Calcium Chloride 100 mg/mL
Calcium Chloride · INJECTION · REMEDYREPACK INC.
Calcium Chloride is a injection containing calcium chloride at 100 mg/mL, taken intravenous. Manufactured by REMEDYREPACK INC..
Key Facts
- Brand Name
- Calcium Chloride
- Generic Name
- Calcium Chloride
- NDC Code (Product)
70518-4180- Manufacturer
- REMEDYREPACK INC.
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS, INTRAVENTRICULAR
- Marketing Status
- Application #
- ANDA203477
- Marketing Start
- 09/24/2024
Recall History
Western Drug
Lack of Assurance of Sterility
Pine Pharmaceuticals, LLC
Lack of Assurance of Sterility
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
GenoGenix LLC
Lack of Assurance of Sterility
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
RXQ Compounding LLC
Lack of Assurance of Sterility
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. (1) Limitations of Use: The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. • Pediatr…
Contraindications
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)
Drug Interactions
7 DRUG INTERACTIONS 7.1 Digoxin Avoid the concomitant use of Calcium Chloride Injection with digoxin. If concomitant use is unavoidable, monitor ECG closely during administration of Calcium Chloride Injection. Synergistic arrhythmias may occur with concomitant use. The use of Calcium Chloride Injection may result in hypercalcemia which increases the risk of digoxin toxicity [see Warnings and Precautions (5.3)]. 7.2 Calcium Channel Blockers Concomitant use of Calcium Chloride Injection and calcium channel blockers may reduce the response to calcium channel blockers. Avoid concomitant use. If concomitant use is unavoidable, monitor blood pressure closely during administration of Calcium Chloride Injection. 7.3 Drugs That Increase the Risk of Hypercalcemia Increase frequency of monitoring of calcium concentrations in patients taking concomitant Calcium Chloride Injection and other drugs that increase the risk of hypercalcemia (e.g., calcipotriene, estrogen, lithium, parathyroid hormone, teriparatide, thiazide diuretics, Vitamin A, and Vitamin D). • Digoxin: Avoid concomitant use with Calcium Chloride Injection. If concomitant use is unavoidable, monitor ECG closely during administrati…
Adverse Reactions
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 pressur…
Frequently Asked Questions
What is Calcium Chloride used for?
Calcium Chloride contains Calcium Chloride. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Calcium Chloride a controlled substance?
Calcium Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Calcium Chloride?
The generic name for Calcium Chloride is Calcium Chloride. There are 6 other brand versions of Calcium Chloride.
What is the NDC code for Calcium Chloride 100 mg/mL?
The NDC (National Drug Code) for Calcium Chloride 100 mg/mL is 70518-4180, listed by REMEDYREPACK INC..