Folgard Os Tablets
WARNING: If your product has iron in it:Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away. @ COMMON USES: It is used to help growth and good health.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Vitamin/Mineral Supplement; Nutritional Supplement
Pharmacologic Class
Nutritional Supplement; Coenzyme
Pregnancy Category
Category A (for essential vitamins at recommended doses; specific high-dose formulations should be discussed with a healthcare provider)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Folgard OS is a vitamin supplement, usually containing high doses of folic acid, vitamin B6, and vitamin B12. It's often used to help lower levels of a substance in your blood called homocysteine, which, when too high, can be a concern for heart health. These vitamins are essential for many body functions, including nerve health and red blood cell formation.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions and read all the information provided. Take your medication as directed, and follow these guidelines:
You can take this medication with or without food. If it causes stomach upset, take it with food.
For best absorption, take this medication at bedtime. If you have questions about the timing, consult your doctor or pharmacist.
Extended-Release Products: Swallow the tablets whole; do not chew, break, or crush them.
Liquid Medication: Measure your dose carefully using the provided measuring device. If one is not included, ask your pharmacist for a measuring device to ensure accurate dosing.
* Chewable Tablets: Chew the tablets thoroughly before swallowing.
Storing and Disposing of Your Medication
Keep your medication in a safe place, out of the reach of children and pets. Store it at room temperature in a dry location, away from heat and light. Avoid storing it in a bathroom.
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 get the most benefit from your medication, follow your doctor's instructions and read all the information provided. Take your medication as directed, and follow these guidelines:
You can take this medication with or without food. If it causes stomach upset, take it with food.
For best absorption, take this medication at bedtime. If you have questions about the timing, consult your doctor or pharmacist.
Extended-Release Products: Swallow the tablets whole; do not chew, break, or crush them.
Liquid Medication: Measure your dose carefully using the provided measuring device. If one is not included, ask your pharmacist for a measuring device to ensure accurate dosing.
* Chewable Tablets: Chew the tablets thoroughly before swallowing.
Storing and Disposing of Your Medication
Keep your medication in a safe place, out of the reach of children and pets. Store it at room temperature in a dry location, away from heat and light. Avoid storing it in a bathroom.
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.
Lifestyle & Tips
- Take as directed by your healthcare provider, usually once daily with or without food.
- Do not exceed the recommended dose unless specifically instructed by your doctor.
- This supplement is part of an overall health plan and does not replace a balanced diet.
- Inform your doctor about all other medications and supplements you are taking, especially if you are on blood thinners, seizure medications, or certain antibiotics.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Typically 1 tablet orally once daily, or as directed by a healthcare professional.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
Hyperhomocysteinemia:
Often 1 tablet daily, providing specific high doses of folic acid, vitamin B6, and vitamin B12.
Pediatric Dosing
Neonatal:
Not established (Folgard OS is not typically indicated for neonates)
Infant:
Not established (Folgard OS is not typically indicated for infants)
Child:
Not established (Folgard OS is not typically indicated for children; specific pediatric multivitamin formulations are available)
Adolescent:
Not established (Consult a healthcare professional for specific dosing)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required for water-soluble vitamins at standard doses.
Moderate:
No specific adjustment typically required for water-soluble vitamins at standard doses.
Severe:
Caution advised with fat-soluble vitamins (A, D, E, K) if present in other multivitamin formulations. For Folgard OS (B vitamins), generally no adjustment needed, but consult nephrologist.
Dialysis:
Water-soluble vitamins may be dialyzable; supplementation may be beneficial, but consult nephrologist for specific needs.
Hepatic Impairment:
Mild:
No specific adjustment typically required.
Moderate:
No specific adjustment typically required.
Severe:
Caution advised with fat-soluble vitamins (A, D, E, K) if present in other multivitamin formulations. For Folgard OS (B vitamins), generally no adjustment needed.
Pharmacology
Mechanism of Action
Folgard OS typically contains high doses of folic acid (Vitamin B9), pyridoxine (Vitamin B6), and cyanocobalamin (Vitamin B12). These B vitamins act as coenzymes in various metabolic pathways. Folic acid and vitamin B12 are crucial for DNA synthesis, red blood cell formation, and the methylation cycle. Vitamin B6 is involved in amino acid metabolism. Together, these vitamins play a key role in the metabolism of homocysteine, converting it to methionine or cysteine, thereby helping to reduce elevated homocysteine levels.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by specific vitamin and formulation (e.g., folic acid ~85% from supplements, B12 requires intrinsic factor for absorption).
Tmax:
Varies (e.g., folic acid ~1-2 hours, B6 ~1-2 hours, B12 ~8-12 hours).
FoodEffect:
Generally enhanced or unaffected by food for water-soluble vitamins. Fat-soluble vitamins require dietary fat for optimal absorption.
Distribution:
Vd:
Varies widely; water-soluble vitamins distribute throughout body water.
ProteinBinding:
Minimal for most water-soluble vitamins; some transport proteins exist (e.g., transcobalamin for B12).
CnssPenetration:
Yes (e.g., B vitamins cross the blood-brain barrier).
Elimination:
HalfLife:
Varies (e.g., folic acid ~3-4 hours, B6 ~15-20 days, B12 ~6 days).
Clearance:
Renal for water-soluble vitamins; excess amounts are excreted in urine.
ExcretionRoute:
Renal (primarily for water-soluble vitamins); Biliary/fecal (for some fat-soluble vitamins if present).
Unchanged:
Significant portion of excess water-soluble vitamins excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Nutritional effects are gradual; biochemical changes (e.g., homocysteine reduction) may be seen within weeks.
PeakEffect:
Not applicable in the acute sense; sustained supplementation leads to optimal tissue levels.
DurationOfAction:
Sustained with daily intake; body stores of some vitamins (e.g., B12) can last for months to years.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
If your product contains iron:
+ Black, tarry, or bloody stools
+ Fever
+ Vomiting blood or coffee ground-like material
+ Stomach cramps
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 persist, contact your doctor:
Common to all products:
+ Upset stomach or vomiting
If your product contains iron:
+ Diarrhea or constipation
+ Change in stool color to green
+ Stomach pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
If your product contains iron:
+ Black, tarry, or bloody stools
+ Fever
+ Vomiting blood or coffee ground-like material
+ Stomach cramps
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 persist, contact your doctor:
Common to all products:
+ Upset stomach or vomiting
If your product contains iron:
+ Diarrhea or constipation
+ Change in stool color to green
+ Stomach pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- Severe stomach upset, nausea, vomiting, or diarrhea.
- Unusual tingling, numbness, or weakness (especially with very high B6 doses).
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
- Any new or worsening 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 conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
Certain types of anemia, such as pernicious anemia, where the body lacks sufficient vitamin B12.
If you are taking levodopa.
If you are taking mineral oil.
* If your product contains iron:
+ If you have excessive iron in your body.
+ If you have hemolytic anemia.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
Certain types of anemia, such as pernicious anemia, where the body lacks sufficient vitamin B12.
If you are taking levodopa.
If you are taking mineral oil.
* If your product contains iron:
+ If you have excessive iron in your body.
+ If you have hemolytic anemia.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because this drug may interfere with certain laboratory tests. Therefore, be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication.
If you have a soy allergy, consult with your doctor before taking this medication, as some products may contain soy. Similarly, if you are allergic to tartrazine (also known as FD&C Yellow No. 5), discuss this with your doctor, as some products may contain this ingredient.
When it comes to administering this medication to children, it is important to note that different brands may be suitable for different age groups. Before giving this drug to a child, consult with your doctor to ensure you are using the correct brand and dosage for their age.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. This will help you make an informed decision about taking the medication, considering both your health and the health of your baby.
If you have a soy allergy, consult with your doctor before taking this medication, as some products may contain soy. Similarly, if you are allergic to tartrazine (also known as FD&C Yellow No. 5), discuss this with your doctor, as some products may contain this ingredient.
When it comes to administering this medication to children, it is important to note that different brands may be suitable for different age groups. Before giving this drug to a child, consult with your doctor to ensure you are using the correct brand and dosage for their age.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. This will help you make an informed decision about taking the medication, considering both your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- For water-soluble vitamins (B vitamins), overdose is rare as excess is typically excreted in urine.
- Very high doses of folic acid can mask vitamin B12 deficiency, potentially leading to irreversible neurological damage.
- Extremely high, long-term doses of vitamin B6 (pyridoxine) can cause severe peripheral neuropathy (nerve damage) characterized by numbness, tingling, and difficulty walking.
- Gastrointestinal upset (nausea, diarrhea).
What to Do:
Discontinue use and seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.
Drug Interactions
Major Interactions
- Methotrexate (Folic acid can interfere with methotrexate's action; high doses of folic acid may reduce efficacy of methotrexate, while low doses are often given to reduce side effects. Careful monitoring is required.)
- Levodopa (Pyridoxine can reduce the efficacy of levodopa, especially when carbidopa is not co-administered. Modern levodopa/carbidopa formulations are less affected.)
Moderate Interactions
- Phenytoin, Phenobarbital, Primidone (Folic acid can decrease serum levels of these antiepileptics, potentially increasing seizure frequency.)
- Tetracyclines, Quinolones (Minerals like calcium, magnesium, iron, zinc, if present in other multivitamin formulations, can chelate these antibiotics, reducing absorption. Separate administration by several hours.)
- Warfarin (Vitamin K, if present in other multivitamin formulations, can antagonize warfarin's anticoagulant effect. High doses of Vitamin E may increase bleeding risk.)
- Colchicine, Metformin, Proton Pump Inhibitors (PPIs) (May reduce vitamin B12 absorption.)
- Isoniazid, Penicillamine, Hydralazine (May increase pyridoxine requirements or cause deficiency.)
Minor Interactions
- Oral Contraceptives (May affect folate and B6 metabolism.)
Monitoring
Baseline Monitoring
Baseline vitamin levels (e.g., homocysteine, folate, B12)
Rationale: To assess deficiency or elevated levels (e.g., hyperhomocysteinemia) before initiation, especially if used for specific conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Homocysteine levels
Frequency: Periodically, as directed by physician (e.g., 3-6 months after initiation, then annually)
Target: < 15 µmol/L (optimal < 10 µmol/L)
Action Threshold: If levels remain elevated despite adequate supplementation, re-evaluate adherence or consider other causes.
Clinical symptoms of deficiency or toxicity
Frequency: Ongoing
Target: Absence of symptoms
Action Threshold: Development of new or worsening symptoms (e.g., neuropathy, fatigue, gastrointestinal issues) warrants investigation.
Symptom Monitoring
- Gastrointestinal upset (nausea, diarrhea, constipation)
- Allergic reactions (rash, itching)
- Neuropathy (with very high doses of B6 over long periods)
- Masking of B12 deficiency (with high folic acid doses without B12)
Special Patient Groups
Pregnancy
Folic acid is crucial during pregnancy to prevent neural tube defects. Vitamin B6 can help with morning sickness. Vitamin B12 is also important for fetal development. Folgard OS, with its specific B vitamin composition, may be used if indicated by a healthcare provider, but a standard prenatal vitamin is usually sufficient for general needs. Always consult a doctor before taking any supplements during pregnancy.
Trimester-Specific Risks:
First Trimester:
Folic acid is critical during the first trimester for neural tube development. B6 may help with nausea.
Second Trimester:
Generally safe and beneficial for ongoing fetal development.
Third Trimester:
Generally safe and beneficial for ongoing fetal development.
Lactation
Generally considered safe and compatible with breastfeeding. B vitamins are excreted in breast milk and are essential for infant development. Consult a healthcare provider.
Infant Risk:
Low risk; generally considered beneficial.
Pediatric Use
Folgard OS is not typically formulated or indicated for general pediatric use. Specific pediatric multivitamin formulations are available. Use only under the guidance of a pediatrician for specific deficiencies or conditions.
Geriatric Use
Generally safe for geriatric patients. Older adults may have increased needs for certain B vitamins (e.g., B12 due to malabsorption). No specific dose adjustment is typically needed, but monitor for potential interactions with polypharmacy.
Clinical Information
Clinical Pearls
- Folgard OS is often prescribed as a medical food or dietary supplement for the management of hyperhomocysteinemia, a condition associated with increased risk of cardiovascular disease and stroke.
- While high doses of folic acid can mask vitamin B12 deficiency, Folgard OS typically contains B12, mitigating this risk. However, always ensure B12 deficiency is ruled out before initiating high-dose folate therapy.
- Patients should be advised that this is a supplement and not a replacement for prescribed medications or a healthy lifestyle.
- The 'OS' in Folgard OS may sometimes be misinterpreted as being primarily for bone health (Osteo), but its primary active ingredients (B vitamins) are targeted at homocysteine metabolism.
Alternative Therapies
- Dietary modifications to increase intake of folate, B6, and B12 rich foods.
- Other specific vitamin supplements (e.g., standalone folic acid, B6, or B12 supplements).
Cost & Coverage
Average Cost:
$15 - $40 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as it is a dietary supplement or medical food; may be covered by some plans with a prescription or specific diagnosis.
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 details. 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.