Folic Acid 1mg Tablets

Manufacturer LEADING Active Ingredient Folic Acid Capsules and Tablets(FOE lik AS id) Pronunciation FOE lik AS id
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.
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Drug Class
Vitamin
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Pharmacologic Class
Water-soluble vitamin; B vitamin; Hematopoietic agent
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Pregnancy Category
Category A
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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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. It's very important for preventing certain birth defects in babies and for treating a type of anemia caused by not having enough folic acid.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider tells you to stop.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor.
  • You can take this medicine with or without food.
  • If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses at once.
  • Store at room temperature away from moisture and heat.
  • Maintain a balanced diet rich in natural folate sources like leafy green vegetables, fruits, nuts, beans, and fortified cereals, although supplementation is often necessary to correct deficiencies.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1 mg orally once daily
Dose Range: 0.4 - 5 mg

Condition-Specific Dosing:

megaloblasticAnemia: 1 mg orally once daily (up to 5 mg initially for severe deficiency)
pregnancyPreventionNeuralTubeDefects: 0.4 mg to 0.8 mg orally once daily (often found in prenatal vitamins)
folateDeficiency: 0.4 mg to 1 mg orally once daily
methotrexateTherapy: 1 mg to 5 mg orally once daily or weekly, depending on methotrexate dose and regimen
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Pediatric Dosing

Neonatal: 0.1 mg/kg/day orally (max 5 mg/day) for deficiency or specific conditions (e.g., premature infants, hemolytic anemia)
Infant: 0.1 mg/kg/day orally (max 5 mg/day) for deficiency or specific conditions
Child: 0.5 mg to 1 mg orally once daily for deficiency or specific conditions (e.g., megaloblastic anemia, chronic hemolytic states)
Adolescent: 0.5 mg to 1 mg orally once daily for deficiency or specific conditions
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; Folic acid is dialyzable but supplementation is often recommended for patients on dialysis due to increased needs.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Folic acid (pteroylglutamic acid) is a water-soluble B vitamin. It is reduced 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 essential for DNA synthesis, cell division, and red blood cell maturation. Folic acid supplementation helps prevent and treat megaloblastic anemia caused by folate deficiency and is crucial for neural tube development during pregnancy.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 85-100% (synthetic folic acid is more bioavailable than dietary folate)
Tmax: 1 hour
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Not readily quantifiable for a vitamin; widely distributed in body tissues, especially liver, where it is stored.
ProteinBinding: Highly protein-bound (to plasma proteins, especially albumin)
CnssPenetration: Limited (requires active transport across the blood-brain barrier)

Elimination:

HalfLife: Several hours (variable, depends on body stores and intake)
Clearance: Not typically reported for a vitamin; primarily eliminated renally.
ExcretionRoute: Renal (urine), primarily as metabolites; small amounts excreted in feces.
Unchanged: Small amounts (excess) excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Days to weeks for hematologic response in deficiency
PeakEffect: Weeks to months for full restoration of folate stores
DurationOfAction: Dependent on continued intake and body stores

Safety & Warnings

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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.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of folate deficiency (if not already present): unusual tiredness, pale skin, shortness of breath, irritability, sore tongue, diarrhea, headache, heart palpitations.
  • Seek medical attention if you experience any new or worsening symptoms.
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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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 any concerns or questions with your doctor. Before consuming alcohol, consult with your doctor to understand any potential risks. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to carefully weigh the benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Folic acid has very low toxicity, even at high doses. Overdose is rare and typically asymptomatic.
  • Extremely high doses (e.g., >15 mg/day) over prolonged periods have rarely been associated with gastrointestinal upset, sleep disturbances, or skin reactions, but these are not common with typical therapeutic doses.

What to Do:

If you suspect an overdose, contact your local poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive as serious toxicity is unlikely.

Drug Interactions

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Major Interactions

  • Methotrexate (high doses of folic acid can reduce methotrexate efficacy, but low-dose supplementation is often used to reduce methotrexate toxicity)
  • Raltitrexed (may reduce efficacy)
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Moderate Interactions

  • Phenytoin (folic acid can decrease phenytoin levels, and phenytoin can decrease folate levels; monitor)
  • Phenobarbital (folic acid can decrease phenobarbital levels)
  • Primidone (folic acid can decrease primidone levels)
  • Trimethoprim (antagonizes folate metabolism, may increase folate requirements)
  • Pyrimethamine (antagonizes folate metabolism, may increase folate requirements)
  • Sulfasalazine (inhibits folate absorption)
  • Cholestyramine (may impair folate absorption)
  • Oral contraceptives (may lower folate levels)

Monitoring

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Baseline Monitoring

Serum folate levels

Rationale: To confirm deficiency or assess baseline status.

Timing: Prior to initiation of therapy for deficiency.

Complete Blood Count (CBC) with differential

Rationale: To assess for megaloblastic anemia (macrocytosis, hypersegmented neutrophils) and monitor response to therapy.

Timing: Prior to initiation of therapy for deficiency.

Serum Vitamin B12 levels

Rationale: To rule out co-existing Vitamin B12 deficiency, as folic acid can mask B12 deficiency symptoms while allowing neurological damage to progress.

Timing: Prior to initiation of therapy for megaloblastic anemia.

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Routine Monitoring

Clinical symptoms (e.g., fatigue, pallor, glossitis)

Frequency: Regularly, as clinically indicated

Target: Resolution or improvement of symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate inadequate dosing or alternative diagnosis.

Complete Blood Count (CBC) with differential

Frequency: Monthly initially, then every 3-6 months once stable (for anemia treatment)

Target: Normalization of red blood cell indices (MCV), hemoglobin, and neutrophil morphology.

Action Threshold: Persistent macrocytosis or anemia despite therapy.

Serum folate levels

Frequency: Not routinely needed once deficiency is corrected and patient is stable on maintenance dose; may be checked if non-response or recurrence of symptoms.

Target: Normal range (e.g., >3 ng/mL or >7 nmol/L)

Action Threshold: Persistently low levels despite supplementation.

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Symptom Monitoring

  • Fatigue
  • Weakness
  • Pallor
  • Shortness of breath
  • Sore tongue (glossitis)
  • Diarrhea
  • Irritability
  • Headache
  • Heart palpitations

Special Patient Groups

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Pregnancy

Folic acid is crucial during pregnancy, especially in the periconceptional period (before and during early pregnancy), to prevent neural tube defects (NTDs) such as spina bifida and anencephaly. It is a Category A drug, meaning adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester (and there is no evidence of risk in later trimesters).

Trimester-Specific Risks:

First Trimester: Essential for neural tube closure; deficiency poses significant risk of NTDs. Supplementation is highly recommended.
Second Trimester: No known risks; continued supplementation supports maternal and fetal growth.
Third Trimester: No known risks; continued supplementation supports maternal and fetal growth.
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Lactation

Folic acid is considered safe during breastfeeding. It is naturally present in breast milk and supplementation is often recommended for lactating mothers to ensure adequate maternal stores and infant intake.

Infant Risk: L1 (Safest) - No adverse effects reported in infants; considered compatible with breastfeeding.
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Pediatric Use

Folic acid is safe and effective for use in pediatric patients for the treatment and prevention of folate deficiency, megaloblastic anemia, and in certain conditions like chronic hemolytic anemias or during methotrexate therapy. Dosing is weight-based or age-specific.

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Geriatric Use

No specific dose adjustments are typically required for geriatric patients. However, elderly individuals may be at higher risk for folate deficiency due to poor dietary intake, malabsorption, or polypharmacy. Monitoring for deficiency and ensuring adequate intake is important.

Clinical Information

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Clinical Pearls

  • Always rule out Vitamin B12 deficiency before treating megaloblastic anemia with folic acid alone, as folic acid can correct the anemia but mask the neurological progression of B12 deficiency.
  • Folic acid is critical for women of childbearing potential, even if not planning pregnancy, due to the importance of early neural tube development.
  • Patients on methotrexate therapy often require folic acid supplementation to mitigate side effects, but the timing and dose must be carefully managed to avoid reducing methotrexate efficacy.
  • Dietary folate is less bioavailable than synthetic folic acid; therefore, supplementation with folic acid is often preferred for therapeutic purposes.
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Alternative Therapies

  • Leucovorin (folinic acid): An active metabolite of folic acid, used to rescue cells from methotrexate toxicity or to enhance fluorouracil's effects.
  • Vitamin B12 (Cyanocobalamin/Methylcobalamin): For megaloblastic anemia caused by B12 deficiency.
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (1mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.