Calcium 600mg + D Tablets

Manufacturer BASIC DRUGS Active Ingredient Calcium and Vitamin D Capsules and Tablets(KAL see um & VYE ta min dee) Pronunciation KAL-see-um & 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; Cholecalciferol (Vitamin D3) or Ergocalciferol (Vitamin D2)
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Pregnancy Category
Not formally assigned for dietary supplements; generally considered safe and essential at recommended daily allowances. High doses may be Category C.
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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 medicine is a combination of calcium and vitamin D. Calcium is a mineral essential for strong bones, healthy teeth, and proper functioning of muscles and nerves. Vitamin D helps your body absorb calcium from food and is also important for bone health and immune function. This supplement helps ensure you get enough of these vital nutrients, especially if your diet is lacking or you have specific health needs.
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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 this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, 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 disposing of medications, 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 dose, skip the missed dose and resume your regular 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 to improve absorption, especially calcium carbonate.
  • Do not take other medications (especially antibiotics, thyroid hormones, bisphosphonates) within 2-4 hours of taking calcium to avoid interactions.
  • Maintain a balanced diet rich in calcium and Vitamin D (e.g., dairy, fortified foods, fatty fish).
  • Engage in regular weight-bearing exercise to support bone health.
  • Ensure adequate sun exposure for natural Vitamin D synthesis, but be mindful of skin cancer risks.
  • Avoid excessive alcohol and caffeine intake, which can affect calcium balance.

Dosing & Administration

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Adult Dosing

Standard Dose: 600 mg elemental calcium and 400-1000 IU (10-25 mcg) Vitamin D daily, often divided into 1-2 doses.
Dose Range: 600 - 1200 mg

Condition-Specific Dosing:

Osteoporosis Prevention: 1000-1200 mg elemental calcium and 800-1000 IU Vitamin D daily.
Dietary Supplementation: 600-1000 mg elemental calcium and 400-800 IU Vitamin D daily.
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Pediatric Dosing

Neonatal: Not established for this combination product; individual calcium and Vitamin D dosing based on specific needs and medical supervision.
Infant: Not established for this combination product; individual calcium and Vitamin D dosing based on specific needs and medical supervision.
Child: Dosing varies by age and indication (e.g., 500-1000 mg elemental calcium and 400-600 IU Vitamin D daily for children 4-8 years, 1300 mg elemental calcium and 600 IU Vitamin D daily for children 9-18 years). Consult pediatrician.
Adolescent: Dosing varies by age and indication (e.g., 1300 mg elemental calcium and 600 IU Vitamin D daily). Consult pediatrician.
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Dose Adjustments

Renal Impairment:

Mild: Generally no specific adjustment for mild impairment, but monitor serum calcium and phosphate levels.
Moderate: Use with caution. Monitor serum calcium, phosphate, and Vitamin D levels closely. May require dose adjustment or specific forms of Vitamin D (e.g., calcitriol).
Severe: Contraindicated in severe hypercalcemia or hypercalciuria. Use with extreme caution and under strict medical supervision. Often requires active Vitamin D metabolites (e.g., calcitriol) and careful calcium management.
Dialysis: Calcium and Vitamin D supplementation must be carefully managed in dialysis patients due to high risk of hypercalcemia, hyperphosphatemia, and vascular calcification. Often requires specific forms of Vitamin D and phosphate binders.

Hepatic Impairment:

Mild: No specific adjustment typically required.
Moderate: No specific adjustment typically required, but severe liver disease may impair 25-hydroxylation of Vitamin D, potentially requiring calcifediol or calcitriol.
Severe: No specific adjustment typically required, but severe liver disease may impair 25-hydroxylation of Vitamin D, potentially requiring calcifediol or calcitriol.

Pharmacology

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Mechanism of Action

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

Absorption:

Bioavailability: Calcium: Approximately 25-35% (varies with dose, food, and calcium salt type). Vitamin D: Readily absorbed from the small intestine (requires bile salts), bioavailability is high (e.g., 50-80%).
Tmax: Calcium: 1-2 hours (for serum calcium peak after oral dose). Vitamin D: 4-6 hours (for parent compound); 24-48 hours (for 25-hydroxyvitamin D).
FoodEffect: Calcium: Absorption is enhanced by food, especially calcium carbonate. Vitamin D: Absorption is enhanced by fatty meals.

Distribution:

Vd: Calcium: Not applicable in the traditional sense as it's a mineral. Vitamin D: Extensively distributed to adipose tissue and muscle; Vd is large (e.g., 0.1-0.5 L/kg).
ProteinBinding: Calcium: Approximately 40-50% bound to plasma proteins (primarily albumin). Vitamin D: >99% bound to vitamin D-binding protein (DBP) and albumin.
CnssPenetration: Calcium: Limited direct CNS penetration. Vitamin D: Metabolites can cross the blood-brain barrier to some extent.

Elimination:

HalfLife: Calcium: Not applicable (homeostatically regulated). Vitamin D (parent compound): Approximately 24 hours. 25-hydroxyvitamin D: 2-3 weeks. 1,25-dihydroxyvitamin D: 4-6 hours.
Clearance: Not available for calcium. Vitamin D: Primarily hepatic and renal clearance of metabolites.
ExcretionRoute: Calcium: Primarily fecal (unabsorbed), some renal. Vitamin D: Primarily biliary/fecal excretion of metabolites; minor renal excretion.
Unchanged: Not applicable for calcium. Vitamin D: Very little unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Calcium: Rapid (within minutes for acute effects on serum levels). Vitamin D: Days to weeks for significant changes in 25-hydroxyvitamin D levels and calcium absorption.
PeakEffect: Calcium: Hours. Vitamin D: Weeks to months for optimal bone health effects.
DurationOfAction: Calcium: Hours (for acute effects). Vitamin D: Weeks to months (due to long half-life of 25-hydroxyvitamin D and its storage in adipose tissue).

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people 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 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Fatigue
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is 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, 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:

  • Severe constipation
  • Nausea or vomiting
  • Loss of appetite
  • Increased thirst or urination
  • Unusual tiredness or weakness
  • Muscle pain
  • Confusion
  • Kidney stones (severe back 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 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. Do not initiate, discontinue, or modify 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 and minimize potential side effects. 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 about its use.
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Overdose Information

Overdose Symptoms:

  • Severe hypercalcemia (calcium toxicity)
  • Nausea, vomiting, constipation, abdominal pain
  • Polyuria, polydipsia (excessive urination and thirst)
  • Muscle weakness, fatigue, lethargy
  • Confusion, stupor, coma
  • Cardiac arrhythmias
  • Kidney damage (nephrocalcinosis, kidney stones)
  • Vascular calcification

What to Do:

Immediately discontinue the supplement. Seek emergency medical attention. Treatment involves hydration (intravenous fluids), loop diuretics (e.g., furosemide) to promote calcium excretion, and in severe cases, calcitonin, bisphosphonates, or dialysis. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Digitalis glycosides (risk of arrhythmias with hypercalcemia)
  • Thiazide diuretics (increased risk of hypercalcemia)
  • Certain bisphosphonates (e.g., alendronate, risedronate - calcium can interfere with absorption if taken concurrently)
  • Levothyroxine (calcium can impair absorption)
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Moderate Interactions

  • Tetracycline antibiotics (reduced absorption of both if taken concurrently)
  • Fluoroquinolone antibiotics (reduced absorption of both if taken concurrently)
  • Iron supplements (reduced absorption of iron)
  • Zinc supplements (reduced absorption of zinc)
  • Phenytoin, barbiturates, carbamazepine (may increase Vitamin D metabolism, reducing its effectiveness)
  • Corticosteroids (may reduce calcium absorption and increase calcium excretion)
  • Orlistat, cholestyramine, mineral oil (may reduce absorption of fat-soluble Vitamin D)
  • Phosphate binders (may reduce calcium absorption)
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Minor Interactions

  • Spinach, rhubarb, whole grains (contain oxalates/phytates that can reduce calcium absorption)
  • Caffeine, alcohol (may increase calcium excretion)

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: Before initiating supplementation, especially in patients with renal impairment or conditions affecting calcium metabolism.

Serum 25-hydroxyvitamin D (25-OH D)

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

Timing: Before initiating supplementation, particularly if deficiency is suspected.

Renal Function (BUN, Creatinine, eGFR)

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

Timing: Before initiating supplementation, 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.

Target: Total: 8.5-10.5 mg/dL; Ionized: 4.5-5.6 mg/dL

Action Threshold: If consistently above upper limit of normal or if symptoms of hypercalcemia develop, reduce dose or discontinue.

Serum 25-hydroxyvitamin D (25-OH D)

Frequency: Every 6-12 months, or as needed to assess response to therapy.

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

Action Threshold: If below target, consider increasing Vitamin D dose. If consistently above 100 ng/mL, consider reducing dose.

Renal Function (BUN, Creatinine, eGFR)

Frequency: Annually or as clinically indicated, especially in patients with renal impairment.

Target: Normal for age/sex

Action Threshold: Significant decline may necessitate dose adjustment or discontinuation.

24-hour Urinary Calcium Excretion

Frequency: Periodically, especially if hypercalcemia or kidney stones are a concern.

Target: <300 mg/24 hours

Action Threshold: If elevated, consider reducing calcium intake or investigating underlying causes.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Polyuria (frequent urination)
  • Polydipsia (increased thirst)
  • Muscle weakness
  • Fatigue
  • Confusion
  • Bone pain
  • Kidney stones (flank pain, hematuria)

Special Patient Groups

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Pregnancy

Calcium and Vitamin D are essential nutrients during pregnancy for fetal skeletal development and maternal bone health. Recommended daily allowances should be met through diet and supplementation if necessary. Excessive doses 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; generally safe at recommended doses.
Third Trimester: Crucial for rapid fetal bone mineralization; generally safe at recommended doses. High doses of Vitamin D may be associated with hypercalcemia in the mother and potential fetal effects, though rare.
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Lactation

Calcium and Vitamin D are essential during lactation for maternal bone health and to ensure adequate levels in breast milk for infant growth. Generally considered safe and beneficial at recommended doses. Consult a healthcare provider for appropriate dosing.

Infant Risk: L1 (Safest) at recommended maternal doses. No adverse effects expected in breastfed infants.
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Pediatric Use

Essential for bone growth and development. Dosing must be carefully tailored to age, weight, and dietary intake. Excessive intake can lead to hypercalcemia and potential kidney damage. Always consult a pediatrician before administering to children.

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Geriatric Use

Elderly individuals are at increased risk of calcium and Vitamin D deficiency due to decreased dietary intake, reduced skin synthesis of Vitamin D, and impaired renal 1-alpha-hydroxylation. Increased daily requirements are often recommended (e.g., 1200 mg calcium, 800-1000 IU Vitamin D). Monitor for hypercalcemia, especially in those with renal impairment.

Clinical Information

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Clinical Pearls

  • Calcium carbonate should be taken with food for optimal absorption, while calcium citrate can be taken with or without food.
  • Divide large doses of calcium (e.g., >500-600 mg elemental calcium) throughout the day to maximize absorption.
  • Ensure adequate fluid intake to prevent constipation, a common side effect of calcium supplementation.
  • Patients with achlorhydria or those on proton pump inhibitors (PPIs) may absorb calcium citrate better than calcium carbonate.
  • Regular monitoring of serum calcium and 25-OH Vitamin D levels is important, especially in patients with underlying medical conditions or those taking high doses.
  • Educate patients on symptoms of hypercalcemia and when to seek medical attention.
  • Consider dietary sources of calcium and Vitamin D first, and use supplements to fill gaps.
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Alternative Therapies

  • Dietary calcium (dairy products, fortified foods, leafy greens)
  • Dietary Vitamin D (fatty fish, fortified foods, sun exposure)
  • Prescription Vitamin D (e.g., ergocalciferol 50,000 IU for deficiency)
  • Bisphosphonates (for osteoporosis treatment)
  • Selective Estrogen Receptor Modulators (SERMs) (for osteoporosis treatment)
  • Parathyroid hormone analogs (for severe osteoporosis)
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Cost & Coverage

Average Cost: $5 - $30 per 30-100 tablets
Generic Available: Yes
Insurance Coverage: Often not covered by insurance as it's an over-the-counter supplement, unless prescribed for a specific medical condition (e.g., osteoporosis) and deemed medically necessary.
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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's a good idea to check with your pharmacist for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.