calcium chloride

calcium chloride is an FDA-registered drug product whose active ingredient is CALCIUM CHLORIDE. It is labelled by Eskayef Pharmaceuticals Limited taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 72658-1879, application ANDA217463, label effective 20260909. It is one of 4 FDA drug label records sharing the active ingredient CALCIUM CHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CALCIUM CHLORIDE are most often described in connection with: calcium chloride, treatment adult, acute symptomatic, hypocalcemia limitations, injection indicated, pediatric patients. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE 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. Calcium chloride injection is a form of calcium indicated for the treatment of adult and pediatric and patients with acute symptomatic hypocalcemia. Limitations of Use: The safety and effectiveness of calcium chloride injection for long-term use has not been established.

2 DOSAGE AND ADMINISTRATION Administer calcium chloride injection by slow intravenous infusion (not to exceed 1 mL/minute), in a central or deep vein . (2.1) Do not use intramuscularly or subcutaneously. (2.1) Do not administer unless solution is clear and seal is intact. (2.1) Stop the administration if the patient complains of any administration-related discomfort, it may be resumed when symptoms disappear. (2.1) The recommended adult dose is from 200 mg to 1,000 mg. (2.2) The recommended pediatric dose is from 2.7 to 5 mg/kg of calcium chloride. (2.2) Repeated injections may be required because of rapid calcium excretion. (2.2) See the full prescribing information for the recommended starting dose in patients with renal impairment. (2.3) Do not mix calcium chloride injection with ceftriaxone or administer these products simultaneously via a Y-site because concurrent use can lead to the formation of ceftriaxone-calcium precipitates. (2.4) 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 vial. For patients who require doses less than 200 mg, use another calcium chloride injection product that allows dosing of less than 200 mg. Individualize the dose for a patient within these dose ranges depending on serum ionized calcium level, severity of hypocalcemia symptoms, and the acuity of hypocalcemia onset. Repeated injections may be required because of rapid excretion of calcium. 2.3 Recommended Starting Dose in Patients with Renal Impairment The recommended starting dose of calcium chloride injection in [see Use in Specific Populations (8.6) ] : Adults with renal impairment is 200 mg. Pediatric patients is 2.7 mg/kg of calcium chloride. 2.4 Drug Incompatibilities Do not mix calcium chloride injection with other drugs simultaneously. Do not mix calcium chloride injection with ceftriaxone or administer these products simultaneously via a Y-site because concurrent use can lead to the formation of ceftriaxone-calcium precipitates [see Warnings and Precautions (5.1) ] : In neonates (28 days of age or younger), concomitant use of calcium chloride injection and ceftriaxone is contraindicated [see Contraindications (4) ] . In patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.

4 CONTRAINDICATIONS 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. (4) Patients with asystole and electromechanical dissociation. (4) Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment, regardless of whether these products would be received at different times or through separate intravenous lines. (4, 5.1)

6 ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 4 drug label records with CALCIUM CHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is calcium chloride used for?
1 INDICATIONS AND USAGE 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. Calcium chloride injection is a form of calcium indicated for the treatment of adult and pediatric and patients with acute …

Who makes calcium chloride?
Eskayef Pharmaceuticals Limited is the labeler of record for calcium chloride. 4 FDA label records share the active ingredient CALCIUM CHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does calcium chloride come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is calcium chloride prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CALCIUM CHLORIDE?
Yes. 4 FDA drug label records list CALCIUM CHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has calcium chloride been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.