FOLIC ACID- folic acid tablet 
Cardinal Health

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Folic Acid

DESCRIPTION

FOLIC ACID TABLETS, USP

Rev. 02/10

Rx Only

DESCRIPTION:

Folic acid, N-[p-[[(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 para-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:

Molecular structure

The molecular formula is C19H19N7O6, and the molecular weight is 441.40.

Each tablet for oral administration contains folic acid 1 mg and the following

inactive ingredients: colloidal silicon dioxide, lactose monohydrate,

microcrystalline cellulose, sodium starch glycolate and stearic acid.

CLINICAL PHARMACOLOGY

CLINICAL 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 of folic acid 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 N5 or N10 positions with formyl, hydroxymethyl, methyl, or formimino

groups. N5-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 mcg 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 mcg/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.

INDICATIONS AND USAGE

INDICATIONS AND USAGE:

Folic acid is effective in the treatment of megaloblastic anemias due to a

deficiency of folic acid (as may be seen in tropical or nontropical sprue)

and in anemias of nutritional origin, pregnancy, infancy, or childhood.

CONTRAINDICATIONS

CONTRAINDICATIONS:

Folic acid is contraindicated in patients who have shown previous intolerance

to the drug.

WARNINGS

WARNINGS:

Administration of folic acid alone is improper therapy for pernicious anemia

and other megaloblastic anemias in which vitamin B12 is deficient.

PRECAUTIONS

General

General:Folic acid in doses above 0.1 mg daily may

obscure pernicious anemia in that hematologic remission can occur while

neurologic manifestations remain progressive.

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 B12 may prevent, halt, or improve the neurologic

changes caused by pernicious anemia.

Interactions

Drug Interactions:Drug InteractionsThere is evidence that the anticonvulsant action of

phenytoin is antagonized by folic acid. A patient whose epilepsy is completely

controlled by phenytoin may require increased doses to prevent

convulsions if folic acid is given.

Folate deficiency may result from increased loss of folate, as in renal dialysis

and/or interference with metabolism (e.g., folic acid antagonists such

as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin,

primidone, and barbiturates; alcohol consumption and, especially,

alcoholic cirrhosis; and the administration of pyrimethamine and

nitrofurantoin.

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 Lactobacillus casei.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, Mutagenesis, Impairment of Fertility:Long-term studies in animals to evaluate carcinogenic potential and studies to evaluate

the mutagenic potential or effect on fertility have not been conducted.

Pregnancy

Teratogenic EffectsPregnancy – Teratogenic Effects –Pregnancy Category A. Folic acid is

usually indicated in the treatment of megaloblastic anemias of pregnancy. Folic acid requirements are markedly increased during pregnancy, and

deficiency will result in fetal damage. (See INDICATIONS AND USAGE.)

Studies in pregnant women have not shown that folic acid increases the

risk of fetal 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

Nursing Mothers: Folic acid is excreted in the milk of lactating mothers.

During lactation, folic acid requirements are markedly increased; however,

amounts present in human milk are adequate to fulfill infant requirements,

although supplementation may be needed in low-birth-weight

infants, in those who are breast-fed by mothers with folic acid deficiency

(50 mcg daily), or in those with infections or prolonged diarrhea.

ADVERSE REACTIONS

ADVERSE REACTIONS:

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, over-activity,

excitement, mental depression, confusion, and impaired judgment.

Decreased vitamin B12 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 diphenylhydantoin. Another investigator

reported decreased diphenylhydantoin serum levels in folate-deficient

patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg

of folic acid daily.

To report SUSPECTED ADVERSE REACTIONS, contact West-ward

Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088

or www.fda.gov/medwatch.

OVERDOSAGE

OVERDOSAGE:

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 B12 may show

reversion of the hematologic parameters to normal, but neurologic manifestations

due to vitamin B12 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.

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION:

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 B12 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, i.e., 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.

HOW SUPPLIED

HOW SUPPLIED:

Folic Acid Tablets USP, 1 mg are Light Yellow, Round, biconvex tablets

debossed “I” on the left side of the bisect and “G” on the right side of bisect on

one side and “210” on other; supplied in bottles of 100 (NDC 0143-9717-01)

and 1000 (NDC 0143-9717-10) .

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:

InvaGen Pharmaceuticals, Inc.

Hauppauge, NY 11788

Distributed by:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Revised February 2010

Folic Acid Tablets USP, 1 mg are available from Cardinal Health in unit

dose cartons of 30.

Cardinal Health

Zanesville, OH 43701

OI82251010

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Folic Acid

Tablets, USP

1 mg

Blister

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Folic Acid

Tablets, USP

1 mg

QTY 30

Carton
FOLIC ACID 
folic acid tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55154-7454(NDC:0143-9717)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
LACTOSE MONOHYDRATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorYELLOW (light) Score2 pieces
ShapeROUNDSize7mm
FlavorImprint Code I;G;and;210
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-7454-96 in 1 CARTON
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08060003/31/197210/31/2012
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-7454)

Revised: 5/2014
 
Cardinal Health