NDC 71872-7044 Calcium Chloride

Calcium Chloride

NDC Product Code 71872-7044

NDC 71872-7044-1

Package Description: 1 CARTON in 1 BAG > 1 SYRINGE in 1 CARTON > 10 mL in 1 SYRINGE

NDC Product Information

Calcium Chloride with NDC 71872-7044 is a a human prescription drug product labeled by Medical Purchasing Solutions, Llc. The generic name of Calcium Chloride is calcium chloride. The product's dosage form is injection and is administered via intravenous; intraventricular form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 828527.

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Calcium Chloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • CALCIUM HYDROXIDE (UNII: PF5DZW74VN)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Intraventricular - Administration within a ventricle.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Medical Purchasing Solutions, Llc
Labeler Code: 71872
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-01-1973 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Calcium Chloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

CALCIUM CHLORIDEINJECTION, USP, 10%13.6 mEq (1 g) per 10 mL100 mg (1.36 mEq)/ mLOsmolarity approximately 2050 mOsmol/L

Description

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


20.

Clinical Pharmacology

Calcium is the fifth most abundant element in the body, the major fraction of which is found in the bony structure. Calcium plays important physiological roles; it is essential for the functional integrity of the nervous and muscular systems; it is necessary for normal cardiac function; and it is one of the factors involved in the mechanism of blood coagulation.

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.

Contraindications

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

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.

General

Calcium Chloride Injection, USP, 10% is irritating to veins and


must not be injected into tissues, since severe necrosis and sloughing may occur. Great care should be taken to avoid extravasation or accidental injection into perivascular tissues.


Solutions should be warmed to body temperature. Injections should be made slowly through a small needle into a large vein to minimize venous irritation and avoid undesirable reactions. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the danger of cardiac syncope. If injected into the ventricular cavity in cardiac resuscitation care must be taken to avoid injection into the myocardial tissue.

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.

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.

Dosage And Administration For Intracardiac Or Intravenous Use Only

INJECT SLOWLYCalcium 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 USEFor 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 USEHypocalcemic DisordersUsual 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 IntoxicationInitial 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 FunctionDosage should be adjusted by constant monitoring of ECG changes during administration.

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 mLTen cartons per package.Syringe Assembly Directions:USE ASEPTIC TECHNIQUEDo 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 OnlyINTERNATIONAL MEDICATION SYSTEMS, LIMITEDSo. El Monte, CA 91733, U.S.A.                                         Rev. 2-13


An Amphastar Pharmaceuticals Company


© INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2013

Principle Display Panel: Syringe Label

Osmolarity approx. 2050 mOsmol per liter (calc.)FOR SLOW INTRAVENOUS USE ONLYSEE INSERT / SINGLE DOSENO PRESERVATIVE ADDEDIMS, LIMITEDRx OnlySo. El Monte, CA 91733, U.S.A. 7633040B 8-1110 mL      1 g (13.6 mEq)       100 mg / mLCALCIUM CHLORIDE INJ., USP, 10%Approx. mL  0   1   2   3   4   5   6   7   8   9

Principle Display Panel: Carton

Luer-Lock Prefilled SyringeRx onlyNDC 76329-3304-1STOCK NO. 3304CALCIUM CHLORIDE INJ. USP, 10%1.36 mEq/ mL (100 mg/ mL)13.6 mEq (1 g) per 10 mLOne 10 mL Single Dose Prefilled SyringeSingle use, do not reuse or resterilize.FOR SLOW INTRAVENOUS USELUER-JET
TM LUER-LOCK PREFILLED SYRINGE

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