Calcium Acetate 667mg Capsules

Manufacturer ROXANE Active Ingredient Calcium Acetate Capsules(KAL see um AS e tate) Pronunciation KAL see um AS e tate
It is used to lower high phosphate levels.
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Drug Class
Phosphate binder
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Pharmacologic Class
Calcium salt, phosphate binder
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Pregnancy Category
Category C
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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 acetate is a medication used by people with kidney disease (especially those on dialysis) to help lower high levels of phosphate in their blood. It works by binding to phosphate in the food you eat, preventing your body from absorbing it. This helps keep your bones healthy and prevents other problems caused by too much phosphate.
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How to Use This Medicine

Taking Your Medication Correctly

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. Take your medication with meals to help your body absorb it properly. Additionally, be sure to follow the diet plan recommended by your doctor.

Important Administration Instructions

Do not chew your medication. Instead, swallow it whole to ensure you receive the correct dose.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place. Avoid storing it in a bathroom, as the moisture and humidity can affect the medication. Keep all medications in a secure location, 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 by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it is 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, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Take calcium acetate capsules with each meal to ensure it binds to the phosphate in your food.
  • Do not take antacids containing aluminum or magnesium without consulting your doctor, as they can interact.
  • Maintain adequate fluid intake unless otherwise advised by your doctor.
  • Separate administration of other medications (especially antibiotics like tetracyclines or fluoroquinolones, thyroid hormones, and bisphosphonates) by several hours (typically 1-2 hours before or 4-6 hours after calcium acetate) to prevent reduced absorption.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose: 1334 mg (2 capsules) orally with each meal. Adjust dose based on serum phosphate levels.
Dose Range: 667 - 10000 mg

Condition-Specific Dosing:

hyperphosphatemia_esrd: Dose adjusted to maintain serum phosphate within target range (typically 2.5-4.5 mg/dL).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Individualized, based on serum phosphate levels and clinical response, under specialist supervision.
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Dose Adjustments

Renal Impairment:

Mild: Not applicable (used in ESRD)
Moderate: Not applicable (used in ESRD)
Severe: Dosing is for patients with severe renal impairment (ESRD). Adjust based on serum phosphate levels.
Dialysis: Dosing is for patients on dialysis. Administer with meals to bind dietary phosphate.

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 acetate binds to dietary phosphate in the gastrointestinal tract, forming insoluble calcium phosphate. This complex is then excreted in the feces, thereby reducing the absorption of phosphate from the diet and lowering serum phosphate levels in patients with end-stage renal disease (ESRD).
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Pharmacokinetics

Absorption:

Bioavailability: Variable (calcium absorption occurs, but primary action is local binding)
Tmax: Not directly applicable for phosphate binding action
FoodEffect: Must be taken with meals for effective phosphate binding

Distribution:

Vd: Not directly applicable for phosphate binding action
ProteinBinding: Approximately 40% of absorbed calcium is protein-bound (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Not applicable for phosphate binding action; absorbed calcium is homeostatically regulated
Clearance: Not applicable for phosphate binding action
ExcretionRoute: Unabsorbed calcium phosphate excreted in feces; absorbed calcium primarily renally excreted
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Within hours (with meal)
PeakEffect: Phosphate reduction observed within days to weeks of consistent dosing
DurationOfAction: As long as taken with meals

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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
+ Nausea and vomiting
+ Constipation
+ Bone pain

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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:

* Upset stomach

Note: This list is not exhaustive, and you may experience other side effects not mentioned here. 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:

  • Severe constipation
  • Nausea
  • Vomiting
  • Loss of appetite
  • Unusual tiredness or weakness
  • Confusion
  • Muscle weakness
  • Increased thirst
  • Increased 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 is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all of the following with your doctor and pharmacist:

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

Before starting, stopping, or changing the dose of any medication, including this one, you must 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. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

To avoid interactions, do not take calcium supplements or products containing calcium, such as antacids, while taking this medication. Additionally, this drug may interfere with the absorption of other oral medications. If you are taking other medications by mouth, your doctor may advise you to take them at a different time than this medication to ensure proper absorption.

If you are pregnant, planning to become pregnant, or breastfeeding, it is crucial to consult with your doctor. You and your doctor 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 (e.g., severe constipation, persistent nausea/vomiting, loss of appetite, confusion, muscle weakness, increased thirst or urination, bone pain, kidney stones, cardiac arrhythmias, coma)

What to Do:

Call 1-800-222-1222 (Poison Control) or seek immediate medical attention. Treatment typically involves hydration, loop diuretics, and potentially calcitonin or bisphosphonates for severe hypercalcemia.

Drug Interactions

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Contraindicated Interactions

  • Hypercalcemia
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Major Interactions

  • Digoxin (increased risk of arrhythmias with hypercalcemia)
  • Tetracyclines (e.g., doxycycline, minocycline - reduced absorption)
  • Fluoroquinolones (e.g., ciprofloxacin, levofloxacin - reduced absorption)
  • Iron supplements (reduced absorption)
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Moderate Interactions

  • Thyroid hormones (e.g., levothyroxine - reduced absorption)
  • Bisphosphonates (e.g., alendronate - reduced absorption)
  • Phenytoin (reduced absorption)
  • Calcium channel blockers (potential for reduced efficacy)
  • Vitamin D analogs (increased risk of hypercalcemia)

Monitoring

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Baseline Monitoring

Serum phosphate

Rationale: To establish baseline levels and guide initial dosing.

Timing: Before initiating therapy

Serum calcium (total and/or ionized)

Rationale: To establish baseline levels and assess risk of hypercalcemia.

Timing: Before initiating therapy

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Routine Monitoring

Serum phosphate

Frequency: Weekly to monthly initially, then monthly to quarterly once stable

Target: Typically 2.5-4.5 mg/dL (varies by guideline)

Action Threshold: Levels outside target range require dose adjustment

Serum calcium (total and/or ionized)

Frequency: Weekly to monthly initially, then monthly to quarterly once stable

Target: Typically 8.4-10.2 mg/dL (varies by guideline)

Action Threshold: Hypercalcemia (e.g., >10.2 mg/dL) requires dose reduction or discontinuation

Symptoms of hypercalcemia

Frequency: Ongoing

Target: Absence of symptoms

Action Threshold: Presence of symptoms (e.g., nausea, vomiting, constipation, confusion, muscle weakness, polyuria, polydipsia) requires immediate evaluation

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Constipation
  • Abdominal pain
  • Loss of appetite
  • Confusion
  • Lethargy
  • Muscle weakness
  • Increased thirst
  • Increased urination

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Maternal hypercalcemia can lead to fetal hypercalcemia, which may result in congenital abnormalities.

Trimester-Specific Risks:

First Trimester: Potential for fetal hypercalcemia if maternal hypercalcemia occurs.
Second Trimester: Potential for fetal hypercalcemia if maternal hypercalcemia occurs.
Third Trimester: Potential for fetal hypercalcemia if maternal hypercalcemia occurs.
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Lactation

L3 - Likely compatible. Calcium is a natural component of breast milk. While calcium acetate is generally considered safe during lactation, monitor the infant for signs of hypercalcemia if maternal doses are high or if the infant has underlying renal issues.

Infant Risk: Low to moderate, primarily if maternal hypercalcemia occurs or if the infant has impaired calcium excretion.
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Pediatric Use

Safety and efficacy not fully established in pediatric patients, especially young children. Dosing is individualized and requires careful monitoring of serum calcium and phosphate levels by a specialist.

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Geriatric Use

No specific dose adjustments needed beyond standard monitoring. Elderly patients may be more susceptible to constipation and should be monitored for symptoms of hypercalcemia.

Clinical Information

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Clinical Pearls

  • Calcium acetate must be taken with meals to effectively bind dietary phosphate; taking it between meals will not be effective for phosphate binding.
  • Regular monitoring of serum calcium and phosphate levels is crucial to prevent hypercalcemia and ensure therapeutic efficacy.
  • Educate patients on the symptoms of hypercalcemia and advise them to report these immediately.
  • Advise patients to separate the administration of calcium acetate from other medications (especially certain antibiotics, thyroid hormones, and bisphosphonates) by several hours to avoid drug interactions due to chelation.
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Alternative Therapies

  • Sevelamer (Renvela, Renagel)
  • Lanthanum carbonate (Fosrenol)
  • Ferric citrate (Auryxia)
  • Sucroferric oxyhydroxide (Velphoro)
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Cost & Coverage

Average Cost: Price range varies widely per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 taken, the amount, and the time it happened.