Vitafol-OB Tablets
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 (essential nutrient supplement, not a drug with a category)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vitafol-OB Tablets are a daily multivitamin and mineral supplement specifically formulated to provide essential nutrients for women who are pregnant, planning to become pregnant, or breastfeeding. It helps support the health of both the mother and the developing baby.
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. Check with your pharmacist to determine the best way to take your medication. When taking your medication, drink a full glass of water.
However, avoid taking antacids within 2 hours before or 2 hours after taking your medication, as this can interfere with its effectiveness. Additionally, do not consume dairy products with your medication, as they may reduce its efficacy.
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 heat and humidity can affect its potency. Keep your medication in a safe place, 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 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 prescription and follow the instructions closely.
Some medications work best when taken with food, while others should be taken on an empty stomach. Check with your pharmacist to determine the best way to take your medication. When taking your medication, drink a full glass of water.
However, avoid taking antacids within 2 hours before or 2 hours after taking your medication, as this can interfere with its effectiveness. Additionally, do not consume dairy products with your medication, as they may reduce its efficacy.
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 heat and humidity can affect its potency. Keep your medication in a safe place, 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 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 the tablet with food to minimize stomach upset.
- If you experience constipation, increase your fluid intake and dietary fiber.
- Do not take with dairy products, tea, or coffee as they can reduce iron absorption.
- Maintain a balanced diet in addition to taking this supplement.
- Store in a cool, dry place, away from direct light and moisture.
- Keep out of reach of children, especially due to the iron content.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
pregnancy:
One tablet orally daily, or as directed by a healthcare professional.
lactation:
One tablet orally daily, or as directed by a healthcare professional.
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:
Generally no specific adjustment for standard doses.
Moderate:
Generally no specific adjustment for standard doses, but monitor individual mineral levels (e.g., iron, potassium) if impairment is severe or if specific deficiencies/excesses are a concern.
Severe:
Use with caution; monitor individual mineral levels (e.g., iron, potassium, phosphorus) and adjust if necessary based on laboratory values. Consult a nephrologist.
Dialysis:
Use with caution; monitor individual mineral levels and adjust as needed. Consult a nephrologist.
Hepatic Impairment:
Mild:
Generally no specific adjustment.
Moderate:
Generally no specific adjustment.
Severe:
Generally no specific adjustment.
Pharmacology
Mechanism of Action
Vitafol-OB Tablets provide essential vitamins and minerals necessary for maternal health and proper fetal development during pregnancy and for nutritional support during lactation. Key components like folic acid support neural tube development, iron prevents maternal anemia, and calcium supports bone health.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, depends on specific vitamin/mineral and formulation (e.g., iron absorption is ~10-30%, folic acid is high).
Tmax:
Variable, typically 1-4 hours for most water-soluble vitamins and minerals.
FoodEffect:
Absorption of some components (e.g., iron) is enhanced by vitamin C and can be reduced by certain foods (e.g., dairy, tea, coffee). Taking with food generally reduces gastrointestinal upset.
Distribution:
Vd:
Widely distributed throughout body tissues and fluids.
ProteinBinding:
Variable; some vitamins (e.g., B12) and minerals (e.g., iron, calcium) are protein-bound.
CnssPenetration:
Yes (e.g., folic acid, B vitamins are essential for CNS function and development).
Elimination:
HalfLife:
Variable, ranging from hours to days depending on the specific vitamin/mineral.
Clearance:
Variable, primarily renal for water-soluble vitamins and unabsorbed minerals, fecal for fat-soluble vitamins and unabsorbed minerals.
ExcretionRoute:
Renal (water-soluble vitamins, some minerals), Fecal (unabsorbed minerals, fat-soluble vitamins).
Unchanged:
Variable, depends on the specific nutrient.
Pharmacodynamics
OnsetOfAction:
Not applicable in the typical pharmacological sense; provides continuous nutritional support.
PeakEffect:
Not applicable.
DurationOfAction:
Provides daily nutritional supplementation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention 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 help 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 persist, contact your doctor for guidance:
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.
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 help 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 persist, contact your doctor for guidance:
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
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Symptoms of iron overdose (severe stomach pain, vomiting, diarrhea, pale or bluish skin, weakness, drowsiness, rapid heart rate)
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 and situations 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 iron overload in your body.
If you have certain types of anemia, such as pernicious anemia, which is characterized by a vitamin B12 deficiency.
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 anticoagulant medications (blood thinners).
You have a history of bleeding problems.
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 you determine if it is safe to take this medication with your other medications 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 and situations 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 iron overload in your body.
If you have certain types of anemia, such as pernicious anemia, which is characterized by a vitamin B12 deficiency.
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 anticoagulant medications (blood thinners).
You have a history of bleeding problems.
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 you determine if it is safe to take this medication with your other medications 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 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 stomach pain
- Nausea
- Vomiting (may contain blood)
- Diarrhea (may be bloody)
- Drowsiness
- Pale or bluish skin
- Weakness
- Rapid or weak pulse
- Low blood pressure
- Seizures
- Coma
What to Do:
In case of accidental overdose, especially in children, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Iron overdose can be fatal.
Drug Interactions
Major Interactions
- Tetracyclines (e.g., doxycycline, minocycline): Iron and calcium can chelate tetracyclines, reducing their absorption. Separate administration by at least 2-4 hours.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Iron and calcium can chelate fluoroquinolones, reducing their absorption. Separate administration by at least 2-4 hours.
- Levothyroxine: Iron and calcium can impair levothyroxine absorption. Separate administration by at least 4 hours.
- Bisphosphonates (e.g., alendronate): Calcium can interfere with bisphosphonate absorption. Separate administration by at least 30 minutes to 2 hours.
Moderate Interactions
- Antacids (containing calcium, magnesium, aluminum): Can reduce iron absorption. Separate administration.
- Proton Pump Inhibitors (PPIs) / H2 Blockers: Can reduce absorption of iron and vitamin B12 due to reduced gastric acid.
- Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital): Can reduce folic acid levels and increase metabolism of vitamin D and K. May require higher doses of these vitamins.
- Methotrexate: Folic acid can reduce the efficacy of methotrexate (a folate antagonist). Avoid concurrent use or use with caution under medical supervision.
- Cholestyramine / Colestipol: Can reduce absorption of fat-soluble vitamins (A, D, E, K).
- Orlistat: Can reduce absorption of fat-soluble vitamins (A, D, E, K).
- Warfarin: Vitamin K can reduce the anticoagulant effect of warfarin. Monitor INR closely if vitamin K intake changes significantly.
Minor Interactions
- Tea/Coffee: Tannins can reduce iron absorption. Avoid taking with iron-containing supplements.
- Dairy products: Calcium in dairy can reduce iron absorption. Avoid taking iron supplements with dairy.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with ferritin
Rationale: To assess baseline iron status and identify pre-existing anemia.
Timing: Prior to or early in pregnancy.
Vitamin D levels (25-hydroxyvitamin D)
Rationale: To assess baseline vitamin D status, especially in at-risk populations.
Timing: Prior to or early in pregnancy.
General nutritional assessment
Rationale: To identify any specific dietary deficiencies or excesses.
Timing: Initial prenatal visit.
Routine Monitoring
Adherence to dosing regimen
Frequency: Each prenatal visit
Target: Daily use as prescribed
Action Threshold: Non-adherence; reinforce importance.
Symptoms of gastrointestinal upset (nausea, constipation)
Frequency: Each prenatal visit
Target: Minimal to no symptoms
Action Threshold: Persistent or severe symptoms; consider dietary adjustments, timing of dose, or alternative formulations.
Hemoglobin/Hematocrit
Frequency: As per standard prenatal care guidelines (e.g., first trimester, 28 weeks)
Target: Normal for pregnancy (e.g., Hb >11 g/dL in 1st/3rd trimester, >10.5 g/dL in 2nd trimester)
Action Threshold: Anemia; investigate cause, consider additional iron supplementation if needed.
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-OB Tablets are specifically designed for use during pregnancy to provide essential vitamins and minerals, including folic acid, iron, and calcium, crucial for fetal development and maternal health. Folic acid is vital for preventing neural tube defects, especially in early pregnancy.
Trimester-Specific Risks:
First Trimester:
Essential for neural tube development (folic acid) and organogenesis. Adequate iron intake is important to build maternal iron stores.
Second Trimester:
Continued need for iron to support increasing maternal blood volume and fetal growth. Calcium and Vitamin D are important for fetal bone development.
Third Trimester:
High demand for iron to prevent maternal anemia and support rapid fetal growth. Continued need for all essential nutrients.
Lactation
Vitafol-OB Tablets provide nutritional support for breastfeeding mothers, helping to replenish maternal nutrient stores depleted during pregnancy and supporting the nutritional content of breast milk. Essential for both maternal well-being and infant nutrition.
Infant Risk:
L1 (No known risk to the infant; essential nutrients are transferred via breast milk and are beneficial for infant development).
Pediatric Use
Not indicated for pediatric use. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.
Geriatric Use
Not specifically indicated for geriatric use. General vitamin and mineral supplementation may be appropriate for geriatric individuals based on individual nutritional needs and deficiencies, but a specific prenatal formulation is not typically required.
Clinical Information
Clinical Pearls
- Emphasize the critical role of folic acid in preventing neural tube defects, especially if taken prior to conception and during the first trimester.
- Advise patients to take the tablet with food to minimize common gastrointestinal side effects like nausea and constipation, which are often exacerbated by iron.
- Educate patients on potential interactions with other medications (e.g., thyroid hormones, antibiotics) and the importance of separating administration times.
- Remind patients that a prenatal vitamin is a supplement and not a substitute for a healthy, balanced diet.
- Stress the importance of keeping iron-containing supplements out of reach of children due to the risk of accidental poisoning.
Alternative Therapies
- Individual vitamin and mineral supplements (e.g., separate folic acid, iron, calcium supplements) if specific deficiencies are identified or if a patient cannot tolerate a combination product.
- Dietary counseling and nutritional guidance to optimize nutrient intake from food sources.
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance plans (prescription or OTC benefit), or available 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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not 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 details about the medication taken, the amount, and the time it happened.