Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1- 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
5 WARNINGS AND PRECAUTIONS End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Calcium chloride injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment.
In patients older than 28 days of age, do not mix or administer simultaneously with ceftriaxone intravenous solutions, even via different infusion lines or at different infusion sites as it can lead to precipitation of ceftriaxone-calcium.
(5.1) Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration: Too rapid an injection exceeding 1 mL/minute may lead to hypotension and syncope.
(2.1, 5.2) Arrhythmias with Concomitant Digoxin Use: Avoid use of calcium chloride injection in patients receiving digoxin.
Closely monitor ECG and calcium levels if concomitant therapy is necessary.
Like all medications, Calcium Chloride Dihydrate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: