Tab-A-vite Beta Carotene Tablets

Manufacturer MAJOR Active Ingredient Vitamins (Multiple/Oral)(VYE ta mins, MUL ti pul/OR al) Pronunciation VYE ta mins, MUL ti pul/OR al
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
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Pharmacologic Class
Vitamin
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Pregnancy Category
Category A (for most vitamins at recommended doses; high doses of some, like Vitamin A, can be Category X)
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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?

Tab-A-vite Beta Carotene Tablets are a type of vitamin supplement, providing essential vitamins and minerals your body needs to function properly. Beta-carotene is a plant pigment that your body converts into Vitamin A, which is important for vision, immune function, and skin health. These tablets help fill nutritional gaps in your diet.
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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, especially a meal containing some fat, to improve the absorption of fat-soluble vitamins like beta-carotene.
  • Do not exceed the recommended dose unless advised by your doctor.
  • Maintain a balanced diet rich in fruits, vegetables, and whole grains.
  • Store in a cool, dry place away from direct light and moisture, out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Typically 1 tablet orally daily, or as directed by a healthcare professional. Specific dosage depends on the exact formulation and concentration of vitamins.

Condition-Specific Dosing:

deficiency: Higher doses may be used to correct specific vitamin deficiencies, under medical supervision.
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Pediatric Dosing

Neonatal: Not established for this specific product; pediatric vitamin formulations exist.
Infant: Not established for this specific product; pediatric vitamin formulations exist.
Child: Not established for this specific product; pediatric vitamin formulations exist.
Adolescent: Typically adult dosing, but specific pediatric formulations are preferred.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment required for standard supplementation.
Moderate: No specific adjustment required for standard supplementation.
Severe: No specific adjustment required for standard supplementation; however, caution with fat-soluble vitamins (A, D, E, K) in severe renal disease due to potential accumulation if not properly excreted.
Dialysis: Specific vitamin supplementation may be required for dialysis patients due to nutrient loss; consult a nephrologist.

Hepatic Impairment:

Mild: No specific adjustment required for standard supplementation.
Moderate: No specific adjustment required for standard supplementation.
Severe: No specific adjustment required for standard supplementation; caution with fat-soluble vitamins (A, D, E, K) in severe hepatic disease due to impaired metabolism and excretion.

Pharmacology

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Mechanism of Action

Vitamins are organic compounds essential for normal growth and nutrition, required in small quantities in the diet because they cannot be synthesized by the body. They act as coenzymes, antioxidants, and structural components, participating in various metabolic processes, energy production, immune function, and cellular repair. Beta-carotene is a precursor to Vitamin A (retinol) and functions as an antioxidant.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on specific vitamin, formulation, and presence of food/fat). Beta-carotene absorption is enhanced by dietary fat.
Tmax: Variable (hours to days, depending on vitamin and formulation).
FoodEffect: Significant for fat-soluble vitamins (A, D, E, K, Beta-carotene); absorption is enhanced when taken with a meal containing fat. Less significant for water-soluble vitamins.

Distribution:

Vd: Variable (depends on specific vitamin).
ProteinBinding: Variable (e.g., Vitamin A binds to retinol-binding protein).
CnssPenetration: Limited for some, essential for others (e.g., B vitamins).

Elimination:

HalfLife: Variable (hours to months, depending on vitamin and body stores). Beta-carotene has a long half-life due to storage in adipose tissue.
Clearance: Variable.
ExcretionRoute: Water-soluble vitamins primarily via renal excretion; fat-soluble vitamins primarily via biliary/fecal excretion.
Unchanged: Variable (some water-soluble vitamins are excreted largely unchanged).
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Pharmacodynamics

OnsetOfAction: Gradual (as nutritional status improves or deficiency is corrected).
PeakEffect: Not typically applicable in the same way as drugs; effects are cumulative over time.
DurationOfAction: Sustained as long as supplementation continues and body stores are maintained.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
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 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. Although many people do not experience any side effects or only have mild ones, it is 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:

Common to all products:
+ Upset stomach or vomiting
If your product contains iron:
+ Diarrhea or constipation
+ Green-colored stools
+ 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 headache
  • Blurred vision
  • Nausea, vomiting, or severe diarrhea
  • Unusual bleeding or bruising
  • Severe skin rash or itching
  • Yellowing of skin (beyond mild carotenemia, which is harmless)
  • Muscle weakness or joint pain
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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:

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and severity.
Certain types of anemia, including pernicious anemia, which is characterized by a lack of vitamin B12 in the body.
If you are taking levodopa, as it may interact with this medication.
If you are taking mineral oil, as it may affect the absorption of this medication.
* If your product contains iron:
+ If you have an excessive amount of iron in your body, which can lead to adverse effects.
+ If you have hemolytic anemia, a condition where red blood cells are destroyed faster than they can be made.

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 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 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. Additionally, if you are allergic to tartrazine (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 appropriate brand and dosage.

If you are pregnant, planning to become pregnant, or are breastfeeding, 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:

  • Hypervitaminosis A (from excessive beta-carotene conversion): dry skin, cracked lips, hair loss, headache, nausea, vomiting, bone pain, liver damage.
  • Hypervitaminosis D: nausea, vomiting, weakness, constipation, confusion, excessive thirst, kidney problems.
  • Hypervitaminosis B6: nerve damage (neuropathy).
  • Excessive iron: stomach pain, nausea, vomiting, liver damage.

What to Do:

If you suspect an overdose, contact a poison control center immediately (e.g., call 1-800-222-1222 in the US) or seek emergency medical attention. Bring the product packaging with you.

Drug Interactions

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Contraindicated Interactions

  • Not typically contraindicated for general multi-vitamins at recommended doses, but specific high-dose vitamins may have contraindications (e.g., high dose Vitamin A in pregnancy).
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Major Interactions

  • Vitamin K and Warfarin (antagonistic effect, reduces anticoagulant efficacy)
  • High-dose Vitamin E and Antiplatelet/Anticoagulant medications (increased bleeding risk)
  • High-dose Beta-carotene in smokers (increased risk of lung cancer, especially in heavy smokers)
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Moderate Interactions

  • Calcium and Iron/Zinc (reduced absorption if taken together)
  • Vitamin B6 (pyridoxine) and Levodopa (can reduce levodopa efficacy, though less common with carbidopa/levodopa formulations)
  • Vitamin C and Iron (enhances iron absorption, potentially problematic in hemochromatosis)
  • Certain antibiotics (e.g., tetracyclines, fluoroquinolones) and mineral supplements (reduced antibiotic absorption)
  • Orlistat (fat-soluble vitamin malabsorption)
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Minor Interactions

  • Not typically significant for general multi-vitamins.

Monitoring

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Baseline Monitoring

Nutritional status assessment (dietary intake, signs of deficiency)

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

Timing: Prior to initiation of supplementation, especially for high-dose or targeted therapy.

Relevant laboratory tests (e.g., Vitamin D levels, B12 levels, iron studies)

Rationale: If specific deficiencies are suspected or being treated.

Timing: As clinically indicated.

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Routine Monitoring

Clinical symptoms of deficiency or toxicity

Frequency: Ongoing

Target: Absence of symptoms

Action Threshold: Development of new symptoms or worsening of existing ones.

Dietary intake review

Frequency: Annually or as needed

Target: Balanced diet with adequate nutrient intake

Action Threshold: Persistent poor dietary habits.

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Symptom Monitoring

  • Fatigue
  • Weakness
  • Skin changes (dryness, rashes)
  • Hair loss
  • Vision changes (e.g., night blindness for Vitamin A deficiency)
  • Neurological symptoms (e.g., paresthesias for B12 deficiency)
  • Gastrointestinal upset (nausea, vomiting, diarrhea, constipation - potential signs of toxicity with high doses)
  • Yellowing of skin (carotenemia from excessive beta-carotene intake, generally harmless)

Special Patient Groups

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Pregnancy

Multi-vitamins, including beta-carotene, are generally safe and often recommended during pregnancy at appropriate doses to support maternal and fetal health. However, high doses of preformed Vitamin A (retinol) are teratogenic and should be avoided. Beta-carotene is generally considered safer as the body converts it to Vitamin A only as needed.

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development; folic acid is particularly important. Avoid excessive Vitamin A.
Second Trimester: Continued nutritional support for fetal growth.
Third Trimester: Continued nutritional support for fetal growth.
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Lactation

Generally safe and often recommended during lactation to ensure adequate nutrient intake for both mother and infant. Vitamins are excreted in breast milk, providing essential nutrients to the infant.

Infant Risk: Low risk at recommended doses; benefits generally outweigh risks.
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Pediatric Use

Specific pediatric multi-vitamin formulations are available and generally preferred for children to ensure appropriate dosing. Consult a pediatrician before administering adult formulations to children.

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Geriatric Use

Older adults may have specific nutritional needs (e.g., higher Vitamin D, B12) due to decreased absorption or dietary intake. Standard multi-vitamins are generally safe, but specific deficiencies should be addressed.

Clinical Information

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Clinical Pearls

  • Educate patients that multi-vitamins are supplements, not substitutes for a healthy diet.
  • Advise patients to inform their healthcare provider about all supplements they are taking, especially before surgery or starting new medications.
  • Emphasize the importance of taking fat-soluble vitamins (A, D, E, K, Beta-carotene) with a meal containing fat for optimal absorption.
  • Caution against exceeding recommended doses, as 'more is not always better' and can lead to toxicity, especially with fat-soluble vitamins.
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Alternative Therapies

  • Dietary modifications to increase intake of vitamin-rich foods (fruits, vegetables, whole grains, lean proteins).
  • Targeted single-vitamin supplementation for specific deficiencies.
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Cost & Coverage

Average Cost: Highly variable, typically $5 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance; typically an out-of-pocket expense.
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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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.