Folic Acid Injection, USP is a sterile, nonpyrogenic solution of sodium folate (5 mg/mL) in Water for Injection, USP intended for intramuscular (IM), intravenous (IV), or subcutaneous (SC) use. This prescription-only parenteral formulation is indicated for the treatment of megaloblastic anemias due to folic acid deficiency, including those associated with tropical or nontropical sprue, nutritional origin, pregnancy, infancy, and childhood.
Each 10 mL multiple-dose vial delivers 50 mg total folic acid (as sodium folate) at a concentration of 5 mg per mL, providing a reliable parenteral option when oral or gastrointestinal absorption is impaired or clinically inadequate.
Key Benefits
- Targeted Megaloblastic Anemia Treatment: Parenterally stimulates production of red blood cells, white blood cells, and platelets in patients with folic acid-deficiency megaloblastic anemias.
- Flexible Administration Routes: Approved for IM, IV, and SC use, supporting clinical versatility when oral folate therapy is not feasible.
- High-Concentration, Multi-Dose Format: Supplied as 50 mg per 10 mL (5 mg/mL) in a flip-top multiple-dose vial for efficient clinical use.
- Sterile and Nonpyrogenic: Manufactured to USP standards, ensuring safety and quality for parenteral administration.
- Clinically Trusted Formulation: Indicated across a broad patient population including adults, pediatric patients, pregnant women, and lactating women.
Dosage and Administration
Parenteral routes (IM, IV, SC) are indicated when the condition is exceptionally severe or when gastrointestinal absorption is known or suspected to be impaired. Inspect solution visually for particulate matter and discoloration prior to administration.
- Usual Therapeutic Dose (Adults and Children, all ages): Up to 1 mg daily. Resistant cases may require larger doses.
- Maintenance — Infants: 0.1 mg per day.
- Maintenance — Children under 4 years: Up to 0.3 mg per day.
- Maintenance — Adults and Children 4+ years: 0.4 mg per day.
- Maintenance — Pregnant and Lactating Women: 0.8 mg per day; minimum 0.1 mg per day.
- Special Populations: Patients with alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection may require increased maintenance doses.
Why Choose Folic Acid Injection, USP?
- Parenteral Access When Oral Routes Fail: Provides reliable folate repletion in patients with malabsorption syndromes, GI impairment, or severe clinical presentations.
- Broad Indicated Population: Effective in adults, children of all ages, and pregnant or lactating women, with weight-based maintenance flexibility.
- Convenient Multi-Dose Vial: The 10 mL flip-top vial (NDC: 39822-1100-1) reduces preparation steps in clinical settings.
Warnings
- Aluminum Toxicity Risk: This product contains aluminum. Patients with impaired renal function, including premature neonates, are at risk for aluminum accumulation leading to CNS and bone toxicity at parenteral levels exceeding 4–5 mcg/kg/day.
- Benzyl Alcohol — Neonatal Risk: Contains benzyl alcohol 15 mg/mL, which has been associated with fatal "Gasping Syndrome" in premature infants.
- Not for Pernicious Anemia Monotherapy: Folic acid alone is inappropriate therapy for pernicious anemia or megaloblastic anemias caused by Vitamin B12 deficiency; hematologic remission may mask progressive neurological damage.
Disclaimer: This product description was generated by AI and is intended for informational purposes only. Please consult the latest package insert.
