Calcium Chloride Dihydrate
FDA Drug Information • Also known as: Calcium Chloride Dihydrate
- Brand Names
- Calcium Chloride Dihydrate
- Dosage Form
- CRYSTAL
- Product Type
- BULK INGREDIENT
Description
11 DESCRIPTION 10% Calcium chloride injection, USP is a sterile, nonpyrogenic, hypertonic solution for single administration only. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca ++ and Cl - ) in water for injection. It is provided in a 10 mL single-dose vial for intravenous injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% calcium chloride injection, USP is 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% calcium chloride injection, USP is oxygen sensitive. Calcium chloride, USP dihydrate is chemically designated CaCl 2 2H 2 O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water. Calcium chloride injection, USP contains no more than 1,000 mcg/L of aluminum [see Warnings and Precautions (5.2)].
What Is Calcium Chloride Dihydrate 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 symptomatic hypocalcemia. (1) Limitations of Use : The safety and effectiveness of calcium chloride injection for long-term use has not been established.
Dosage and 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 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...
Side Effects (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 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
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 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).
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)
Pregnancy and Breastfeeding
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.
Overdosage
10 OVERDOSAGE 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)] .
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Calcium chloride injection, USP (clear solution) is supplied in single-dose vial as follows: Unit of Sale and Product Description Strength NDC 10 mL vials packaged in a carton of 10 10% (1,000 mg/10 mL) (100 mg/mL) 70069-773-10 The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.