Calcium Citrate+d3 Tablets

Manufacturer 21ST CENTURY HEALTHCARE Active Ingredient Calcium and Vitamin D Capsules and Tablets(KAL see um & VYE ta min dee) Pronunciation KAL-see-um SY-trayt plus VYE-tuh-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 Supplement; Vitamin Supplement; Bone Health Agent
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Pharmacologic Class
Calcium salt; Vitamin D analog (Cholecalciferol)
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Pregnancy Category
Category C (at doses exceeding recommended daily allowance, otherwise considered essential nutrient)
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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?

This medication is a combination of calcium and vitamin D. Calcium is a mineral essential for strong bones, teeth, and proper functioning of muscles and nerves. Vitamin D helps your body absorb calcium and phosphorus, which are also important for bone health. It's often used to prevent or treat bone loss (osteoporosis) and to ensure you get enough of these vital nutrients.
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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 location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

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 of Vitamin D, especially if it contains fat.
  • Divide calcium doses throughout the day (e.g., 500-600 mg at a time) for optimal absorption.
  • Maintain a balanced diet rich in calcium and vitamin D (e.g., dairy products, fortified foods, fatty fish).
  • Engage in regular weight-bearing exercise (e.g., walking, jogging) to support bone health.
  • Avoid smoking and excessive alcohol consumption, as these can negatively impact bone density.
  • Stay hydrated by drinking plenty of water.

Dosing & Administration

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Adult Dosing

Standard Dose: Calcium: 1000-1200 mg elemental calcium daily (divided doses); Vitamin D3: 600-800 IU (15-20 mcg) daily for general supplementation. Higher doses may be used for deficiency or specific conditions under medical supervision.
Dose Range: 500 - 2500 mg

Condition-Specific Dosing:

osteoporosisPrevention: Calcium: 1200 mg elemental calcium daily; Vitamin D3: 800-1000 IU daily
vitaminDDeficiency: Vitamin D3: 1000-50,000 IU daily or weekly, depending on severity and physician guidance, often for a limited period, followed by maintenance dose.
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Pediatric Dosing

Neonatal: Not established for this combination product; individual calcium and vitamin D supplementation based on specific needs.
Infant: Not established for this combination product; individual calcium and vitamin D supplementation based on specific needs. Vitamin D3: 400 IU daily for breastfed infants.
Child: Calcium: 700-1300 mg elemental calcium daily (age-dependent); Vitamin D3: 600 IU daily. Specific doses vary by age and indication.
Adolescent: Calcium: 1300 mg elemental calcium daily; Vitamin D3: 600 IU daily. Specific doses vary by age and indication.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment for mild impairment, but monitor serum calcium and vitamin D levels. Use with caution.
Moderate: Use with caution. Monitor serum calcium, phosphorus, and 25-hydroxyvitamin D levels closely. Vitamin D activation (to 1,25-dihydroxyvitamin D) is impaired in renal disease. May require active vitamin D analogs (e.g., calcitriol) instead of cholecalciferol.
Severe: Contraindicated or used with extreme caution. Risk of hypercalcemia and hyperphosphatemia. Active vitamin D analogs are typically preferred for bone mineral disease in severe renal impairment.
Dialysis: Contraindicated or used with extreme caution. Risk of hypercalcemia and hyperphosphatemia. Active vitamin D analogs are typically preferred for bone mineral disease in dialysis patients.

Hepatic Impairment:

Mild: No specific adjustment needed for calcium. Vitamin D activation (25-hydroxylation) occurs in the liver; monitor 25-hydroxyvitamin D levels.
Moderate: Monitor 25-hydroxyvitamin D levels. May require higher doses of Vitamin D3 or active vitamin D analogs if deficiency persists.
Severe: Monitor 25-hydroxyvitamin D levels. May require higher doses of Vitamin D3 or active vitamin D analogs if deficiency persists.

Pharmacology

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Mechanism of Action

Calcium: An essential mineral for bone formation, maintenance, and strength. It plays crucial roles in nerve impulse transmission, muscle contraction, blood coagulation, and cellular signaling. Vitamin D3 (Cholecalciferol): 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 influences parathyroid hormone secretion.
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Pharmacokinetics

Absorption:

Bioavailability: Calcium Citrate: Approximately 20-30% elemental calcium absorbed (better absorbed than calcium carbonate, especially on an empty stomach). Vitamin D3: Approximately 50-80% absorbed from the small intestine, dependent on bile salts and dietary fat.
Tmax: Calcium: 1-2 hours (for peak serum concentration after oral dose). Vitamin D3: 4-5 hours (for peak serum concentration of cholecalciferol).
FoodEffect: Calcium Citrate: Can be taken with or without food, as its absorption is less dependent on stomach acid than calcium carbonate. Vitamin D3: Absorption is enhanced when taken with fatty meals.

Distribution:

Vd: Calcium: Approximately 0.2 L/kg (extracellular fluid). Vitamin D3: Large volume of distribution, stored in adipose tissue and muscle.
ProteinBinding: Calcium: Approximately 40-50% bound to plasma proteins (primarily albumin). Vitamin D3: >99% bound to vitamin D-binding protein (DBP) and albumin.
CnssPenetration: Limited for calcium. Limited for Vitamin D3 (active metabolites may cross, but primary role is peripheral).

Elimination:

HalfLife: Calcium: Variable, depends on physiological state; serum half-life is short, but bone turnover is long. Vitamin D3: Parent compound (cholecalciferol) half-life is approximately 24 hours; 25-hydroxyvitamin D half-life is 2-3 weeks; 1,25-dihydroxyvitamin D half-life is 4-6 hours.
Clearance: Not readily quantifiable for calcium in a typical pharmacokinetic sense. Vitamin D3: Hepatic and renal clearance of metabolites.
ExcretionRoute: Calcium: Primarily fecal (unabsorbed), renal (filtered and reabsorbed). Vitamin D3: Primarily fecal (as metabolites), minor renal excretion.
Unchanged: Calcium: Minimal unchanged excretion. Vitamin D3: Minimal unchanged excretion; primarily excreted as metabolites.
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Pharmacodynamics

OnsetOfAction: Long-term for bone health benefits (weeks to months). Acute effects on serum calcium levels within hours.
PeakEffect: Long-term for bone health benefits (months). Acute effects on serum calcium levels within hours.
DurationOfAction: Long-term for bone health benefits (continuous supplementation required). Serum calcium effects last for hours.

Safety & Warnings

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Side Effects

Serious 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 experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:

Upset stomach or vomiting
Constipation

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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:

  • Severe nausea or vomiting
  • Persistent constipation
  • Unusual thirst or frequent urination
  • Muscle weakness or fatigue
  • Confusion or changes in mental status
  • Bone pain
  • Signs of kidney stones (e.g., severe back or side pain, blood in urine)
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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 symptoms you experienced.
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 dosage 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 tartrazine.

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 maximize the benefits of this medication. 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 to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe hypercalcemia symptoms (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, confusion, coma)
  • Kidney damage (nephrocalcinosis, kidney stones)
  • Cardiac arrhythmias

What to Do:

Immediately discontinue the supplement. Seek emergency medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment may involve intravenous fluids, diuretics, and other medications to lower calcium levels.

Drug Interactions

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Major Interactions

  • Thiazide diuretics (increased risk of hypercalcemia with Vitamin D)
  • Digoxin (increased risk of arrhythmias with hypercalcemia)
  • Certain anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine - can increase vitamin D metabolism, leading to deficiency)
  • Orlistat (can reduce absorption of fat-soluble vitamins, including Vitamin D)
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Moderate Interactions

  • Tetracycline antibiotics (e.g., doxycycline, minocycline - calcium can chelate, reducing absorption; separate administration by at least 2-4 hours)
  • Fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin - calcium can chelate, reducing absorption; separate administration by at least 2-6 hours)
  • Bisphosphonates (e.g., alendronate, risedronate - calcium can interfere with absorption; separate administration by at least 30-60 minutes)
  • Thyroid hormones (e.g., levothyroxine - calcium can interfere with absorption; separate administration by at least 4 hours)
  • Iron supplements (calcium can reduce iron absorption; separate administration by at least 2 hours)
  • Zinc supplements (calcium can reduce zinc absorption; separate administration by at least 2 hours)
  • Corticosteroids (can decrease calcium absorption and increase vitamin D metabolism)
  • Proton pump inhibitors (e.g., omeprazole, pantoprazole - may reduce calcium absorption, especially calcium carbonate, less so for calcium citrate)
  • Cholestyramine, colestipol (can reduce absorption of fat-soluble vitamins, including Vitamin D)
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Minor Interactions

  • Fiber-rich foods (e.g., bran, whole grains - can reduce calcium absorption)
  • Oxalic acid (in spinach, rhubarb) and phytic acid (in whole grains, legumes) - can reduce calcium absorption

Monitoring

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Baseline Monitoring

Serum Calcium (total and/or ionized)

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

Timing: Prior to initiation of high-dose supplementation or if clinical suspicion.

Serum 25-hydroxyvitamin D (25-OH D)

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

Timing: Prior to initiation of supplementation, especially for deficiency treatment.

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, especially in elderly or those with risk factors for renal disease.

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Routine Monitoring

Serum Calcium (total and/or ionized)

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

Target: 8.5-10.2 mg/dL (total calcium); 4.6-5.3 mg/dL (ionized calcium)

Action Threshold: >10.5 mg/dL (total calcium) or symptoms of hypercalcemia; consider dose reduction or discontinuation.

Serum 25-hydroxyvitamin D (25-OH D)

Frequency: Every 3-6 months until target level achieved, then annually or as clinically indicated.

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

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 as clinically indicated, especially in patients with renal impairment or on high doses.

Target: Stable within patient's baseline range.

Action Threshold: Significant decline in eGFR or increase in creatinine; consider dose adjustment or discontinuation.

24-hour Urine Calcium (if hypercalciuria risk)

Frequency: Periodically, if history of kidney stones or hypercalciuria.

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

Action Threshold: >250-300 mg/24 hours; consider dose reduction or discontinuation.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Excessive thirst (polydipsia)
  • Frequent urination (polyuria)
  • Muscle weakness
  • Fatigue
  • Confusion
  • Irritability
  • Loss of appetite
  • Bone pain
  • Kidney stones

Special Patient Groups

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Pregnancy

Calcium and Vitamin D are essential nutrients during pregnancy for fetal bone development and maternal health. Recommended daily allowances should be met. Excessive doses of Vitamin D (above 4000 IU/day) should be avoided unless specifically prescribed by a physician 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 fetal bone mineralization; generally safe at recommended doses.
Third Trimester: Critical for rapid fetal bone growth; generally safe at recommended doses.
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Lactation

Calcium and Vitamin D are compatible with breastfeeding and are essential for both mother and infant. Recommended daily allowances should be met. Vitamin D is transferred into breast milk in small amounts; maternal supplementation can improve infant vitamin D status.

Infant Risk: Low risk at recommended maternal doses; considered safe and beneficial.
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Pediatric Use

Dosing must be carefully adjusted by age and weight to meet specific daily requirements and avoid toxicity. Excessive intake of calcium or vitamin D can lead to hypercalcemia and potential kidney damage in children. Always consult a pediatrician.

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Geriatric Use

Elderly individuals often have increased needs for calcium and vitamin D due to decreased dietary intake, reduced skin synthesis of vitamin D, and impaired renal 1-alpha-hydroxylation. They are at higher risk for osteoporosis and fractures. However, renal function should be monitored, as impaired kidney function can increase the risk of hypercalcemia with supplementation.

Clinical Information

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Clinical Pearls

  • Calcium citrate is generally preferred over calcium carbonate for patients on proton pump inhibitors or H2 blockers, or those with achlorhydria, as its absorption is less dependent on stomach acid.
  • For optimal calcium absorption, doses should be limited to 500-600 mg of elemental calcium per single dose. If higher daily doses are needed, divide them throughout the day.
  • Vitamin D deficiency is common; testing 25-hydroxyvitamin D levels is crucial to guide appropriate dosing, especially for therapeutic purposes.
  • Always advise patients to inform their healthcare providers about all supplements they are taking, due to potential drug-nutrient interactions.
  • Encourage dietary sources of calcium and vitamin D as a primary approach, with supplements used to fill gaps.
  • Hypercalcemia is the primary concern with excessive intake; educate patients on symptoms and the importance of not exceeding recommended doses without medical supervision.
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Alternative Therapies

  • Dietary calcium and vitamin D intake
  • Other forms of Vitamin D (e.g., Ergocalciferol - Vitamin D2, Calcitriol - active Vitamin D analog)
  • Bisphosphonates (e.g., alendronate, risedronate) for osteoporosis treatment
  • Denosumab for osteoporosis treatment
  • Teriparatide for osteoporosis treatment
  • Raloxifene for osteoporosis prevention/treatment
  • Calcitonin for osteoporosis treatment
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Cost & Coverage

Average Cost: Varies widely ($5 - $30+) per 30-120 tablets/capsules
Generic Available: Yes
Insurance Coverage: Often OTC, may be covered by FSA/HSA. Prescription forms or high-dose vitamin D may be covered by some insurance plans (Tier 3 or 4).
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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, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.