You are here: Home > Prescription(RX) Drugs > C > Calcium Chloride (General Injectables & Vaccines, Inc)

Name:Calcium Chloride
Manufacturer:General Injectables & Vaccines, Inc
Category:Prescription Marketed Drugs


10% Calcium Chloride 100 mg/mL Injection, USP 10 mL Single Dose Vial

CALCIUM CHLORIDE  - calcium chloride injection, solution 
General Injectables & Vaccines, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

10% Calcium Chloride 100 mg/mL Injection, USP 10 mL Single Dose Vial

Description

Each mL contains: Calcium Chloride Dihydrate 100 mg in Water for Injection q.s. pH (range 5.5-7.5) adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Each 10 mL contains 13.6 mEq Calcium and 13.6 mEq Chloride. The molecular weight is 147.02 and the molecular formula is CaCl2•2H2O. Sterile, nonpyrogenic.

Clinical Pharmacology

Calcium is the fifth most abundant element in the body; the major fraction is in bone. It is essential for the functional integrity of the nervous and muscular systems, for normal cardiac contractility and the coagulation of blood. It also functions as an enzyme cofactor and affects the secretory activity of endocrine and exocrine glands.

Indications and Usage

Calcium Chloride is indicated in the immediate treatment of hypocalcemic tetany. Other therapy, such as parathyroid hormone or vitamin D, may be indicated according to the etiology of the tetany. It is also important to institute oral calcium therapy as soon as practicable. Calcium salts have been used as adjunctive therapy in a number of conditions, including the following:

Insect bites or stings, such as Black Widow Spider bites.

Sensitivity reactions, particularly when characterized by urticaria.

As an aid in the treatment of depression due to overdosage of magnesium sulfate.

As an aid in the management of the acute symptoms in lead colic.

In cardiac resuscitation, particularly after open heart surgery, calcium chloride has been used when epinephrine has failed to improve weak or ineffective myocardial contractions.

Contraindications

In cardiac resuscitation, the use of calcium chloride is contraindicated in the presence of ventricular fibrillation.

Warnings

This solution is suitable only for intravenous use. Calcium chloride solution injection into muscle or into subcutaneous or perivascular tissue may cause severe necrosis and sloughing. Intravenous injections of this drug must be made with great care to avoid leakage into the perivascular tissue. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

To avoid undesirable reactions that may follow intravenous administration of calcium chloride, the rate of injection should not exceed 0.5 mL to 1 mL per minute. Because of the danger involved in the simultaneous use of calcium salts and drug of the digitalis group, a digitalized patient should not receive an intravenous injection of a calcium compound unless the indications are clearly defined.

Use In Pregnancy

Safety for use in pregnancy has not been established. Use of calcium chloride in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

Administration and Dosage

The usual adult dose of this preparation varies from 5 to 10 mL at intervals of 1 to 3 days. In cardiac resuscitation, the usual dose is 2 to 4 mL injected into the ventricular cavity. Care should be taken to avoid injection into the cardiac muscle. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

Treatment of Overdose

Inadvertent systemic overloading with calcium ion can produce an acute hypercalcemic syndrome. The syndrome is characterized by weakness, lethargy, intractable nausea and vomiting, coma, and sudden death, and a markedly elevated plasma calcium level. It is suggested that details of treatment of this problem be obtained by reference to Harrison’s Principles of Internal Medicine Sixth Edition, pg. 475, column 2, “Acute Hypercalcemic Syndrome”.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

How Supplied

Calcium Chloride Injection, USP 10%. (No preservative added).

NDC 0517-2710-25 10 mL single dose vial packed in a box of 25

Sample Outer Label

Label


CALCIUM CHLORIDE 
calcium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-710(NDC:0517-2710)
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcium Chloride (Calcium) Calcium Chloride 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Hydroxide  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-710-25 1 VIAL, SINGLE-DOSE ( VIAL) in 1 BAG contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BAG (52584-710-25)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2010

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 08/2010 General Injectables & Vaccines, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback