a trace amount of the drug appeared in the urine. An oral dose of 5 mg in 1 study and a dose of 40 μg/kg of body weight in another study resulted in approximately 50% of the dose appearing in the urine. After a single oral dose of 15 mg, up to 90% of the dose was recovered in the urine. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered folic acid have also been recovered in the feces. Folic acid is also excreted in the milk of lactating mothers.
Non-Clinical Toxicology
Folic acid is contraindicated in patients who have shown previous intolerance to the drug.Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B is deficient.
Drug Interactions:
False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of
General:
There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Folic acid is relatively nontoxic in man. Rare instances of allergic responses to folic acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg of folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgement. Decreased vitamin B serum levels may occur in patients receiving prolonged folic acid therapy.
In an uncontrolled study, orally administered folic acid was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or phenytoin. Another investigator reported decreased phenytoin serum levels in folate-deficient patients receiving phenytoin who were treated with 5 mg or 15 mg of folic acid daily.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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