Calcium Chloride CALCIUM CHLORIDE MEDICAL PURCHASING SOLUTIONS, LLC FDA Approved Calcium Chloride Injection, USP, 10%, is a sterile aqueous solution containing, in each mL, 100 mg (1.36 mEq) calcium chloride. The pH of the solution may have been adjusted with hydrochloric acid and / or calcium hydroxide, when necessary. The air above the liquid in the individual containers has been displaced by flushing with nitrogen during the filling operation. The preparation contains no antimicrobial preservatives and is intended as a single-dose vial; once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit. Calcium Chloride, USP, contains two molecules of water of hydration and is chemically designated as CaCl 2 • 2H 2 0.
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Substance Calcium Chloride
Route
INTRAVENOUS INTRAVENTRICULAR
Package NDC

Drug Facts

Composition & Profile

Strengths
10 % 10 ml
Quantities
10 ml 1 count
Treats Conditions
Indications And Usage Calcium Chloride Injection Usp 10 Is Indicated In The Treatment Of Hypocalcemia In Conditions Requiring A Prompt Increase In Plasma Calcium Levels E G Neonatal Tetany And Tetany Due To Parathyroid Deficiency Vitamin D Deficiency And Alkalosis And For Prevention Of Hypocalcemia During Exchange Transfusions As Adjunctive Therapy In The Management Of Acute Symptoms In Lead Colic In The Treatment Of Magnesium Intoxication Due To Overdosage Of Magnesium Sulfate In Severe Hyperkalemia To Combat Deleterious Effects On Electrocardiographic Ecg Function Pending Correction Of The Potassium Level In The Extracellular Fluid In Cardiac Resuscitation Particularly After Open Heart Surgery When Epinephrine Fails To Improve Weak Or Ineffective Myocardial Contractions

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
M4I0D6VV5M
Packaging

HOW SUPPLIED CALCIUM CHLORIDE INJECTION, USP, 10% In unit-use packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. Stock No. 3304 NDC 76329-3304-1 10 mL Ten cartons per package. Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at controlled room temperature 15° to 30°C (59° to 86°F). Rx Only INTERNATIONAL MEDICATION SYSTEMS, LIMITED So. El Monte, CA 91733, U.S.A. Rev. 2-13 An Amphastar Pharmaceuticals Company © INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2013 Instructions; PRINCIPLE DISPLAY PANEL: Syringe Label Osmolarity approx. 2050 mOsmol per liter (calc.) FOR SLOW INTRAVENOUS USE ONLY SEE INSERT / SINGLE DOSE NO PRESERVATIVE ADDED IMS, LIMITED Rx Only So. El Monte, CA 91733, U.S.A. 7633040B 8-11 10 mL 1 g (13.6 mEq) 100 mg / mL CALCIUM CHLORIDE INJ., USP, 10% Approx. mL 0 1 2 3 4 5 6 7 8 9 Label; PRINCIPLE DISPLAY PANEL: Carton Luer-Lock Prefilled Syringe Rx only NDC 76329-3304-1 STOCK NO. 3304 CALCIUM CHLORIDE INJ. USP, 10% 1.36 mEq/ mL (100 mg/ mL) 13.6 mEq (1 g) per 10 mL One 10 mL Single Dose Prefilled Syringe Single use, do not reuse or resterilize. FOR SLOW INTRAVENOUS USE LUER-JET TM LUER-LOCK PREFILLED SYRINGE Carton; PRINCIPAL DISPLAY PANEL: Outer package label NDC 71872-7044-1 1 - Prefilled Syringe Calcium Chloride Inj. USP, 10% Rx Only calclabel

Package Descriptions
  • HOW SUPPLIED CALCIUM CHLORIDE INJECTION, USP, 10% In unit-use packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. Stock No. 3304 NDC 76329-3304-1 10 mL Ten cartons per package. Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at controlled room temperature 15° to 30°C (59° to 86°F). Rx Only INTERNATIONAL MEDICATION SYSTEMS, LIMITED So. El Monte, CA 91733, U.S.A. Rev. 2-13 An Amphastar Pharmaceuticals Company © INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2013 Instructions
  • PRINCIPLE DISPLAY PANEL: Syringe Label Osmolarity approx. 2050 mOsmol per liter (calc.) FOR SLOW INTRAVENOUS USE ONLY SEE INSERT / SINGLE DOSE NO PRESERVATIVE ADDED IMS, LIMITED Rx Only So. El Monte, CA 91733, U.S.A. 7633040B 8-11 10 mL 1 g (13.6 mEq) 100 mg / mL CALCIUM CHLORIDE INJ., USP, 10% Approx. mL 0 1 2 3 4 5 6 7 8 9 Label
  • PRINCIPLE DISPLAY PANEL: Carton Luer-Lock Prefilled Syringe Rx only NDC 76329-3304-1 STOCK NO. 3304 CALCIUM CHLORIDE INJ. USP, 10% 1.36 mEq/ mL (100 mg/ mL) 13.6 mEq (1 g) per 10 mL One 10 mL Single Dose Prefilled Syringe Single use, do not reuse or resterilize. FOR SLOW INTRAVENOUS USE LUER-JET TM LUER-LOCK PREFILLED SYRINGE Carton
  • PRINCIPAL DISPLAY PANEL: Outer package label NDC 71872-7044-1 1 - Prefilled Syringe Calcium Chloride Inj. USP, 10% Rx Only calclabel

Overview

Calcium Chloride Injection, USP, 10%, is a sterile aqueous solution containing, in each mL, 100 mg (1.36 mEq) calcium chloride. The pH of the solution may have been adjusted with hydrochloric acid and / or calcium hydroxide, when necessary. The air above the liquid in the individual containers has been displaced by flushing with nitrogen during the filling operation. The preparation contains no antimicrobial preservatives and is intended as a single-dose vial; once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit. Calcium Chloride, USP, contains two molecules of water of hydration and is chemically designated as CaCl 2 • 2H 2 0.

Indications & Usage

Calcium Chloride Injection, USP, 10% is indicated: In the treatment of hypocalcemia in conditions requiring a prompt increase in plasma calcium levels (e.g., neonatal tetany and tetany due to parathyroid deficiency, vitamin D deficiency and alkalosis) and for prevention of hypocalcemia during exchange transfusions. As adjunctive therapy in the management of acute symptoms in lead colic. In the treatment of magnesium intoxication due to overdosage of magnesium sulfate. In severe hyperkalemia, to combat deleterious effects on electrocardiographic (ECG) function, pending correction of the potassium level in the extracellular fluid. In cardiac resuscitation, particularly after open heart surgery, when epinephrine fails to improve weak or ineffective myocardial contractions.

Dosage & Administration

FOR INTRACARDIAC OR INTRAVENOUS USE ONLY INJECT SLOWLY Calcium Chloride Injection, USP, 10%, is administered only by slow intravenous injection (not to exceed 1 mL/min) and / or in cardiac resuscitation, by injection into the ventricular cavity. It must not be injected into the myocardium. The usual precautions for intravenous therapy should be observed. If time permits, the solution should be warmed to body temperature. The injection should be halted if the patient complains of any discomfort; it may be resumed when symptoms disappear. Following injection, the patient should remain recumbent for a short time. INTRACARDIAC USE For cardiac resuscitation, inject into the ventricular cavity, not into the heart muscle. Usual Adult Dosage: 200 to 800 mg (2 to 8 mL) when injected into the ventricular cavity. Pediatric Dosage: 0.2 mL/kg of body weight. INTRAVENOUS USE Hypocalcemic Disorders Usual Adult Dosage: 500 mg to 1 g (5 to 10 mL) at intervals of 1 to 3 days, depending on the response of the patient and / or results of serum calcium determinations. Repeated injections may be required because of rapid excretion of calcium. Pediatric Dosage: 0.2 mL /kg of body weight. Maximum 1-10 mL/day. Magnesium Intoxication Initial Adult Dose: 500 mg (5 mL) administered promptly and the patient observed for signs of recovery before further doses are given. Hyperkalemic ECG Disturbances of Cardiac Function Dosage should be adjusted by constant monitoring of ECG changes during administration.

Warnings & Precautions
WARNINGS Calcium chloride should be injected into a large vein very slowly, as it may cause peripheral vasodilatation and a cutaneous burning sensation. A moderate fall in blood pressure due to vasodilatation may attend the injection. Since calcium chloride is an acidifying salt, it is usually undesirable in the treatment of hypocalcemia or renal insufficiency.
Contraindications

Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation.

Adverse Reactions

Rapid I.V. injection may cause the patient to complain of tingling sensations, a calcium taste, a sense of oppression or “heat wave.” Injections of calcium chloride are accompanied by peripheral vasodilation as well as a local “burning” sensation, and there may be a moderate fall in blood pressure.

Drug Interactions

Because of the danger involved in the simultaneous use of calcium salts and drugs of the digitalis group, a digitalized patient should not receive an intravenous injection of a calcium compound unless the indications are clearly defined. Calcium salts should not generally be mixed with carbonates, phosphates, sulfates or tartrates in parenteral admixtures.


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