Tab-A-vite Multivit W/iron Tablets

Manufacturer RUGBY LABORATORIES Active Ingredient Vitamins (Multiple/Oral)(VYE ta mins, MUL ti pul/OR al) Pronunciation VYE ta mins, MUL ti pul with EYE-urn
WARNING: If your product has iron in it: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: It is used to help growth and good health.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Nutritional Supplement; Vitamin/Mineral Supplement
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Pharmacologic Class
Multivitamin; Mineral (Iron)
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Pregnancy Category
Category A (for typical prenatal/multivitamin doses)
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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?

This medication is a multivitamin with iron. It provides your body with essential vitamins and minerals that you might not be getting enough of from your diet alone. Iron is especially important for making red blood cells and carrying oxygen in your body. It helps support overall health, energy levels, and proper body functions.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions and read all the information provided. Take your medication as directed, and follow these guidelines:

You can take this medication with or without food. If it upsets your stomach, try taking it with food.
For best results, take this medication at bedtime. If you have questions about the timing, consult your doctor or pharmacist.
Extended-Release Products: Swallow the tablets whole; do not chew, break, or crush them.
Liquid Medication: Measure your dose carefully using the provided measuring device. If one is not included, ask your pharmacist for a device to measure your medication accurately.
* Chewable Tablets: Chew the tablets thoroughly before swallowing.

Storing and Disposing of Your Medication

Keep your medication in a safe place, out of the reach of children and pets. Store it at room temperature in a dry location, away from heat and light. Avoid storing it in a bathroom.

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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take with food to improve absorption and reduce stomach upset, especially with iron.
  • Avoid taking with dairy products, tea, coffee, or high-fiber foods, as these can reduce iron absorption. If you must, separate by at least 2 hours.
  • Consider taking with a source of Vitamin C (e.g., orange juice) to enhance iron absorption.
  • Maintain a balanced diet rich in fruits, vegetables, and whole grains.
  • Store in a cool, dry place, away from direct light and moisture. Keep out of reach of children, as iron overdose can be fatal in young children.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 tablet orally once daily, preferably with a meal
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

deficiency: Dosing may be adjusted based on specific vitamin/mineral deficiencies as determined by a healthcare professional.
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Pediatric Dosing

Neonatal: Not established (specific infant formulations required)
Infant: Not established (specific infant formulations required)
Child: Product-specific; generally not recommended for young children unless specifically formulated for pediatric use. For older children (e.g., 12+ years), 1 tablet orally once daily may be appropriate, consult product label.
Adolescent: 1 tablet orally once daily, preferably with a meal (typically for ages 12+ years)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically needed for standard doses.
Moderate: Use with caution; monitor for accumulation of fat-soluble vitamins (A, D, E, K) and minerals (e.g., iron, potassium, phosphorus).
Severe: Use with caution; significant accumulation risk for certain vitamins/minerals. Consult a nephrologist. Avoid high doses of Vitamin A and D.
Dialysis: Specific formulations for dialysis patients are available; general multivitamins may not be appropriate due to altered mineral balance (e.g., potassium, phosphorus, iron).

Hepatic Impairment:

Mild: No specific adjustment typically needed for standard doses.
Moderate: Use with caution; monitor for accumulation of fat-soluble vitamins (A, D, E, K).
Severe: Use with caution; significant accumulation risk for fat-soluble vitamins, especially Vitamin A. Consult a hepatologist.

Pharmacology

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Mechanism of Action

Multivitamins with iron provide essential vitamins and minerals that are crucial cofactors for numerous metabolic processes, enzyme functions, and cellular activities. Iron is a vital component of hemoglobin, myoglobin, and various enzymes, essential for oxygen transport and cellular respiration. Vitamins act as coenzymes or precursors to coenzymes, participating in energy metabolism, immune function, cell growth, and antioxidant defense. Supplementation aims to prevent or correct nutritional deficiencies.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable depending on the specific vitamin/mineral, its form, presence of other dietary components, and individual physiological factors. Iron absorption is typically 5-15% but can increase to 20-30% in iron-deficient states.
Tmax: Variable; generally 1-4 hours for most water-soluble vitamins and iron. Fat-soluble vitamins are absorbed with dietary fats.
FoodEffect: Generally enhanced absorption of fat-soluble vitamins with food. Iron absorption can be reduced by certain foods (e.g., dairy, tea, coffee, high-fiber foods) but enhanced by Vitamin C. Taking with food can also reduce gastrointestinal upset.

Distribution:

Vd: Variable; water-soluble vitamins distribute into body water, fat-soluble vitamins are stored in adipose tissue and liver. Iron is primarily bound to transferrin in plasma and stored as ferritin or hemosiderin.
ProteinBinding: Variable; some vitamins (e.g., Vitamin D, A) are highly protein-bound. Iron is extensively bound to transferrin.
CnssPenetration: Limited for many vitamins/minerals; specific transport mechanisms exist for some (e.g., thiamine, folate).

Elimination:

HalfLife: Variable; minutes to days for water-soluble vitamins, weeks to months for fat-soluble vitamins (due to storage). Iron has no true half-life as it is conserved and recycled.
Clearance: Variable; primarily renal for water-soluble vitamins. Biliary excretion for some fat-soluble vitamins.
ExcretionRoute: Renal (water-soluble vitamins, excess minerals), Fecal (unabsorbed iron, some fat-soluble vitamins), Biliary (some fat-soluble vitamins).
Unchanged: Variable; significant portions of water-soluble vitamins may be excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Not applicable in the acute sense; benefits accrue over time with consistent supplementation to correct or prevent deficiencies.
PeakEffect: Not applicable; refers to sustained nutritional support.
DurationOfAction: Not applicable; refers to ongoing physiological support.

Safety & Warnings

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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
If your product contains iron:
+ 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Common to all products:
+ Upset stomach or vomiting
If your product contains iron:
+ Diarrhea or constipation
+ Change in stool color to green
+ Stomach pain

Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, vomiting, diarrhea, pale or bluish skin, lethargy (signs of iron overdose - seek immediate medical attention).
  • Persistent nausea, vomiting, constipation, or diarrhea.
  • Unusual fatigue, weakness, or muscle pain.
  • Changes in vision or skin.
  • Signs of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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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 before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, as well as the symptoms you experienced
Certain types of anemia, such as pernicious anemia, which is characterized by a lack of vitamin B12 in the body
If you are currently taking levodopa
If you are taking mineral oil
* If your product contains iron and you have:
+ Excessive iron levels in your body
+ Hemolytic anemia

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 medications. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 a soy allergy, consult with your doctor before taking this medication, as some products may contain soy. Similarly, if you are allergic to tartrazine (also known as FD&C Yellow No. 5), discuss this with your doctor, as some products may contain this ingredient.

When administering this medication to children, note that different brands may be suitable for different age groups. Therefore, it is crucial to consult with your doctor before giving this drug to a child to ensure you are using the correct brand and dosage.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Initial symptoms (within 6 hours): severe stomach pain, nausea, vomiting (may be bloody), diarrhea, lethargy, pallor, cyanosis, shock.
  • Latent period (6-24 hours): apparent recovery.
  • Later symptoms (12-48 hours): metabolic acidosis, shock, liver failure, coagulopathy, coma, death.
  • Delayed effects (weeks): pyloric stenosis, liver cirrhosis.

What to Do:

In case of suspected overdose, especially in children, seek immediate emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve gastric lavage, whole bowel irrigation, and chelation therapy (e.g., deferoxamine) for iron toxicity.

Drug Interactions

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Major Interactions

  • Levothyroxine (iron can decrease absorption)
  • Tetracyclines (iron can decrease absorption)
  • Fluoroquinolones (iron can decrease absorption)
  • Bisphosphonates (iron can decrease absorption)
  • Mycophenolate mofetil (iron can decrease absorption)
  • Warfarin (Vitamin K can antagonize effect; Vitamin E can potentiate effect at high doses)
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Moderate Interactions

  • Antacids (can decrease iron absorption)
  • H2-receptor antagonists (can decrease iron absorption)
  • Proton pump inhibitors (can decrease iron absorption)
  • Cholestyramine (can decrease absorption of fat-soluble vitamins)
  • Orlistat (can decrease absorption of fat-soluble vitamins)
  • Phenytoin (folate and Vitamin D metabolism)
  • Levodopa (Vitamin B6 can reduce efficacy at high doses)
  • Thiazide diuretics (can increase calcium levels, caution with Vitamin D)
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Minor Interactions

  • Dietary fiber (can decrease iron absorption)
  • Calcium supplements (can decrease iron absorption)

Monitoring

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Baseline Monitoring

Nutritional status assessment (dietary intake, symptoms of deficiency)

Rationale: To determine the need for supplementation and identify specific deficiencies.

Timing: Prior to initiating supplementation, especially if deficiency is suspected.

Hemoglobin, Hematocrit, Ferritin (if iron deficiency suspected)

Rationale: To assess iron status.

Timing: Prior to initiating iron supplementation.

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Routine Monitoring

Symptoms of deficiency or toxicity

Frequency: Ongoing, patient self-monitoring

Target: Absence of symptoms

Action Threshold: Report any new or worsening symptoms to healthcare provider.

Adherence to dosing regimen

Frequency: Periodically during follow-up visits

Target: Consistent daily intake

Action Threshold: Address non-adherence to ensure efficacy.

Iron studies (e.g., ferritin, transferrin saturation)

Frequency: Every 3-6 months, or as clinically indicated, if treating iron deficiency.

Target: Within normal limits or target range for deficiency correction.

Action Threshold: Adjust dose or investigate other causes if levels are not improving or become excessive.

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Symptom Monitoring

  • Gastrointestinal upset (nausea, constipation, diarrhea, dark stools - common with iron)
  • Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
  • Symptoms of iron overdose (severe stomach pain, vomiting, diarrhea, pale or bluish skin, lethargy, shock)
  • Symptoms of fat-soluble vitamin toxicity (e.g., Vitamin A: dry skin, hair loss, liver damage; Vitamin D: hypercalcemia, nausea, vomiting, weakness, kidney stones)

Special Patient Groups

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Pregnancy

Multivitamins with iron are often recommended during pregnancy (as prenatal vitamins) to meet increased nutritional demands and prevent deficiencies like iron-deficiency anemia and neural tube defects (due to folate). However, specific prenatal formulations are preferred as they contain appropriate levels of vitamins and minerals for pregnancy.

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development (folate). Avoid excessive Vitamin A (retinol) due to teratogenicity risk.
Second Trimester: Continued need for iron to support increased blood volume and fetal growth.
Third Trimester: High demand for iron and other nutrients for rapid fetal growth and preparation for delivery.
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Lactation

Multivitamins with iron are generally safe and often recommended during lactation to support maternal health and ensure adequate nutrient transfer to breast milk. Consult a healthcare provider for appropriate dosing.

Infant Risk: Low risk with standard doses; benefits generally outweigh risks. Excessive doses of certain vitamins (e.g., Vitamin A, D) could theoretically pose a risk to the infant, but this is rare with typical multivitamin use.
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Pediatric Use

Specific pediatric formulations (e.g., chewable tablets, liquids) are available and recommended for children. Adult formulations may contain excessive amounts of certain vitamins/minerals for children, especially iron, which can be toxic in overdose. Always keep iron-containing products out of reach of children.

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Geriatric Use

Older adults may have specific nutritional needs (e.g., increased Vitamin D, B12, calcium) and may benefit from a multivitamin. However, they may also be on multiple medications, increasing the risk of drug-nutrient interactions. Renal and hepatic function should be considered, especially for fat-soluble vitamins.

Clinical Information

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Clinical Pearls

  • Iron is best absorbed on an empty stomach, but taking it with food can reduce gastrointestinal side effects (nausea, constipation). If stomach upset occurs, take with a small meal.
  • Vitamin C enhances iron absorption; consider taking the multivitamin with orange juice or a Vitamin C-rich food.
  • Be aware of potential interactions with other medications, especially thyroid hormones, antibiotics (tetracyclines, fluoroquinolones), and antacids. Separate administration times by at least 2 hours.
  • Keep all iron-containing products out of reach of children, as iron overdose is a leading cause of poisoning fatalities in young children.
  • This supplement is intended to complement, not replace, a balanced diet. It is not a substitute for healthy eating habits.
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Alternative Therapies

  • Dietary modifications to increase intake of iron-rich foods (e.g., red meat, fortified cereals, leafy greens) and vitamin-rich foods.
  • Individual iron supplements (e.g., ferrous sulfate, ferrous gluconate) for specific iron deficiency anemia.
  • Individual vitamin supplements (e.g., Vitamin D, B12, Folic Acid) for specific deficiencies.
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Cost & Coverage

Average Cost: $5 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Generally Over-The-Counter (OTC) and not covered by prescription drug plans. May be eligible for FSA/HSA reimbursement.
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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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.