Calcium Carb 1250mg/5ml Susp

Manufacturer ROXANE Active Ingredient Calcium Carbonate Suspension (Antacid)(KAL see um KAR bun ate) Pronunciation KAL-see-um KAR-bun-ate
It is used to treat heartburn and upset stomach.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antacid; Mineral Supplement (Calcium)
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Pharmacologic Class
Inorganic Salt; Gastric Acid Neutralizer
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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 an antacid that helps relieve heartburn, sour stomach, and indigestion by neutralizing stomach acid. It can also be used as a calcium supplement to help maintain healthy bones.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all accompanying information carefully. Before each use, shake the medication well. When measuring liquid doses, use the provided measuring device or ask your pharmacist for one if it's not included.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of 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. If you're unsure about the best disposal method, consult your pharmacist. You may also want to check if there are drug take-back programs available 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 if using for calcium supplementation to enhance absorption.
  • Drink a full glass of water after taking the suspension to help it work effectively and prevent constipation.
  • Avoid taking calcium carbonate at the same time as other medications, especially antibiotics (like tetracyclines or fluoroquinolones), iron supplements, or thyroid hormones. Separate doses by at least 2-4 hours.
  • Limit intake of high-calcium foods or other calcium supplements if you are taking high doses of calcium carbonate, to avoid excessive calcium levels.
  • Maintain adequate fluid intake to help prevent constipation, a common side effect.

Dosing & Administration

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Adult Dosing

Standard Dose: 1250 mg (5 mL) to 2500 mg (10 mL) orally as needed, up to 7500 mg (30 mL) in 24 hours for antacid use.
Dose Range: 1250 - 7500 mg

Condition-Specific Dosing:

Antacid Use: 1250 mg (5 mL) to 2500 mg (10 mL) orally as needed, typically 1-3 hours after meals and at bedtime. Do not exceed 7500 mg (30 mL) in 24 hours.
Calcium Supplementation (Elemental Calcium): Dosage varies based on dietary intake and individual needs, typically 1000-1200 mg elemental calcium per day in divided doses. 1250 mg Calcium Carbonate contains 500 mg elemental calcium. Consult a healthcare professional for specific supplementation needs.
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Pediatric Dosing

Neonatal: Not established for antacid use; consult physician for calcium supplementation.
Infant: Not established for antacid use; consult physician for calcium supplementation.
Child: Antacid use: 6-11 years: 625 mg (2.5 mL) to 1250 mg (5 mL) as needed, up to 3750 mg (15 mL) in 24 hours. Calcium supplementation: Consult physician for specific dosing based on age and dietary needs.
Adolescent: Antacid use: 12 years and older: Same as adult dosing. Calcium supplementation: Consult physician for specific dosing based on age and dietary needs.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum calcium levels.
Moderate: Use with caution; monitor serum calcium levels closely. Avoid chronic high doses due to risk of hypercalcemia and renal calculi.
Severe: Contraindicated or use with extreme caution; significant risk of hypercalcemia. Avoid if possible.
Dialysis: Use with extreme caution; monitor serum calcium and phosphate levels closely. May be used as a phosphate binder under strict medical supervision, but other binders are often preferred.
Note: Calcium carbonate can exacerbate hypercalcemia in patients with renal impairment. Monitor serum calcium and phosphate levels.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Note: Hepatic impairment does not significantly affect calcium carbonate metabolism or elimination, but monitor for hypercalcemia if other risk factors are present.

Pharmacology

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Mechanism of Action

Calcium carbonate acts as an antacid by neutralizing hydrochloric acid in the stomach, forming calcium chloride, water, and carbon dioxide. This increases gastric pH, which can relieve symptoms of heartburn, indigestion, and sour stomach. As a calcium supplement, it provides elemental calcium necessary for bone formation, nerve and muscle function, and other physiological processes.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (15-30% of elemental calcium absorbed from the GI tract), dependent on gastric pH, presence of food, and vitamin D status.
Tmax: Approximately 1-2 hours (for elemental calcium absorption).
FoodEffect: Absorption is enhanced when taken with food, especially for calcium supplementation, as food stimulates gastric acid secretion, which aids in the dissolution of calcium carbonate.

Distribution:

Vd: Not applicable for calcium carbonate itself; elemental calcium is widely distributed throughout the body, primarily in bone (99%).
ProteinBinding: Approximately 40-45% of serum calcium is protein-bound (primarily to albumin).
CnssPenetration: Limited (ionized calcium can cross the blood-brain barrier, but calcium carbonate itself does not).

Elimination:

HalfLife: Not applicable for calcium carbonate; serum calcium half-life is tightly regulated by homeostatic mechanisms.
Clearance: Regulated by renal excretion and bone deposition/resorption.
ExcretionRoute: Unabsorbed calcium is eliminated in feces. Absorbed calcium is primarily excreted renally, with some biliary excretion.
Unchanged: Most of the ingested calcium carbonate is converted to calcium chloride in the stomach; unabsorbed calcium carbonate is excreted unchanged in feces.
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes for antacid effect).
PeakEffect: Within 30-60 minutes for antacid effect.
DurationOfAction: Approximately 30-60 minutes when taken on an empty stomach; up to 3 hours when taken with food.
Note: The antacid effect is local in the stomach. The systemic effects of calcium supplementation are long-term.

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. Many people have either no side effects or only mild ones. If you encounter any of the following side effects, or if any other side effects 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, consult your doctor. For medical advice regarding side effects, contact 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 or persistent constipation
  • Nausea, vomiting, or loss of appetite that doesn't go away
  • Unusual tiredness or weakness
  • Increased thirst or urination
  • Muscle weakness or bone pain
  • Confusion or changes in mental status
  • Signs of kidney stones (e.g., severe back 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.
If you have high calcium levels in your blood.

This is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have or have had in the past.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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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. This drug can interfere with the absorption of other oral medications, which may require you to take them at a different time. Be sure to discuss this with your doctor to determine the best schedule for your medications. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, you must consult your doctor to weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe constipation
  • Nausea
  • Vomiting
  • Abdominal pain
  • Muscle weakness
  • Fatigue
  • Confusion
  • Polyuria (frequent urination)
  • Polydipsia (excessive thirst)
  • Anorexia
  • Cardiac arrhythmias (in severe cases)
  • Coma (in severe cases)

What to Do:

If you suspect an overdose, contact a poison control center immediately (call 1-800-222-1222 in the US) or seek emergency medical attention. Management typically involves discontinuing calcium carbonate, hydration, and potentially loop diuretics to promote calcium excretion. In severe cases, hemodialysis may be necessary.

Drug Interactions

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Contraindicated Interactions

  • Hypercalcemia
  • Severe renal impairment (unless used as a phosphate binder under strict supervision)
  • History of renal calculi (calcium-containing)
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Major Interactions

  • Tetracyclines (e.g., doxycycline, minocycline): Decreased absorption of tetracyclines due to chelation. Separate administration by at least 2-4 hours.
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Decreased absorption of fluoroquinolones due to chelation. Separate administration by at least 2-6 hours.
  • Iron supplements (e.g., ferrous sulfate): Decreased absorption of iron. Separate administration by at least 2 hours.
  • Thyroid hormones (e.g., levothyroxine): Decreased absorption of thyroid hormones. Separate administration by at least 4 hours.
  • Bisphosphonates (e.g., alendronate, risedronate): Decreased absorption of bisphosphonates. Separate administration by at least 30 minutes to 2 hours (depending on bisphosphonate).
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Moderate Interactions

  • Digoxin: Hypercalcemia can potentiate digoxin toxicity. Monitor ECG and serum digoxin levels.
  • Thiazide diuretics (e.g., hydrochlorothiazide): Increased risk of hypercalcemia due to decreased renal calcium excretion.
  • Phenytoin: May decrease phenytoin absorption. Separate administration by 2-3 hours.
  • Phosphate binders (other): Concurrent use may lead to excessive calcium or phosphate imbalance.
  • Vitamin D analogs (e.g., calcitriol): Increased risk of hypercalcemia due to enhanced calcium absorption.
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Minor Interactions

  • Acid-suppressing agents (e.g., PPIs, H2 blockers): May reduce calcium carbonate solubility and absorption, especially if used for calcium supplementation. Take calcium carbonate with food.
  • Corticosteroids: May decrease calcium absorption and increase calcium excretion, potentially necessitating higher calcium supplementation.

Monitoring

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Baseline Monitoring

Serum Calcium

Rationale: To establish baseline levels, especially if patient has pre-existing conditions (e.g., renal impairment) or is on other medications affecting calcium.

Timing: Before initiating chronic or high-dose therapy.

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete calcium and identify patients at higher risk for hypercalcemia.

Timing: Before initiating chronic or high-dose therapy.

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Routine Monitoring

Serum Calcium

Frequency: Periodically (e.g., every 3-6 months) for chronic high-dose use or in patients with renal impairment; as needed for acute symptoms.

Target: 8.5-10.5 mg/dL (total calcium)

Action Threshold: >10.5 mg/dL (hypercalcemia) or significant increase from baseline; consider dose reduction or discontinuation.

Symptoms of Hypercalcemia

Frequency: Daily (patient self-monitoring)

Target: Absence of symptoms

Action Threshold: Nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, fatigue, confusion; seek medical attention.

Renal Function (BUN, Creatinine)

Frequency: Periodically (e.g., every 6-12 months) for chronic high-dose use, or more frequently in patients with pre-existing renal impairment.

Target: Within normal limits for age/sex

Action Threshold: Significant increase in BUN/Creatinine; consider dose adjustment or discontinuation.

Serum Phosphate

Frequency: Periodically for chronic high-dose use, especially if used as a phosphate binder.

Target: 2.5-4.5 mg/dL

Action Threshold: <2.5 mg/dL (hypophosphatemia); consider dietary phosphate intake or alternative binders.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Generally considered safe for use during pregnancy for antacid purposes and as a calcium supplement when taken at recommended doses. Calcium requirements increase during pregnancy. However, excessive doses should be avoided due to the theoretical risk of hypercalcemia in the mother and fetus.

Trimester-Specific Risks:

First Trimester: Low risk at recommended doses.
Second Trimester: Low risk at recommended doses.
Third Trimester: Low risk at recommended doses.
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Lactation

Considered safe for use during lactation. Calcium is a normal component of breast milk. Maternal calcium carbonate use at recommended doses is unlikely to cause adverse effects in the breastfed infant.

Infant Risk: Low risk (L1).
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Pediatric Use

Use in children, especially those under 6 years, should be under the guidance of a healthcare professional. Dosing for antacid use is lower than adults and should be carefully measured. For calcium supplementation, age-appropriate dietary reference intakes should be considered, and excessive intake should be avoided.

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Geriatric Use

Generally safe, but use with caution in elderly patients, especially those with pre-existing renal impairment, as they are at increased risk for hypercalcemia and constipation. Monitor renal function and serum calcium levels periodically. Start with lower doses for antacid use if needed.

Clinical Information

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Clinical Pearls

  • Calcium carbonate is most effective as an antacid when taken 1-3 hours after meals and at bedtime.
  • For calcium supplementation, taking calcium carbonate with food enhances its absorption due to increased gastric acid secretion.
  • Advise patients to separate calcium carbonate administration from other medications (especially antibiotics, iron, thyroid hormones) by at least 2-4 hours to prevent drug interactions.
  • Warn patients about the potential for constipation, especially with higher doses. Adequate fluid intake and dietary fiber can help mitigate this.
  • Be mindful of the elemental calcium content: 1250 mg of calcium carbonate contains 500 mg of elemental calcium.
  • Avoid chronic high doses in patients with renal impairment due to the risk of hypercalcemia and renal stone formation.
  • Milk-alkali syndrome (hypercalcemia, metabolic alkalosis, and renal impairment) is a rare but serious complication associated with excessive intake of calcium and absorbable alkali (like calcium carbonate).
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Alternative Therapies

  • Other antacids (e.g., aluminum hydroxide, magnesium hydroxide, sodium bicarbonate)
  • H2-receptor antagonists (e.g., famotidine, ranitidine - OTC for heartburn)
  • Proton pump inhibitors (e.g., omeprazole, lansoprazole - OTC for frequent heartburn)
  • Alginic acid-containing products (e.g., Gaviscon)
  • Dietary calcium sources (for supplementation)
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Cost & Coverage

Average Cost: Not applicable for OTC products; price varies widely by retailer and brand. per bottle
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription drug plans as it is an over-the-counter (OTC) medication. May be eligible for FSA/HSA reimbursement.
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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 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 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.