Calcium Chloride Dihydrate 100 mg/mL
Calcium Chloride Dihydrate · INJECTION, SOLUTION · Somerset Therapeutics, LLC
Calcium Chloride Dihydrate is a injection, solution containing calcium chloride dihydrate at 100 mg/mL, taken intravenous. Manufactured by Somerset Therapeutics, LLC.
Key Facts
- Brand Name
- Calcium Chloride Dihydrate
- Generic Name
- Calcium Chloride Dihydrate
- NDC Code (Product)
70069-773- Manufacturer
- Somerset Therapeutics, LLC
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA218133
- Marketing Start
- 12/19/2024
Recall History
Western Drug
Lack of Assurance of Sterility
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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 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 …
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 Digoxin: Avoid concomitant use with calcium chloride injection. If concomitant use is unavoidable, monitor ECG closely during administration of calcium chloride injection. (5.3, 7.1) Calcium Channel Blockers: Avoid concomitant use with calcium chloride injection. If concomitant use is unavoidable, monitor blood pressure closely during administration of calcium chloride injection. (7.2) Drugs That Increase the Risk of Hypercalcemia: Increase the frequency of calcium concentration monitoring in patients taking calcium chloride injection concomitantly with other drugs that increase the risk of hypercalcemia. (7.3) 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 co…
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 pressure Adverse reacti…
Frequently Asked Questions
What is Calcium Chloride Dihydrate used for?
Calcium Chloride Dihydrate contains Calcium Chloride Dihydrate. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Calcium Chloride Dihydrate a controlled substance?
Calcium Chloride Dihydrate is not classified as a controlled substance by the DEA.
What is the generic name for Calcium Chloride Dihydrate?
The generic name for Calcium Chloride Dihydrate is Calcium Chloride Dihydrate. There are no other listed brand versions of Calcium Chloride Dihydrate.
What is the NDC code for Calcium Chloride Dihydrate 100 mg/mL?
The NDC (National Drug Code) for Calcium Chloride Dihydrate 100 mg/mL is 70069-773, listed by Somerset Therapeutics, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)