Folic Acid 800mcg Tablets

Manufacturer RUGBY LABORATORIES 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, Hematopoietic Agent
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Pharmacologic Class
Water-soluble vitamin (B vitamin)
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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 B vitamin that helps your body make healthy new cells, including red blood cells. It's very important for pregnant women to take it to help prevent serious birth defects of the brain and spine in their babies. It's also used to treat certain types of anemia caused by a lack of this vitamin.
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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, and continue taking it even if you feel well. It's essential to adhere to your doctor's or healthcare provider's advice to ensure the best results.

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 the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the proper disposal method. You may also want to explore 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses, as this can be harmful.
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Lifestyle & Tips

  • Take exactly as prescribed or as directed on the label.
  • Can be taken with or without food.
  • If you miss a dose, take it as soon as you remember. If it's close to your next dose, skip the missed dose and continue your regular schedule. Do not double dose.
  • Store at room temperature away from light and moisture.
  • Maintain a balanced diet rich in folate (leafy green vegetables, fruits, fortified cereals).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 800 mcg orally once daily (for neural tube defect prevention in pregnancy planning/early pregnancy)
Dose Range: 400 - 5000 mg

Condition-Specific Dosing:

Megaloblastic Anemia (due to folate deficiency): 1 mg orally once daily; maintenance 0.4-0.8 mg daily
Neural Tube Defect Prevention (high risk): 4 mg orally once daily
Dietary Supplementation: 400 mcg orally once daily
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Pediatric Dosing

Neonatal: Not established (consult specialist for specific conditions)
Infant: 0.1 mg orally once daily (for megaloblastic anemia); maintenance 0.03-0.1 mg daily
Child: 0.1-1 mg orally once daily (for megaloblastic anemia); maintenance 0.1-0.4 mg daily
Adolescent: 0.1-1 mg orally once daily (for megaloblastic anemia); maintenance 0.4-0.8 mg daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific adjustment needed; supplementation may be beneficial due to potential loss during dialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Folic acid (folate) is a water-soluble B vitamin (B9) essential for numerous metabolic processes, including DNA synthesis and repair, cell division, and red blood cell formation. It acts as a coenzyme in the transfer of one-carbon units in the synthesis of purines and pyrimidines (components of DNA and RNA), and in the interconversion of amino acids. Specifically, it is crucial for the methylation cycle and the conversion of homocysteine to methionine.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not readily quantifiable, widely distributed to body tissues, primarily stored in the liver.
ProteinBinding: High (to plasma proteins)
CnssPenetration: Limited, but active transport mechanisms exist for folate into the CSF.

Elimination:

HalfLife: Several hours (variable, depends on folate status)
Clearance: Primarily renal, with some enterohepatic recirculation.
ExcretionRoute: Renal (urine), small amounts in feces.
Unchanged: Small amounts of unchanged folic acid are excreted in urine, especially with high doses.
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Pharmacodynamics

OnsetOfAction: Days to weeks (for correction of deficiency symptoms)
PeakEffect: Weeks to months (for full repletion of body 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.
It's essential to note that this list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor.
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing) - seek immediate medical attention.
  • Any new or worsening neurological symptoms (e.g., numbness, tingling, weakness, balance problems) if you have not had your vitamin B12 levels checked, as folic acid can mask B12 deficiency.
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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 allergic reaction you experienced, including any symptoms that occurred.
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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose 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:

  • Generally considered non-toxic even at high doses, but very high doses (e.g., >15 mg/day) may rarely cause:
  • Gastrointestinal upset (nausea, bloating, gas)
  • Sleep disturbances
  • Irritability
  • Skin reactions

What to Do:

Discontinue use. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Major Interactions

  • Methotrexate (high doses of folic acid can interfere with methotrexate's antineoplastic effect; however, low-dose folic acid is often used as 'leucovorin rescue' or to mitigate side effects of low-dose methotrexate in autoimmune diseases)
  • Pyrimethamine (antagonizes effects)
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Moderate Interactions

  • Anticonvulsants (e.g., phenytoin, phenobarbital, primidone): Folic acid can decrease serum levels of these drugs, potentially increasing seizure frequency. Conversely, these drugs can lower folate levels.
  • Sulfasalazine: Inhibits folate absorption and metabolism.
  • Trimethoprim: Antagonizes folate metabolism.
  • Chloramphenicol: May antagonize hematopoietic response to folic acid.
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Minor Interactions

  • Oral contraceptives: May slightly lower folate levels.
  • Metformin: May decrease vitamin B12 and folate absorption.

Monitoring

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Baseline Monitoring

Serum Folate Level

Rationale: To confirm folate deficiency if suspected, or to establish baseline before high-dose therapy.

Timing: Before initiating therapy for deficiency.

Serum Vitamin B12 Level

Rationale: Crucial to rule out vitamin B12 deficiency before initiating folic acid therapy, as folic acid can mask the hematological symptoms of B12 deficiency while neurological damage progresses.

Timing: Before initiating therapy for suspected megaloblastic anemia.

Complete Blood Count (CBC)

Rationale: To assess for megaloblastic anemia (macrocytic red blood cells) and monitor response to therapy.

Timing: Before initiating therapy for suspected megaloblastic anemia.

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Routine Monitoring

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

Frequency: Periodically, as needed

Target: Resolution of symptoms

Action Threshold: Persistent or worsening symptoms may indicate inadequate dosing or alternative diagnosis.

CBC (if treating anemia)

Frequency: Monthly until normalized, then as clinically indicated

Target: Normal red blood cell indices (MCV, MCH)

Action Threshold: Lack of improvement or worsening anemia.

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Symptom Monitoring

  • Allergic reactions (rash, itching, hives, swelling of face/lips/tongue/throat, severe dizziness, trouble breathing)
  • Gastrointestinal upset (nausea, bloating, gas)
  • Irritability
  • Sleep disturbances

Special Patient Groups

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Pregnancy

Category A. Folic acid is essential during pregnancy, especially in the periconceptional period (before and during early pregnancy), to prevent neural tube defects (NTDs) such as spina bifida and anencephaly. All women of childbearing age are recommended to take 400-800 mcg daily. Higher doses (4 mg daily) are recommended for women with a history of NTD-affected pregnancies or other high-risk factors.

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development; deficiency poses significant risk of NTDs.
Second Trimester: Continued importance for fetal growth and development.
Third Trimester: Continued importance for fetal growth and maternal health.
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Lactation

L1 (Safest). Folic acid is excreted into breast milk and is considered compatible with breastfeeding. It is important for both maternal and infant health.

Infant Risk: No known adverse effects on breastfed infants. Beneficial for infant growth and development.
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Pediatric Use

Safe and effective for treating folate deficiency and certain anemias in children. Dosing is weight-based or age-based depending on the indication. Essential for normal growth and development.

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Geriatric Use

No specific dose adjustments are typically needed. Elderly patients may be at higher risk for folate deficiency due to poor diet, malabsorption, or drug interactions. Ensure vitamin B12 deficiency is ruled out before high-dose folate supplementation.

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 allow irreversible neurological damage from B12 deficiency to progress.
  • Folic acid supplementation is critical for all women of childbearing age, not just those planning pregnancy, due to the high rate of unplanned pregnancies and the critical window for neural tube development (first 28 days post-conception).
  • High doses of folic acid (e.g., 5 mg) are typically reserved for individuals with a history of neural tube defects, malabsorption syndromes, or specific drug interactions.
  • Dietary folate is found in leafy green vegetables, citrus fruits, beans, and fortified grains. However, synthetic folic acid in supplements and fortified foods is more bioavailable.
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Alternative Therapies

  • Dietary sources rich in folate (e.g., spinach, broccoli, asparagus, fortified cereals, legumes, oranges)
  • Leucovorin (folinic acid) - a reduced form of folate, used in specific clinical situations like methotrexate rescue.
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (800mcg)
Generic Available: Yes
Insurance Coverage: Tier 1 (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 your 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 medication taken, the amount, and the time it occurred.