Vitamin D3 1,000unit Chew Tablets

Manufacturer MASON Active Ingredient Cholecalciferol Chewables(kole e kal SI fer ole) Pronunciation koh-lee-KAL-sif-er-ol
It is used to treat or prevent vitamin D deficiency.
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Drug Class
Vitamin, Nutritional Supplement
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Pharmacologic Class
Fat-soluble vitamin, Vitamin D analog
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Pregnancy Category
Not formally categorized as a drug; essential nutrient, generally safe at recommended doses. High doses may be Category C.
FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vitamin D3 (Cholecalciferol) is a vitamin that helps your body absorb calcium and phosphorus, which are essential for strong bones and teeth. It also plays a role in muscle function and immune health. This chewable tablet provides a convenient way to get your daily dose of Vitamin D3.
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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 should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication. Be sure to chew your medication well before swallowing.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.

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.
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Lifestyle & Tips

  • Take with food, especially a meal containing some fat, to improve absorption.
  • Consider safe sun exposure (10-15 minutes, 2-3 times per week) for natural vitamin D production, but always use sun protection to prevent skin damage.
  • Include vitamin D-rich foods in your diet, such as fatty fish (salmon, mackerel), fortified milk, cereals, and orange juice.

Dosing & Administration

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Adult Dosing

Standard Dose: 1000 IU (25 mcg) daily for general supplementation/maintenance
Dose Range: 600 - 4000 mg

Condition-Specific Dosing:

general_health_maintenance: 600-2000 IU daily
vitamin_d_deficiency_treatment: 50,000 IU once weekly or 6,000 IU daily for 8 weeks, followed by maintenance (doses higher than 1000 IU typically require medical supervision)
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Pediatric Dosing

Neonatal: 400 IU daily (for breastfed infants or those consuming less than 1 liter of vitamin D-fortified formula/milk)
Infant: 400 IU daily (up to 1 year of age)
Child: 600-1000 IU daily (1-18 years of age)
Adolescent: 600-1000 IU daily (1-18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment for cholecalciferol
Moderate: No specific dose adjustment for cholecalciferol
Severe: Cholecalciferol may not be effectively converted to its active form (calcitriol) in severe renal impairment (eGFR <30 mL/min/1.73m²). Active vitamin D analogs (e.g., calcitriol) may be required. Consult nephrologist.
Dialysis: Cholecalciferol may be used, but active vitamin D analogs are often preferred due to impaired 1-alpha-hydroxylation. Monitor calcium, phosphate, and PTH closely.

Hepatic Impairment:

Mild: No specific dose adjustment
Moderate: No specific dose adjustment
Severe: No specific dose adjustment for cholecalciferol, but impaired 25-hydroxylation may occur in severe liver disease, potentially reducing efficacy. Monitor 25(OH)D levels.

Pharmacology

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Mechanism of Action

Cholecalciferol (Vitamin D3) is a fat-soluble vitamin that is metabolically inert. It is hydroxylated in the liver to 25-hydroxyvitamin D (calcifediol or calcidiol) and then in the kidneys to 1,25-dihydroxyvitamin D (calcitriol), the biologically active form. Calcitriol acts as a hormone, primarily regulating calcium and phosphate homeostasis. It promotes calcium and phosphate absorption from the intestine, reabsorption in the kidneys, and plays a crucial role in bone mineralization and remodeling. It also has immunomodulatory and anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, depends on formulation and presence of dietary fat. Enhanced with fatty meals.
Tmax: Approximately 10-24 hours for cholecalciferol; 2-4 days for 25(OH)D (calcifediol)
FoodEffect: Absorption is significantly enhanced when taken with a fatty meal.

Distribution:

Vd: Large, distributes into adipose tissue
ProteinBinding: Primarily bound to vitamin D-binding protein (DBP) and albumin (>99%)
CnssPenetration: Limited

Elimination:

HalfLife: Cholecalciferol: Approximately 24 hours. 25-hydroxyvitamin D: 2-3 weeks. 1,25-dihydroxyvitamin D: 4-6 hours.
Clearance: Not precisely quantified for cholecalciferol, but metabolites are cleared via hepatic and renal pathways.
ExcretionRoute: Mainly biliary/fecal, with some renal excretion of metabolites.
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Slow, effects on serum 25(OH)D levels are seen within days, but steady-state levels and clinical effects (e.g., bone mineralization) may take weeks to months.
PeakEffect: Peak serum 25(OH)D levels typically reached after 2-3 months of consistent daily dosing.
DurationOfAction: Due to storage in adipose tissue and the long half-life of 25(OH)D, effects can persist for several weeks after discontinuation of supplementation.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you have side effects that bother you or persist, contact your doctor for guidance.

Reporting Side Effects
This list is not exhaustive, and you may have questions about other potential side effects. If you do, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Signs of too much vitamin D (hypercalcemia): Nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, muscle weakness, fatigue, confusion, and kidney stones. Contact your doctor if you experience these symptoms.
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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, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Malabsorption syndrome
+ Overactive parathyroid gland
+ Sarcoidosis
+ Elevated levels of vitamin D or calcium in your body
+ Williams syndrome

This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. Never start, stop, or adjust the dose of any medication without first consulting 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. To avoid excessive intake, do not take any additional supplements containing vitamin D unless advised by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe nausea and vomiting
  • Extreme thirst and frequent urination
  • Constipation
  • Muscle weakness and joint pain
  • Fatigue and confusion
  • Kidney stones
  • Heart rhythm abnormalities (in severe cases)

What to Do:

If you suspect an overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the U.S.). Treatment typically involves stopping vitamin D intake, hydration, and sometimes medications to lower calcium levels.

Drug Interactions

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Major Interactions

  • Thiazide diuretics (e.g., hydrochlorothiazide): May increase risk of hypercalcemia due to decreased urinary calcium excretion.
  • Digoxin: Hypercalcemia induced by vitamin D can potentiate digoxin toxicity, leading to arrhythmias.
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Moderate Interactions

  • Corticosteroids (e.g., prednisone): May reduce vitamin D effects by impairing calcium absorption and increasing vitamin D metabolism.
  • Anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine): May increase vitamin D metabolism, leading to lower 25(OH)D levels and potentially requiring higher vitamin D doses.
  • Bile acid sequestrants (e.g., cholestyramine, colestipol): May impair absorption of fat-soluble vitamins, including vitamin D. Administer vitamin D at least 2 hours before or 4-6 hours after.
  • Mineral oil, Orlistat: May impair absorption of fat-soluble vitamins, including vitamin D.
  • Calcipotriene (topical psoriasis treatment): Concomitant use with high doses of oral vitamin D may increase risk of hypercalcemia.

Monitoring

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Baseline Monitoring

Serum 25-hydroxyvitamin D [25(OH)D]

Rationale: To assess baseline vitamin D status and guide initial dosing.

Timing: Before initiating high-dose supplementation or if deficiency is suspected.

Serum Calcium

Rationale: To establish baseline and monitor for hypercalcemia, especially with higher doses or concomitant medications.

Timing: Before initiating supplementation.

Serum Phosphate

Rationale: To establish baseline, as vitamin D affects phosphate homeostasis.

Timing: Before initiating supplementation.

Parathyroid Hormone (PTH)

Rationale: To assess for secondary hyperparathyroidism in deficiency or to evaluate calcium metabolism disorders.

Timing: If deficiency is suspected or in patients with bone/mineral disorders.

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Routine Monitoring

Serum 25-hydroxyvitamin D [25(OH)D]

Frequency: 3-6 months after initiating high-dose therapy, then annually for maintenance if deficiency was present. Not typically needed for routine 1000 IU supplementation in healthy individuals.

Target: 30-100 ng/mL (75-250 nmol/L)

Action Threshold: If levels remain below 30 ng/mL, consider dose adjustment or investigate malabsorption. If levels exceed 100 ng/mL, consider dose reduction.

Serum Calcium

Frequency: Periodically, especially with higher doses or in patients with renal impairment. Annually for routine supplementation.

Target: 8.5-10.2 mg/dL

Action Threshold: If >10.5 mg/dL, investigate hypercalcemia, reduce/stop vitamin D, and hydrate.

Serum Phosphate

Frequency: Periodically, especially with higher doses or in patients with renal impairment. Annually for routine supplementation.

Target: 2.5-4.5 mg/dL

Action Threshold: Monitor for significant deviations.

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Symptom Monitoring

  • Symptoms of hypercalcemia: Nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion, kidney stones.

Special Patient Groups

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Pregnancy

Vitamin D is essential during pregnancy for maternal and fetal bone health. Recommended daily intake is typically 600 IU, but higher doses (e.g., 1000-2000 IU) may be recommended by healthcare providers, especially for women at risk of deficiency. Generally considered safe and beneficial at recommended doses.

Trimester-Specific Risks:

First Trimester: Essential for early fetal development; generally safe at recommended doses.
Second Trimester: Continues to be essential for fetal bone and tooth development; generally safe at recommended doses.
Third Trimester: Important for calcium transfer to the fetus and maternal bone health; generally safe at recommended doses.
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Lactation

Vitamin D is excreted into breast milk in small amounts. Supplementation of the mother with vitamin D can increase breast milk vitamin D levels, but often not enough to meet the infant's needs. Breastfed infants typically require direct vitamin D supplementation (400 IU daily). Generally considered safe for lactating mothers at recommended doses.

Infant Risk: Low risk to infant at maternal doses up to 4000 IU daily; higher doses should be used with caution and under medical supervision.
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Pediatric Use

Essential for bone growth and development. Specific dosing recommendations vary by age (400 IU for infants, 600-1000 IU for children/adolescents). Chewable tablets are suitable for children who can safely chew and swallow. Ensure appropriate dosage for age.

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Geriatric Use

Older adults are at higher risk for vitamin D deficiency due to decreased skin synthesis, reduced dietary intake, and potential malabsorption. Higher doses (e.g., 800-2000 IU daily) may be recommended to maintain adequate levels and support bone health. Monitor for hypercalcemia, especially if also taking calcium supplements.

Clinical Information

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Clinical Pearls

  • Advise patients to take vitamin D3 with their largest meal of the day or a meal containing fat to maximize absorption.
  • While 1000 IU is a common maintenance dose, many individuals, especially those with limited sun exposure or certain medical conditions, may require higher doses (e.g., 2000-4000 IU daily) to achieve optimal 25(OH)D levels. Doses above 4000 IU should be guided by a healthcare professional and serum 25(OH)D levels.
  • Chewable tablets are a good option for patients who have difficulty swallowing pills.
  • Educate patients on the symptoms of hypercalcemia to prevent toxicity, although rare with typical supplementation doses.
  • Regular monitoring of 25(OH)D levels is generally not necessary for healthy individuals taking 1000 IU daily, but is recommended for those on higher doses, with malabsorption, or with conditions affecting vitamin D metabolism.
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Alternative Therapies

  • Calcitriol (active vitamin D analog, used in severe renal disease or hypoparathyroidism)
  • Alfacalcidol (another active vitamin D analog)
  • Sun exposure (natural source of Vitamin D)
  • Dietary sources of Vitamin D (e.g., fatty fish, fortified foods)
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Cost & Coverage

Average Cost: $5 - $20 per 30-100 tablets (1000 IU)
Generic Available: Yes
Insurance Coverage: Generally considered an over-the-counter (OTC) supplement; typically not covered by prescription drug insurance plans. May be eligible for Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA).
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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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.