Folic Acid 5mg/ml Inj, 10ml
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.
Drug Class
Vitamin; Antianemic
Pharmacologic Class
Water-soluble vitamin; B vitamin; Folic acid derivative
Pregnancy Category
Category A
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Folic acid is a type of B vitamin that your body needs to make healthy new cells, especially red blood cells. This injection is used to treat or prevent certain types of anemia (low red blood cells) caused by a lack of folic acid.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. This medication is administered via injection into a muscle, under the skin, or into a vein. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
Continue taking your medication as directed by your doctor or healthcare provider, even if you are feeling well. Properly dispose of used needles and syringes in a designated sharps disposal container. Do not reuse needles or other equipment. When the container is full, follow local regulations for disposal. If you have any questions or concerns, consult with your doctor or pharmacist.
Storing and Disposing of Your Medication
In most cases, this medication will be administered in a hospital or doctor's office. If you need to store it at home, follow the storage instructions provided by your doctor. Protect the medication from light.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. This medication is administered via injection into a muscle, under the skin, or into a vein. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
Continue taking your medication as directed by your doctor or healthcare provider, even if you are feeling well. Properly dispose of used needles and syringes in a designated sharps disposal container. Do not reuse needles or other equipment. When the container is full, follow local regulations for disposal. If you have any questions or concerns, consult with your doctor or pharmacist.
Storing and Disposing of Your Medication
In most cases, this medication will be administered in a hospital or doctor's office. If you need to store it at home, follow the storage instructions provided by your doctor. Protect the medication from light.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Maintain a balanced diet rich in folate (leafy green vegetables, fruits, fortified cereals).
- Avoid excessive alcohol consumption, as it can interfere with folate absorption and metabolism.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Megaloblastic Anemia: 1 mg IM/IV/SC daily until clinical remission occurs. Maintenance: 0.5 mg daily for chronic hemolytic states or in patients on parenteral nutrition. Folate Deficiency: 0.4 mg to 1 mg IM/IV/SC daily.
Dose Range:
0.4 - 1 mg
Condition-Specific Dosing:
Megaloblastic Anemia:
1 mg IM/IV/SC daily
Folate Deficiency:
0.4 mg to 1 mg IM/IV/SC daily
Chronic Hemolytic States/Parenteral Nutrition (Maintenance):
0.5 mg IM/IV/SC daily
Pediatric Dosing
Neonatal:
Megaloblastic Anemia: 0.5 mg IM/IV/SC daily. Maintenance: 0.1 mg IM/IV/SC daily.
Infant:
Megaloblastic Anemia: 0.5 mg IM/IV/SC daily. Maintenance: 0.1 mg IM/IV/SC daily.
Child:
Megaloblastic Anemia: 0.5 mg IM/IV/SC daily. Maintenance: 0.1 mg IM/IV/SC daily.
Adolescent:
Megaloblastic Anemia: 1 mg IM/IV/SC daily. Maintenance: 0.5 mg IM/IV/SC daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment generally needed.
Moderate:
No adjustment generally needed.
Severe:
No adjustment generally needed.
Dialysis:
Folic acid is dialyzable, but supplementation is usually part of standard care for dialysis patients. No specific dose adjustment beyond routine supplementation.
Hepatic Impairment:
Mild:
No adjustment generally needed.
Moderate:
No adjustment generally needed.
Severe:
No adjustment generally needed.
Pharmacology
Mechanism of Action
Folic acid (pteroylglutamic acid) is a water-soluble B vitamin. It is essential for the synthesis of nucleoproteins and the maintenance of normal erythropoiesis. It is converted in the body to tetrahydrofolate, which is a coenzyme for various metabolic processes, including the synthesis of purine and pyrimidine nucleotides, and the interconversion of amino acids. It is crucial for DNA synthesis and repair, cell division, and red blood cell maturation.
Pharmacokinetics
Absorption:
Bioavailability:
100% (for IV/IM administration)
Tmax:
Not applicable for IV administration (immediate effect). For IM, peak plasma levels within 30-60 minutes.
FoodEffect:
Not applicable for parenteral administration.
Distribution:
Vd:
Approximately 1.7 L/kg
ProteinBinding:
High (to plasma proteins, primarily albumin)
CnssPenetration:
Limited, but active transport mechanisms exist. Levels in CSF are lower than in plasma.
Elimination:
HalfLife:
Approximately 30-60 minutes (for unmetabolized folic acid after IV dose); however, the biological half-life of tissue folate stores is much longer (several months).
Clearance:
Not readily quantifiable for the vitamin itself due to tissue uptake and metabolism.
ExcretionRoute:
Renal (primarily as metabolites, some unchanged folic acid at high doses). Some enterohepatic recirculation.
Unchanged:
Minimal at physiological doses; up to 50% at very high doses.
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes for IV administration, clinical response for anemia may take days to weeks).
PeakEffect:
Not directly applicable for vitamin replacement; clinical effects are gradual.
DurationOfAction:
Tissue stores can last for several months once replenished.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as 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.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as 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.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Symptoms of anemia (e.g., extreme tiredness, weakness, pale skin, shortness of breath, dizziness, lightheadedness, fast heartbeat).
- Symptoms of allergic reaction (rare): rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss your test results with your doctor.
Before consuming alcohol, consult with your doctor to understand any potential risks or interactions. This medication may contain aluminum, which can lead to aluminum toxicity with long-term use. The risk of aluminum toxicity is higher if you have kidney problems or if you are a premature infant. Discuss this risk with your doctor to determine the best course of action.
Some formulations of this medication may contain benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as high doses can cause serious side effects, particularly when combined with other medications containing benzyl alcohol. Consult with your doctor to confirm whether this product contains benzyl alcohol and to discuss alternative options.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor immediately. You and your doctor will need to weigh the benefits and risks of this medication to you and your baby to make an informed decision about treatment.
Before consuming alcohol, consult with your doctor to understand any potential risks or interactions. This medication may contain aluminum, which can lead to aluminum toxicity with long-term use. The risk of aluminum toxicity is higher if you have kidney problems or if you are a premature infant. Discuss this risk with your doctor to determine the best course of action.
Some formulations of this medication may contain benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as high doses can cause serious side effects, particularly when combined with other medications containing benzyl alcohol. Consult with your doctor to confirm whether this product contains benzyl alcohol and to discuss alternative options.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor immediately. You and your doctor will need to weigh the benefits and risks of this medication to you and your baby to make an informed decision about treatment.
Overdose Information
Overdose Symptoms:
- Folic acid has very low toxicity. Symptoms of acute overdose are rare but may include gastrointestinal upset (nausea, bloating), irritability, sleep disturbances, or allergic reactions (rare).
What to Do:
Discontinue use. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Major Interactions
- Methotrexate (high doses of folic acid can reduce methotrexate efficacy, though leucovorin is used for rescue)
- Raltitrexed (may reduce efficacy)
Moderate Interactions
- Phenytoin (folic acid may decrease phenytoin levels, increasing seizure risk)
- Phenobarbital (folic acid may decrease phenobarbital levels)
- Primidone (folic acid may decrease primidone levels)
- Trimethoprim (antagonizes folic acid metabolism)
- Pyrimethamine (antagonizes folic acid metabolism)
- Sulfasalazine (inhibits folic acid absorption)
- Cholestyramine (may impair absorption if given orally, less relevant for injection)
Minor Interactions
- Oral contraceptives (may slightly decrease folate levels)
- Alcohol (interferes with folate metabolism and absorption)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess severity of anemia, red blood cell indices (MCV, MCH), and rule out other causes of anemia.
Timing: Prior to initiation of therapy.
Serum Folate Level
Rationale: To confirm folate deficiency.
Timing: Prior to initiation of therapy.
Serum Vitamin B12 Level
Rationale: To rule out concomitant Vitamin B12 deficiency, as folic acid can mask the hematological signs of B12 deficiency while neurological damage progresses.
Timing: Prior to initiation of therapy.
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Weekly initially, then monthly until stable, then as clinically indicated.
Target: Normal ranges for age and sex.
Action Threshold: Persistent anemia or worsening indices may indicate inadequate dosing or other underlying issues.
Serum Folate Level
Frequency: Not routinely needed once deficiency is corrected and patient is stable, unless clinical suspicion of recurrence.
Target: Normal range (e.g., >3 ng/mL or >6.8 nmol/L).
Action Threshold: Levels below normal may indicate need for dose adjustment or investigation of malabsorption.
Symptom Monitoring
- Resolution of fatigue
- Improvement in pallor
- Resolution of glossitis or other oral symptoms
- Absence of new neurological symptoms (important if B12 deficiency was not ruled out)
Special Patient Groups
Pregnancy
Folic acid is crucial during pregnancy to prevent neural tube defects. It is a Category A drug, meaning adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Trimester-Specific Risks:
First Trimester:
Essential for neural tube development; deficiency leads to increased risk of neural tube defects. No known risk from appropriate supplementation.
Second Trimester:
No known risk; continued supplementation supports fetal growth and maternal health.
Third Trimester:
No known risk; continued supplementation supports fetal growth and maternal health.
Lactation
Folic acid is excreted into breast milk. It is considered safe and compatible with breastfeeding. Supplementation may be necessary for lactating mothers to meet their own needs and ensure adequate folate in breast milk.
Infant Risk:
Low risk; considered safe for the breastfed infant.
Pediatric Use
Used to treat megaloblastic anemia and other folate deficiencies in pediatric patients. Dosing is weight-based or age-based. Safety and efficacy are well-established.
Geriatric Use
No specific dose adjustments are generally required based on age alone. Elderly patients may have increased risk of folate deficiency due to poor nutrition, malabsorption, or polypharmacy. Monitor for concomitant Vitamin B12 deficiency.
Clinical Information
Clinical Pearls
- Always rule out Vitamin B12 deficiency before initiating folic acid therapy for megaloblastic anemia, as folic acid can correct the hematological abnormalities of B12 deficiency while allowing irreversible neurological damage to progress.
- Folic acid injection is preferred for patients with malabsorption syndromes or those unable to take oral medications.
- While generally safe, very high doses of folic acid can potentially mask B12 deficiency or interact with certain antiepileptic drugs.
- Folic acid is crucial for women of childbearing potential to prevent neural tube defects, even before conception.
Alternative Therapies
- Dietary modification (folate-rich foods)
- Oral folic acid supplementation
- Leucovorin (folinic acid, an active metabolite, used in specific situations like methotrexate rescue)
Cost & Coverage
Average Cost:
Typically low cost per 10ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 (preferred generic)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.