Certavite W/antioxidantstablets

Manufacturer RUGBY LABORATORIES Active Ingredient Vitamins (Multiple/Oral)(VYE ta mins, MUL ti pul/OR al) Pronunciation SER-tuh-vite with AN-tee-OK-sih-dants TAB-lets
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
Vitamins; Minerals; Antioxidants
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Pregnancy Category
Category A (for most vitamins at recommended doses, but caution with high doses of certain vitamins like Vitamin A)
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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?

Certavite with Antioxidants is a daily multivitamin and mineral supplement designed to provide essential nutrients that you might not get enough of from your diet alone. It also contains antioxidants, which help protect your body's cells from damage.
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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 your medication with or without food. If it upsets your stomach, try taking it with food.
For best results, take your medication at bedtime. If you have questions about the timing, consult your doctor or pharmacist.

Special Instructions for Extended-Release Products

Swallow extended-release tablets or capsules whole. Do not chew, break, or crush them.

Measuring Liquid Medication

Measure liquid doses carefully using the measuring device that comes with your medication. If one is not provided, ask your pharmacist for a device to measure your medication accurately.

Chewable Tablets

Chew chewable tablets well before swallowing.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Protect your medication from heat and light.
Keep all medications 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.
If it's close to the time for your next dose, skip the missed dose and return to 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, especially for fat-soluble vitamins, and to reduce stomach upset.
  • Do not exceed the recommended dose unless advised by a healthcare professional.
  • Maintain a balanced diet as supplements are not a substitute for healthy eating.
  • Store in a cool, dry place away from direct sunlight and out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet daily, or as directed by a healthcare professional.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

general_health: One tablet daily with food.
deficiency_prevention: One tablet daily.
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Pediatric Dosing

Neonatal: Not established (specific infant formulations required)
Infant: Not established (specific infant formulations required)
Child: Not established (specific pediatric formulations required, consult pediatrician)
Adolescent: One tablet daily, or as directed by a healthcare professional (if product is suitable for adolescents)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically needed for standard multi-vitamin doses.
Moderate: Use with caution; monitor levels of fat-soluble vitamins (A, D, E, K) and minerals (e.g., phosphorus, potassium) if present in high amounts. Consult physician.
Severe: Use with caution; significant risk of accumulation of fat-soluble vitamins and certain minerals. Avoid high doses of Vitamin A and D. Consult nephrologist.
Dialysis: Specific vitamin/mineral supplements designed for dialysis patients are preferred. Avoid standard multi-vitamins unless directed by nephrologist.

Hepatic Impairment:

Mild: No specific adjustment typically needed for standard multi-vitamin doses.
Moderate: Use with caution; monitor levels of fat-soluble vitamins (A, D, E, K) as absorption/metabolism may be altered. Consult physician.
Severe: Use with caution; risk of accumulation of fat-soluble vitamins, especially Vitamin A. Avoid high doses of Vitamin A. Consult hepatologist.

Pharmacology

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Mechanism of Action

Vitamins are organic compounds essential for normal growth, metabolism, and physiological function. They act as coenzymes, enzyme precursors, antioxidants, and structural components. Antioxidants (e.g., Vitamins C, E, Beta-carotene, Selenium) protect cells from oxidative damage caused by free radicals.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on specific vitamin, formulation, presence of food, and individual factors). Water-soluble vitamins (B, C) are generally well-absorbed but not stored. Fat-soluble vitamins (A, D, E, K) require dietary fat for absorption and are stored in the body.
Tmax: Variable (typically 1-8 hours for individual vitamins)
FoodEffect: Generally enhanced absorption for fat-soluble vitamins when taken with food containing fat. May reduce gastrointestinal upset for some vitamins/minerals.

Distribution:

Vd: Variable (depends on specific vitamin)
ProteinBinding: Variable (e.g., Vitamin D metabolites are highly protein-bound; Vitamin B12 binds to intrinsic factor and transcobalamins)
CnssPenetration: Limited for some, essential for others (e.g., B vitamins for neurological function)

Elimination:

HalfLife: Variable (minutes to days for water-soluble; days to months for fat-soluble)
Clearance: Variable (renal for water-soluble; biliary/fecal for fat-soluble)
ExcretionRoute: Renal (water-soluble); Biliary/Fecal (fat-soluble)
Unchanged: Variable (significant for water-soluble vitamins)
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Pharmacodynamics

OnsetOfAction: Gradual (nutritional effects are cumulative over days to weeks)
PeakEffect: Chronic supplementation for sustained nutritional benefits
DurationOfAction: Continuous with daily intake; body stores for fat-soluble vitamins can last longer.

Safety & Warnings

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Side Effects

Serious 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. 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
+ Change in stool color to green
+ Stomach pain

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach upset, nausea, vomiting, or diarrhea
  • Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
  • Unusual fatigue, muscle weakness, or bone pain (potential signs of hypervitaminosis)
  • Changes in vision or skin color
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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 to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction 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 medication contains iron:
+ If you have an excessive amount of iron in your body (iron overload).
+ 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 (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 treatments. Never start, stop, or change 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 (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 a child, it is crucial to consult with your doctor first, as different brands may be suitable for different age groups.

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 this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea, vomiting, diarrhea, abdominal pain
  • Headache, dizziness, blurred vision
  • Fatigue, muscle weakness
  • Hair loss, dry skin, cracked lips (Vitamin A toxicity)
  • Hypercalcemia (excess calcium from Vitamin D toxicity)
  • Peripheral neuropathy (high dose Vitamin B6 toxicity)
  • Liver damage (high dose niacin or Vitamin A)

What to Do:

Discontinue use immediately. Seek emergency medical attention. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Warfarin (Coumadin, Jantoven) with Vitamin K (can reduce anticoagulant effect)
  • Tetracycline antibiotics (e.g., doxycycline, minocycline) with calcium, iron, magnesium, zinc (reduced antibiotic absorption)
  • Fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin) with calcium, iron, magnesium, zinc (reduced antibiotic absorption)
  • Retinoids (e.g., isotretinoin, acitretin) with high-dose Vitamin A (increased risk of hypervitaminosis A)
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Moderate Interactions

  • Antiplatelet drugs (e.g., aspirin, clopidogrel) and Anticoagulants (e.g., heparin, dabigatran) with high-dose Vitamin E (potential increased bleeding risk)
  • Diuretics (e.g., thiazides, loop diuretics) with certain minerals (e.g., potassium, magnesium, calcium - can alter levels)
  • Proton pump inhibitors (e.g., omeprazole) and H2 blockers (e.g., ranitidine) with Vitamin B12 (reduced absorption)
  • Levothyroxine (Synthroid) with calcium, iron (reduced thyroid hormone absorption)
  • Phenytoin (Dilantin) with folic acid (reduced phenytoin levels, reduced folic acid efficacy)
  • Methotrexate with folic acid (folic acid can reduce methotrexate efficacy, but often co-administered to reduce side effects)
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Minor Interactions

  • Orlistat (Xenical, Alli) with fat-soluble vitamins (reduced absorption of A, D, E, K)
  • Cholestyramine (Questran) with fat-soluble vitamins (reduced absorption of A, D, E, K)

Monitoring

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Baseline Monitoring

Dietary intake assessment

Rationale: To determine if supplementation is necessary or if dietary changes are sufficient.

Timing: Prior to starting supplementation

Baseline vitamin/mineral levels (if deficiency suspected)

Rationale: To confirm deficiency and guide specific supplementation.

Timing: Prior to starting supplementation

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Routine Monitoring

Clinical symptoms of deficiency or toxicity

Frequency: Ongoing

Target: Absence of symptoms

Action Threshold: Development of new or worsening symptoms

Adherence to dosing

Frequency: Regularly

Target: Consistent daily intake

Action Threshold: Missed doses or inconsistent use

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Symptom Monitoring

  • Gastrointestinal upset (nausea, constipation, diarrhea)
  • Headache
  • Skin rash or flushing
  • Unusual fatigue or weakness
  • Changes in urine color (e.g., bright yellow from B vitamins)
  • Signs of hypervitaminosis (e.g., blurred vision, hair loss, bone pain for Vitamin A; hypercalcemia for Vitamin D)

Special Patient Groups

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Pregnancy

Generally safe and often recommended (e.g., prenatal vitamins containing folic acid) at recommended doses. However, high doses of certain vitamins, particularly Vitamin A (retinol form), can be teratogenic. Consult a healthcare provider for appropriate prenatal supplementation.

Trimester-Specific Risks:

First Trimester: High doses of Vitamin A (retinol) are teratogenic. Folic acid is crucial for neural tube development.
Second Trimester: Generally safe at recommended doses. Continued need for essential nutrients.
Third Trimester: Generally safe at recommended doses. Continued need for essential nutrients.
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Lactation

Generally safe and often beneficial at recommended doses. Vitamins are excreted in breast milk, providing nutrients to the infant. High doses of certain vitamins should be avoided.

Infant Risk: Low risk at recommended maternal doses. High doses of fat-soluble vitamins could theoretically accumulate in infant.
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Pediatric Use

Specific pediatric formulations are available and recommended for children. Dosing must be age-appropriate to avoid toxicity, especially with fat-soluble vitamins and iron. Consult a pediatrician before administering multi-vitamins to children.

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Geriatric Use

May have increased needs for certain vitamins (e.g., Vitamin B12 due to malabsorption, Vitamin D due to reduced skin synthesis and dietary intake). May also be at higher risk for drug-nutrient interactions due to polypharmacy. Consult a healthcare provider.

Clinical Information

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Clinical Pearls

  • Multi-vitamins are intended to supplement, not replace, a healthy diet.
  • Take with food to enhance absorption and minimize gastrointestinal upset.
  • Be aware of specific vitamin/mineral content, especially if taking other supplements or medications, to avoid excessive intake or interactions.
  • Patients with specific deficiencies or medical conditions may require targeted single-vitamin supplements rather than a general multi-vitamin.
  • Educate patients that 'more is not always better' with vitamins, as excessive intake of certain vitamins (especially fat-soluble ones) can be harmful.
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Alternative Therapies

  • Dietary modifications to increase intake of nutrient-rich foods (fruits, vegetables, whole grains, lean proteins)
  • Targeted single-vitamin or mineral supplements for specific deficiencies (e.g., Vitamin D, Iron, B12)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Not typically covered by prescription drug insurance plans. May be eligible for Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA) with a Letter of Medical Necessity.
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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.