Calcium 500mg W/ Vit D Chw Tablets

Manufacturer RUGBY LABS Active Ingredient Calcium and Vitamin D Chewable 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
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Pharmacologic Class
Calcium Supplement; Vitamin D Analog
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Pregnancy Category
Not available (generally considered safe at recommended dietary intake levels, but excessive intake can be harmful)
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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 chewable tablets are a dietary supplement used to help ensure you get enough of these important nutrients. Calcium is essential for strong bones and teeth, and also helps your muscles and nerves work properly. Vitamin D helps your body absorb calcium and is also important for bone health and your immune system. These chewable tablets are a convenient way to supplement your diet, especially if you don't get enough calcium or Vitamin D from food or sunlight.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food to help your body absorb it properly.
Chew your medication thoroughly before swallowing, unless the packaging indicates that it can be swallowed whole or dissolved in your mouth. If you're unsure, consult with your pharmacist.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:

Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure 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 by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

Take the missed dose as soon as you remember.
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 the missed one.
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Lifestyle & Tips

  • Take with food to improve absorption, especially for Vitamin D.
  • If taking more than 500-600 mg of elemental calcium at once, split the dose throughout the day for better absorption.
  • Maintain a balanced diet rich in calcium (dairy products, leafy greens) and Vitamin D (fatty fish, fortified foods).
  • Engage in regular weight-bearing exercise (e.g., walking, jogging) to support bone health.
  • Limit excessive alcohol intake and smoking, as these can negatively impact bone density.
  • Ensure adequate sun exposure (10-30 minutes several times a week) for natural Vitamin D production, while being mindful of skin cancer risks.

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 tablets daily, typically providing 500-1000 mg elemental calcium and 200-400 IU Vitamin D per tablet. Dosing should be adjusted to meet individual dietary needs and recommended daily allowances (RDAs).
Dose Range: 500 - 1200 mg

Condition-Specific Dosing:

osteoporosis_prevention: 1000-1200 mg elemental calcium and 600-800 IU Vitamin D daily, often split into divided doses.
calcium_deficiency: Dose adjusted based on severity of deficiency and serum calcium levels, under medical supervision.
vitamin_d_deficiency: Dose adjusted based on severity of deficiency and serum 25(OH)D levels, under medical supervision.
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Pediatric Dosing

Neonatal: Not established for this specific product. Calcium and Vitamin D needs are met through breast milk or formula, with supplemental Vitamin D (400 IU/day) often recommended for breastfed infants.
Infant: Not established for this specific product. RDA for elemental calcium: 200-260 mg/day. RDA for Vitamin D: 400 IU/day.
Child: Not established for this specific product. RDA for elemental calcium: 700-1000 mg/day. RDA for Vitamin D: 600 IU/day.
Adolescent: Not established for this specific product. RDA for elemental calcium: 1300 mg/day. RDA for Vitamin D: 600 IU/day.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution. Monitor serum calcium and phosphate levels. Adjustment may be needed.
Moderate: Use with caution. Monitor serum calcium, phosphate, and parathyroid hormone (PTH) levels closely. Dosage adjustment likely required. Avoid high doses of calcium and Vitamin D.
Severe: Contraindicated or used with extreme caution under strict medical supervision. Risk of hypercalcemia and hyperphosphatemia is high. Active Vitamin D forms (e.g., calcitriol) may be preferred over cholecalciferol.
Dialysis: Contraindicated or used with extreme caution under strict medical supervision. Calcium and Vitamin D supplementation should be managed by a nephrologist due to high risk of hypercalcemia, hyperphosphatemia, and vascular calcification.

Hepatic Impairment:

Mild: No specific adjustment typically required for calcium. Vitamin D activation (25-hydroxylation) may be impaired in severe liver disease, but mild impairment usually does not necessitate dose adjustment.
Moderate: No specific adjustment typically required for calcium. Monitor Vitamin D levels; higher doses of cholecalciferol or active Vitamin D forms may be considered if deficiency persists.
Severe: No specific adjustment typically required for calcium. Vitamin D activation (25-hydroxylation) may be significantly impaired. Monitor 25(OH)D levels and consider active Vitamin D forms if deficiency is present and cholecalciferol is ineffective.

Pharmacology

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Mechanism of Action

Calcium is an essential mineral for bone formation, maintenance, and strength. It also plays crucial roles in nerve transmission, muscle contraction, blood clotting, and cellular signaling. Vitamin D (specifically Vitamin D3, cholecalciferol) is a fat-soluble vitamin that is metabolized in the liver to 25-hydroxyvitamin D (calcidiol) and then in the kidneys to 1,25-dihydroxyvitamin D (calcitriol), the active form. Calcitriol primarily functions to regulate calcium and phosphate homeostasis by promoting their absorption from the gut, reabsorption in the kidneys, and mobilization from bone, thereby maintaining serum calcium levels necessary for metabolic functions and bone mineralization.
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Pharmacokinetics

Absorption:

Bioavailability: Calcium: Approximately 25-35% (varies with dose, food, and individual calcium status). Vitamin D: Highly variable, typically 50-80% (fat-soluble, absorbed via lymphatic system).
Tmax: Calcium: Not well-defined for chronic supplementation, peak serum levels typically 2-4 hours post-ingestion. Vitamin D: Cholecalciferol peak serum levels 4-5 hours post-ingestion.
FoodEffect: Calcium: Absorption can be enhanced when taken with food, especially for calcium carbonate. Vitamin D: Enhanced absorption when taken with fatty meals due to its fat-soluble nature.

Distribution:

Vd: Calcium: Approximately 0.35 L/kg (primarily in bone, with a small fraction in extracellular fluid). Vitamin D: Widely distributed, stored in adipose tissue, liver, and muscle.
ProteinBinding: Calcium: Approximately 40-45% bound to plasma proteins (primarily albumin). Vitamin D: Cholecalciferol and its metabolites are highly protein-bound (>99%) to vitamin D-binding protein (DBP) and albumin.
CnssPenetration: Calcium: Limited. Vitamin D: Metabolites can cross the blood-brain barrier.

Elimination:

HalfLife: Calcium: Complex, with various compartments; effective half-life of absorbed calcium is days to weeks. Vitamin D: Cholecalciferol (parent compound) ~24 hours; 25(OH)D ~2-3 weeks; 1,25(OH)2D ~4-6 hours.
Clearance: Calcium: Primarily via fecal excretion (unabsorbed calcium) and renal excretion (filtered and reabsorbed). Vitamin D: Metabolites are primarily cleared via biliary excretion into feces.
ExcretionRoute: Calcium: Fecal (major), Renal (minor). Vitamin D: Biliary/Fecal (major), Renal (minor for water-soluble metabolites).
Unchanged: Calcium: Not applicable (elemental). Vitamin D: Very little unchanged cholecalciferol is excreted; primarily metabolized.
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Pharmacodynamics

OnsetOfAction: Not acutely measurable for chronic supplementation; effects on bone density and calcium/vitamin D status are gradual, over weeks to months.
PeakEffect: Not acutely measurable; peak effects on bone mineral density and correction of deficiency are observed after several months of consistent supplementation.
DurationOfAction: Effects persist as long as supplementation continues and adequate levels are maintained. Stores of Vitamin D (25(OH)D) can last for weeks to months after cessation.

Safety & Warnings

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Side Effects

Urgent 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 minor 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

Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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
  • Unusual tiredness or weakness
  • Frequent urination or increased thirst
  • Muscle pain or weakness
  • Confusion or changes in mental status
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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 in conjunction with all your other medications and health conditions. Never start, stop, or adjust 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 before taking this drug, as some formulations 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, discuss with your doctor the best timing for taking other medications by mouth in relation to this drug.

Adhere to the dietary plan recommended by your doctor to ensure optimal management of your condition. If you have phenylketonuria (PKU), a condition where the body cannot break down the amino acid phenylalanine, inform your doctor, as some products may contain phenylalanine.

If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby. This will help you make an informed decision about your treatment.
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Overdose Information

Overdose Symptoms:

  • Hypercalcemia (excessively high calcium levels)
  • Nausea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Polyuria (frequent urination)
  • Polydipsia (excessive thirst)
  • Fatigue
  • Muscle weakness
  • Confusion
  • Irritability
  • Anorexia
  • Kidney stones
  • Kidney damage (in severe, prolonged cases)
  • Cardiac arrhythmias (rare, severe cases)

What to Do:

If you suspect an overdose, seek immediate medical attention or call a poison control center. In the U.S., call 1-800-222-1222. Management typically involves discontinuing the supplement, hydration, and potentially 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 antacids containing aluminum (can increase aluminum absorption with calcium)
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Moderate Interactions

  • Levothyroxine (calcium can impair absorption; separate dosing by at least 4 hours)
  • Tetracycline antibiotics (calcium can chelate; separate dosing by at least 2-4 hours)
  • Fluoroquinolone antibiotics (calcium can chelate; separate dosing by at least 2-4 hours)
  • Bisphosphonates (calcium can impair absorption; separate dosing by at least 30-60 minutes)
  • Iron supplements (calcium can impair absorption; separate dosing by at least 2 hours)
  • Corticosteroids (can decrease calcium absorption and increase Vitamin D metabolism)
  • Phenytoin, Phenobarbital (can increase Vitamin D metabolism)
  • Orlistat, Cholestyramine (can decrease absorption of fat-soluble Vitamin D)
  • Mineral oil (can decrease absorption of fat-soluble Vitamin D)
  • Oxalic acid (in spinach, rhubarb) and Phytic acid (in whole grains, legumes) (can reduce calcium absorption)
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Minor Interactions

  • Zinc supplements (high doses of calcium can interfere with zinc absorption)
  • Caffeine (may slightly increase urinary 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: Prior to initiation of high-dose supplementation or if symptoms of calcium imbalance are present.

Serum 25-hydroxyvitamin D [25(OH)D]

Rationale: To assess baseline Vitamin D status and guide appropriate dosing, especially if deficiency is suspected.

Timing: Prior to initiation of supplementation, particularly if high doses are considered or deficiency is suspected.

Renal Function (Serum Creatinine, eGFR)

Rationale: To assess kidney function, as impaired renal function can affect calcium and Vitamin D metabolism and increase risk of hypercalcemia.

Timing: Prior to initiation of supplementation, especially in elderly patients or those with pre-existing renal conditions.

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Routine Monitoring

Serum Calcium (total)

Frequency: Annually for routine supplementation; more frequently (e.g., every 3-6 months) for high-dose supplementation or in patients with renal impairment or risk factors for hypercalcemia.

Target: 8.5-10.2 mg/dL

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

Serum 25-hydroxyvitamin D [25(OH)D]

Frequency: Every 6-12 months if treating deficiency; annually for maintenance if concerns exist.

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

Action Threshold: <20 ng/mL (consider dose increase); >100 ng/mL (consider dose reduction/discontinuation due to potential toxicity)

Renal Function (Serum Creatinine, eGFR)

Frequency: Annually for routine supplementation; more frequently (e.g., every 6-12 months) in patients with pre-existing renal impairment or those on high doses.

Target: Stable, within normal limits for age/sex

Action Threshold: Significant decline in eGFR or increase in creatinine (re-evaluate calcium/Vitamin D dosing)

Urinary Calcium Excretion (24-hour urine calcium)

Frequency: Consider if hypercalcemia is present or suspected, or in patients with a history of kidney stones.

Target: <300 mg/24 hours

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

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Polyuria (frequent urination)
  • Polydipsia (excessive thirst)
  • Fatigue
  • Muscle weakness
  • Confusion
  • Irritability
  • Loss of appetite
  • Bone pain

Special Patient Groups

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Pregnancy

Calcium and Vitamin D are essential during pregnancy for fetal bone development and maternal health. Recommended daily intake for pregnant women is 1000-1300 mg elemental calcium and 600 IU Vitamin D. Supplementation is generally considered safe and beneficial at recommended doses. Excessive intake should be avoided as it can lead to hypercalcemia in the mother and potentially affect fetal development.

Trimester-Specific Risks:

First Trimester: Generally safe at recommended doses. No known specific risks associated with appropriate supplementation.
Second Trimester: Generally safe at recommended doses. Crucial for rapid fetal bone growth.
Third Trimester: Generally safe at recommended doses. Continued importance for fetal skeletal mineralization.
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Lactation

Calcium and Vitamin D are important for lactating mothers and are transferred into breast milk. Recommended daily intake for lactating women is 1000-1300 mg elemental calcium and 600 IU Vitamin D. Supplementation at recommended doses is considered safe and compatible with breastfeeding (L1). Excessive intake should be avoided.

Infant Risk: Low risk to infant when maternal intake is within recommended dietary allowances. Excessive maternal intake could theoretically lead to high levels in breast milk, but this is rare and typically requires very high doses.
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Pediatric Use

Dosing must be carefully adjusted based on age and weight to meet age-specific RDAs. Excessive intake can lead to hypercalcemia and hypervitaminosis D, which can be more severe in children due to their smaller body mass and developing organs. Always consult a pediatrician before administering supplements to children.

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Geriatric Use

Elderly individuals are at increased risk for calcium and Vitamin D deficiency due to decreased dietary intake, reduced skin synthesis of Vitamin D, and impaired renal 1-alpha-hydroxylation. Supplementation is often recommended for bone health and fall prevention. However, caution is advised in those with impaired renal function or a history of kidney stones, as they may be more susceptible to hypercalcemia. Monitoring of serum calcium and renal function is particularly important.

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.
  • Split calcium doses if taking more than 500-600 mg elemental calcium at once, as absorption efficiency decreases with larger single doses.
  • Vitamin D is fat-soluble; taking it with a meal containing some fat can enhance absorption.
  • Regular monitoring of serum 25(OH)D levels is recommended, especially when treating Vitamin D deficiency, to ensure adequate levels without toxicity.
  • Educate patients on symptoms of hypercalcemia (e.g., nausea, constipation, polyuria, fatigue) and advise them to seek medical attention if these occur.
  • Consider potential drug interactions, especially with thyroid hormones, certain antibiotics, and bisphosphonates, and advise patients to separate dosing times.
  • While supplements are helpful, emphasize the importance of dietary sources of calcium and Vitamin D, and weight-bearing exercise for bone health.
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Alternative Therapies

  • Dietary modifications (increased intake of calcium-rich foods like dairy, fortified plant milks, leafy greens; Vitamin D-rich foods like fatty fish, fortified cereals)
  • Sun exposure (for Vitamin D synthesis)
  • Prescription Vitamin D (e.g., ergocalciferol or cholecalciferol in higher doses for severe deficiency)
  • Other bone-building medications (e.g., bisphosphonates, denosumab, teriparatide) for osteoporosis, as determined by a healthcare provider.
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Cost & Coverage

Average Cost: $5 - $30 per 60-120 tablets
Generic Available: Yes
Insurance Coverage: Generally not covered by insurance as an over-the-counter (OTC) supplement. May be covered if prescribed by a physician for a specific medical condition (e.g., severe deficiency, osteoporosis) and dispensed by a pharmacy.
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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 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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.