Folic Acid (Lexi-Drugs)

Pronunciation

(FOE lik AS id)

Brand Names: US

FA-8 [OTC]

Brand Names: Canada

JAMP-Folic Acid; NOVO-Folacid [DSC]; SANDOZ Folic Acid

Pharmacologic Category

Vitamin, Water Soluble

Dosing: Adult

Megaloblastic and macrocytic anemias due to folate deficiency:

Oral: 1 to 5 mg once daily (Cook 2014); doses up to 15 mg once daily have also been recommended (Hoffbrand 2015).

Manufacturer’s labeling: Dosing in the prescribing information may not reflect current clinical practice. Oral, IM, IV, SubQ: Initial: 0.4 to 1 mg/day.

Maintenance dose: 0.4 mg/day

Pregnant and lactating women: Maintenance dose: 0.8 mg/day

Methanol poisoning (off-label use): Therapy should continue until methanol and formic acid have been completely eliminated (Zakharov 2015). Cofactors are adjunctive to antidotal therapy and should never be used alone.

IV: 50 to 70 mg every 4 hours (Osterloh 1986)

Oral: 50 mg every 3 to 4 hours (Zakharov 2015)

Prevention of neural tube defects (off-label use): Oral:

Females of childbearing potential: 0.4 mg/day (ACOG 187 2017) or 0.4 to 0.8 mg/day (USPSTF 2017). Supplementation should start ≥1 month prior to pregnancy and continue through 12 weeks gestation (ACOG 187 2017).

Females at high risk, who have had a previous pregnancy with a neural tube defect, or with family history of neural tube defects: 4 mg/day. Supplementation should start ≥3 months prior to pregnancy and continue through 12 weeks gestation (ACOG 187 2017)

Supplementation to reduce toxicity associated with antifolate chemotherapy (off-label use): Oral:

To reduce toxicity associated with pemetrexed: Administer folic acid 0.35 to 1 mg once daily, beginning 1 to 3 weeks prior to pemetrexed treatment initiation; continue for 3 weeks after the last pemetrexed dose; administer with intramuscular cyanocobalamin supplementation (Scagliotti 2008, Vogelzang 2003).

To reduce toxicity associated with pralatrexate: Administer folic acid 1 to 1.25 mg once daily (O’Connor 2011), beginning 10 days prior to pralatrexate treatment initiation; continue for 30 days after the last pralatrexate dose; administer with intramuscular cyanocobalamin supplementation.

Dosing: Geriatric

Refer to adult dosing. Vitamin B12 deficiency must be ruled out before initiating folate therapy due to frequency of combined nutritional deficiencies.

Dosing: Pediatric

Adequate intake (AI): Oral: Note: Dosing presented as dietary folate equivalents (DFE) to adjust for ~50% decreased bioavailability of food folate compared with that of folic acid supplement.

1-6 months: 65 mcg/day

7-12 months: 80 mcg/day

Recommended daily allowance (RDA): Oral: Note: Dosing presented as dietary folate equivalents (DFE) to adjust for ~50% decreased bioavailability of food folate compared with that of folic acid supplement.

1-3 years: 150 mcg/day

4-8 years: 200 mcg/day

9-13 years: 300 mcg/day

Adolescents ≥14 years: 400 mcg/day

Anemia (folic acid deficiency); treatment: Oral, IM, IV, SubQ:

Infants: 0.1 mg/day

Children <4 years: Up to 0.3 mg/day

Children >4 years and Adolescents: 0.4 mg/day

Parenteral nutrition, maintenance requirement of folic acid (Vanek, 2012): IV:

Infants: 56 mcg/kg/day

Children and Adolescents ≤13 years: 140 mcg/day

Adolescents ≥14 years: 400 mcg/day

Gingival hyperplasia due to phenytoin, prevention: Limited data available: Oral: Children ≥6 years and Adolescents: 0.5 mg/day was used in a double-blind, randomized, placebo-controlled trial of 120 pediatric patients (treatment arm, n=62; age range: 6-15 years) who were started on phenytoin therapy within the last month for a seizure disorder; results showed a statistically significant difference in development of hyperplasia (treatment arm: 21% vs placebo: 88%); severity of cases less in treatment arm than placebo; study duration: 6 months (Arya, 2011)

Use: Labeled Indications

Megaloblastic and macrocytic anemias due to folate deficiency: Treatment of megaloblastic and macrocytic anemias due to folate deficiency

Use: Off-Label: Adult

  Adjunctive cofactory therapy in methanol toxicity (alternative to leucovorin calcium)Level of Evidence [G]

The American Academy of Clinical Toxicology (AACT) guidelines recognize the lack of human data for the use of folic acid derivatives in the treatment of methanol toxicity and advise, without an evidence-based recommendation, that the administration of leucovorin (or folic acid as a suitable alternative) should be considered in patients with suspected or confirmed methanol poisoning Ref.

  Neural tube defectsLevel of Evidence [G]

National guidelines recommend the use of oral folic acid before conception and during early pregnancy to reduce the risk of NTDs. Access Full Off-Label Monograph

  Supplementation to reduce toxicity associated with antifolate chemotherapyLevel of Evidence [A]

Data from 2 phase III studies and a phase II study support the use of folic acid supplementation (with intramuscular cyanocobalamin supplementation) in patients receiving the antimetabolite (antifolate) chemotherapeutic agents pemetrexed and pralatrexate Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Bipolar Disorder:

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD), “Collaborative Update of CANMAT Guidelines for the Management of Patients with Bipolar Disorder – Update 2013,” February 2013

Other:

WHO, “Intermittent Iron and Folic Acid Supplementation in Menstruating Women,” 2011

Administration: IM

May also be administered by deep IM injection.

Administration: IV

May administer ≤5 mg dose undiluted over ≥1 minute or may dilute ≤5 mg in 50 mL of NS or D5W and infuse over 30 minutes. May also be added to IV maintenance solutions and given as an infusion.

Administration: Injectable Detail

pH: 8 to 11

Administration: Pediatric

Oral: May be administered without regard to meals

Parenteral:

IM, SubQ: May administer undiluted deep IM or SubQ

IV: May administer doses ≤5 mg undiluted over ≥1 minute or may further dilute and infuse over 30 minutes. May also be given as an infusion when added to IV maintenance solutions.

Dietary Considerations

As of January 1998, the FDA has required manufacturers of enriched flour, bread, corn meal, pasta, rice, and other grain products to add folic acid to their products. The intent is to help decrease the risk of neural tube defects by increasing folic acid intake. Other foods which contain folic acid include dark green leafy vegetables, citrus fruits and juices, and lentils.

Dietary adequate intake (AI) (IOM 1998): Expressed as folate equivalents:

1 to 6 months: 65 mcg/day

7 to 12 months: 80 mcg/day

Dietary recommended daily allowance (RDA) (IOM 1998): Expressed as dietary folate equivalents:

1 to 3 years: 150 mcg/day

4 to 8 years: 200 mcg/day

9 to 13 years: 300 mcg/day

>13 years: 400 mcg/day

Pregnancy: 600 mcg/day

Lactation: 500 mcg/day

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F); protect from light.

Preparation for Administration: Pediatric

Parenteral: IV: May further dilute doses ≤5 mg in 50 mL of NS or D5W; maximum concentration: 0.1 mg/mL. May also be added to IV maintenance solution.

Compatibility

See Trissel’s IV Compatibility Database

Extemporaneously Prepared

A 1 mg/mL folic acid oral solution may be made with tablets. Heat 90 mL of purified water almost to boiling. Dissolve parabens (methylparaben 200 mg and propylparaben 20 mg) in the heated water; cool to room temperature. Crush one-hundred 1 mg tablets, then dissolve folic acid in the solution. Adjust pH to 8-8.5 with sodium hydroxide 10%; add sufficient quantity of purified water to make 100 mL; mix well. Stable for 30 days at room temperature (Allen, 2007).

A 0.05 mg/mL folic acid oral solution may be prepared using the injectable formulation (5 mg/mL). Mix 1 mL of injectable folic acid with 90 mL of purified water. Adjust pH to 8-8.5 with sodium hydroxide 10%; add sufficient quantity of purified water to make 100 mL; mix well. Stable for 30 days at room temperature (Nahata, 2004).

Allen LV Jr, “Folic Acid 1-mg/mL Oral Liquid,” Int J Pharm Compound, 2007, 11(3):244.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations, 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to folic acid or any component of the formulation

Warnings/Precautions

Disease-related concerns:

• Anemia: Monotherapy: Not appropriate for monotherapy with pernicious, aplastic, or normocytic anemias when anemia is present with vitamin B12 deficiency.

• Pernicious anemia: Doses >0.1 mg/day may obscure pernicious anemia with continuing irreversible nerve damage progression.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register 2002). See manufacturer’s labeling.

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP [“Inactive” 1997], CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

Other warnings/precautions:

• Resistance to treatment: May occur with depressed hematopoiesis, alcoholism, and deficiencies of other vitamins.

Geriatric Considerations

Elderly frequently have combined nutritional deficiencies. Must rule out vitamin B12 deficiency before initiating folate therapy. Elderly, due to decreased nutrient intake, may benefit from daily intake of a multiple vitamin with minerals.

Pregnancy Considerations

Water soluble vitamins cross the placenta (IOM 1998).

Folate requirements increase during pregnancy (IOM 1998). Folate supplementation during the periconceptual period decreases the risk of neural tube defects. All females planning a pregnancy or who may potentially become pregnant should begin folic acid supplementation prior to conception. Higher doses are required in females at high risk of neural tube defects (ACOG 2017; USPSTF 2017). Folic acid is also indicated for the treatment of anemias due to folate deficiency in pregnant women.

Breast-Feeding Considerations

Folate is present in breast milk; concentrations are not affected by dietary intake unless the mother has a severe deficiency. Folate requirements increase in breastfeeding women (IOM 1998).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined.

Cardiovascular: Flushing (slight)

Central nervous system: Malaise (general)

Dermatologic: Erythema, pruritus, skin rash

Hypersensitivity: Hypersensitivity reaction

Respiratory: Bronchospasm

Metabolism/Transport Effects

None known.

Drug Interactions 

Capecitabine: Folic Acid may enhance the adverse/toxic effect of Capecitabine. Risk C: Monitor therapy

Floxuridine: Folic Acid may enhance the adverse/toxic effect of Floxuridine. Risk C: Monitor therapy

Fluorouracil (Systemic): Folic Acid may enhance the adverse/toxic effect of Fluorouracil (Systemic). Risk C: Monitor therapy

Fosphenytoin: Folic Acid may decrease the serum concentration of Fosphenytoin. Risk C: Monitor therapy

Green Tea: May decrease the serum concentration of Folic Acid. Risk C: Monitor therapy

PHENobarbital: Folic Acid may decrease the serum concentration of PHENobarbital. Risk C: Monitor therapy

Phenytoin: Folic Acid may decrease the serum concentration of Phenytoin. Risk C: Monitor therapy

Primidone: Folic Acid may decrease the serum concentration of Primidone. Additionally, folic acid may decrease concentrations of active metabolites of primidone (e.g., phenobarbital).Risk C: Monitor therapy

Pyrimethamine: Folic Acid may diminish the therapeutic effect of Pyrimethamine. Management: Folic acid doses greater than 2.5 mg per day should be avoided due to the potential for sulfadoxine/pyrimethamine treatment failure. Consider limiting folic acid use to no more than 0.4 mg per day for women of child-bearing age. Risk D: Consider therapy modification

Raltitrexed: Folic Acid may diminish the therapeutic effect of Raltitrexed. Risk X: Avoid combination

Sulfadoxine: Folic Acid may diminish the therapeutic effect of Sulfadoxine. Management: Folic acid doses greater than 2.5 mg per day should be avoided due to the potential for sulfadoxine/pyrimethamine treatment failure. Consider limiting folic acid use to no more than 0.4 mg per day for women of child-bearing age. Risk D: Consider therapy modification

SulfaSALAzine: May decrease the serum concentration of Folic Acid. Risk C: Monitor therapy

Tegafur: Folic Acid may enhance the adverse/toxic effect of Tegafur. Risk C: Monitor therapy

Test Interactions

Falsely low serum concentrations may occur with the Lactobacillus casei assay method in patients on anti-infectives (eg, tetracycline)

Reference Range

Therapeutic: 0.005 to 0.015 mcg/mL

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral [preservative free]:

FA-8: 0.8 mg [dye free, sugar free, yeast free]

Generic: 5 mg, 20 mg

Solution, Injection, as sodium folate:

Generic: 5 mg/mL (10 mL)

Tablet, Oral:

Generic: 400 mcg, 800 mcg, 1 mg

Tablet, Oral [preservative free]:

FA-8: 800 mcg [dye free]

Generic: 400 mcg, 800 mcg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection, as sodium folate:

Generic: 5 mg/mL (10ml)

Tablet, Oral:

Generic: 5 mg, 25 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • B03BB01
Generic Available (US)

Yes

Pricing: US

Capsules (FA-8 Oral)

0.8 mg (per each): $0.04

Capsules (Folic Acid Oral)

5 mg (per each): $0.07

20 mg (per each): $0.08

Solution (Folic Acid Injection)

5 mg/mL (per mL): $5.41

Tablets (FA-8 Oral)

800 mcg (per each): $0.04

Tablets (Folic Acid Oral)

1 mg (per each): $0.04 – $0.36

400 mcg (per each): $0.02

800 mcg (per each): $0.02 – $0.03

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Folic acid is necessary for formation of a number of coenzymes in many metabolic systems, particularly for purine and pyrimidine synthesis; required for nucleoprotein synthesis and maintenance in erythropoiesis; stimulates WBC and platelet production in folate deficiency anemia.

In the treatment of methanol intoxication, folic acid enhances the metabolism of formic acid, the toxic metabolite of methanol, to nontoxic metabolites (Barceloux 2002).

Pharmacodynamics/Kinetics

Onset of action: Peak effect: Oral: 0.5 to 1 hour

Absorption: Proximal part of small intestine

Metabolism: Hepatic

Bioavailability: Oral: Folic acid supplement: ~100%; In presence of food: 85%; Dietary folate: 50% (IOM 1998)

Time to peak: Oral: 1 hour

Excretion: Urine

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Folacin; Folate; Pteroylglutamic Acid; Vitamin B9

FDA Approval Date
February 18, 1986
References

Alimta (pemetrexed) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; June 2018.

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 187: Neural Tube Defects. Obstet Gynecol. 2017;130(6):e279-e290. doi: 10.1097/AOG.0000000000002412.[PubMed 29189693]

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Aluminum in large and small volume parenterals used in total parenteral nutrition. Fed Regist. 2002;67(244):77792-77793. To be codified at 21 CFR §201.323.

Barceloux DG, Bond GR, Krenzelok EP, et al, “American Academy of Clinical Toxicology Practice Guidelines on the Treatment of Methanol Poisoning,” J Toxicol Clin Toxicol, 2002, 40(4):415-46.[PubMed 12216995]

Bibbins-Domingo K, Grossman DC, Curry SJ, et al; US Preventive Services Task Force. Folic acid supplementation for the prevention of neural tube defects: US Preventive Services Task Force recommendation statement. JAMA. 2017;317(2):183-189. doi: 10.1001/jama.2016.19438.[PubMed 28097362]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Cook K, Lyons WL. Chapter 80. Anemias. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 9e. New York, NY: McGraw-Hill; 2014.

Davis RE, “Clinical Chemistry of Folic Acid,” Adv Clin Chem, 1986, 25:233-94.[PubMed 3087140]

Department of Health and Human Services, Food and Drug Administration, Nutrition Labeling, Fed Regist, 1980, 45:69043.

Folic acid [prescribing information]. Schaumburg, IL: APP Pharmaceuticals, LLC; August 2011.

Gahart BL and Nazareno AR, 2014 Intravenous Medications: A Handbook for Nurses and Health Professionals, 30th ed, St Louis, MO: Elsevier/Mosby, 2014, 547-48.

Hoffbrand A. Megaloblastic Anemias. In: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison’s Principles of Internal Medicine, 19e. New York, NY: McGraw-Hill; 2015.

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

IOM (Institute of Medicine), Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline, Washington, DC: National Academy Press, 1998.

Lambie DG and Johnson RH, “Drugs and Folate Metabolism,” Drugs, 1985, 30(2):145-55.[PubMed 3896745]

Lange H, Suryapranata H, De Luca G, et al, “Folate Therapy and In-Stent Restenosis After Coronary Stenting,” N Engl J Med, 2004, 350(26):2673-81.[PubMed 15215483]

Lewis DP, Van Dyke DC, Willhite LA, et al, “Phenytoin-Folic Acid Interaction,” Ann Pharmacother, 1995, 29(7-8):726-35.[PubMed 8520091]

Liem A, Reynierse-Buitenwerf GH, Zwinderman AH, et al, “Secondary Prevention With Folic Acid: Effects on Clinical Outcomes,” J Am Coll Cardiol, 2003, 41(12):2105-13.[PubMed 12821232]

O’Connor OA, Pro B, Pinter-Brown L, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011;29(9):1182-1189. doi: 10.1200/JCO.2010.29.9024.[PubMed 21245435]

Olszewski AJ, Szostak WB, Bialkowska M, et al, “Reduction of Plasma Lipid and Homocysteine Levels by Pyridoxine, Folate, Cobalamin, Choline, Riboflavin, and Troxerutin in Atherosclerosis,” Atherosclerosis, 1989, 75(1):1-6.[PubMed 2930611]

Osterloh JD, Pond SM, Grady S, and Becker CE. Serum folate concentrations in methanol intoxication as a criterion for hemodialysis. Ann Internal Med. 1986;104:200-203.[PubMed 3946945]

Savage DG and Lindenbaum J, “Folate-Cobalamin Interactions,” Bailey LB, ed, Folate in Health and Disease, New York: Marcel Dekker, Inc, 1995, 237-85.

Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008;26(21):3543-3551. doi: 10.1200/JCO.2007.15.0375.[PubMed 18506025]

Schnyder G, Roffi M, Flammer Y, et al, “Effect of Homocysteine-Lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Clinical Outcome After Percutaneous Coronary Intervention: The Swiss Heart Study: A Randomized Controlled Trial,” JAMA, 2002, 288(8):973-9.[PubMed 12190367]

US Preventive Services Task Force (USPSTF); Bibbins-Domingo K, Grossman DC, Curry SJ, et al. Folic acid supplementation for the prevention of neural tube defects: US Preventive Services Task Force Recommendation Statement. JAMA. 2017;317(2):183-189. doi: 10.1001/jama.2016.19438.[PubMed 28097362]

Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003;21(14):2636-2664. doi: 10.1200/JCO.2003.11.136.[PubMed 12860938]

Zakharov S, Pelclova D, Navratil T, et al. Fomepizole versus ethanol in the treatment of acute methanol poisoning: Comparison of clinical effectiveness in a mass poisoning outbreak. Clin Toxicol. 2015;53(8):797-806. doi: 10.3109/15563650.2015.1059946.[PubMed 26109326]

Brand Names: International

A.F. Valdecasas (MX); Acfol (ES, LB, PT); Acide Folique CCD (FR); Acido Folico (AR, CO, EC, PE); Acido Folico Fada (AR); Acifol (AR, RO); Anemolat (ID); Apo-Folic (NZ); Bio-Folic (BE); Clonfolic (IE); Conacid (AR); Elvefocal (AR); Endofolin (BR); Enhansid (PH); Feri (PH); Filicine (GR, MT); Fionat (ID); Folac (BD); Folacid (PL); Folacin (BR, HR, RU, SE, TW); Folart (PH); Folate (BD); Folavit (BE, LU); Folbiol (TR); Folcid (PH); Folee-1 (LK); Foli 5 (IL); Foliage (PH); Foliamin (HK, JP, TH); Folic Acid DHA (MY); Folic Acid Pharm Ecologist (AR); Folicap (EG); Folicid (KR); Folicil (CY, HK, LB, MT, PT); Folicum (AE, BH, KW, QA, SA); Folimax (PH); Folimen (CR, DO, GT, HN, NI, PA, SV); Folimet (DK); Folin (BR); Folina (IT, MY); Folinsyre ”Dak” (DK); Foliphar (BE); Folitab (QA); Folivit (TH); Folivita (SA); Folivital (MX); Foloicare (AE); Folsan (AT, HR); Folsyre (NO); Folverlan (DE); Folvit (EG); Folvite (AE, BB, BM, BS, BZ, CH, CY, FI, GY, IL, IQ, IR, JM, JO, KW, LY, NL, OM, SA, SR, SY, TT, YE); Gravi-Fol (DE); Gravida (BE); Huma-Folacid (HU); Ingafol (IN, LK); Lexpec (GB); Megafol (AU); Mithra Folic (BE); Nufolic (ID); Obstetra (EG); Prinac AC (MX); Quatro (ID); RubieFol (DE); Tecnovorin (BR); Tesha-1 (LK); Tifol (UA); Tonixan (PY); Travital Folic Acid (BE); Vifolin (AE, CY, IL, IQ, IR, JO, KW, LY, OM, SA, SY, YE)

Folic Acid (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(FOE lik AS id)

Brand Names: US

FA-8 [OTC]

Brand Names: Canada

Apo-Folic

What is this drug used for?
  • It is used to help with some kinds of anemia.
  • This vitamin is used to aid the diet needs before, during, and after pregnancy.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to folic acid or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Talk with your doctor before you drink alcohol.
  • If you are taking phenytoin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Injection:
  • This drug may contain aluminum. There is a chance of aluminum toxicity if you are on this drug for a long time. The risk is greater if you have kidney problems. The risk is also higher in premature infants. Talk with the doctor.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Tablets and capsules:
  • Take with or without food.
  • Injection:
  • It is given as a shot into a muscle, under the skin, or into a vein.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to take this drug as you have been told by your doctor. Do not use more than you were told to use.
  • Wash your hands before and after use.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • All products:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Tablets and capsules:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • Most of the time, this drug will be given in a hospital or doctor’s office. If stored at home, follow how to store as you were told by the doctor.
  • Protect from light.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Folic Acid (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(FOE lik AS id)

Brand Names: US

FA-8 [OTC]

Brand Names: Canada

Apo-Folic

What is this drug used for?
  • It is used to help with some kinds of anemia.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child is taking phenytoin, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • Injection:
  • This drug may contain aluminum. There is a chance of aluminum toxicity if your child is on this drug for a long time. The risk is greater if your child has kidney problems. The risk is also higher in premature infants. Talk with the doctor.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if your child has any side effects that bother your child or do not go away.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Tablets and capsules:
  • Give this drug with or without food.
  • Injection:
  • It is given as a shot into a muscle, under the skin, or into a vein.
  • If you will be giving your child the shot, your child’s doctor or nurse will teach you how to give the shot.
  • Follow how to give this drug as you have been told by your child’s doctor. Do not give more than you were told to give.
  • Wash your hands before and after use.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
  • All products:
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Tablets and capsules:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • Most of the time, this drug will be given in a hospital or doctor’s office. If stored at home, follow how to store as you were told by the doctor.
  • Protect from light.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.