Vitafol Fe+ 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
Vitamin/Mineral Supplement; Prenatal Supplement
Pharmacologic Class
Multivitamin; Iron Supplement; Folic Acid Supplement
Pregnancy Category
Not applicable; essential for pregnancy
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitafol Fe+ is a prescription prenatal vitamin that provides essential vitamins and minerals, especially iron and folic acid, to support the health of both the mother and the developing baby during pregnancy and while breastfeeding. It helps prevent common deficiencies and supports healthy growth and development.
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 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 storage in a bathroom.
- Protect it from heat sources.
- Keep all medications 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. Do not take two doses at the same time or take extra doses to make up for a 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 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 storage in a bathroom.
- Protect it from heat sources.
- Keep all medications 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. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take exactly as prescribed by your doctor.
- Swallow the capsule whole; do not crush or chew.
- Take with food if it causes stomach upset.
- Avoid taking with dairy products, antacids, or certain antibiotics (like tetracyclines or fluoroquinolones) as they can interfere with iron absorption. Separate doses by at least 2-4 hours.
- Maintain a balanced diet in addition to taking the supplement.
- Stay well-hydrated to help prevent constipation, a common side effect of iron.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One capsule orally once daily
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
pregnancy:
One capsule orally once daily
lactation:
One capsule orally once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (unless specifically indicated for adolescent pregnancy, then adult dose applies)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
Use with caution; monitor iron levels due to potential for accumulation in severe renal failure. Consult nephrologist.
Dialysis:
Use with caution; monitor iron levels. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment needed
Moderate:
No specific adjustment needed
Severe:
No specific adjustment needed
Pharmacology
Mechanism of Action
Vitafol Fe+ provides essential vitamins and minerals necessary to support the increased nutritional demands of pregnancy and lactation, as well as fetal development. Key components include:
- Folic Acid: Crucial for DNA synthesis, cell division, and prevention of neural tube defects.
- Iron: Essential for hemoglobin formation, oxygen transport, and prevention of maternal anemia.
- Other Vitamins (e.g., B vitamins, Vitamin C, D, E): Act as coenzymes in various metabolic processes, support immune function, bone health, and antioxidant activity.
- Minerals (e.g., Calcium, Zinc, Iodine): Support bone development, immune function, thyroid hormone synthesis, and overall cellular function.
- Folic Acid: Crucial for DNA synthesis, cell division, and prevention of neural tube defects.
- Iron: Essential for hemoglobin formation, oxygen transport, and prevention of maternal anemia.
- Other Vitamins (e.g., B vitamins, Vitamin C, D, E): Act as coenzymes in various metabolic processes, support immune function, bone health, and antioxidant activity.
- Minerals (e.g., Calcium, Zinc, Iodine): Support bone development, immune function, thyroid hormone synthesis, and overall cellular function.
Pharmacokinetics
Absorption:
Bioavailability:
Varies significantly by individual vitamin/mineral and formulation (e.g., iron absorption is regulated by body stores).
Tmax:
Varies by component (e.g., iron typically 2-4 hours, water-soluble vitamins rapidly absorbed).
FoodEffect:
Absorption of some components (e.g., iron) can be affected by food (e.g., reduced by dairy, increased by Vitamin C). Taking with food can reduce GI upset.
Distribution:
Vd:
Widely distributed throughout body tissues and fluids.
ProteinBinding:
Varies by component (e.g., iron binds to transferrin, Vitamin D to DBP).
CnssPenetration:
Yes (e.g., B vitamins, some minerals are essential for CNS function).
Elimination:
HalfLife:
Varies significantly by component (e.g., water-soluble vitamins have shorter half-lives, fat-soluble vitamins can accumulate).
Clearance:
Varies by component (renal for water-soluble, biliary for some fat-soluble).
ExcretionRoute:
Renal (water-soluble vitamins, some minerals); Biliary/Fecal (some fat-soluble vitamins, unabsorbed minerals).
Unchanged:
Varies by component.
Pharmacodynamics
OnsetOfAction:
Nutritional benefits are gradual and cumulative, supporting physiological processes over time.
PeakEffect:
Not applicable in the same way as a drug; refers to sustained nutritional support.
DurationOfAction:
Provides daily nutritional support; benefits are sustained with continued use.
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
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. 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:
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.
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
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. 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:
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 stomach pain or cramping
- Persistent nausea or vomiting
- Severe constipation or diarrhea
- Allergic reaction symptoms (rash, itching/swelling, severe dizziness, trouble breathing)
- Signs of iron overdose (e.g., severe vomiting, diarrhea, bloody stools, rapid heart rate, low blood pressure, lethargy, gray/blue skin color) - seek immediate medical attention.
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 excessive amount 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 (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health problems. Never start, stop, or change the dose of any medication without first consulting 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 excessive amount 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 (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health problems. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of 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 all of your healthcare providers and laboratory personnel that you are taking it. If you have been diagnosed with 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
- Vomiting (may be bloody)
- Diarrhea (may be bloody)
- Abdominal pain
- Lethargy
- Pale or bluish skin
- Rapid, weak pulse
- Low blood pressure
- Drowsiness
- Seizures
- Coma
What to Do:
In case of suspected overdose, especially iron overdose, seek immediate medical attention. Call emergency services (911 in the US) or Poison Control (1-800-222-1222). Management may involve gastric lavage, chelation therapy (e.g., deferoxamine for iron), and supportive care.
Drug Interactions
Major Interactions
- Levothyroxine (iron can decrease absorption)
- Tetracyclines/Fluoroquinolones (iron can chelate and decrease absorption)
- Bisphosphonates (iron can decrease absorption)
- Methotrexate (high doses of folic acid can interfere with its action)
Moderate Interactions
- Antacids/H2 blockers/PPIs (can decrease iron absorption)
- Cholestyramine (can decrease absorption of fat-soluble vitamins)
- Phenytoin/Phenobarbital/Primidone (folic acid can decrease anticonvulsant levels)
- Oral contraceptives (can affect levels of some B vitamins and folic acid)
- Zinc (high doses can interfere with copper absorption)
- Calcium (can interfere with iron absorption)
Minor Interactions
- Coffee/Tea (tannins can reduce iron absorption)
- Dietary fiber (can reduce absorption of some minerals)
Monitoring
Baseline Monitoring
Nutritional status assessment
Rationale: To identify pre-existing deficiencies and tailor care.
Timing: Prior to conception or early in pregnancy
Hemoglobin/Hematocrit
Rationale: To assess for anemia, especially iron-deficiency anemia.
Timing: Baseline and periodically during pregnancy
Serum Ferritin
Rationale: To assess iron stores.
Timing: Baseline if iron deficiency is suspected or high risk
Routine Monitoring
Adherence to dosing regimen
Frequency: At each prenatal visit
Target: Consistent daily intake
Action Threshold: Non-adherence; provide counseling
Gastrointestinal side effects (nausea, constipation)
Frequency: At each prenatal visit
Target: Minimal to no side effects
Action Threshold: Persistent or severe symptoms; counsel on administration (e.g., with food, time of day) or consider alternative formulation.
Overall maternal well-being and fetal growth
Frequency: Routine prenatal visits
Target: Healthy pregnancy progression
Action Threshold: Concerns about maternal health or fetal development; investigate underlying causes.
Symptom Monitoring
- Nausea
- Constipation
- Stomach upset
- Dark stools (due to iron)
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Vitafol Fe+ is specifically formulated for use during pregnancy to meet increased nutritional demands and support fetal development. It is considered essential for preventing neural tube defects (due to folic acid) and maternal iron deficiency anemia.
Trimester-Specific Risks:
First Trimester:
Essential for neural tube development (folic acid) and establishing iron stores.
Second Trimester:
Continues to support fetal growth and maternal blood volume expansion.
Third Trimester:
Crucial for continued fetal development, especially brain and red blood cell formation, and maintaining maternal iron status.
Lactation
Recommended during lactation to ensure adequate nutrient transfer to breast milk and to support maternal recovery and continued nutritional needs.
Infant Risk:
Low risk; provides essential nutrients to the infant via breast milk.
Pediatric Use
Not indicated for general pediatric use. Specific pediatric formulations or individual supplements would be used if needed.
Geriatric Use
Not typically indicated for geriatric use as a prenatal vitamin. Other multivitamin formulations would be more appropriate for general geriatric nutritional support.
Clinical Information
Clinical Pearls
- Emphasize the importance of consistent daily intake for optimal benefit, especially folic acid early in pregnancy.
- Counsel patients on potential GI side effects (nausea, constipation) common with iron, and strategies to mitigate them (e.g., taking with food, increasing fiber and fluid intake).
- Advise patients to separate administration from medications that interact with iron (e.g., levothyroxine, antacids, certain antibiotics).
- Reinforce that prenatal vitamins are a supplement to, not a replacement for, a healthy and balanced diet.
- Educate on the serious risks of iron overdose, especially in young children, and the importance of keeping the product out of reach.
Alternative Therapies
- Individual iron supplements (e.g., ferrous sulfate, ferrous gluconate)
- Individual folic acid supplements
- Other single vitamin/mineral supplements based on specific deficiencies
Cost & Coverage
Average Cost:
$30 - $80 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription insurance plans, especially if prescribed as a medical food. Coverage tier varies (Tier 1-3).
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 your 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 medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.