1 mg QD (>1 mg QD adds no hematologic effect; resistant cases may require larger doses)
Maintenance after symptoms subside and blood picture normalizes
Adults
0.4 mg QD
0.4 mg QD
Maintenance after symptoms subside and blood picture normalizes
Pregnant and lactating women
0.8 mg QD
0.8 mg QD
Maintenance after symptoms subside and blood picture normalizes
Children ≥4 yr
0.4 mg QD
0.4 mg QD
Maintenance after symptoms subside and blood picture normalizes
Children <4 yr
Up to 0.3 mg QD
Up to 0.3 mg QD
Maintenance after symptoms subside and blood picture normalizes
Infants
0.1 mg QD
0.1 mg QD
Renal Undefined
Hepatic Undefined
Daily doses >1 mg do not enhance the hematologic effect and the excess is excreted unchanged in urine; maintenance should never be less than 0.1 mg/day.
Instructions
Oral administration is preferred; patients with malabsorption who cannot absorb food folates can still absorb oral folic acid.
Parenteral administration is not advocated but may be necessary in some patients (e.g., those on parenteral or enteral alimentation).
Do not use doses >0.1 mg unless vitamin B12 deficiency has been ruled out or is being adequately treated with cobalamin.
Keep patients under close supervision and adjust the maintenance dose if relapse appears imminent.
The maintenance dose may need to be increased in alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection.
Cautions
Doses >0.1 mg may correct the hematologic picture of vitamin B12 deficiency while neurologic damage progresses — rule out or adequately treat B12 deficiency with cobalamin first.
Decreased serum vitamin B12 levels may occur with prolonged folic acid therapy.
Allergic sensitization has been reported after both oral and parenteral administration.
Adverse reactions
Allergic sensitization after oral or parenteral administration; rare allergic responses — erythema, rash, pruritus, general malaise, respiratory difficulty from bronchospasm; one report of anaphylaxis-like symptoms after injection
GI (reported at 15 mg/day for 1 month): anorexia, nausea, abdominal distention, flatulence, bitter or bad taste
Decreased serum vitamin B12 with prolonged therapy
Increased incidence of seizures reported in some epileptic patients receiving phenobarbital, primidone, or phenytoin (diphenylhydantoin) who were given oral folic acid (uncontrolled study)
Decreased phenytoin (diphenylhydantoin) serum levels reported in folate-deficient patients on phenytoin treated with folic acid 5 mg or 15 mg daily
Pregnancy Pregnancy Category A — folic acid requirements are markedly increased in pregnancy and deficiency causes fetal damage; usually indicated for megaloblastic anemia of pregnancy, with no evidence of increased fetal abnormality risk.
Lactation No lactation section on the label; the dosing section specifies a 0.8 mg daily maintenance dose for lactating women.
NO BOXED WARNINGS
Principal riskMasks the anemia of B12 deficiency while neuropathy progresses