Folic acid (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.
Dosing Informaton
- Parenteral Administration: IM, IV and SC routes may be used if the disease is exceptionally severe or if gastrointestinal absorption may be, or is known to be, impaired.
- Usual Therapeutic Dosage—In adults and children (regardless of age): up to 1 mg daily.Resistant cases may require larger doses.
- Maintenance Level: When clinical symptoms have subsided and the blood picture has become normal, a maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under four years of age, 0.4 mg for adults and children four or more years of age and 0.8 mg for pregnant and lactating women, per day, but never less than 0.1 mg per day. Patient should be kept under close supervision and adjustment of the 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.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Folic acid (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Folic acid (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Folic acid (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Folic acid (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Folic acid (injection) in pediatric patients.
Contraindications
There is limited information regarding Folic acid (injection) Contraindications in the drug label.
Warnings
- This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
- Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
- Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
- This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
PRECAUTIONS=
- Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Adverse Reactions
Clinical Trials Experience
- Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Postmarketing Experience
There is limited information regarding Folic acid (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Folic acid (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Folic acid (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Folic acid (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Folic acid (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Folic acid (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Folic acid (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Folic acid (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Folic acid (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Folic acid (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Folic acid (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Folic acid (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Folic acid (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Folic acid (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Folic acid (injection) Administration in the drug label.
Monitoring
There is limited information regarding Folic acid (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Folic acid (injection) and IV administrations.
Overdosage
There is limited information regarding Folic acid (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Folic acid (injection) Pharmacology in the drug label.
Mechanism of Action
- In man, an exogenous source of folate is required for nucleoprotein synthesis and maintenance of normal erythropoiesis. Folic acid, whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells and platelets in persons suffering from certain megaloblastic anemias.
Structure
- Folic Acid Injection, USP is a sterile, nonpyrogenic solution of sodium folate (prepared by the addition of sodium hydroxide to folic acid) in Water for Injection intended for intramuscular (IM), intravenous (IV) or subcutaneous (SC) use.
- Folic Acid is a complex organic compound present in liver, yeast and other substances, which may be prepared synthetically. It is a yellow or yellowish orange, odorless crystalline powder. It is very slightly soluble in water, insoluble in alcohol, chloroform, ether; readily dissolves in dilute solutions of alkali hydroxides and carbonates, and has the following structural formula.
Pharmacodynamics
There is limited information regarding Folic acid (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Folic acid (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Folic acid (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Folic acid (injection) Clinical Studies in the drug label.
How Supplied
- Folic Acid Injection, USP (5 mg/mL) is available as:
tab
Storage
- Store at 20° to 25°C (68° to 77°F)
- PROTECT FROM LIGHT.
- Retain vial in carton until contents are used.
Images
Drug Images
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Package and Label Display Panel
PACKAGE LABEL - PRINCIPAL DISPLAY - Folic Acid 10 mL Vial Label
NDC 63323-184-10
18410
Folic Acid Injection, USP
5 mg/mL
For IM, IV, or SC Use
10 mL
Rx only
Multiple Dose Vial
PACKAGE LABEL - PRINCIPAL DISPLAY - Folic Acid 10 mL Vial Carton Label
NDC 63323-184-10
18410
Folic Acid Injection, USP
5 mg/mL
For IM, IV, or SC Use
10 mL
Multiple Dose Vial
Rx only {{#ask: Label Page::Folic acid (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Folic acid (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Folic acid (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Folic acid (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Folic acid (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.