Vitafol Ultra 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
Intended for use in pregnancy (Generally considered safe and beneficial)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitafol Ultra is a daily vitamin and mineral supplement specifically formulated to support the nutritional needs of women before, during, and after pregnancy. It helps ensure you and your baby get essential nutrients like folic acid for healthy brain and spinal cord development, iron to prevent anemia, and calcium for strong bones.
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 prescription and follow the instructions closely.
Some medications are best taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication. Always take your medication with a full glass of water.
There are certain products you should avoid taking with your medication. Do not take antacids within 2 hours before or 2 hours after taking your medication. Additionally, avoid consuming dairy products with your medication, as they may interfere with 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 and moisture. Avoid storing your medication in a bathroom, as the humidity and temperature fluctuations can affect its potency. Keep your medication away from heat sources and store it in a dry place.
It's essential to keep all medications out of the reach of children and pets to prevent accidental ingestion. Store your medication in a safe and secure location.
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 the missed one.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Some medications are best taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication. Always take your medication with a full glass of water.
There are certain products you should avoid taking with your medication. Do not take antacids within 2 hours before or 2 hours after taking your medication. Additionally, avoid consuming dairy products with your medication, as they may interfere with 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 and moisture. Avoid storing your medication in a bathroom, as the humidity and temperature fluctuations can affect its potency. Keep your medication away from heat sources and store it in a dry place.
It's essential to keep all medications out of the reach of children and pets to prevent accidental ingestion. Store your medication in a safe and secure location.
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 the missed one.
Lifestyle & Tips
- Take one capsule daily, preferably with food to minimize stomach upset.
- Do not exceed the recommended dose.
- Maintain a balanced diet in addition to taking this supplement.
- Stay hydrated by drinking plenty of water.
- Store at room temperature, away from moisture and heat, and out of reach of children.
- Report any severe or persistent side effects to your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One capsule daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required.
Moderate:
No specific adjustment typically required.
Severe:
Caution with specific mineral accumulation (e.g., magnesium, potassium) in severe impairment; consult healthcare provider.
Dialysis:
Consult healthcare provider; specific mineral levels may need monitoring.
Hepatic Impairment:
Mild:
No specific adjustment typically required.
Moderate:
No specific adjustment typically required.
Severe:
No specific adjustment typically required.
Pharmacology
Mechanism of Action
Vitafol Ultra provides a comprehensive blend of essential vitamins and minerals crucial for maternal health and optimal fetal development during preconception, pregnancy, and lactation. Key components like folic acid support neural tube formation, iron prevents maternal anemia and supports fetal erythropoiesis, calcium and vitamin D are vital for fetal skeletal development and maternal bone health, and other vitamins/minerals act as cofactors in various metabolic processes.
Pharmacokinetics
Absorption:
Bioavailability:
Variable by nutrient (e.g., folic acid ~100%, iron ~10-15%, fat-soluble vitamins require bile salts)
Tmax:
Variable by nutrient (e.g., folic acid 1-6 hours, iron 2-4 hours)
FoodEffect:
Absorption of some nutrients (e.g., iron) may be enhanced or reduced by food; generally recommended with food to reduce GI upset.
Distribution:
Vd:
Variable by nutrient; widely distributed to tissues.
ProteinBinding:
Variable by nutrient (e.g., folic acid extensively protein-bound, iron bound to transferrin)
CnssPenetration:
Yes (for some components like folate, B vitamins)
Elimination:
HalfLife:
Variable by nutrient (e.g., folic acid ~3-9 hours, water-soluble vitamins generally shorter, fat-soluble longer storage)
Clearance:
Varies by nutrient (renal for water-soluble vitamins, fecal for some minerals)
ExcretionRoute:
Renal (water-soluble vitamins, excess minerals), Fecal (unabsorbed components, some minerals)
Unchanged:
Variable
Pharmacodynamics
OnsetOfAction:
Nutritional effects are gradual and cumulative, not acute. Benefits accrue over weeks to months of consistent supplementation.
PeakEffect:
Long-term cumulative effect on nutritional status and fetal development.
DurationOfAction:
Continuous supplementation required for sustained benefit.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
Black, tarry, or bloody stools
Fever
Vomiting blood or material that looks like coffee grounds
Stomach cramps
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 not mentioned here. 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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
Black, tarry, or bloody stools
Fever
Vomiting blood or material that looks like coffee grounds
Stomach cramps
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 not mentioned here. 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:
- Severe or persistent constipation or diarrhea
- Persistent nausea or vomiting that interferes with daily activities
- Symptoms of an allergic reaction (e.g., rash, itching, swelling of the face/tongue/throat, severe dizziness, trouble breathing)
- Signs of iron overdose (e.g., severe abdominal pain, vomiting, diarrhea, black tarry stools, weakness, pale skin, rapid heartbeat)
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 treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have an excessive amount of iron in your body (iron overload).
If you have certain types of anemia, including pernicious anemia, which is characterized by a deficiency of vitamin B12.
If you are currently taking mineral oil.
If you are taking levodopa, a medication used to treat Parkinson's disease.
If you are taking acitretin, a medication used to treat severe psoriasis.
Additional Considerations for Products Containing Omega-3 Fatty Acids:
If you are taking anticoagulant medications (blood thinners) to prevent blood clots.
If you have a bleeding disorder or experience bleeding problems.
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 treatments and health conditions. Never start, stop, or modify the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have an excessive amount of iron in your body (iron overload).
If you have certain types of anemia, including pernicious anemia, which is characterized by a deficiency of vitamin B12.
If you are currently taking mineral oil.
If you are taking levodopa, a medication used to treat Parkinson's disease.
If you are taking acitretin, a medication used to treat severe psoriasis.
Additional Considerations for Products Containing Omega-3 Fatty Acids:
If you are taking anticoagulant medications (blood thinners) to prevent blood clots.
If you have a bleeding disorder or experience bleeding problems.
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 treatments and health conditions. Never start, stop, or modify 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 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:
- Severe nausea and vomiting
- Diarrhea
- Abdominal pain
- Metallic taste
- Fatigue
- Weakness
- Dizziness
- Black, tarry stools (especially with iron overdose)
- In severe cases of iron overdose: liver damage, metabolic acidosis, shock, coma, and death.
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Management may include gastric lavage, chelation therapy (for iron), and supportive care depending on the specific nutrient and severity of overdose.
Drug Interactions
Major Interactions
- Antacids (calcium, magnesium, aluminum-containing): May reduce absorption of iron and other minerals. Separate administration by at least 2-4 hours.
- Thyroid hormones (e.g., levothyroxine): Iron and calcium can chelate thyroid hormones, reducing absorption. Separate administration by at least 4 hours.
- Tetracyclines/Fluoroquinolones: Iron and calcium can chelate these antibiotics, significantly reducing their absorption. Separate administration by at least 2-6 hours.
- Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital): May reduce folate levels and increase folate requirements. Monitor folate status.
- Bisphosphonates: Calcium and iron can interfere with absorption. Separate administration by at least 30 minutes to 2 hours.
Moderate Interactions
- Levodopa: Iron may reduce levodopa absorption. Separate administration.
- Proton Pump Inhibitors/H2 Blockers: May reduce iron absorption due to altered gastric pH. Consider iron forms less dependent on acid.
- Cholestyramine/Colestipol: May reduce absorption of fat-soluble vitamins (A, D, E, K). Administer prenatal vitamin several hours before or after.
- Diuretics (Thiazide): May increase serum calcium levels.
- Zinc supplements: High doses of zinc can interfere with copper absorption (Vitafol Ultra contains both).
Minor Interactions
- Dietary fiber: May reduce mineral absorption if consumed in very large quantities simultaneously.
- Caffeine/Tea: May reduce non-heme iron absorption. Advise taking iron-containing supplements with water or orange juice (Vitamin C enhances iron absorption).
Monitoring
Baseline Monitoring
Baseline nutritional status (e.g., Complete Blood Count (CBC) for anemia, Vitamin D levels, Ferritin)
Rationale: To identify pre-existing deficiencies and guide supplementation or dietary advice.
Timing: Prior to or early in pregnancy (first trimester).
Routine Monitoring
Hemoglobin/Hematocrit
Frequency: As per routine prenatal care (e.g., once per trimester or more frequently if indicated)
Target: Normal for pregnancy (varies by trimester)
Action Threshold: Below normal range, indicating potential anemia, requiring further investigation and possible dose adjustment or additional iron supplementation.
Patient tolerance and adherence
Frequency: At each prenatal visit
Target: Consistent daily intake with minimal side effects
Action Threshold: Significant GI upset, constipation, or non-adherence; consider alternative formulations or dietary adjustments.
Symptom Monitoring
- Constipation
- Nausea
- Stomach upset
- Dark or black stools (common and harmless due to iron)
- Diarrhea
- Metallic taste
Special Patient Groups
Pregnancy
Vitafol Ultra is specifically designed and recommended for use during pregnancy to provide essential nutrients for maternal health and optimal fetal development. Folic acid is particularly crucial for neural tube development, especially in the first trimester and preconception period.
Trimester-Specific Risks:
First Trimester:
Crucial for neural tube development (folic acid) and organogenesis. Benefits of supplementation significantly outweigh any risks.
Second Trimester:
Supports continued fetal growth, brain development, and maternal nutritional needs as blood volume expands.
Third Trimester:
Supports rapid fetal growth, bone development, and prepares the mother for delivery and lactation. Iron needs are highest in this trimester.
Lactation
Recommended during lactation to support maternal nutritional needs and ensure adequate nutrient content in breast milk for infant growth and development.
Infant Risk:
L1 (Safest) - No known risk to the infant; beneficial for both mother and infant.
Pediatric Use
Not indicated for general pediatric use. Specific vitamin/mineral deficiencies in children would require different formulations and dosing tailored to their age and specific needs.
Geriatric Use
Not specifically formulated for the geriatric population. While some components are beneficial, a general multivitamin or specific supplements tailored to geriatric needs may be more appropriate.
Clinical Information
Clinical Pearls
- Emphasize the critical importance of consistent daily intake of prenatal vitamins, especially folic acid, starting at least one month prior to conception and continuing through the first trimester to prevent neural tube defects.
- Advise patients to take Vitafol Ultra with food to minimize common gastrointestinal side effects such as nausea and constipation, which are often exacerbated by iron content.
- Educate patients that dark or black stools are a common and harmless side effect of iron supplementation and do not indicate bleeding.
- Remind patients that a prenatal vitamin is a supplement and not a replacement for a healthy, balanced diet rich in fruits, vegetables, whole grains, and lean proteins.
- Counsel patients on potential drug-nutrient interactions, particularly with antacids, thyroid hormones, and certain antibiotics, advising them to separate administration times.
Alternative Therapies
- Individual vitamin/mineral supplements if specific deficiencies are identified and a comprehensive prenatal is not desired or tolerated (e.g., separate folic acid, iron, calcium, vitamin D supplements).
- Dietary counseling to optimize nutrient intake from food sources.
Cost & Coverage
Average Cost:
Typically $20-$60 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance plans (prescription or OTC benefit), or available for purchase over-the-counter.
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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.