pharmacopeia
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/api/v1/drug/calcium-chloride

Indications

Sourced from openFDA
  • Calcium Chloride Injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established.

Contraindications

Sourced from openFDA
  • Calcium Chloride Injection is contraindicated in: • Patients with ventricular fibrillation • Patients with asystole and electromechanical dissociation Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Warnings and Precautions (5.1)]. Calcium Chloride Injection is contraindicated in: • Patients with ventricular fibrillation.contraindicated

Dosage & administration

Sourced from openFDA

2.1 Important Administration Instructions Administer Calcium Chloride Injection by slow intravenous infusion in a central or deep vein in adults and pediatric patients (with or without renal impairment); do not administer by bolus [see Warnings and Precautions (5.2, 5.4)]. The maximum recommended infusion rate is 1 mL/minute (100 mg/minute). Additional important administration instructions regarding Calcium Chloride Injection are as follows: • Do not use intramuscularly or subcutaneously to avoid tissue necrosis calcinosis cutis [see Warnings and Precautions (5.4)]. • Visually inspect for particulate matter and discoloration prior to administration (the solution is clear, and the seal is intact). Do not administer if the solution is unclear or the seal is not intact. • Stop the administration if the patient complains of any administration-related discomfort; administration may be resumed when symptoms disappear. • Discard the unused portion. • If time permits, allow the solution to warm to body temperature. 2.2 Recommended Dosage and Administration The recommended dose range of Calcium Chloride Injection in: • Adults is from 200 mg to 1,000 mg. • Pediatric patients is from 2.7 to 5 mg/kg of calcium chloride. Dosing of this Calcium Chloride Injection product is not possible in patients who require doses less than 200 mg because the recommended dose cannot be achieved with the supplied syringe. For patients who require doses less than 200 mg, use another calcium chloride injection product that allows dosing of less than 200 mg.

Warnings & precautions

Sourced from openFDA

5.1 End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates The use of Calcium Chloride Injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Contraindications (4)]. Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have occurred when ceftriaxone and calcium were administered either simultaneously or non-simultaneously and through different intravenous lines. In-vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups. In patients older than 28 days of age, Calcium Chloride Injection and ceftriaxone intravenous solutions may be administered sequentially one after another if infusion lines at different sites are used, infusion lines are replaced, or infusion lines are thoroughly flushed between infusions with physiological salt solution to avoid precipitation. Do not mix or administer Calcium Chloride Injection simultaneously with ceftriaxone, even if using different infusion lines or different infusion sites as it can lead to precipitation of ceftriaxone-calcium [see Dosage and Administration (2.4)].

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are also described elsewhere in the labeling: • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions (5.1)] • Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration [see Warnings and Precautions (5.2)] • Arrhythmias with Concomitant Digoxin Use [see Warnings and Precautions (5.3)] • Tissue Necrosis and Calcinosis [see Warnings and Precautions (5.4)] • Aluminum toxicity [see Warnings and Precautions (5.5)] The following adverse reactions have been identified in literature and postmarketing reports of calcium chloride. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: • Nervous system disorders: Paraesthesia (upon rapid injection), calcium taste • General disorders and administration site conditions: Sense of oppression, sense of “heat wave”, local burning sensation, injection site extravasation, injection site reactions • Cardiovascular disorders: Peripheral vasodilatation, decreased blood pressure Adverse reactions have included paraesthesia (upon rapid injection), calcium taste, sense of oppression, sense of “heat wave”, local burning sensation, injection site extravasation, injection site reactions, peripheral vasodilatation, and decreased blood pressure. (6) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Administration of Calcium Chloride Injection for the treatment of acute symptomatic hypocalcemia during pregnancy is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with development of hypocalcemia during pregnancy (see Clinical Considerations). Animal reproduction studies have not been conducted with Calcium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal/Neonatal Risk Maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. Infants born to mothers with hypocalcemia can develop fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures. 8.2 Lactation Risk Summary Calcium is present in human milk.

Overdosage

Sourced from openFDA

Overdosage of Calcium Chloride Injection may lead to hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is ≥12 mg/dL, and include shortening of QT interval, bradycardia, hypertension, anorexia, nausea, vomiting, bowel hypomotility and constipation, muscle weakness, bone pain, decreased concentration, depression, weakness, fatigue, confusion, hallucinations, disorientation, hypotonicity, seizures, and coma. Hypercalcemia effects on kidney include diminished ability to concentrate urine and diuresis. In the event of overdosage, promptly discontinue Calcium Chloride Injection , the patient should be re-evaluated and appropriate countermeasures should be instituted, if necessary [see Warnings and Precautions (5), Adverse Reactions (6)].

Approval history

Sourced from openFDA
  • Mar 22, 1971NDANDA016679Baxter Hlthcare
  • Mar 22, 1971NDANDA016682Baxter Hlthcare
  • Aug 13, 1975NDANDA017608Otsuka Icu Medcl
  • Jan 26, 1976NDANDA017641Otsuka Icu Medcl
  • Sep 27, 1978NDANDA017512Vantive Us Hlthcare
  • Aug 6, 1979NDANDA018156B Braun
  • May 16, 1980NDANDA018251Otsuka Icu Medcl
  • Feb 19, 1982NDANDA018494Baxter Hlthcare

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Calcium Chloride, Injection, 100 mg/1 mL (NDC 0409-4928-34)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • DELFLEX® w/Dextrose, Solution, 1.5% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 49230-206-94)To be discontinued
    Sponsor: Fresenius Medical Care North America
    Updated
  • DELFLEX® w/Dextrose, Solution, 1.5% Low Mg/Low Ca 2L, 5/cs (NDC 46163-206-92)To be discontinued
    Sponsor: Fresenius Medical Care North America
    Updated
  • DELFLEX® w/Dextrose, Solution, 2.5% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 49230-209-94)To be discontinued
    Sponsor: Fresenius Medical Care North America
    Updated
  • DELFLEX® w/Dextrose, Solution, 2.5% Low Mg/Low Ca 2L, 5/cs (NDC 49230-209-92)To be discontinued
    Sponsor: Fresenius Medical Care North America
    Updated
  • DELFLEX® w/Dextrose, Solution, 4.25% Low Mg/Low Ca 2.5L/3L, 5/cs (NDC 46163-212-94)To be discontinued
    Sponsor: Fresenius Medical Care North America
    Updated
  • DELFLEX® w/Dextrose, Solution, 4.25% Low Mg/Low Ca 2L, 5/cs (NDC 46163-212-92)To be discontinued
    Sponsor: Fresenius Medical Care North America
    Updated

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.
50,635 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. 1Death7,76115%
  2. 2Peritonitis3,8697.6%
  3. 3Peritonitis Bacterial2,5265.0%
  4. 4Hypotension1,8843.7%
  5. 5Peritoneal Dialysis Complication1,7483.5%
  6. 6Myocardial Infarction1,5333.0%
  7. 7Pneumonia1,5243.0%
  8. 8Infection1,4692.9%
  9. 9Dyspnoea1,3962.8%
  10. 10Sepsis1,2922.6%
  11. 11Abdominal Pain1,2722.5%
  12. 12Fluid Overload1,2112.4%
  13. 13Vomiting1,1582.3%
  14. 14Abdominal Distension1,1512.3%
  15. 15Malaise1,1312.2%

Literature

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Recent PubMed references pinned to Calcium Chloride 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 349 ClinicalTrials.gov registrations naming Calcium Chloride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Calcium Chloride used for?
According to FDA labeling, Calcium Chloride carries indications including: Calcium Chloride Injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Calcium Chloride?
Calcium Chloride is classified as Acidifiers, Calcium, Electrolyte solutions, Increased Cardiac Muscle Organized Electrical Activity.
What are the brand names for Calcium Chloride?
Calcium Chloride is marketed under brand names including BSS Ophthalmic Solution, Clinimix E 2.75/5, Clinimix E 4.25/10, Clinimix E 4.25/5, Clinimix E 5/15, Clinimix E 5/20, Clinimix E 5/25, Dianeal Low Calcium 1.5.
What are the contraindications for Calcium Chloride?
Calcium Chloride labeling lists contraindications including: Calcium Chloride Injection is contraindicated in: • Patients with ventricular fibrillation • Patients with asystole and electromechanical dissociation Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Warnings and Precautions (5.1)]. Calcium Chloride Injection is contraindicated in: • Patients with ventricular fibrillation.. Always consult the full prescribing information and a clinician.
Note. Data for calcium-chloride 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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