Folgard Rx Tabs (new Formula)
It is used to help growth and good health.It is used to treat or prevent low vitamin B6.It is used to treat or prevent low vitamin B12.
Drug Class
Vitamin supplement; Agent for hyperhomocysteinemia
Pharmacologic Class
Water-soluble vitamins (B-complex)
Pregnancy Category
Category A (for Folic Acid in recommended amounts; B for B6/B12, generally considered safe)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Folgard Rx Tabs is a vitamin supplement containing high doses of Folic Acid (Vitamin B9), Vitamin B12, and Vitamin B6. These vitamins are important for your body's metabolism, especially for processing a substance called homocysteine. High levels of homocysteine have been linked to certain health problems, and this supplement helps your body break it down more effectively.
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 with your medication and follow the instructions closely. Some products may need to be taken on an empty stomach, so be sure to check with your pharmacist for specific guidance on how to take your medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or look into drug take-back programs in your area.
What to Do If You Miss 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. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Some products may need to be taken on an empty stomach, so be sure to check with your pharmacist for specific guidance on how to take your medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or look into drug take-back programs in your area.
What to Do If You Miss 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. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed by your doctor, usually once daily.
- Can be taken with or without food.
- Do not exceed the recommended dose.
- Maintain a balanced diet rich in fruits, vegetables, and whole grains.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Regular follow-up appointments and blood tests (if recommended) are important to monitor your progress.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (2.2 mg Folic Acid, 25 mcg Cyanocobalamin, 25 mg Pyridoxine HCl) orally once daily.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
hyperhomocysteinemia:
One tablet orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (use typically based on specific deficiency and lower doses)
Adolescent:
Not established (adult dosing may be considered for specific indications under medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment generally needed for typical doses.
Moderate:
No specific adjustment generally needed for typical doses.
Severe:
No specific adjustment generally needed for typical doses; monitor for potential accumulation of pyridoxine in very high doses, but unlikely with Folgard Rx Tabs.
Dialysis:
Water-soluble vitamins are dialyzable; supplementation may be beneficial, but specific Folgard Rx Tabs adjustment not well-defined. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment generally needed.
Moderate:
No specific adjustment generally needed.
Severe:
No specific adjustment generally needed.
Pharmacology
Mechanism of Action
Folgard Rx Tabs provides high doses of Folic Acid (Vitamin B9), Cyanocobalamin (Vitamin B12), and Pyridoxine (Vitamin B6), which are essential cofactors in the methionine-homocysteine metabolic pathway. Folic acid and vitamin B12 are crucial for the remethylation of homocysteine to methionine via methionine synthase. Vitamin B6 is a cofactor for cystathionine beta-synthase, an enzyme involved in the transsulfuration pathway that converts homocysteine to cystathionine. By providing these vitamins, the product aims to facilitate the metabolism of homocysteine, thereby reducing elevated homocysteine levels.
Pharmacokinetics
Absorption:
Bioavailability:
Folic Acid: High (nearly 100% for synthetic folic acid); Cyanocobalamin: ~1-5% (oral, dose-dependent); Pyridoxine: High
Tmax:
Folic Acid: 1-6 hours; Cyanocobalamin: 8-12 hours; Pyridoxine: 1-2 hours
FoodEffect:
Folic Acid: Minimal effect; Cyanocobalamin: Absorption may be slightly enhanced with food; Pyridoxine: Minimal effect
Distribution:
Vd:
Folic Acid: ~1.7 L/kg; Cyanocobalamin: Not well-defined, widely distributed; Pyridoxine: Widely distributed
ProteinBinding:
Folic Acid: High (~60-90%); Cyanocobalamin: High (to transcobalamins); Pyridoxine: High (to albumin and hemoglobin)
CnssPenetration:
Folic Acid: Limited; Cyanocobalamin: Yes; Pyridoxine: Yes
Elimination:
HalfLife:
Folic Acid: ~3-9 hours; Cyanocobalamin: ~6 days (tissue half-life); Pyridoxine: ~15-20 days (PLP)
Clearance:
Not well-defined for combination; primarily renal for water-soluble vitamins
ExcretionRoute:
Primarily renal (urine); small amounts in feces
Unchanged:
Folic Acid: Small amount; Cyanocobalamin: Small amount; Pyridoxine: Small amount
Pharmacodynamics
OnsetOfAction:
Correction of biochemical markers (e.g., homocysteine) may take weeks to months. Clinical symptom improvement varies.
PeakEffect:
Peak reduction in homocysteine levels typically observed after several weeks to months of consistent supplementation.
DurationOfAction:
Effects persist as long as supplementation continues and stores are maintained.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
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
+ Swelling of the mouth, face, lips, tongue, or throat
A burning, numbness, or tingling feeling that is not normal
Swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
Diarrhea
Itching
Feeling sleepy
Upset stomach
Headache
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
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
+ Swelling of the mouth, face, lips, tongue, or throat
A burning, numbness, or tingling feeling that is not normal
Swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
Diarrhea
Itching
Feeling sleepy
Upset stomach
Headache
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unusual tingling, numbness, or burning sensations (especially in hands or feet) - could indicate high B6 intake, though rare at this dose.
- Severe allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing) - seek immediate medical attention.
- Any new or worsening neurological symptoms.
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.
If you have been diagnosed with Leber's optic atrophy, a specific eye condition.
* If you are currently taking levodopa, as this may interact with the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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.
If you have been diagnosed with Leber's optic atrophy, a specific eye condition.
* If you are currently taking levodopa, as this may interact with the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you or someone else accidentally takes this drug, seek immediate medical attention. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Generally, water-soluble vitamins have low toxicity. However, very high doses of Pyridoxine (Vitamin B6) over prolonged periods can cause sensory neuropathy (nerve damage) characterized by numbness, tingling, and difficulty with coordination.
- Folic acid and B12 are generally considered safe even at high doses, but excessive folic acid can mask a B12 deficiency.
What to Do:
If overdose is suspected, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive and symptomatic.
Drug Interactions
Major Interactions
- Folic Acid + Methotrexate (high doses of folic acid can reduce methotrexate efficacy, though low-dose supplementation is often used to mitigate side effects)
- Pyridoxine + Levodopa (Pyridoxine can reverse the effects of levodopa, especially when levodopa is used without a decarboxylase inhibitor like carbidopa. This interaction is less relevant with modern levodopa/carbidopa formulations.)
Moderate Interactions
- Folic Acid + Antiepileptic drugs (e.g., Phenytoin, Carbamazepine, Valproate) - Folic acid can decrease antiepileptic drug levels, potentially increasing seizure risk. Antiepileptic drugs can also lower folate levels.
- Folic Acid + Sulfasalazine - Sulfasalazine can inhibit folic acid absorption.
- Cyanocobalamin + Metformin - Metformin can decrease vitamin B12 absorption.
- Cyanocobalamin + Proton pump inhibitors (PPIs) / H2-receptor antagonists - Can reduce B12 absorption due to decreased gastric acid.
- Cyanocobalamin + Colchicine - Can impair B12 absorption.
- Pyridoxine + Isoniazid, Cycloserine, Hydralazine, Penicillamine - These drugs can act as pyridoxine antagonists or increase its excretion, leading to B6 deficiency.
Minor Interactions
- Folic Acid + Oral contraceptives - May slightly lower folate levels.
- Cyanocobalamin + Chloramphenicol - May reduce hematologic response to B12 in anemic patients.
Monitoring
Baseline Monitoring
Homocysteine levels
Rationale: To establish baseline and confirm indication for hyperhomocysteinemia.
Timing: Prior to initiation of therapy.
Serum Folate, Vitamin B12, and Pyridoxal 5'-phosphate (PLP) levels
Rationale: To assess baseline vitamin status and identify specific deficiencies.
Timing: Prior to initiation of therapy, especially if deficiency is suspected.
Routine Monitoring
Homocysteine levels
Frequency: Every 3-6 months initially, then annually once stable.
Target: < 10-12 µmol/L (varies by lab and clinical context)
Action Threshold: If levels remain elevated despite adherence, reassess compliance, absorption, or consider alternative/additional therapies.
Clinical symptoms (e.g., fatigue, neurological symptoms)
Frequency: Ongoing, at each follow-up visit.
Target: Improvement or resolution of symptoms.
Action Threshold: Worsening or new symptoms may indicate inadequate treatment or other underlying conditions.
Symptom Monitoring
- Fatigue
- Weakness
- Numbness or tingling (neuropathy)
- Memory issues
- Mood changes
- Gastrointestinal upset
Special Patient Groups
Pregnancy
Folic acid is crucial during pregnancy to prevent neural tube defects. The doses of B6 and B12 in Folgard Rx Tabs are generally considered safe and often beneficial during pregnancy. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Folic acid is most critical during the periconceptional period and first trimester for neural tube development.
Second Trimester:
Generally safe and beneficial.
Third Trimester:
Generally safe and beneficial.
Lactation
Folic acid, B6, and B12 are excreted in breast milk but are generally considered safe and compatible with breastfeeding at typical supplemental doses. They are essential for infant development.
Infant Risk:
Low risk to infant; generally considered safe.
Pediatric Use
Use in pediatric populations is not routinely established for Folgard Rx Tabs specifically. Individual vitamin deficiencies should be addressed with appropriate pediatric formulations and dosing under medical supervision.
Geriatric Use
Elderly patients may have an increased risk of vitamin B12 deficiency due to malabsorption (e.g., atrophic gastritis, use of certain medications). Supplementation with these vitamins can be particularly beneficial in this population, especially for managing homocysteine levels. No specific dose adjustment is typically needed, but monitoring for B12 deficiency is important.
Clinical Information
Clinical Pearls
- Folgard Rx Tabs is often prescribed as a medical food for the dietary management of hyperhomocysteinemia, a risk factor for cardiovascular disease and certain neurological conditions.
- The 'New Formula' typically refers to specific high-dose combinations of these three B vitamins aimed at optimizing homocysteine metabolism.
- While generally safe, it's important to rule out underlying causes of vitamin deficiencies (e.g., pernicious anemia for B12) before relying solely on supplementation.
- High doses of folic acid can mask a vitamin B12 deficiency, potentially allowing neurological damage from B12 deficiency to progress undetected. Therefore, ensuring adequate B12 status is crucial when supplementing with high-dose folic acid.
- Patients should be advised that this is a medical food/supplement and not a prescription drug in the traditional sense, though it requires a prescription for dispensing.
Alternative Therapies
- Individual vitamin supplements (Folic Acid, Vitamin B12, Vitamin B6)
- Dietary modifications to increase intake of folate-rich foods (leafy greens, legumes), B12-rich foods (meat, dairy), and B6-rich foods (poultry, fish, potatoes).
Cost & Coverage
Average Cost:
$30 - $60 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often not covered by standard insurance plans as it is classified as a medical food or dietary supplement. Coverage may vary based on specific plan and diagnosis (e.g., documented hyperhomocysteinemia).
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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.