Calcium 500 W/vit D3 Tablets

Manufacturer MASON Active Ingredient Calcium and Vitamin D Capsules and Tablets(KAL see um & VYE ta min dee) Pronunciation KAL-see-um & VYE-ta-min dee
It is used to help growth and good health.It is used to prevent or treat soft, brittle bones (osteoporosis).It is used to treat or prevent low calcium levels.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Mineral and Vitamin Supplement
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Pharmacologic Class
Calcium Salt; Vitamin D Analog (Cholecalciferol)
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Pregnancy Category
Essential nutrient; Category C if exceeding recommended daily allowance due to potential for hypercalcemia/hypervitaminosis D
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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?

Calcium and Vitamin D are essential nutrients that work together to build and maintain strong bones. Calcium is the main building block of bones, and Vitamin D helps your body absorb calcium from food and supplements. This combination helps prevent bone loss and conditions like osteoporosis.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication with food, as directed.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on proper disposal. You may also want to explore local drug take-back programs.

Missing 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 one.
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Lifestyle & Tips

  • Take with food to improve absorption, especially if it contains fat for Vitamin D.
  • If taking more than 500-600 mg of elemental calcium per dose, split the dose throughout the day for better absorption.
  • Maintain a balanced diet rich in calcium (dairy, leafy greens) and Vitamin D (fatty fish, fortified foods).
  • Engage in regular weight-bearing exercise (e.g., walking, jogging, weightlifting) to support bone health.
  • Avoid smoking and excessive alcohol consumption, as these can negatively impact bone density.
  • Ensure adequate sun exposure (10-15 minutes daily, depending on skin type and location) for natural Vitamin D production, but protect against sunburn.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet (500 mg elemental Calcium with Vitamin D3) orally once or twice daily, typically with food. Total daily calcium intake from all sources (diet + supplements) should not exceed 2000-2500 mg.
Dose Range: 500 - 1000 mg

Condition-Specific Dosing:

osteoporosis prevention: 1000-1200 mg elemental Calcium and 600-800 IU Vitamin D3 daily (often split into two doses)
calcium deficiency: Dose adjusted based on severity and dietary intake
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Pediatric Dosing

Neonatal: Not established (typically managed via infant formula or breast milk)
Infant: Not established (typically managed via infant formula or breast milk; specific supplementation only under medical supervision)
Child: Dosing varies by age and weight; typically 500-1000 mg elemental Calcium and 400-600 IU Vitamin D3 daily, based on dietary intake and specific needs. Consult pediatrician.
Adolescent: 1000-1300 mg elemental Calcium and 600 IU Vitamin D3 daily, based on dietary intake and specific needs.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum calcium and phosphate.
Moderate: Use with caution; monitor serum calcium and phosphate closely. Dose adjustment may be necessary to avoid hypercalcemia.
Severe: Contraindicated in severe renal impairment with hypercalcemia. Use with extreme caution and frequent monitoring if necessary, as hypercalcemia risk is high. Vitamin D metabolism is impaired.
Dialysis: Contraindicated in hypercalcemia. If used, requires very careful monitoring of serum calcium, phosphate, and PTH. Non-calcium based phosphate binders may be preferred.

Hepatic Impairment:

Mild: No specific adjustment typically needed for calcium. Vitamin D activation may be impaired in severe liver disease, but less so for D3 than D2.
Moderate: No specific adjustment typically needed for calcium. Monitor Vitamin D levels and consider activated forms if severe deficiency persists.
Severe: No specific adjustment typically needed for calcium. Monitor Vitamin D levels; impaired activation of Vitamin D may occur, requiring activated Vitamin D metabolites (e.g., calcitriol).

Pharmacology

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Mechanism of Action

Calcium is an essential mineral for bone formation, nerve impulse transmission, muscle contraction, and blood coagulation. Vitamin D (cholecalciferol, D3) is a fat-soluble vitamin that, after hydroxylation in the liver (to 25-hydroxyvitamin D) and kidneys (to 1,25-dihydroxyvitamin D, calcitriol), acts as a hormone. Calcitriol promotes intestinal absorption of calcium and phosphate, regulates bone mineralization, and influences parathyroid hormone secretion.
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Pharmacokinetics

Absorption:

Bioavailability: Calcium: Varies (20-40%) depending on salt form, dose, and presence of Vitamin D. Vitamin D3: Readily absorbed from the small intestine (up to 80%) in the presence of bile salts.
Tmax: Calcium: 1-2 hours (for serum peak). Vitamin D3: 4-5 hours (for cholecalciferol); 24 hours (for 25-OH D).
FoodEffect: Calcium absorption is enhanced by food (especially with Vitamin D). Vitamin D absorption is enhanced by fatty meals.

Distribution:

Vd: Calcium: Primarily in bone (99%). Vitamin D3: Distributed to adipose tissue, muscle, and liver.
ProteinBinding: Calcium: Approximately 40-50% bound to plasma proteins (albumin). Vitamin D3: Primarily bound to vitamin D-binding protein (DBP) and albumin.
CnssPenetration: Limited for both calcium and Vitamin D metabolites.

Elimination:

HalfLife: Calcium: Complex, depends on physiological state. Vitamin D3: Parent compound ~24 hours; 25-OH D ~15-30 days; 1,25-OH D ~4-6 hours.
Clearance: Calcium: Primarily renal excretion (filtered and reabsorbed). Vitamin D3: Biliary excretion of metabolites.
ExcretionRoute: Calcium: Fecal (unabsorbed) and Renal. Vitamin D3: Fecal (primarily as metabolites).
Unchanged: Calcium: Minimal unchanged excretion. Vitamin D3: Minimal unchanged excretion.
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Pharmacodynamics

OnsetOfAction: Calcium: Immediate (for acute effects); weeks to months (for bone density changes). Vitamin D: Days to weeks (for significant changes in calcium absorption and serum levels).
PeakEffect: Calcium: Hours (for serum levels); months to years (for bone density). Vitamin D: Weeks to months (for optimal serum 25-OH D levels).
DurationOfAction: Calcium: Hours (for serum levels); continuous supplementation needed for sustained bone health. Vitamin D: Weeks to months (due to storage in adipose tissue and long half-life of 25-OH D).

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Upset stomach or vomiting
Constipation

Note: This is not an exhaustive list of all possible side effects. 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:

  • Signs of too much calcium (hypercalcemia): Nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, muscle weakness, fatigue, confusion, bone pain, kidney stones.
  • Signs of too much Vitamin D (hypervitaminosis D): Similar to hypercalcemia, plus headache, metallic taste, weight loss.
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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:
+ High calcium levels
+ High vitamin D levels
+ Kidney stones
+ Low phosphate levels

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

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change 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. If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor, as some formulations of this drug may contain this ingredient.

When taking this medication, be aware that it may interfere with the absorption of other oral medications. To minimize potential interactions, your doctor may recommend taking other oral drugs at a different time than this medication. Discuss your medication schedule with your doctor to ensure safe and effective use.

Adhere to the dietary plan recommended by your doctor to optimize the benefits of this medication. If you are pregnant, planning to become pregnant, or are currently breast-feeding, 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 to make an informed decision about its use.
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Overdose Information

Overdose Symptoms:

  • Severe nausea, vomiting, constipation
  • Extreme thirst and frequent urination
  • Muscle weakness, joint pain
  • Confusion, lethargy, stupor
  • Kidney stones, kidney damage
  • Cardiac arrhythmias (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 US). Treatment involves discontinuing the supplement, hydration, and potentially medications to lower calcium levels.

Drug Interactions

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Contraindicated Interactions

  • Hypercalcemia
  • Hypervitaminosis D
  • Severe renal impairment (without close monitoring)
  • Nephrolithiasis (history of calcium stones, unless cause is identified and managed)
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Major Interactions

  • Thiazide diuretics (increased risk of hypercalcemia)
  • Digoxin (increased risk of cardiac arrhythmias in hypercalcemia)
  • Tetracycline antibiotics (e.g., doxycycline, minocycline - reduced absorption of antibiotic due to chelation; separate by 2-4 hours)
  • Fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin - reduced absorption of antibiotic due to chelation; separate by 2-4 hours)
  • Levothyroxine (reduced absorption of thyroid hormone; separate by 4 hours)
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Moderate Interactions

  • Bisphosphonates (e.g., alendronate - reduced absorption of bisphosphonate; separate by 30-60 minutes)
  • Iron supplements (reduced absorption of iron; separate by 2 hours)
  • Zinc supplements (reduced absorption of zinc; separate by 2 hours)
  • Corticosteroids (reduce calcium absorption and increase calcium excretion; may require higher calcium/Vitamin D doses)
  • Phenytoin, Barbiturates (may increase Vitamin D metabolism, potentially requiring higher Vitamin D doses)
  • Orlistat, Cholestyramine (may reduce absorption of fat-soluble Vitamin D; separate dosing or monitor levels)
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Minor Interactions

  • Spinach, rhubarb, whole grains (contain oxalates/phytates that can reduce calcium absorption; consume separately or in moderation)

Monitoring

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Baseline Monitoring

Serum Calcium (total and ionized)

Rationale: To establish baseline levels and identify pre-existing hypercalcemia or hypocalcemia.

Timing: Prior to initiation of supplementation, especially in patients with renal impairment or other risk factors.

Serum 25-hydroxyvitamin D (25-OH D)

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

Timing: Prior to initiation of supplementation.

Renal Function (BUN, Creatinine, eGFR)

Rationale: To assess kidney function, as renal impairment increases risk of hypercalcemia and affects Vitamin D metabolism.

Timing: Prior to initiation, especially in elderly or those with risk factors for kidney disease.

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Routine Monitoring

Serum Calcium (total and ionized)

Frequency: Every 3-6 months initially, then annually or as clinically indicated, especially with higher doses or risk factors.

Target: 8.5-10.2 mg/dL (total); 4.5-5.6 mg/dL (ionized)

Action Threshold: >10.5 mg/dL (total) or symptoms of hypercalcemia; investigate cause, reduce dose, or discontinue.

Serum 25-hydroxyvitamin D (25-OH D)

Frequency: Every 6-12 months, or after 3 months of dose change to confirm adequacy, then annually.

Target: 30-100 ng/mL (optimal: 40-60 ng/mL)

Action Threshold: <30 ng/mL (consider dose increase); >100 ng/mL (consider dose reduction to avoid toxicity).

Renal Function (BUN, Creatinine, eGFR)

Frequency: Annually, or more frequently in patients with pre-existing renal impairment or risk factors.

Target: Stable within patient's baseline

Action Threshold: Significant decline in eGFR or increase in BUN/Creatinine; reassess calcium/Vitamin D dosing.

Urine Calcium (24-hour)

Frequency: Consider in patients with history of kidney stones or persistent hypercalcemia.

Target: <300 mg/24 hours

Action Threshold: >300 mg/24 hours; investigate cause, reduce dose, or discontinue.

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Symptom Monitoring

  • Symptoms of hypercalcemia: Nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion, bone pain, kidney stones.
  • Symptoms of hypocalcemia (rare with supplementation unless underlying issue): Muscle cramps, numbness/tingling, tetany.
  • Symptoms of hypervitaminosis D: Similar to hypercalcemia, plus anorexia, weight loss, headache, metallic taste.

Special Patient Groups

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Pregnancy

Calcium and Vitamin D are essential during pregnancy for fetal skeletal development and maternal bone health. Recommended daily allowances should be met through diet and supplementation if needed. Excessive intake should be avoided due to potential risks of hypercalcemia in the mother and fetus.

Trimester-Specific Risks:

First Trimester: Essential for early fetal development; generally safe at recommended doses.
Second Trimester: Continued importance for skeletal growth; monitor intake.
Third Trimester: Critical for rapid fetal bone mineralization; ensure adequate intake, but avoid excessive doses.
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Lactation

Calcium and Vitamin D are transferred into breast milk. Adequate maternal intake is important to meet both maternal and infant needs. Generally considered safe and beneficial at recommended doses.

Infant Risk: Low risk at recommended maternal doses; high maternal doses could theoretically lead to hypercalcemia in the infant, but this is rare.
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Pediatric Use

Essential for bone growth and development. Dosing must be carefully adjusted based on age, weight, and dietary intake to avoid deficiency or excess. Consult a pediatrician for appropriate dosing.

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Geriatric Use

Highly recommended for older adults due to increased risk of osteoporosis, falls, and fractures. Age-related decline in calcium absorption and Vitamin D synthesis necessitates adequate supplementation. Renal function should be monitored due to increased risk of hypercalcemia.

Clinical Information

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Clinical Pearls

  • Calcium carbonate (often found in 500mg tablets) should be taken with food for optimal absorption, as it requires stomach acid. Calcium citrate can be taken with or without food.
  • Split calcium doses throughout the day (e.g., 500-600 mg elemental calcium per dose) to maximize absorption, as the body can only absorb a limited amount at one time.
  • Always consider total daily calcium intake from both diet and supplements to avoid exceeding the tolerable upper intake level (UL), which is typically 2000-2500 mg/day for adults.
  • Vitamin D deficiency is common; regular monitoring of 25-OH D levels is crucial, especially in at-risk populations (e.g., elderly, limited sun exposure, malabsorption).
  • Educate patients on symptoms of hypercalcemia to ensure early detection and intervention.
  • Advise patients to separate calcium/Vitamin D supplements from other medications that can interact (e.g., antibiotics, thyroid hormones) by several hours.
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Alternative Therapies

  • Dietary sources of calcium (dairy products, fortified foods, leafy greens)
  • Dietary sources of Vitamin D (fatty fish, fortified milk/cereals, sun exposure)
  • Prescription Vitamin D (e.g., ergocalciferol, calcitriol) for severe deficiency or specific conditions
  • Bisphosphonates (e.g., alendronate, risedronate) for osteoporosis treatment
  • Denosumab, Teriparatide, Romosozumab (other osteoporosis medications)
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Cost & Coverage

Average Cost: $5 - $30 per 30-100 tablets
Generic Available: Yes
Insurance Coverage: Often OTC; generally not covered by insurance unless prescribed for a specific medical condition (e.g., osteoporosis) or as part of a specific health plan's formulary.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.