Vitafol-One Capsules
WARNING: 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: This vitamin is used to aid the diet needs before, during, and after pregnancy.
Drug Class
Nutritional Supplement; Prenatal Vitamin
Pharmacologic Class
Multivitamin/Mineral Supplement
Pregnancy Category
Not applicable (designed for use in pregnancy, not categorized like a drug)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitafol-One is a daily vitamin and mineral supplement specifically formulated to provide the extra nutrients you and your baby need before, during, and after pregnancy. It helps ensure your body has enough essential vitamins like folic acid to prevent birth defects, and minerals like iron to prevent anemia, supporting both your health and your baby's development.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Some medications work best when taken with food, while others should be taken on an empty stomach. If you're unsure, consult your pharmacist for guidance on the best way to take your medication. Always take your medication with a full glass of water.
There are some important precautions to keep in mind when taking this medication:
- Do not take antacids within 2 hours before or 2 hours after taking your medication.
- Avoid consuming dairy products with your medication, as they may reduce its effectiveness.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
- Store it at room temperature, protected from light.
- Keep it in a dry place, avoiding bathrooms and areas exposed to heat.
- Ensure all medications are kept in a safe location, out of the reach of children and pets.
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 continue with your regular dosing schedule. Remember:
- Never take two doses at the same time.
- Avoid taking extra doses.
To ensure you get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Some medications work best when taken with food, while others should be taken on an empty stomach. If you're unsure, consult your pharmacist for guidance on the best way to take your medication. Always take your medication with a full glass of water.
There are some important precautions to keep in mind when taking this medication:
- Do not take antacids within 2 hours before or 2 hours after taking your medication.
- Avoid consuming dairy products with your medication, as they may reduce its effectiveness.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
- Store it at room temperature, protected from light.
- Keep it in a dry place, avoiding bathrooms and areas exposed to heat.
- Ensure all medications are kept in a safe location, out of the reach of children and pets.
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 continue with your regular dosing schedule. Remember:
- Never take two doses at the same time.
- Avoid taking extra doses.
Lifestyle & Tips
- Take with food to improve absorption and reduce stomach upset.
- Maintain a balanced diet in addition to taking the supplement.
- Store at room temperature, away from moisture and heat.
- Keep out of reach of children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One capsule daily
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
pregnancy:
One capsule daily, typically starting prior to conception and continuing throughout pregnancy.
lactation:
One capsule daily, continuing throughout the breastfeeding period.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (designed for adults of childbearing age)
Dose Adjustments
Renal Impairment:
Mild:
Generally no specific adjustment required.
Moderate:
Generally no specific adjustment required; caution with specific mineral components (e.g., iron, potassium) if present in high doses and severe impairment.
Severe:
Generally no specific adjustment required; caution with specific mineral components (e.g., iron, potassium) if present in high doses and severe impairment. Consult physician.
Dialysis:
Considerations for specific mineral components (e.g., iron, potassium) may be necessary. Consult physician.
Hepatic Impairment:
Mild:
Generally no specific adjustment required.
Moderate:
Generally no specific adjustment required.
Severe:
Generally no specific adjustment required.
Pharmacology
Mechanism of Action
Vitafol-One provides essential vitamins and minerals necessary to meet the increased nutritional demands during preconception, pregnancy, and lactation. It supports maternal health, optimal fetal growth and development, and infant health via breast milk. Key components like folic acid prevent neural tube defects, iron prevents maternal anemia, and calcium supports fetal bone development.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by specific vitamin/mineral and formulation (e.g., chelated forms, active forms).
Tmax:
Varies by component, generally hours.
FoodEffect:
Often enhanced with food for better absorption (e.g., fat-soluble vitamins, iron) and to reduce gastrointestinal upset.
Distribution:
Vd:
Varies by component.
ProteinBinding:
Varies by component.
CnssPenetration:
Yes (e.g., B vitamins, folate).
Elimination:
HalfLife:
Varies by component (e.g., water-soluble vitamins have shorter half-lives, fat-soluble longer).
Clearance:
Varies by component.
ExcretionRoute:
Renal (water-soluble vitamins), Biliary/Fecal (fat-soluble vitamins).
Unchanged:
Varies by component.
Pharmacodynamics
OnsetOfAction:
Gradual; nutritional benefits accrue over time with consistent daily use.
PeakEffect:
Not applicable in a single-dose sense; sustained benefit with daily use.
DurationOfAction:
Daily supplementation required for continuous benefit.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 medical attention 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
+ Swelling of the mouth, face, lips, tongue, or throat
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 do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Change in stool color to green
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
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 medical attention 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
+ Swelling of the mouth, face, lips, tongue, or throat
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 do not go away, contact your doctor:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Change in stool color to green
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
Seek Immediate Medical Attention If You Experience:
- Severe stomach upset
- Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Black, tarry stools (common with iron, but report if severe or accompanied by other symptoms like abdominal pain)
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
If you have an excess of iron in your body (iron overload)
If you have certain types of anemia, such as pernicious anemia, which is characterized by a lack of vitamin B12
If you are currently taking mineral oil
If you are taking levodopa
If you are taking acitretin
Additionally, if your medication contains omega-3 fatty acids, you should also inform your doctor if:
You are taking a blood thinner (anticoagulant)
You have bleeding problems or disorders
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 you determine if it is safe to take this medication with your existing health conditions and other drugs. Never start, stop, or change the dose 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
If you have an excess of iron in your body (iron overload)
If you have certain types of anemia, such as pernicious anemia, which is characterized by a lack of vitamin B12
If you are currently taking mineral oil
If you are taking levodopa
If you are taking acitretin
Additionally, if your medication contains omega-3 fatty acids, you should also inform your doctor if:
You are taking a blood thinner (anticoagulant)
You have bleeding problems or disorders
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 you determine if it is safe to take this medication with your existing health conditions and other drugs. Never start, stop, or change the dose 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 drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and laboratory personnel that you are taking it. If you have phenylketonuria (PKU), consult with your doctor, as some formulations of this medication may contain phenylalanine. Additionally, if you are breastfeeding, discuss the potential risks to your baby with your doctor to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Stomach pain
- Constipation
- Headache
- Fatigue
- Metallic taste
- Hair loss (with excessive Vitamin A)
- Liver damage (with excessive Vitamin A or Iron)
- Nerve damage (with excessive Vitamin B6)
What to Do:
Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Bring the product container with you.
Drug Interactions
Major Interactions
- Methotrexate (high doses of folic acid can interfere with methotrexate's action, though typical prenatal doses are usually safe)
- Anticoagulants (e.g., Warfarin, if Vitamin K content is high, can reduce anticoagulant effect)
Moderate Interactions
- Thyroid hormones (iron and calcium can impair absorption of levothyroxine)
- Tetracyclines/Fluoroquinolones (iron and calcium can chelate, reducing antibiotic absorption)
- Antacids (can reduce iron absorption)
- Bisphosphonates (calcium can impair absorption)
- Phenytoin (folic acid can reduce phenytoin levels)
Monitoring
Baseline Monitoring
Nutritional status assessment (dietary intake, pre-existing deficiencies)
Rationale: To identify specific needs or potential deficiencies before and during pregnancy.
Timing: Pre-conception or early pregnancy
Routine Monitoring
General maternal and fetal health (as per standard prenatal care)
Frequency: Throughout pregnancy and lactation
Target: Healthy growth and development
Action Threshold: Signs of deficiency or complications
Symptom Monitoring
- Nausea
- Constipation (common with iron)
- Upset stomach
- Allergic reactions (rare)
Special Patient Groups
Pregnancy
Vitafol-One is specifically designed and indicated for use during pregnancy to support maternal and fetal health. It provides essential nutrients like folic acid, iron, and calcium, which are crucial for fetal development and preventing maternal deficiencies.
Trimester-Specific Risks:
First Trimester:
Crucial for neural tube development (folic acid) and organogenesis. Generally safe and recommended.
Second Trimester:
Supports continued fetal growth and maternal blood volume expansion. Generally safe and recommended.
Third Trimester:
Supports rapid fetal growth, bone development, and prepares for delivery. Generally safe and recommended.
Lactation
Vitafol-One is indicated for use during lactation to ensure adequate nutrient transfer to breast milk and support maternal recovery and energy levels. Generally considered safe and beneficial.
Infant Risk:
Low risk; provides essential nutrients to the infant via breast milk.
Pediatric Use
Not indicated for pediatric use (children); designed for adults of childbearing age.
Geriatric Use
Not specifically indicated for geriatric use; nutritional needs differ. Consult a healthcare provider.
Clinical Information
Clinical Pearls
- Emphasize the importance of consistent daily intake, especially folic acid before and during early pregnancy to prevent neural tube defects.
- Advise taking with food to minimize gastrointestinal upset, particularly from iron.
- Educate patients that dark stools are a common and harmless side effect of iron supplementation.
- Remind patients that prenatal vitamins are supplements, not substitutes for a healthy, balanced diet.
- Discuss potential interactions with other medications, especially thyroid hormones, antibiotics, and antacids.
Alternative Therapies
- Individual vitamin/mineral supplements tailored to specific deficiencies (e.g., separate folic acid, iron, calcium supplements), though a comprehensive prenatal is generally preferred.
Cost & Coverage
Average Cost:
Varies widely, typically $30-$100 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance, may require prescription or be covered under pharmacy benefits as a vitamin/supplement. Tier 1 or 2.
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. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 information about the medication taken, the amount, and the time it happened.