Calcium 600+d (400u) Tablets

Manufacturer LEADER BRAND PRODUCTS Active Ingredient Calcium and Vitamin D Capsules and Tablets(KAL see um & VYE ta min dee) Pronunciation KAL-see-um and 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; Bone Health Agent
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Pharmacologic Class
Mineral (Calcium); Vitamin D Analog (Cholecalciferol)
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Pregnancy Category
Category C (due to Vitamin D at higher doses, generally considered safe at recommended supplement doses)
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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, two important nutrients that work together to keep your bones strong and healthy. Calcium is the main building block of bones, and vitamin D helps your body absorb calcium from your diet.
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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

Store your 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. 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, check with your pharmacist for guidance on the best disposal method or inquire about potential drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is 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 the missed one.
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Lifestyle & Tips

  • Take with food to improve absorption, especially if it's calcium carbonate.
  • Do not take at the same time as certain medications (e.g., antibiotics, thyroid hormones). Separate by at least 2-4 hours.
  • Maintain a balanced diet rich in calcium (dairy, leafy greens) and vitamin D (fatty fish, fortified foods).
  • Engage in weight-bearing exercise (e.g., walking, jogging) to support bone health.
  • Limit excessive caffeine and alcohol intake, which can affect bone density.
  • Avoid smoking, as it negatively impacts bone health.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet (600 mg Calcium, 400 IU Vitamin D) once or twice daily with food.
Dose Range: 600 - 1200 mg

Condition-Specific Dosing:

osteoporosisPrevention: 600-1200 mg Calcium and 400-800 IU Vitamin D daily, often divided doses.
dietarySupplementation: 600 mg Calcium and 400 IU Vitamin D daily.
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Pediatric Dosing

Neonatal: Not established (specific pediatric formulations/doses required)
Infant: Not established (specific pediatric formulations/doses required)
Child: Dosing varies by age and dietary intake; consult pediatrician. Typical daily calcium intake for 4-8 years: 1000 mg; 9-18 years: 1300 mg. Vitamin D: 600 IU.
Adolescent: Dosing varies by age and dietary intake; consult pediatrician. Typical daily calcium intake: 1300 mg. Vitamin D: 600 IU.
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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. May require dose adjustment or alternative forms of Vitamin D (e.g., calcitriol).
Severe: Contraindicated in severe hypercalcemia or hypercalciuria. Use with extreme caution; monitor serum calcium, phosphate, and PTH. May require active Vitamin D metabolites.
Dialysis: Contraindicated in hypercalcemia. Use with extreme caution; often requires active Vitamin D metabolites and careful calcium management.

Hepatic Impairment:

Mild: No specific adjustment typically needed for Calcium. Vitamin D metabolism may be impaired; monitor 25-OH Vitamin D levels.
Moderate: No specific adjustment typically needed for Calcium. Vitamin D metabolism may be impaired; monitor 25-OH Vitamin D levels and adjust dose as needed.
Severe: No specific adjustment typically needed for Calcium. Vitamin D metabolism may be significantly impaired; monitor 25-OH Vitamin D levels and adjust dose as needed. Consider active Vitamin D metabolites if deficiency persists.

Pharmacology

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Mechanism of Action

Calcium is an essential mineral necessary for bone formation, nerve impulse transmission, muscle contraction, and blood coagulation. Vitamin D (Cholecalciferol) is a fat-soluble vitamin that plays a crucial role in maintaining calcium and phosphate homeostasis. It promotes the absorption of calcium and phosphate from the gastrointestinal tract and regulates their reabsorption in the kidneys, thereby facilitating bone mineralization and remodeling. Vitamin D also has immunomodulatory and anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: Calcium: Varies by salt (e.g., Calcium Carbonate ~20-30% with food, Calcium Citrate ~25-35% independent of food). Vitamin D: ~50-80% (fat-soluble, requires bile salts).
Tmax: Calcium: 1-4 hours. Vitamin D: 4-5 hours (for cholecalciferol).
FoodEffect: Calcium Carbonate absorption is enhanced by food (acidic environment). Calcium Citrate absorption is less affected by food. Vitamin D absorption is enhanced by dietary fat.

Distribution:

Vd: Calcium: ~0.35 L/kg (primarily in bone). Vitamin D: Large (stored in adipose tissue and muscle).
ProteinBinding: Calcium: ~40-50% (to albumin and globulins). Vitamin D: >99% (to Vitamin D binding protein and albumin).
CnssPenetration: Limited for Calcium. Limited for Vitamin D (active metabolites may cross).

Elimination:

HalfLife: Calcium: Variable, depends on body stores and intake. Vitamin D: Cholecalciferol ~15-30 days (storage half-life); 25-OH Vitamin D ~2-3 weeks; 1,25-OH Vitamin D ~4-6 hours.
Clearance: Not readily quantifiable for Calcium as a nutrient. Vitamin D: Not typically reported as a single clearance value due to storage.
ExcretionRoute: Calcium: Primarily fecal (unabsorbed), renal (filtered and reabsorbed). Vitamin D: Primarily fecal (bile), minor renal.
Unchanged: Calcium: Varies based on absorption. Vitamin D: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Gradual (weeks to months for bone health benefits).
PeakEffect: Gradual (weeks to months).
DurationOfAction: Sustained with regular intake.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 attention immediately:

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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Upset stomach or vomiting
Constipation

Note: This is not an exhaustive list of 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:

  • Severe constipation
  • Nausea or vomiting
  • Unusual tiredness or weakness
  • Increased thirst or urination
  • Muscle pain or weakness
  • Confusion
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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 optimize the benefits of this medication. If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they 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 nausea and vomiting
  • Constipation
  • Loss of appetite
  • Extreme thirst
  • Frequent urination
  • Muscle weakness
  • Fatigue
  • Confusion
  • Kidney stones
  • 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 may involve stopping the supplement, hydration, and medications to lower calcium levels.

Drug Interactions

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Contraindicated Interactions

  • Thiazide diuretics (risk of hypercalcemia with high doses of calcium/vitamin D)
  • Digoxin (risk of arrhythmias with hypercalcemia)
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Major Interactions

  • Tetracycline antibiotics (e.g., doxycycline, minocycline) - Calcium can chelate, reducing absorption. Separate by 2-4 hours.
  • Fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin) - Calcium can chelate, reducing absorption. Separate by 2-6 hours.
  • Levothyroxine - Calcium can impair absorption. Separate by at least 4 hours.
  • Bisphosphonates (e.g., alendronate, risedronate) - Calcium can impair absorption. Separate by at least 30-60 minutes.
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Moderate Interactions

  • Iron supplements - Calcium can reduce iron absorption. Separate by 2 hours.
  • Zinc supplements - High calcium intake can reduce zinc absorption.
  • Proton pump inhibitors (e.g., omeprazole, pantoprazole) - May reduce calcium carbonate absorption (less impact on calcium citrate).
  • Corticosteroids (e.g., prednisone) - May reduce calcium absorption and increase calcium excretion, increasing vitamin D requirements.
  • Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital) - May increase vitamin D metabolism, leading to deficiency.
  • Bile acid sequestrants (e.g., cholestyramine) - May impair absorption of fat-soluble Vitamin D. Separate administration.
  • Mineral oil - May impair absorption of fat-soluble Vitamin D. Avoid concurrent use.
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Minor Interactions

  • Fiber-rich foods (e.g., oat bran, spinach) - May reduce calcium absorption due to phytates/oxalates.
  • Caffeine - May slightly increase urinary calcium excretion.

Monitoring

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Baseline Monitoring

Serum Calcium

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

Timing: Before initiating supplementation, especially with higher doses or risk factors.

Serum 25-hydroxyvitamin D

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

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

Renal Function (SCr, eGFR)

Rationale: To assess kidney's ability to excrete calcium and metabolize Vitamin D, especially in patients with renal impairment.

Timing: Before initiating supplementation in patients with known or suspected renal issues.

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Routine Monitoring

Serum Calcium

Frequency: Annually for routine supplementation; more frequently (e.g., every 3-6 months) for higher doses, renal impairment, or symptoms of hypercalcemia.

Target: 8.5-10.2 mg/dL (total calcium)

Action Threshold: >10.5 mg/dL (investigate, reduce dose, or discontinue)

Serum 25-hydroxyvitamin D

Frequency: Every 6-12 months, or as needed to achieve target levels (e.g., 30-60 ng/mL).

Target: 30-60 ng/mL (75-150 nmol/L)

Action Threshold: <20 ng/mL (consider dose increase); >100 ng/mL (consider dose reduction)

Urinary Calcium (24-hour)

Frequency: Periodically if hypercalciuria is suspected or with high doses.

Target: <300 mg/24 hours

Action Threshold: >300 mg/24 hours (investigate, reduce dose)

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Increased thirst
  • Increased urination
  • Fatigue
  • Muscle weakness
  • Confusion
  • Bone pain

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 intake for pregnant women is 1000-1300 mg calcium and 600 IU vitamin D. This supplement is generally considered safe at recommended doses. Excessive intake should be avoided.

Trimester-Specific Risks:

First Trimester: Generally safe at recommended doses. Essential for early fetal development.
Second Trimester: Generally safe at recommended doses. Continued importance for fetal bone mineralization.
Third Trimester: Generally safe at recommended doses. Critical for rapid fetal bone growth.
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Lactation

Calcium and Vitamin D are excreted in breast milk. Supplementation at recommended doses is generally considered safe and beneficial for both mother and infant. Recommended daily intake for lactating women is 1000-1300 mg calcium and 600 IU vitamin D.

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

Dosing must be carefully adjusted based on age, weight, and dietary intake to meet recommended daily allowances. Excessive intake can lead to hypercalcemia and hypervitaminosis D, which can be harmful to developing bones and kidneys. Consult a pediatrician for appropriate dosing.

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Geriatric Use

Elderly individuals are at higher risk for calcium and vitamin D deficiency due to decreased dietary intake, reduced skin synthesis of vitamin D, and impaired renal hydroxylation of vitamin D. Supplementation is often recommended for bone health. However, monitor for hypercalcemia, especially in those with renal impairment or taking other medications that affect calcium levels (e.g., thiazide diuretics).

Clinical Information

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Clinical Pearls

  • Calcium carbonate should be taken with food to maximize absorption, while calcium citrate can be taken with or without food.
  • For doses exceeding 500-600 mg of elemental calcium, divide the dose throughout the day to optimize absorption.
  • Vitamin D is crucial for calcium absorption; ensure adequate intake of both for optimal bone health.
  • Advise patients to separate calcium/vitamin D supplements from certain medications (e.g., thyroid hormones, tetracyclines, fluoroquinolones, bisphosphonates) by several hours to prevent drug interactions.
  • Educate patients on symptoms of hypercalcemia (e.g., nausea, constipation, increased thirst/urination) and advise them to report these to their healthcare provider.
  • Regular weight-bearing exercise and a balanced diet are equally important for bone health as supplementation.
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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, cholecalciferol at higher doses)
  • Bisphosphonates (for osteoporosis treatment)
  • Selective Estrogen Receptor Modulators (SERMs) (for osteoporosis treatment)
  • Parathyroid hormone analogs (for osteoporosis treatment)
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Cost & Coverage

Average Cost: $5 - $20 per 100 tablets
Generic Available: Yes
Insurance Coverage: Not typically covered by prescription insurance as it's an OTC supplement. May be eligible for FSA/HSA.
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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 this 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, including the amount taken and the time it happened, to ensure you receive the best possible care.