Calcium 500mg Tablets

Manufacturer MAGNO-HUMPHRIES LABORATORIES Active Ingredient Calcium Carbonate Capsules and Tablets(KAL see um KAR bun ate) Pronunciation KAL-see-um KAR-bun-ate
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; Antacid
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Pharmacologic Class
Calcium salt; Antacid
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Pregnancy Category
Category C
FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Calcium carbonate is a common mineral supplement that helps keep your bones strong and healthy. It can also be used as an antacid to relieve heartburn and indigestion by neutralizing stomach acid.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take this medication with meals to help your body absorb it properly.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, 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 specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about 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 absorption and reduce stomach upset.
  • If taking as a supplement, divide doses throughout the day (e.g., 500-600 mg at a time) for better absorption.
  • Ensure adequate Vitamin D intake, as Vitamin D is essential for calcium absorption.
  • Avoid taking calcium carbonate at the same time as other medications (especially antibiotics, thyroid hormones, bisphosphonates) to prevent interactions. Separate by at least 2-4 hours.
  • Maintain adequate fluid intake to prevent constipation.
  • Do not exceed recommended doses without consulting a healthcare professional.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For dietary supplement: 1000-1200 mg elemental calcium daily in divided doses. For antacid: 500-1500 mg elemental calcium as needed, not exceeding 7500 mg/day.
Dose Range: 500 - 7500 mg

Condition-Specific Dosing:

osteoporosis_prevention: 1000-1200 mg elemental calcium daily in divided doses (e.g., 500-600 mg twice daily)
antacid: 500-1500 mg elemental calcium as needed, up to 7500 mg/day
hypocalcemia: Varies significantly based on severity, often higher doses under medical supervision
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Pediatric Dosing

Neonatal: Not established for routine use; specific medical conditions may warrant use under strict supervision.
Infant: Not established for routine use; specific medical conditions may warrant use under strict supervision.
Child: Dietary supplement: 800-1300 mg elemental calcium daily depending on age. Antacid: 400 mg elemental calcium as needed, not exceeding 2500 mg/day (ages 2-5) or 5000 mg/day (ages 6-11).
Adolescent: Dietary supplement: 1300 mg elemental calcium daily. Antacid: 500-1500 mg elemental calcium as needed, not exceeding 7500 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment for mild impairment, but monitor serum calcium and phosphate.
Moderate: Use with caution. Monitor serum calcium and phosphate closely. Avoid high doses. May contribute to hypercalcemia or calcification.
Severe: Contraindicated in severe hypercalcemia. Use with extreme caution, if at all, in severe renal impairment due to risk of hypercalcemia and soft tissue calcification. Doses should be significantly reduced and closely monitored.
Dialysis: Often used as a phosphate binder in dialysis patients, but specific dosing depends on serum calcium and phosphate levels. Avoid if hypercalcemic. Non-calcium based binders are often preferred.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Calcium carbonate provides elemental calcium, an essential mineral for bone formation, nerve transmission, muscle contraction, and blood coagulation. As an antacid, it neutralizes gastric acid by reacting with hydrochloric acid in the stomach to form calcium chloride, water, and carbon dioxide, thereby increasing gastric pH.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 20-30% of elemental calcium is absorbed from calcium carbonate, but this can vary widely depending on dose, food intake, and vitamin D status.
Tmax: Not directly applicable for elemental calcium absorption; antacid effect is immediate.
FoodEffect: Absorption of calcium carbonate is enhanced when taken with food, especially meals containing protein, due to increased gastric acid secretion which aids dissolution. Food also reduces GI side effects.

Distribution:

Vd: Not applicable for elemental calcium; calcium is widely distributed throughout the body, primarily in bone.
ProteinBinding: Approximately 40-45% of circulating calcium is protein-bound (primarily to albumin).
CnssPenetration: Limited (ionized calcium does not readily cross the blood-brain barrier).

Elimination:

HalfLife: Not applicable for elemental calcium; calcium homeostasis is tightly regulated.
Clearance: Regulated by kidneys and bone turnover.
ExcretionRoute: Primarily fecal (unabsorbed calcium), with a smaller portion excreted renally (filtered and reabsorbed).
Unchanged: Not applicable (it is an ion).
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Pharmacodynamics

OnsetOfAction: Antacid effect: Immediate. Mineral supplementation: Gradual, over weeks to months for bone health benefits.
PeakEffect: Antacid effect: Within minutes. Mineral supplementation: Not a distinct peak effect, rather a sustained physiological role.
DurationOfAction: Antacid effect: 30-60 minutes (can be longer if taken with food). Mineral supplementation: Continuous physiological effect.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or swelling of the mouth, face, lips, tongue, or throat.

Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Most side effects are mild and temporary. However, if you encounter any of the following or any other side effects that bother you or do not go away, contact your doctor for advice:
- Constipation.

Important Note
This list does not include all possible side effects. If you have concerns about side effects or need further information, consult your doctor. For medical advice regarding side effects, contact your healthcare provider. 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, vomiting, loss of appetite
  • Increased thirst or urination
  • Muscle weakness or fatigue
  • Confusion or changes in mental status
  • Kidney stones (flank 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 as a result of the allergy.
If you have elevated calcium levels in your blood.

Additionally, this medication may interact with other health conditions or medications. To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Your existing health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.
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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 soy allergy, consult your doctor before taking this drug, as some formulations may contain soy.

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 treatment.

If you are pregnant, planning to become pregnant, or are breastfeeding, 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 treatment.
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Overdose Information

Overdose Symptoms:

  • Severe constipation
  • Nausea, vomiting, abdominal pain
  • Muscle weakness, fatigue
  • Confusion, lethargy
  • Increased thirst and urination (polyuria, polydipsia)
  • Cardiac arrhythmias (in severe cases)
  • Kidney stones, kidney failure (with chronic overdose)

What to Do:

Discontinue calcium carbonate. Hydration with intravenous fluids to promote calcium excretion. Loop diuretics may be used. In severe cases, calcitonin or bisphosphonates may be administered. Monitor serum calcium, renal function, and electrolytes. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Dofetilide (risk of QT prolongation)
  • Tetracyclines (e.g., doxycycline, minocycline) - reduced absorption
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) - reduced absorption
  • Bisphosphonates (e.g., alendronate, risedronate) - reduced absorption
  • Thyroid hormones (e.g., levothyroxine) - reduced absorption
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Moderate Interactions

  • Iron supplements - reduced absorption
  • Zinc supplements - reduced absorption
  • Phenytoin - reduced absorption
  • Digoxin - increased risk of arrhythmias in hypercalcemia
  • Thiazide diuretics (e.g., hydrochlorothiazide) - increased risk of hypercalcemia
  • Corticosteroids - may decrease calcium absorption
  • Proton pump inhibitors (e.g., omeprazole) - may reduce calcium absorption over long-term use
  • H2-receptor antagonists (e.g., ranitidine) - may reduce calcium absorption over long-term use
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Minor Interactions

  • Certain dietary fibers (e.g., phytic acid, oxalic acid) - may reduce calcium absorption

Monitoring

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Baseline Monitoring

Serum Calcium

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

Timing: Before initiating high-dose or long-term therapy, especially in patients with renal impairment or conditions affecting calcium metabolism.

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function, as renal impairment increases the risk of hypercalcemia and soft tissue calcification.

Timing: Before initiating high-dose or long-term therapy.

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Routine Monitoring

Serum Calcium

Frequency: Periodically (e.g., every 3-6 months) for patients on high-dose or long-term therapy, or those with renal impairment.

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

Action Threshold: If consistently above upper limit of normal, consider dose reduction or discontinuation. If symptoms of hypercalcemia develop, check immediately.

Serum Phosphate

Frequency: Periodically for patients with renal impairment or those using calcium carbonate as a phosphate binder.

Target: 2.5-4.5 mg/dL (0.81-1.45 mmol/L)

Action Threshold: Monitor for hyperphosphatemia or calcium-phosphate product exceeding 55 mg²/dL².

Renal Function (BUN, Creatinine)

Frequency: Annually or more frequently in patients with pre-existing renal impairment or on long-term high-dose therapy.

Target: Normal range for age/sex

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

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Symptom Monitoring

  • Symptoms of hypercalcemia: Nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion, cardiac arrhythmias.
  • Symptoms of milk-alkali syndrome: Headache, nausea, vomiting, weakness, confusion, hypercalcemia, metabolic alkalosis, renal impairment.

Special Patient Groups

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Pregnancy

Calcium requirements increase during pregnancy. Calcium carbonate is generally considered safe and often recommended as a supplement to meet increased maternal and fetal needs. It is also used for heartburn relief. Category C due to lack of adequate, well-controlled studies in pregnant women, but widely used and considered safe.

Trimester-Specific Risks:

First Trimester: No known specific risks; often recommended for general nutritional needs.
Second Trimester: No known specific risks; continued importance for fetal bone development.
Third Trimester: No known specific risks; continued importance for fetal bone development and maternal bone health.
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Lactation

Calcium is a normal component of breast milk. Calcium carbonate is considered safe during lactation and is often recommended to ensure adequate maternal calcium intake, which supports both maternal bone health and provides calcium for the infant via breast milk. Infant risk is low.

Infant Risk: L1 (Safest) - No evidence of risk to the infant. Calcium is a normal component of breast milk and is essential for infant growth.
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Pediatric Use

Generally safe for use in children for dietary supplementation or as an antacid, with age-appropriate dosing. Dosing should be carefully calculated based on elemental calcium content and age/weight. Risk of hypercalcemia with excessive doses.

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Geriatric Use

Elderly patients are at increased risk for osteoporosis and often require calcium supplementation. However, they may also have age-related decline in renal function, increasing the risk of hypercalcemia. Use with caution and monitor renal function and serum calcium, especially with high doses or concomitant use of thiazide diuretics.

Clinical Information

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Clinical Pearls

  • Calcium carbonate contains 40% elemental calcium (e.g., a 1250 mg tablet of calcium carbonate provides 500 mg elemental calcium).
  • Best absorbed when taken with food due to increased stomach acid production.
  • For optimal absorption, doses of elemental calcium should not exceed 500-600 mg at one time.
  • Crucial to separate administration from other medications (especially antibiotics, thyroid hormones, bisphosphonates) by at least 2-4 hours to prevent absorption interference.
  • Can cause constipation; adequate fluid and fiber intake are important.
  • Long-term high doses, especially with concomitant Vitamin D supplementation, can lead to hypercalcemia and potentially kidney stones or milk-alkali syndrome.
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Alternative Therapies

  • For osteoporosis: Bisphosphonates, Denosumab, Teriparatide, Romosozumab, Raloxifene, Vitamin D supplementation.
  • For antacid: Aluminum hydroxide, Magnesium hydroxide, Sodium bicarbonate, H2-receptor antagonists (e.g., famotidine), Proton pump inhibitors (e.g., omeprazole).
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Cost & Coverage

Average Cost: $5 - $20 per 100 tablets (500mg elemental calcium)
Generic Available: Yes
Insurance Coverage: Often over-the-counter (OTC) and not covered by prescription plans, or covered as Tier 1/Preferred Generic if prescribed.
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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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.