Calcium/d3 600mg-200iu Tablets

Manufacturer RUGBY LABORATORIES 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 Supplement; Vitamin Supplement; Bone Health Agent
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Pharmacologic Class
Calcium Salt; Vitamin D Analog (Cholecalciferol)
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Pregnancy Category
Not formally assigned (Dietary Supplement); generally considered safe at recommended doses, but excessive intake should be avoided. Consult physician.
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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 and teeth, and it also helps your nerves, muscles, and heart work properly. Vitamin D helps your body absorb calcium and is also important for bone health and your immune system. This supplement is used to prevent or treat low calcium levels and to support bone health, especially in people who don't get enough calcium or vitamin D from their 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 as directed.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, avoiding storage in bathrooms. Ensure all medications are stored safely and 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. You may also have access to 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'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 calcium absorption and reduce stomach upset.
  • If taking other medications, especially antibiotics, thyroid hormones, or bisphosphonates, separate the dosing of calcium/vitamin D by at least 2-4 hours.
  • Maintain a balanced diet rich in calcium and vitamin D.
  • Engage in regular weight-bearing exercise (e.g., walking, jogging) to support bone health.
  • Avoid excessive alcohol intake and smoking, which can negatively impact bone density.
  • Ensure adequate sun exposure (if safe and appropriate) for natural vitamin D production, but do not rely solely on this for vitamin D intake.

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 tablets daily, typically with food
Dose Range: 600 - 1200 mg

Condition-Specific Dosing:

Osteoporosis Prevention: 600-1200 mg elemental calcium and 200-800 IU Vitamin D daily, often in divided doses.
Dietary Supplementation: 600 mg elemental calcium and 200 IU Vitamin D daily, or as directed by a healthcare professional.
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Pediatric Dosing

Neonatal: Not established (fixed combination not typically used)
Infant: Not established (fixed combination not typically used)
Child: Not generally recommended for routine pediatric use in this specific fixed-dose combination without medical supervision. Dosing for calcium and vitamin D in children is highly age and weight-dependent.
Adolescent: Not generally recommended for routine adolescent use in this specific fixed-dose combination without medical supervision. Dosing for calcium and vitamin D in adolescents is highly age and weight-dependent.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum calcium and vitamin D levels.
Moderate: Use with caution; monitor serum calcium, phosphate, and vitamin D levels closely. May require dose adjustment or alternative forms of vitamin D.
Severe: Contraindicated or use with extreme caution; risk of hypercalcemia and hyperphosphatemia. Vitamin D metabolism is impaired. Requires close medical supervision and specific management.
Dialysis: Contraindicated or use with extreme caution; risk of hypercalcemia and hyperphosphatemia. Requires close medical supervision and specific management, often with active vitamin D metabolites.

Hepatic Impairment:

Mild: No specific dose adjustment typically required for calcium. Vitamin D activation (25-hydroxylation) occurs in the liver, but significant impairment is usually needed to affect this step.
Moderate: Use with caution; monitor vitamin D levels. May require dose adjustment or alternative forms of vitamin D if severe liver disease is present.
Severe: Use with caution; monitor vitamin D levels. May require dose adjustment or alternative forms of vitamin D if severe liver disease is present.

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, D3) is a fat-soluble vitamin that plays a crucial role in maintaining calcium and phosphate homeostasis. It promotes the absorption of calcium from the gastrointestinal tract, facilitates the incorporation of calcium into the bone matrix, and regulates parathyroid hormone (PTH) secretion. Vitamin D is converted in the liver to 25-hydroxyvitamin D (calcifediol) and then in the kidneys to the active form, 1,25-dihydroxyvitamin D (calcitriol), which mediates its effects.
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Pharmacokinetics

Absorption:

Bioavailability: Calcium: Varies (20-40% for calcium carbonate, influenced by dose, food, and vitamin D status). Vitamin D3: Well absorbed from the small intestine, especially in the presence of dietary fat.
Tmax: Calcium: Approximately 1-2 hours (for peak serum levels after oral intake). Vitamin D3: Approximately 4-5 hours.
FoodEffect: Calcium: Absorption of calcium carbonate is enhanced when taken with food. Vitamin D3: Enhanced absorption with fatty meals.

Distribution:

Vd: Calcium: Primarily distributed in bone (99%). Vitamin D3: Widely distributed, stored in adipose tissue and muscle.
ProteinBinding: Calcium: Approximately 40-50% bound to plasma proteins (albumin). Vitamin D3: Primarily bound to vitamin D-binding protein (DBP) and albumin.
CnssPenetration: Limited for calcium. Vitamin D metabolites can cross the blood-brain barrier to some extent.

Elimination:

HalfLife: Calcium: Complex, depends on bone turnover and renal excretion. Vitamin D3 (parent compound): Approximately 24 hours. 25-hydroxyvitamin D: Approximately 2-3 weeks. 1,25-dihydroxyvitamin D: Approximately 4-6 hours.
Clearance: Calcium: Primarily renal excretion, regulated by PTH and calcitonin. Vitamin D3: Metabolites are excreted.
ExcretionRoute: Calcium: Fecal (unabsorbed) and renal. Vitamin D3: Primarily biliary/fecal excretion of metabolites, with some renal excretion.
Unchanged: Calcium: Minimal unchanged excretion. Vitamin D3: Very little unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Chronic effect; not an acute onset. Effects on bone density and calcium homeostasis develop over weeks to months.
PeakEffect: Chronic effect; peak bone density changes and calcium homeostasis stabilization occur over months to years.
DurationOfAction: Chronic effect; continued supplementation is required to maintain benefits.

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
+ 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. Although 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, 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:

  • Signs of too much calcium (hypercalcemia): severe nausea, vomiting, constipation, loss of appetite, increased thirst, increased urination, muscle weakness, fatigue, confusion, or kidney stones (severe back/side pain, blood in urine).
  • Signs of allergic reaction: rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing (rare).
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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 of 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 advise you to take other oral medications at a different time than this drug. 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 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 hypercalcemia (calcium levels >12 mg/dL): nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, polyuria, polydipsia, bone pain, kidney stones, cardiac arrhythmias, coma.
  • Hypervitaminosis D: similar symptoms to hypercalcemia, often accompanied by elevated 25-OH D levels.

What to Do:

If overdose is suspected, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US). Management typically involves discontinuing the supplement, hydration, and potentially loop diuretics or corticosteroids to lower calcium levels. In severe cases, dialysis may be required.

Drug Interactions

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Contraindicated Interactions

  • Thiazide diuretics (increased risk of hypercalcemia)
  • Digoxin (increased risk of arrhythmias with hypercalcemia)
  • Phosphate supplements (risk of hyperphosphatemia and soft tissue calcification in renal impairment)
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Major Interactions

  • Tetracycline antibiotics (e.g., doxycycline, minocycline): Calcium can chelate these antibiotics, reducing their absorption. Separate administration by at least 2-4 hours.
  • Fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin): Calcium can chelate these antibiotics, reducing their absorption. Separate administration by at least 2-6 hours.
  • Levothyroxine: Calcium can impair absorption. Separate administration by at least 4 hours.
  • Bisphosphonates (e.g., alendronate, risedronate): Calcium can impair absorption. Separate administration by at least 30 minutes to 2 hours.
  • Iron supplements: Calcium can reduce iron absorption. Separate administration by at least 2 hours.
  • Corticosteroids (e.g., prednisone): Can decrease calcium absorption and increase calcium excretion, potentially increasing vitamin D requirements.
  • Orlistat, Cholestyramine, Colestipol (bile acid sequestrants): Can reduce absorption of fat-soluble vitamins, including Vitamin D. Separate administration or monitor vitamin D levels.
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Moderate Interactions

  • Phenytoin, Carbamazepine, Phenobarbital (antiepileptic drugs): Can increase vitamin D metabolism, potentially leading to vitamin D deficiency.
  • Mineral oil, Olestra: Can reduce absorption of fat-soluble vitamins, including Vitamin D.
  • Aluminum-containing antacids: Concurrent use with calcium can increase aluminum absorption, especially in renal impairment.
  • Calcium channel blockers (e.g., verapamil, diltiazem): Large doses of calcium may reduce the effectiveness of these drugs.
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Minor Interactions

  • Spinach, rhubarb, bran, whole cereals (contain oxalates/phytates): Can reduce calcium absorption. Take calcium supplements at a different time or with meals not containing these in large amounts.

Monitoring

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Baseline Monitoring

Serum Calcium

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 therapy.

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.

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Routine Monitoring

Serum Calcium

Frequency: Periodically (e.g., every 3-6 months initially, then annually for stable patients, or as clinically indicated)

Target: 8.5-10.2 mg/dL (2.1-2.55 mmol/L)

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

Serum 25-hydroxyvitamin D (25-OH D)

Frequency: Periodically (e.g., every 6-12 months, or as clinically indicated)

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

Action Threshold: If consistently above 100 ng/mL, consider dose reduction or discontinuation to avoid toxicity.

Renal Function (BUN, Creatinine, eGFR)

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

Target: Normal for age

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

Urine Calcium (24-hour)

Frequency: If hypercalcemia or hypercalciuria is suspected, or in patients with a history of kidney stones.

Target: <300 mg/24 hours

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

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Loss of appetite
  • Excessive thirst
  • Frequent urination
  • 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 both maternal and fetal bone health. Recommended daily allowances should be met through diet and supplementation if necessary. Excessive intake, particularly of Vitamin D, can be harmful. Use at recommended doses under medical supervision.

Trimester-Specific Risks:

First Trimester: Essential for early fetal development; generally safe at recommended doses.
Second Trimester: Continued importance for fetal skeletal development; generally safe at recommended doses.
Third Trimester: Crucial for rapid fetal bone mineralization; generally safe at recommended doses.
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Lactation

Calcium and Vitamin D are excreted into breast milk and are essential for the infant. Supplementation at recommended doses is generally considered safe and beneficial for both mother and infant. Excessive intake should be avoided.

Infant Risk: Low risk at recommended maternal doses; high maternal doses could theoretically lead to hypercalcemia in the infant, though rare.
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Pediatric Use

This specific fixed-dose combination is generally not recommended for routine use in young children without specific medical guidance due to the fixed calcium and vitamin D amounts. Dosing for calcium and vitamin D in children should be individualized based on age, weight, and dietary intake. Risk of hypercalcemia with inappropriate dosing.

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Geriatric Use

Elderly patients are at increased risk for osteoporosis and vitamin D deficiency. This supplement is often beneficial. However, age-related decline in renal function necessitates careful monitoring of serum calcium and vitamin D levels to avoid hypercalcemia and hypercalciuria. Increased risk of drug interactions due to polypharmacy.

Clinical Information

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Clinical Pearls

  • Always advise patients to take calcium carbonate with food to enhance absorption and minimize gastrointestinal upset.
  • Remind patients to separate calcium/vitamin D supplements from other medications (especially antibiotics, thyroid hormones, and bisphosphonates) by at least 2-4 hours to prevent absorption interference.
  • Educate patients on the symptoms of hypercalcemia (e.g., nausea, constipation, excessive thirst, frequent urination) and to report them to their healthcare provider.
  • Emphasize that while essential, more is not always better; excessive intake of calcium and vitamin D can lead to adverse effects, including kidney stones and soft tissue calcification.
  • For patients with a history of kidney stones, consider monitoring 24-hour urine calcium excretion.
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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 in higher doses)
  • Bisphosphonates (e.g., alendronate, risedronate) for osteoporosis treatment
  • Denosumab (for osteoporosis treatment)
  • Teriparatide (for osteoporosis treatment)
  • Raloxifene (for osteoporosis prevention/treatment in postmenopausal women)
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Cost & Coverage

Average Cost: Highly variable per 30 tablets
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription drug plans; may be covered by Flexible Spending Accounts (FSAs) or Health Savings Accounts (HSAs) if 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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance. 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.