Calcium Citrate 200mg Tablets

Manufacturer RUGBY LABORATORIES Active Ingredient Calcium Citrate(KAL see um SIT rate) Pronunciation KAL-see-um SIT-rate
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; Bone health agent
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Pharmacologic Class
Calcium salt
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Pregnancy Category
Category A
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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 citrate is a form of calcium, an essential mineral that your body needs for strong bones and teeth, as well as for proper nerve and muscle function. It's often used as a supplement to help prevent or treat calcium deficiency, especially for people who don't get enough calcium from their diet or who have conditions like osteoporosis.
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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

Store this medication at room temperature in a dry location, avoiding the bathroom. Protect it from heat sources. Keep all medications in a secure place, out of the reach of children and pets, to prevent accidental ingestion.

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 calcium citrate with or without food, as it is well-absorbed regardless of stomach acid.
  • Divide your daily calcium dose into smaller amounts (e.g., 200-600 mg elemental calcium per dose) throughout the day for better absorption.
  • Ensure adequate Vitamin D intake (from diet, sunlight, or supplements) as Vitamin D is crucial for calcium absorption.
  • Maintain a balanced diet rich in calcium-containing foods (e.g., dairy products, leafy greens, fortified foods).
  • Engage in regular weight-bearing exercise to support bone health.
  • Limit excessive intake of caffeine, sodium, and protein, which can increase calcium excretion.

Dosing & Administration

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Adult Dosing

Standard Dose: 200-600 mg elemental calcium (1-3 tablets of 200mg elemental calcium) orally 2-3 times daily, with or without food, to achieve a total daily intake of 1000-1200 mg elemental calcium from diet and supplements.
Dose Range: 400 - 1200 mg

Condition-Specific Dosing:

Osteoporosis prevention: 1000-1200 mg elemental calcium daily (total from diet and supplements), often divided into 2-3 doses.
Hypocalcemia: Dose individualized based on severity and underlying cause, often higher initial doses followed by maintenance.
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Pediatric Dosing

Neonatal: Not established for routine supplementation; specific medical conditions may warrant use under strict medical supervision.
Infant: Not established for routine supplementation; specific medical conditions may warrant use under strict medical supervision. Daily intake from formula/breast milk is usually sufficient.
Child: 4-8 years: 800-1000 mg elemental calcium daily (total from diet and supplements). 9-18 years: 1300 mg elemental calcium daily (total from diet and supplements). Doses should be divided.
Adolescent: 1300 mg elemental calcium daily (total from diet and supplements), often divided into 2-3 doses.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum calcium and renal function.
Moderate: Use with caution; monitor serum calcium and renal function closely. Dosage adjustment may be necessary to avoid hypercalcemia.
Severe: Contraindicated in severe renal impairment due to risk of hypercalcemia and soft tissue calcification, unless used as a phosphate binder under strict medical supervision. If used, monitor serum calcium, phosphate, and PTH closely.
Dialysis: Generally avoided as a calcium supplement unless specifically indicated as a phosphate binder, in which case doses are highly individualized and require close monitoring of calcium, phosphate, and PTH.

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 is an essential mineral necessary for numerous physiological processes, including bone formation and maintenance, nerve impulse transmission, muscle contraction, blood coagulation, and cellular signaling. As a supplement, calcium citrate provides an exogenous source of calcium to maintain or restore adequate calcium levels in the body, particularly for bone health.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 20-30% (elemental calcium from calcium citrate).
Tmax: 2-4 hours (for peak serum calcium levels after oral administration).
FoodEffect: Less dependent on stomach acid for absorption compared to calcium carbonate; can be taken with or without food, but often recommended with food for better tolerance.

Distribution:

Vd: Not applicable for an essential mineral; calcium is distributed throughout the body, with 99% stored in bones and teeth, and 1% in extracellular fluid and soft tissues.
ProteinBinding: Approximately 40-50% of serum calcium is protein-bound (primarily to albumin).
CnssPenetration: Limited (calcium ion concentrations in CNS are tightly regulated).

Elimination:

HalfLife: Not a typical pharmacokinetic parameter for an essential mineral; serum calcium levels are homeostatically regulated.
Clearance: Regulated by renal excretion and reabsorption, influenced by PTH and calcitonin.
ExcretionRoute: Primarily renal (urine), with some fecal excretion (unabsorbed calcium).
Unchanged: Not applicable (calcium is an ion).
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Pharmacodynamics

OnsetOfAction: Not acutely measurable for bone health benefits; chronic supplementation is required. For acute hypocalcemia, effects on serum calcium can be seen within hours.
PeakEffect: Not acutely measurable for bone health benefits.
DurationOfAction: Not acutely measurable for bone health benefits; effects are sustained with continued intake.

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Fatigue
+ 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Constipation
Stomach pain
Upset stomach
Vomiting
* Decreased appetite

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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. Your doctor can provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Signs of too much calcium (hypercalcemia): severe constipation, nausea, vomiting, loss of appetite, increased thirst, increased urination, muscle weakness, fatigue, confusion. Contact your doctor if these occur.
  • Signs of kidney stones (rare with appropriate dosing): severe back or side pain, blood in urine, painful urination.
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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.

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 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 in conjunction with 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 many other medications, so if you are taking other drugs, consult with your doctor or pharmacist to determine if you should take them at a different time than this medication.

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.
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Overdose Information

Overdose Symptoms:

  • Severe hypercalcemia symptoms (nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, confusion, lethargy)
  • Cardiac arrhythmias (in severe cases)
  • Kidney dysfunction or kidney stones (with chronic excessive intake)

What to Do:

Discontinue calcium citrate. Seek immediate medical attention. Management typically involves hydration (intravenous fluids), loop diuretics (if renal function allows), and in severe cases, calcitonin or bisphosphonates. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Contraindicated Interactions

  • Hypercalcemia
  • Severe renal impairment (unless used as a phosphate binder under strict medical supervision)
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Major Interactions

  • Digoxin (increased risk of arrhythmias due to hypercalcemia)
  • Thiazide diuretics (increased risk of hypercalcemia due to reduced calcium excretion)
  • Phosphate binders (e.g., sevelamer, lanthanum; can reduce calcium absorption if taken concurrently)
  • Dofetilide (increased risk of QT prolongation and torsades de pointes)
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Moderate Interactions

  • Bisphosphonates (e.g., alendronate, risedronate; calcium can reduce absorption; separate administration by at least 30-60 minutes)
  • Thyroid hormones (e.g., levothyroxine; calcium can reduce absorption; separate administration by at least 4 hours)
  • Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin; calcium can chelate and reduce absorption; separate administration by at least 2-6 hours)
  • Tetracycline antibiotics (e.g., doxycycline, minocycline; calcium can chelate and reduce absorption; separate administration by at least 2-4 hours)
  • Iron supplements (calcium can reduce iron absorption; separate administration by at least 2 hours)
  • Zinc supplements (calcium can reduce zinc absorption; separate administration by at least 2 hours)
  • Corticosteroids (long-term use can decrease calcium absorption and increase excretion, necessitating higher calcium intake)
  • Loop diuretics (e.g., furosemide; can increase calcium excretion, potentially leading to hypocalcemia with prolonged use)
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Minor Interactions

  • Not many distinct minor interactions beyond those affecting absorption of other medications.

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 high-dose or long-term supplementation, especially in patients with renal impairment or other risk factors.

Serum Creatinine / eGFR

Rationale: To assess renal function, as impaired renal function increases the risk of hypercalcemia.

Timing: Prior to initiation of high-dose or long-term supplementation, especially in elderly or those with known renal issues.

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Routine Monitoring

Serum Calcium

Frequency: Periodically (e.g., every 6-12 months) for patients on high-dose or long-term therapy, or more frequently if risk factors for hypercalcemia exist (e.g., renal impairment, concomitant medications).

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

Action Threshold: If serum calcium consistently exceeds upper limit of normal, consider dose reduction or discontinuation.

Symptoms of Hypercalcemia

Frequency: Ongoing patient education and self-monitoring.

Target: Absence of symptoms

Action Threshold: If symptoms like nausea, vomiting, constipation, polyuria, polydipsia, muscle weakness, or confusion occur, seek medical attention and check serum calcium.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Loss of appetite
  • Increased thirst (polydipsia)
  • Increased urination (polyuria)
  • Muscle weakness
  • Fatigue
  • Confusion
  • Irregular heartbeat (rare, severe hypercalcemia)

Special Patient Groups

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Pregnancy

Calcium is an essential nutrient during pregnancy for fetal bone development and maternal bone health. Calcium citrate is generally considered safe and often recommended to meet increased daily calcium requirements (1000-1300 mg elemental calcium/day depending on age). Avoid excessive intake.

Trimester-Specific Risks:

First Trimester: Essential for early fetal development; no known specific risks at recommended doses.
Second Trimester: Continued importance for fetal skeletal growth; no known specific risks at recommended doses.
Third Trimester: Crucial for rapid fetal bone mineralization; no known specific risks at recommended doses.
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Lactation

Calcium is essential during lactation to support milk production and maternal bone health. Calcium citrate is generally considered safe and often recommended to meet increased daily calcium requirements (1000-1300 mg elemental calcium/day depending on age). Avoid excessive intake.

Infant Risk: Minimal to no risk to the breastfed infant at recommended maternal doses; calcium is a natural component of breast milk.
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Pediatric Use

Calcium is crucial for bone growth and development in children and adolescents. Dosing should be based on age-specific recommended daily allowances (RDAs) and total calcium intake from diet. Use with caution in very young children; liquid formulations may be preferred. Avoid exceeding upper intake limits.

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Geriatric Use

Calcium supplementation is particularly important for older adults to prevent and manage osteoporosis. However, monitor renal function more closely due to age-related decline in kidney function, which can increase the risk of hypercalcemia. Start with lower doses and titrate as needed, ensuring adequate Vitamin D intake.

Clinical Information

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Clinical Pearls

  • Calcium citrate is generally preferred over calcium carbonate for individuals taking acid-reducing medications (e.g., PPIs, H2 blockers) or those with achlorhydria, as its absorption is less dependent on stomach acid.
  • For optimal absorption, calcium supplements should be taken in divided doses, typically not exceeding 500-600 mg of elemental calcium per single dose.
  • Always consider total daily calcium intake from both diet and supplements when determining dosage.
  • Adequate Vitamin D intake is crucial for calcium absorption and utilization; ensure patients are also taking sufficient Vitamin D.
  • Advise patients to separate calcium citrate from other medications that it may interact with (e.g., thyroid hormones, bisphosphonates, certain antibiotics) by at least 2-4 hours.
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Alternative Therapies

  • Calcium Carbonate (requires stomach acid for absorption, higher elemental calcium per tablet)
  • Calcium Gluconate (often used intravenously for acute hypocalcemia)
  • Calcium Lactate
  • Dietary calcium intake (e.g., dairy products, fortified foods, leafy greens)
  • Vitamin D supplementation (essential for calcium absorption)
  • Bisphosphonates (e.g., alendronate, risedronate - for osteoporosis treatment)
  • Denosumab (for osteoporosis treatment)
  • Teriparatide (for osteoporosis treatment)
  • Raloxifene (for osteoporosis prevention/treatment)
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Cost & Coverage

Average Cost: $5 - $25 per 60-120 tablets
Generic Available: Yes
Insurance Coverage: Generally OTC; typically not covered by insurance unless prescribed for a specific medical condition (e.g., severe hypocalcemia, certain bone disorders) and deemed medically necessary.
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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 facilitate prompt and effective treatment.