Vitafol-OB (30) Tabs + DHA (30)caps

Manufacturer EXELTIS Active Ingredient Prenatal Vitamin Pronunciation VEE-tah-fol O-BEE plus D-H-A
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.
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Drug Class
Nutritional Supplement; Prenatal Vitamin/Mineral
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Pharmacologic Class
Multivitamin/Mineral Combination; Omega-3 Fatty Acid
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Pregnancy Category
Not applicable (intended for use in pregnancy)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vitafol-OB + DHA is a special vitamin and mineral supplement designed for women who are pregnant or breastfeeding. It contains important nutrients like folic acid, iron, calcium, and DHA (an omega-3 fatty acid) that are essential for your health and the healthy development of your baby's brain and eyes.
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How to Use This Medicine

HOW IS THIS DRUG BEST TAKEN? Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this drug.Take with a full glass of water.Do not take antacids within 2 hours before or 2 hours after taking this drug.Do not take dairy products with this drug. Dairy products may make this drug not work as well. HOW DO I STORE AND/OR THROW OUT THIS DRUG? Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.Protect from heat.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. WHAT DO I DO IF I MISS A DOSE? Take a missed dose as soon as you think about it.If it is close to the time for your next dose, skip the missed dose and go back to your normal time.Do not take 2 doses at the same time or extra doses.
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Lifestyle & Tips

  • Take with food to improve absorption and reduce stomach upset.
  • Do not take with antacids, dairy products, or calcium supplements within 2 hours of taking this product, as they can interfere with iron absorption.
  • Maintain a balanced diet in addition to taking this supplement.
  • Store at room temperature away from moisture and heat.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet and one softgel capsule daily
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

pregnancy: One tablet and one softgel capsule daily
lactation: One tablet and one softgel capsule daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally needed, but caution with iron accumulation in severe cases.
Moderate: No specific adjustment generally needed, but caution with iron accumulation in severe cases.
Severe: Use with caution; monitor for iron accumulation. Consult healthcare provider.
Dialysis: Use with caution; monitor for iron accumulation. Consult healthcare provider.

Hepatic Impairment:

Mild: No specific adjustment generally needed.
Moderate: No specific adjustment generally needed.
Severe: No specific adjustment generally needed, but caution with fat-soluble vitamins (A, D, E, K) in severe cholestasis.

Pharmacology

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Mechanism of Action

Vitafol-OB + DHA provides essential vitamins, minerals, and omega-3 fatty acids (DHA) necessary to support maternal health during pregnancy and lactation, and to promote healthy fetal/infant development. These nutrients play crucial roles in various physiological processes, including cell growth, red blood cell formation, bone development, neurological development, and immune function.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, depends on specific nutrient and formulation (e.g., iron absorption is enhanced by Vitamin C, inhibited by calcium).
Tmax: Not applicable for combination product; individual nutrients have varying Tmax (e.g., water-soluble vitamins absorbed quickly, fat-soluble vitamins absorbed with dietary fat).
FoodEffect: Generally recommended to take with food to enhance absorption of fat-soluble vitamins and minimize gastrointestinal upset (especially from iron).

Distribution:

Vd: Not applicable for combination product; individual nutrients distribute widely to tissues.
ProteinBinding: Variable for individual components (e.g., Vitamin D metabolites, iron, calcium).
CnssPenetration: Yes (many vitamins and minerals cross the blood-brain barrier; DHA is crucial for brain development).

Elimination:

HalfLife: Not applicable for combination product; individual nutrients have varying half-lives (e.g., water-soluble vitamins excreted renally, fat-soluble vitamins stored).
Clearance: Not applicable for combination product.
ExcretionRoute: Renal (water-soluble vitamins, some minerals); Biliary/Fecal (some fat-soluble vitamins, unabsorbed minerals).
Unchanged: Variable for individual components.
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Pharmacodynamics

OnsetOfAction: Nutritional effects are gradual and cumulative, not acute.
PeakEffect: Not applicable for a nutritional supplement.
DurationOfAction: Sustained nutritional support with daily intake.
Confidence: Medium

Safety & Warnings

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Side Effects

WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.Black, tarry, or bloody stools. Fever.Throwing up blood or throw up that looks like coffee grounds.Stomach cramps. WHAT ARE SOME OTHER SIDE EFFECTS OF THIS DRUG? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:Constipation, diarrhea, stomach pain, upset stomach, or throwing up.Heartburn.Change in color of stool to green.These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda. gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain
  • Persistent nausea or vomiting
  • Severe constipation or diarrhea
  • Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing)
  • Dark, tarry stools (may indicate excessive iron or GI bleeding, though common with iron supplementation)
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Before Using This Medicine

WHAT DO I NEED TO TELL MY DOCTOR BEFORE I TAKE THIS DRUG? TELL YOUR DOCTOR: All products:If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.If you have too much iron in your body.If you have certain types of anemia where there is not enough vitamin B12 in the body like pernicious anemia.If you are taking mineral oil.If you are taking levodopa.If you are taking acitretin.Products with omega-3 fatty acids:If you are taking a blood thinner.If you have bleeding problems.This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
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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 all 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.
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Overdose Information

Overdose Symptoms:

  • Severe stomach pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Black or tarry stools
  • Weakness
  • Pale skin
  • Bluish lips/fingernails
  • Shallow breathing
  • Rapid heartbeat
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call Poison Control (1-800-222-1222). Iron overdose can be fatal, especially in children.

Drug Interactions

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Major Interactions

  • Levothyroxine (iron and calcium can impair absorption)
  • Tetracycline antibiotics (iron and calcium can impair absorption)
  • Quinolone antibiotics (iron and calcium can impair absorption)
  • Anticoagulants (e.g., Warfarin - Vitamin K can reduce anticoagulant effect)
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Moderate Interactions

  • Antacids (can reduce iron absorption)
  • Bisphosphonates (calcium can impair absorption)
  • Thyroid hormones (calcium and iron can impair absorption)
  • Phenytoin (folate can reduce phenytoin levels)
  • Diuretics (thiazide diuretics can increase calcium reabsorption)
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Minor Interactions

  • Fiber supplements (can reduce mineral absorption if taken concurrently)

Monitoring

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Baseline Monitoring

Nutritional status assessment (dietary intake, pre-existing deficiencies)

Rationale: To identify specific needs or existing deficiencies before supplementation.

Timing: Pre-conception or early pregnancy

Hemoglobin/Hematocrit

Rationale: To assess for anemia, especially iron-deficiency anemia, which is common in pregnancy.

Timing: Baseline and periodically during pregnancy

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Routine Monitoring

Patient symptoms (e.g., nausea, constipation)

Frequency: Daily/as needed

Target: Absence of significant GI upset

Action Threshold: Persistent or severe symptoms may require dose adjustment or change in product.

Adherence to regimen

Frequency: Regularly

Target: Consistent daily intake

Action Threshold: Poor adherence may lead to suboptimal nutritional status.

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Symptom Monitoring

  • Nausea
  • Constipation
  • Diarrhea
  • Stomach upset
  • Allergic reactions (rare)

Special Patient Groups

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Pregnancy

Essential for healthy maternal and fetal development. Provides necessary vitamins, minerals (especially folate and iron), and DHA for neural tube development, red blood cell formation, and brain/eye development.

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development (folate) and organogenesis. Reduces risk of birth defects.
Second Trimester: Supports rapid fetal growth and maternal blood volume expansion (iron, calcium).
Third Trimester: Continues to support fetal growth, bone development, and brain maturation (DHA, calcium, iron).
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Lactation

Recommended during lactation to ensure adequate nutrient transfer to breast milk for infant growth and development, and to replenish maternal stores.

Infant Risk: Generally considered safe and beneficial for the infant. DHA is particularly important for infant brain and eye development via breast milk.
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Pediatric Use

Not indicated for pediatric use outside of specific medical conditions and under strict medical supervision. This product is formulated for pregnant/lactating adults.

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Geriatric Use

Not specifically formulated for geriatric use, though individual components may be beneficial. Geriatric patients have different nutritional needs and potential for polypharmacy interactions.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of consistent daily intake, especially folate in early pregnancy, to prevent neural tube defects.
  • Advise patients that iron in prenatal vitamins can cause constipation and dark stools; recommend increasing fiber and fluid intake.
  • Taking the supplement with a meal can help reduce nausea and improve absorption.
  • Educate patients on potential interactions with other medications, particularly thyroid hormones, antibiotics, and antacids.
  • While supplements are important, stress that they do not replace a healthy, balanced diet.
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Alternative Therapies

  • Dietary modifications to increase nutrient intake (though often insufficient to meet pregnancy demands for certain nutrients like folate and iron).
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Cost & Coverage

Average Cost: $30 - $60 per 30 tablets + 30 capsules
Generic Available: Yes
Insurance Coverage: Often covered by insurance, typically Tier 1 or 2 for generic versions. Brand names may require higher co-pays.
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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 information. If you have any questions or concerns about this 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 details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.