pharmacopeia

Calcium

CalciumUS-FDASourced from openFDA
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Mechanism of action

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Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

Indications

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  • Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.

Contraindications

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  • Patients with hypercalcemia. Hypercalcemia.contraindicated

Dosage & administration

Sourced from openFDA

The recommended initial dose of calcium acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3-4 capsules with each meal. Starting dose is 2 capsules with each meal. (2) Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached. Most patients require 3-4 capsules with each meal. (2)

Warnings & precautions

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Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules. ( 5.1 ) Hypercalcemia may aggravate digitalis toxicity. ( 5.2 ) 5.1 Hypercalcemia Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium based nonprescription antacids, concurrently with calcium acetate. An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the calcium acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia. More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well. Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification.

Adverse reactions

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Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ]. The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. ( 6.1 ) In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, calcium acetate has been generally well tolerated. Calcium acetate was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of calcium acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Pregnancy Category C Calcium acetate capsules contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1) ] . Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. 8.2 Labor and Delivery The effects of calcium acetate on labor and delivery are unknown. 8.3 Nursing Mothers A calcium acetate capsule contains calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Overdosage

Sourced from openFDA

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ].

Approval history

Sourced from openFDA
  • Aug 13, 1975NDANDA017608Otsuka Icu Medcl
  • Jan 26, 1976NDANDA017641Otsuka Icu Medcl
  • Mar 16, 1976NDANDA017604Pharmaco
  • Sep 27, 1978NDANDA017512Vantive Us Hlthcare
  • Aug 6, 1979NDANDA018156B Braun
  • May 16, 1980NDANDA018251Otsuka Icu Medcl
  • Feb 26, 1982NDANDA018608Hospira
  • Dec 27, 1982NDANDA018681B Braun

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
595,222 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fatigue39,1726.6%
  2. 2Nausea35,3375.9%
  3. 3Drug Ineffective33,0205.5%
  4. 4Diarrhoea32,4755.5%
  5. 5Pain29,0604.9%
  6. 6Dyspnoea28,5454.8%
  7. 7Off Label Use27,9494.7%
  8. 8Headache26,4164.4%
  9. 9Arthralgia24,5644.1%
  10. 10Dizziness24,0234.0%
  11. 11Death23,3623.9%
  12. 12Asthenia22,7853.8%
  13. 13Vomiting21,6683.6%
  14. 14Fall20,1853.4%
  15. 15Pain In Extremity19,7223.3%

Literature

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Recent PubMed references pinned to Calcium as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 5,601 ClinicalTrials.gov registrations naming Calcium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Calcium work?
Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
What is Calcium used for?
According to FDA labeling, Calcium carries indications including: Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Calcium?
Calcium is classified as Calcium.
What are the contraindications for Calcium?
Calcium labeling lists contraindications including: Patients with hypercalcemia. Hypercalcemia.. Always consult the full prescribing information and a clinician.
Note. Data for calcium is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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