Vitamin D3 2,000iu Tablets

Manufacturer NATIONAL VITAMIN Active Ingredient Cholecalciferol Capsules and Tablets(kole e kal SI fer ole) Pronunciation kole-e-kal-SI-fer-ole
It is used to treat or prevent vitamin D deficiency.
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Drug Class
Vitamin
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Pharmacologic Class
Vitamin D analog
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Pregnancy Category
Category C (for doses exceeding RDA)
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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?

Vitamin D3 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 tablet provides a common daily dose to help maintain healthy vitamin D levels.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, it's essential to 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 your pharmacist for guidance on the best way to take your medication.

It's also important to note that some strengths of this medication may not be taken daily. Make sure you understand your dosage schedule, and don't hesitate to ask your doctor if you have any questions.

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 it in a bathroom, and keep it out of reach of children and pets. When you're finished with your medication or it's 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. Instead, check with your pharmacist for guidance on the best disposal method, or look into local drug take-back programs.

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 dosage schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take with food, preferably a fatty meal, to enhance absorption.
  • Consider regular sun exposure (10-30 minutes, several times a week) while being mindful of skin cancer risk.
  • Ensure adequate dietary calcium intake (dairy products, fortified foods, leafy greens).
  • Regular weight-bearing exercise can also support bone health.

Dosing & Administration

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Adult Dosing

Standard Dose: 2,000 IU (50 mcg) orally once daily for maintenance or mild deficiency
Dose Range: 2000 - 4000 mg

Condition-Specific Dosing:

deficiency_treatment: 50,000 IU once weekly for 8-12 weeks, then maintenance
osteoporosis_prevention: 800-2000 IU daily with calcium
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Pediatric Dosing

Neonatal: 400 IU daily (AAP recommendation)
Infant: 400 IU daily (AAP recommendation)
Child: 600-1000 IU daily (maintenance), higher for deficiency
Adolescent: 600-1000 IU daily (maintenance), higher for deficiency
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for cholecalciferol, but active vitamin D forms (calcitriol) may be preferred in severe CKD.
Moderate: No specific adjustment needed for cholecalciferol, but active vitamin D forms (calcitriol) may be preferred in severe CKD.
Severe: Cholecalciferol may not be effective in severe renal impairment (e.g., GFR <30 mL/min/1.73m2) due to impaired 1-alpha-hydroxylation. Active vitamin D analogs (e.g., calcitriol, paricalcitol) are typically used.
Dialysis: Cholecalciferol is generally not recommended for primary treatment of vitamin D deficiency in dialysis patients; active vitamin D analogs are preferred.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor vitamin D levels.
Severe: No specific adjustment needed, but monitor vitamin D levels as metabolism may be affected.

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) and then in the kidneys to the active form, 1,25-dihydroxyvitamin D (calcitriol). Calcitriol acts as a hormone, regulating calcium and phosphate homeostasis. It promotes intestinal absorption of calcium and phosphate, stimulates bone resorption and mineralization, and influences parathyroid hormone secretion.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable, depends on fat intake and GI health
Tmax: Approximately 10-24 hours for 25(OH)D
FoodEffect: Enhanced absorption with fatty meals

Distribution:

Vd: Not readily quantifiable due to extensive tissue storage
ProteinBinding: Primarily bound to vitamin D-binding protein (DBP) and albumin
CnssPenetration: Limited

Elimination:

HalfLife: Cholecalciferol: ~24 hours; 25(OH)D: ~2-3 weeks; 1,25(OH)2D: ~4-6 hours
Clearance: Not precisely defined due to storage and enterohepatic recirculation
ExcretionRoute: Primarily biliary/fecal, some renal
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Weeks to months for significant changes in bone mineral density or clinical symptoms
PeakEffect: Weeks to months for stable serum 25(OH)D levels
DurationOfAction: Weeks to months after discontinuation, due to storage in adipose tissue

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

While rare, some individuals 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
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain

Other Potential Side Effects

As with all medications, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor or seek medical help.

Please note that 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.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
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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.
  • Seek medical attention if these symptoms occur.
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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 and its symptoms.
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

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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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 or products containing vitamin D unless advised by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe hypercalcemia (calcium levels >12 mg/dL)
  • Nausea, vomiting, anorexia, constipation
  • Polyuria, polydipsia, dehydration
  • Muscle weakness, fatigue, headache
  • Confusion, stupor, coma
  • Cardiac arrhythmias
  • Renal failure (due to calcium deposition)

What to Do:

Discontinue vitamin D and calcium supplements. Hydration with intravenous saline. Loop diuretics (e.g., furosemide) may be used to increase calcium excretion. Calcitonin or bisphosphonates may be used in severe cases. Hemodialysis for life-threatening hypercalcemia. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Thiazide diuretics (may increase risk of hypercalcemia)
  • Digoxin (hypercalcemia may precipitate arrhythmias)
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Moderate Interactions

  • Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital - may increase vitamin D metabolism)
  • Corticosteroids (may reduce vitamin D effects and calcium absorption)
  • Orlistat (may reduce absorption of fat-soluble vitamins, including D)
  • Cholestyramine, colestipol (may reduce absorption of fat-soluble vitamins, including D)
  • Mineral oil (may reduce absorption of fat-soluble vitamins, including D)
  • Rifampin (may increase vitamin D metabolism)

Monitoring

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Baseline Monitoring

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

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

Timing: Before initiating therapy, especially for deficiency.

Serum Calcium

Rationale: To monitor for hypercalcemia, especially with higher doses or in susceptible individuals.

Timing: Before initiating therapy.

Serum Phosphate

Rationale: To monitor for hyperphosphatemia, especially with higher doses.

Timing: Before initiating therapy.

Parathyroid Hormone (PTH)

Rationale: To assess secondary hyperparathyroidism, if present.

Timing: Before initiating therapy, if clinically indicated.

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Routine Monitoring

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

Frequency: 3-6 months after initiating or changing dose, then annually for maintenance

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

Action Threshold: If <30 ng/mL, consider dose increase; if >100 ng/mL, consider dose reduction/cessation.

Serum Calcium

Frequency: Periodically, especially during initial treatment or with higher doses (e.g., monthly for first few months, then every 3-6 months)

Target: 8.5-10.2 mg/dL

Action Threshold: If >10.5 mg/dL, investigate cause, reduce dose, or discontinue.

Serum Phosphate

Frequency: Periodically, especially during initial treatment or with higher doses

Target: 2.5-4.5 mg/dL

Action Threshold: If >4.5 mg/dL, investigate cause, reduce dose, or discontinue.

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Symptom Monitoring

  • Symptoms of hypercalcemia (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, confusion)
  • Symptoms of vitamin D deficiency (fatigue, muscle weakness, bone pain, mood changes)

Special Patient Groups

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Pregnancy

Generally considered safe and important for fetal bone development. Recommended daily intake is 600 IU. Higher doses (e.g., 2000 IU) are often used to treat or prevent deficiency, but doses exceeding 4000 IU should be used with caution and under medical supervision due to potential for hypercalcemia.

Trimester-Specific Risks:

First Trimester: Adequate vitamin D is important for early fetal development.
Second Trimester: Continued importance for skeletal development.
Third Trimester: Crucial for fetal bone mineralization and maternal vitamin D stores.
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Lactation

Cholecalciferol is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding. Maternal supplementation with 2000-6000 IU/day can increase breast milk vitamin D levels, potentially providing sufficient vitamin D for the infant, though direct infant supplementation (400 IU/day) is often recommended.

Infant Risk: L1 (Safest - compatible with breastfeeding, low risk to infant)
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Pediatric Use

Essential for bone growth and development. Dosing varies by age and vitamin D status. Infants exclusively breastfed or consuming less than 1 liter of vitamin D-fortified formula/milk daily should receive 400 IU/day. Children and adolescents typically require 600-1000 IU/day for maintenance. Higher doses are used for deficiency treatment under medical supervision.

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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 impaired renal 1-alpha-hydroxylation. Doses of 800-2000 IU/day are commonly recommended for maintenance and fall prevention. Monitoring for hypercalcemia is important, especially with co-morbidities or concomitant medications.

Clinical Information

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Clinical Pearls

  • Cholecalciferol (D3) is generally preferred over ergocalciferol (D2) as it is more potent and effective at raising and maintaining serum 25(OH)D levels.
  • Vitamin D is fat-soluble; absorption is best when taken with a meal containing fat.
  • Many factors influence vitamin D status, including sun exposure, skin pigmentation, age, obesity, and certain medical conditions (e.g., malabsorption syndromes, chronic kidney disease).
  • The primary goal of vitamin D supplementation is to achieve and maintain a serum 25(OH)D level of 30-100 ng/mL (75-250 nmol/L).
  • While 2000 IU is a common maintenance dose, higher doses (e.g., 50,000 IU weekly) are often required to correct significant deficiency.
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Alternative Therapies

  • Ergocalciferol (Vitamin D2)
  • Calcitriol (active vitamin D analog, used in renal disease)
  • Paricalcitol (active vitamin D analog, used in renal disease)
  • Doxercalciferol (active vitamin D analog, used in renal disease)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (2000 IU)
Generic Available: Yes
Insurance Coverage: Tier 1 (often OTC, not typically covered by prescription plans unless prescribed for specific conditions)
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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 happened.