Calcium Oyster Shell 500mg Tablets

Manufacturer MARLEX PHARMACEUTICALS 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 B
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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 carbonate is a mineral supplement that helps build and maintain strong bones. 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with meals 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. Many areas offer drug take-back programs, which your pharmacist can help you find.

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 continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take calcium carbonate with food to improve absorption, especially for supplementation.
  • If using as an antacid, chew tablets thoroughly before swallowing.
  • Do not take calcium carbonate at the same time as other medications (especially antibiotics, thyroid hormones, iron) due to potential interactions. Separate by at least 2-4 hours.
  • Ensure adequate Vitamin D intake, as it is essential for calcium absorption.
  • Maintain a balanced diet and engage in weight-bearing exercise for bone health.
  • Drink plenty of water to help prevent constipation, a common side effect.

Dosing & Administration

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Adult Dosing

Standard Dose: Calcium Supplementation: 500 mg - 1000 mg elemental calcium daily, divided doses. Antacid: 500 mg - 1500 mg calcium carbonate as needed.
Dose Range: 200 - 2500 mg

Condition-Specific Dosing:

Calcium Oyster Shell 500mg Tablets: Provides approximately 200 mg elemental calcium per 500 mg calcium carbonate tablet. Dosing should be based on elemental calcium needs.
Osteoporosis Prevention: 1000-1200 mg elemental calcium daily (often combined with Vitamin D).
Antacid Use: Chew 1-4 tablets as symptoms occur, not to exceed 7500 mg calcium carbonate (3000 mg elemental calcium) in 24 hours.
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Pediatric Dosing

Neonatal: Not established for routine use; specific medical conditions only.
Infant: Not established for routine use; specific medical conditions only. (e.g., hypocalcemia: 50-150 mg/kg/day elemental calcium in divided doses).
Child: Calcium Supplementation (4-8 years): 800 mg elemental calcium daily. (9-18 years): 1300 mg elemental calcium daily. Antacid: Consult physician; generally not recommended for children under 6 years.
Adolescent: Calcium Supplementation: 1300 mg elemental calcium daily. Antacid: As per adult dosing, but consult physician for prolonged use.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum calcium.
Moderate: Use with caution; monitor serum calcium closely. May require dose reduction.
Severe: Contraindicated in severe renal impairment due to risk of hypercalcemia and hyperphosphatemia. If used, extreme caution and frequent monitoring of serum calcium and phosphate.
Dialysis: Contraindicated as a calcium supplement due to hypercalcemia risk. May be used as a phosphate binder under strict medical supervision with frequent monitoring.

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 acts as a dietary supplement by providing 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 and relieving heartburn and indigestion.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 20-30% of elemental calcium is absorbed from calcium carbonate, highly dependent on gastric acid presence and dose. Absorption is enhanced by vitamin D.
Tmax: Antacid effect: Rapid (minutes). Systemic absorption: 1-2 hours for peak serum calcium levels.
FoodEffect: Absorption is enhanced when taken with food, especially for calcium supplementation, as food stimulates gastric acid secretion, which is necessary for calcium carbonate dissolution and absorption.

Distribution:

Vd: Not applicable for a mineral; calcium is distributed throughout the body, primarily in bones (99%).
ProteinBinding: Approximately 40-45% of serum calcium is protein-bound (primarily to albumin).
CnssPenetration: Limited; calcium ions do not readily cross the blood-brain barrier in significant amounts.

Elimination:

HalfLife: Not applicable for an ion; serum calcium levels are tightly regulated by homeostatic mechanisms.
Clearance: Regulated by kidneys and bone turnover.
ExcretionRoute: Unabsorbed calcium is excreted in feces. Absorbed calcium is primarily excreted renally (glomerular filtration and tubular reabsorption).
Unchanged: Most absorbed calcium is utilized or excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Antacid: Within minutes. Calcium supplementation: Long-term effects on bone density.
PeakEffect: Antacid: 30-60 minutes. Calcium supplementation: Not applicable for acute effect.
DurationOfAction: Antacid: 30-60 minutes (depending on gastric emptying). Calcium supplementation: Sustained effect with regular intake.

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
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat

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. Contact your doctor if you experience:
- Constipation
- Any other side effects that bother you or do not go away

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. 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 that doesn't go away
  • Unusual tiredness or weakness
  • Frequent urination or increased thirst
  • Muscle pain or weakness
  • Confusion or irritability
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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.
If you have elevated calcium levels in your blood.

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 medications you are taking
Any natural products or vitamins you are using
* Your overall health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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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 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 treatment.
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Overdose Information

Overdose Symptoms:

  • Severe constipation
  • Nausea
  • Vomiting
  • Abdominal pain
  • Loss of appetite
  • Increased thirst
  • Increased urination
  • Muscle weakness
  • Fatigue
  • Confusion
  • Kidney stones (with chronic overdose)
  • Milk-alkali syndrome (with excessive intake of calcium and absorbable alkali)

What to Do:

Discontinue calcium carbonate. Seek immediate medical attention. Hydration with intravenous fluids may be necessary to promote calcium excretion. In severe cases, loop diuretics or calcitonin may be used. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Thiazide diuretics (concurrent use may lead to hypercalcemia)
  • Digoxin (in patients with hypercalcemia, increased risk of arrhythmias)
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Major Interactions

  • Tetracycline antibiotics (e.g., doxycycline, minocycline): Calcium can chelate these antibiotics, significantly reducing their absorption. Separate administration by at least 2-4 hours.
  • Fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin): Similar to tetracyclines, calcium can chelate these, reducing absorption. Separate administration by at least 2-6 hours.
  • Levothyroxine: Calcium can impair levothyroxine absorption. Separate administration by at least 4 hours.
  • Bisphosphonates (e.g., alendronate, risedronate): Calcium can interfere with 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.
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Moderate Interactions

  • Phenytoin: Calcium may reduce phenytoin absorption.
  • Calcium channel blockers (e.g., verapamil, diltiazem): High doses of calcium may theoretically reduce the effectiveness of these drugs.
  • Corticosteroids: May decrease calcium absorption and increase calcium excretion, potentially increasing calcium requirements.
  • Proton Pump Inhibitors (PPIs) and H2-receptor antagonists: May reduce gastric acid, which is necessary for calcium carbonate dissolution and absorption, especially in older adults or those with achlorhydria.
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Minor Interactions

  • Foods high in oxalic acid (spinach, rhubarb) or phytic acid (whole grains, beans): Can reduce calcium absorption.
  • Alcohol and caffeine: May increase calcium excretion.

Monitoring

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Baseline Monitoring

Serum Calcium

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

Timing: Before initiating high-dose or long-term supplementation, especially in patients with renal impairment or conditions predisposing to hypercalcemia.

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete calcium and prevent accumulation.

Timing: Before initiating high-dose or long-term supplementation, particularly in elderly or those with suspected renal impairment.

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Routine Monitoring

Serum Calcium

Frequency: Periodically (e.g., every 6-12 months) for patients on high-dose or long-term supplementation; more frequently if renal impairment or symptoms of hypercalcemia.

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; investigate cause of hypercalcemia.

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

Action Threshold: Monitor for hyperphosphatemia or hypophosphatemia.

Symptoms of Hypercalcemia

Frequency: Ongoing patient education and self-monitoring.

Target: Absence of symptoms

Action Threshold: If symptoms (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness) occur, check serum calcium immediately.

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Symptom Monitoring

  • Constipation
  • Nausea
  • Vomiting
  • Abdominal pain
  • Loss of appetite
  • Increased thirst (polydipsia)
  • Increased urination (polyuria)
  • Muscle weakness
  • Fatigue
  • Confusion
  • Headache

Special Patient Groups

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Pregnancy

Calcium carbonate is generally considered safe and often recommended during pregnancy to meet increased calcium requirements, especially for bone development of the fetus and maternal bone health. It is also commonly used as an antacid for pregnancy-related heartburn. Adhere to recommended daily allowances.

Trimester-Specific Risks:

First Trimester: No known risks at recommended doses.
Second Trimester: No known risks at recommended doses.
Third Trimester: No known risks at recommended doses.
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Lactation

Calcium is a normal component of breast milk. Calcium carbonate is considered safe for use during lactation at recommended doses, as it helps meet the mother's calcium needs without posing significant risk to the infant.

Infant Risk: Low risk; calcium is naturally present in breast milk and essential for infant development.
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Pediatric Use

Dosing varies significantly by age and indication (supplementation vs. antacid). Antacid use generally not recommended for children under 6 without medical advice. Careful monitoring is required to avoid hypercalcemia, especially in infants and young children.

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Geriatric Use

Elderly patients may have reduced gastric acid secretion, which can impair calcium carbonate absorption; citrate forms may be better absorbed. Increased risk of constipation. Renal function often declines with age, increasing the risk of hypercalcemia. Monitor serum calcium and renal function closely.

Clinical Information

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Clinical Pearls

  • Calcium carbonate contains approximately 40% elemental calcium. A 500mg calcium carbonate tablet provides 200mg elemental calcium.
  • For optimal absorption, calcium carbonate should be taken with food, as gastric acid is required for its dissolution.
  • Separate calcium carbonate administration from other medications (especially iron, thyroid hormones, and certain antibiotics) by at least 2-4 hours to prevent absorption interference.
  • High doses or long-term use, especially in patients with renal impairment, can lead to hypercalcemia. Monitor serum calcium levels.
  • Calcium carbonate is also an effective antacid, but its use for this purpose should be limited to avoid excessive calcium intake and potential side effects like constipation or milk-alkali syndrome.
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Alternative Therapies

  • Other calcium salts (e.g., Calcium Citrate, Calcium Gluconate, Calcium Lactate - Calcium citrate is better absorbed in individuals with low stomach acid or those taking PPIs/H2-blockers).
  • Other antacids (e.g., Aluminum Hydroxide, Magnesium Hydroxide, Sodium Bicarbonate).
  • H2-receptor antagonists (e.g., famotidine, ranitidine) for heartburn.
  • Proton Pump Inhibitors (e.g., omeprazole, pantoprazole) for more severe acid reflux.
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Cost & Coverage

Average Cost: $5 - $20 per 100 tablets
Generic Available: Yes
Insurance Coverage: Generally Over-The-Counter (OTC) and not covered by prescription drug plans, unless prescribed for a specific medical condition (e.g., hypocalcemia, phosphate binding) and covered under a medical benefit or specific plan allowance.
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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 details. 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. 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 information about the medication taken, the amount, and the time it happened.