Calcium Citrate W/ Vit D Tablets

Manufacturer NATIONAL VITAMIN 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/Vitamin Supplement; Bone Health Agent
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Pharmacologic Class
Calcium Salt; Vitamin D Analog
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Pregnancy Category
Category A (at recommended doses), C (at 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?

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. Taking this combination can help prevent bone loss and reduce the risk of fractures, especially as you get older.
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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 to ensure proper absorption.

Storing and Disposing of Your Medication

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

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 for better absorption, especially Vitamin D.
  • If taking large doses of calcium, divide them throughout the day (e.g., no more than 500-600 mg elemental calcium per single dose) 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.
  • Ensure adequate sun exposure (10-15 minutes, 2-3 times per week) for natural vitamin D production, but be mindful of skin cancer risk.
  • Avoid smoking and excessive alcohol consumption, which can negatively impact bone density.

Dosing & Administration

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Adult Dosing

Standard Dose: Elemental Calcium: 500-1200 mg/day in divided doses; Vitamin D: 600-1000 IU/day (or higher for deficiency, up to 4000 IU/day)
Dose Range: 500 - 1200 mg

Condition-Specific Dosing:

osteoporosis_prevention: 1000-1200 mg elemental calcium/day, 600-800 IU Vitamin D/day
osteoporosis_treatment: 1000-1200 mg elemental calcium/day, 800-1000 IU Vitamin D/day (often higher for deficiency)
dietary_supplementation: 500-600 mg elemental calcium/day, 400-600 IU Vitamin D/day
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Pediatric Dosing

Neonatal: Not established (consult pediatrician for specific needs)
Infant: Not established (consult pediatrician for specific needs)
Child: Elemental Calcium: 500-1000 mg/day; Vitamin D: 400-600 IU/day (dosing varies by age and weight, consult pediatrician)
Adolescent: Elemental Calcium: 1000-1300 mg/day; Vitamin D: 600-800 IU/day
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Dose Adjustments

Renal Impairment:

Mild: Monitor serum calcium and vitamin D levels; adjust dose as needed.
Moderate: Use with caution. Monitor serum calcium, phosphate, and vitamin D levels closely. May require dose reduction or use of active vitamin D metabolites (e.g., calcitriol) instead of cholecalciferol.
Severe: Contraindicated in severe hypercalcemia. Use with extreme caution. Often requires significant dose reduction or avoidance of cholecalciferol. Monitor closely for hypercalcemia and hyperphosphatemia.
Dialysis: Generally avoid cholecalciferol. Active vitamin D metabolites (e.g., calcitriol, paricalcitol) are preferred for managing secondary hyperparathyroidism. Calcium supplementation should be carefully managed to avoid hypercalcemia and vascular calcification.

Hepatic Impairment:

Mild: No specific dose adjustment typically required.
Moderate: No specific dose adjustment typically required, as primary metabolism of Vitamin D to 25-OH D occurs in the liver. However, significant liver disease may impair this conversion. Monitor vitamin D levels.
Severe: No specific dose adjustment typically required, but monitor vitamin D levels as conversion to 25-OH D may be impaired.

Pharmacology

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Mechanism of Action

Calcium is an essential mineral necessary for bone formation, maintenance, and strength. It plays crucial roles in nerve impulse transmission, muscle contraction, blood coagulation, and cellular signaling. Vitamin D (cholecalciferol) is a fat-soluble vitamin that is metabolized in the liver to 25-hydroxyvitamin D (calcifediol) and then in the kidneys to 1,25-dihydroxyvitamin D (calcitriol), the active form. Calcitriol promotes intestinal absorption of calcium and phosphate, regulates bone mineralization, and maintains serum calcium and phosphate homeostasis. It also has roles in immune function, cell growth, and inflammation.
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Pharmacokinetics

Absorption:

Bioavailability: Calcium Citrate: Approximately 20-30% elemental calcium absorbed (less dependent on stomach acid than carbonate). Vitamin D: Approximately 50-80% absorbed (fat-soluble, requires bile salts).
Tmax: Calcium: 1-2 hours (for peak serum concentration after oral dose). Vitamin D: 4-12 hours (for cholecalciferol, but active metabolite formation is slower).
FoodEffect: Calcium Citrate: Can be taken with or without food, but absorption may be slightly enhanced with food. Vitamin D: Enhanced absorption when taken with fatty meals.

Distribution:

Vd: Calcium: Approximately 0.2 L/kg (primarily in bone). Vitamin D: Extensively distributed to adipose tissue, muscle, and liver.
ProteinBinding: Calcium: Approximately 40-50% bound to plasma proteins (albumin). Vitamin D: >99% bound to vitamin D-binding protein (DBP) and albumin.
CnssPenetration: Limited (Calcium); Limited (Vitamin D, but metabolites can cross blood-brain barrier)

Elimination:

HalfLife: Calcium: Variable, depends on body stores and intake. Vitamin D (cholecalciferol): Approximately 24 hours (initial), but storage in fat can extend elimination. 25-OH D: 2-3 weeks. 1,25-OH D: 4-6 hours.
Clearance: Not readily quantifiable for calcium. Vitamin D clearance is complex due to storage and enterohepatic recirculation.
ExcretionRoute: Calcium: Primarily fecal (unabsorbed), renal (filtered and reabsorbed). Vitamin D: Primarily biliary/fecal (metabolites), minor renal.
Unchanged: Calcium: Negligible (absorbed portion). Vitamin D: Negligible (absorbed portion).
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Pharmacodynamics

OnsetOfAction: Long-term (weeks to months for bone health benefits)
PeakEffect: Long-term (months to years for optimal bone density)
DurationOfAction: Long-term (effects persist as long as supplementation continues and stores are maintained)

Safety & Warnings

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Side Effects

Important Side Effects to Report to Your Doctor 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, seek medical attention 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Upset stomach or vomiting
Constipation

Note: 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 for medical advice. 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.
  • Signs of kidney stones: Severe back or side pain, blood in urine, painful urination.
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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 advise you to take 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 maximize the benefits of this medication. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, notify 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:

  • Severe hypercalcemia (calcium levels >12 mg/dL): Cardiac arrhythmias, kidney damage, coma.
  • Symptoms of hypervitaminosis D: Anorexia, weight loss, polyuria, polydipsia, nausea, vomiting, constipation, muscle weakness, fatigue, headache, metallic taste, bone pain, kidney stones, kidney failure.

What to Do:

Immediately discontinue calcium and vitamin D supplementation. Seek emergency medical attention. Hydration with intravenous fluids, loop diuretics (e.g., furosemide) to promote calcium excretion, and in severe cases, calcitonin or bisphosphonates may be used. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Hypercalcemia
  • Hypervitaminosis D
  • Severe renal impairment (without careful monitoring and specific vitamin D forms)
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Major Interactions

  • Thiazide diuretics (increased risk of hypercalcemia)
  • Digoxin (increased risk of cardiac arrhythmias due to hypercalcemia)
  • Certain antibiotics (e.g., tetracyclines, fluoroquinolones - reduced absorption of both due to chelation; separate administration by at least 2-4 hours)
  • Bisphosphonates (reduced absorption; separate administration by at least 30-60 minutes)
  • Levothyroxine (reduced absorption; separate administration by at least 4 hours)
  • Verapamil and other calcium channel blockers (calcium may reduce efficacy)
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Moderate Interactions

  • Iron supplements (reduced absorption of both; separate administration by 2-4 hours)
  • Zinc supplements (reduced absorption of both; separate administration by 2-4 hours)
  • Corticosteroids (may decrease calcium absorption and increase calcium excretion, requiring higher doses of calcium/vitamin D)
  • Orlistat, Cholestyramine, Mineral oil (may reduce absorption of fat-soluble Vitamin D)
  • Phenytoin, Barbiturates (may increase vitamin D metabolism, requiring higher doses)
  • Phosphate binders (may increase risk of hypercalcemia if calcium-based)
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Minor Interactions

  • Spinach, rhubarb, whole grains (contain oxalates/phytates that can reduce calcium absorption, but generally not clinically significant with varied diet)

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 therapy.

Serum 25-hydroxyvitamin D (25-OH D)

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

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine, eGFR)

Rationale: To assess kidney function, as renal impairment affects calcium and vitamin D metabolism and excretion.

Timing: Prior to initiation of therapy.

Serum Phosphate

Rationale: To assess baseline phosphate levels, especially in renal impairment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Calcium (total and ionized)

Frequency: Every 3-6 months initially, then annually or as clinically indicated.

Target: Total: 8.5-10.2 mg/dL; Ionized: 4.5-5.6 mg/dL

Action Threshold: If consistently above upper limit of normal (e.g., >10.5 mg/dL total calcium), reduce dose or discontinue.

Serum 25-hydroxyvitamin D (25-OH D)

Frequency: Every 6-12 months, or 3 months after dose adjustment for deficiency.

Target: >30 ng/mL (optimal 30-60 ng/mL)

Action Threshold: If <30 ng/mL, consider increasing vitamin D dose. If >100 ng/mL, reduce or discontinue vitamin D.

Renal Function (BUN, Creatinine, eGFR)

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

Target: Stable eGFR, within normal limits for age.

Action Threshold: Significant decline in eGFR or rise in creatinine may necessitate dose adjustment or discontinuation.

24-hour Urinary Calcium Excretion

Frequency: Consider if hypercalcemia develops or if there is a history of kidney stones.

Target: <250 mg/24 hours (women), <300 mg/24 hours (men)

Action Threshold: Elevated levels may indicate excessive absorption or excretion, increasing kidney stone risk.

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Symptom Monitoring

  • Symptoms of hypercalcemia: Nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, fatigue, muscle weakness, confusion, headache, bone pain.
  • Symptoms of hypervitaminosis D: Similar to hypercalcemia, plus anorexia, weight loss, metallic taste.

Special Patient Groups

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Pregnancy

Calcium and Vitamin D are essential during pregnancy for fetal bone development and maternal bone health. Recommended daily allowances (RDAs) should be met through diet and supplementation if necessary. Excessive doses should be avoided.

Trimester-Specific Risks:

First Trimester: Essential for early fetal development; generally safe at RDA.
Second Trimester: Continued importance for fetal skeletal mineralization; generally safe at RDA.
Third Trimester: High demand for calcium transfer to fetus; generally safe at RDA.
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Lactation

Calcium and Vitamin D are excreted in breast milk. Supplementation at recommended doses is generally safe and important for both mother and infant. Excessive doses should be avoided.

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 toxicity. Consult a pediatrician for appropriate dosing.

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Geriatric Use

Crucial for preventing and treating osteoporosis. Older adults often have reduced calcium absorption and impaired vitamin D synthesis in the skin and kidney, increasing their need for supplementation. Monitor renal function and serum calcium/vitamin D levels closely due to increased risk of hypercalcemia and kidney stones.

Clinical Information

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Clinical Pearls

  • Calcium citrate is generally preferred for individuals with achlorhydria (low stomach acid) or those taking proton pump inhibitors (PPIs) or H2 blockers, as its absorption is less dependent on stomach acid compared to calcium carbonate.
  • For optimal absorption, calcium supplements should be taken in divided doses, typically no more than 500-600 mg of elemental calcium at one time.
  • Always check the elemental calcium content, not just the total calcium salt weight, when determining dosage.
  • Vitamin D is best absorbed when taken with a meal containing fat.
  • Educate patients about potential drug interactions, especially with thyroid hormones, bisphosphonates, and certain antibiotics, emphasizing the need for spaced administration.
  • Regular monitoring of serum calcium and 25-OH D levels is important, especially in patients with underlying conditions or those on higher doses.
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Alternative Therapies

  • Dietary calcium intake (dairy products, fortified foods, leafy greens)
  • Dietary vitamin D intake (fatty fish, fortified foods, sun exposure)
  • Other osteoporosis medications (e.g., bisphosphonates, denosumab, teriparatide, romosozumab) for severe osteoporosis
  • Magnesium supplementation (often co-administered for bone health)
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Cost & Coverage

Average Cost: $5 - $30 per 30-100 tablets
Generic Available: Yes
Insurance Coverage: Often Over-The-Counter (OTC), may be covered by Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA). Some prescription plans may cover if prescribed for a medical condition.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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 details about the overdose, including the medication taken, the amount, and the time it occurred.