Calcium Chloride
Hospira, Inc.
Human Prescription Drug
NDC 0409-4928Calcium Chloride is a human prescription drug labeled by 'Hospira, Inc.'. National Drug Code (NDC) number for Calcium Chloride is 0409-4928. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Calcium Chloride drug includes Calcium Chloride - 100 mg/mL . The currest status of Calcium Chloride drug is Active.
Drug Information:
| Drug NDC: | 0409-4928 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Calcium Chloride |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Calcium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hospira, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CALCIUM CHLORIDE - 100 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
INTRAVENTRICULAR
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 24 Jan, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Hospira, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 828527
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | M4I0D6VV5M
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Blood Coagulation Factor [EPC]
Calcium [CS]
Cations
Divalent [CS]
Increased Coagulation Factor Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0409-4928-34 | 10 CARTON in 1 CONTAINER (0409-4928-34) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE | 24 Jan, 2006 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Calcium chloride calcium chloride calcium chloride calcium cation chloride ion water hydrochloric acid sodium hydroxide
Indications and Usage:
Indications and usage 10% calcium chloride injection, usp is indicated (1) for the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, (2) in the treatment of magnesium intoxication due to overdosage of magnesium sulfate and (3) to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ecg), pending correction of the increased potassium level in the extracellular fluid. 10% calcium chloride injection, usp also may be used in cardiac resuscitation when weak or inadequate contractions return following defibrillation or when epinephrine injection has failed to strengthen myocardial contractions.
Warnings:
Warnings 10% calcium chloride injection, usp 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. warning: 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.
Dosage and Administration:
Dosage and administration 10% calcium chloride injection, usp 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. the usual adult dosage in hypocalcemic disorders ranges from 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. in magnesium intoxication, an initial adult dose of 500 mg (5 ml) should be administered promptly and the patient observed for signs o
Read more...f recovery before further doses are given. in hyperkalemic ecg disturbances of cardiac function, the dosage of calcium chloride injection should be titrated by constant monitoring of ecg changes during administration. in cardiac resuscitation, the usual adult dosage ranges from 500 mg to 1 g (5 to 10 ml) intravenously, or from 200 to 800 mg (2 to 8 ml) when injected into the ventricular cavity. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions . to prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.
Contraindications:
Contraindications calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity.
Adverse Reactions:
Adverse reactions rapid injection may cause the patient to complain of tingling sensations, a calcium taste, a sense of oppression or âheat waveâ. injections of calcium chloride are accompanied by peripheral vasodilatation as well as a local âburningâ sensation and there may be a moderate fall in blood pressure. should perivascular infiltration occur, i.v. administration at that site should be discontinued at once. local infiltration of the affected area with 1% procaine hydrochloride, to which hyaluronidase may be added, will often reduce venospasm and dilute the calcium remaining in the tissues locally. local application of heat may also be helpful.
Overdosage:
Overdosage too rapid injection may produce lowering of blood pressure and cardiac syncope. persistent hypercalcemia from overdosage of calcium is unlikely because of rapid excretion. in the event of untoward effects from excessive calcium administration, the drug should be discontinued promptly, the patient re-evaluated and appropriate countermeasures instituted, if necessary. see precautions and adverse reactions .
Description:
Description 10% calcium chloride injection, usp is a sterile, nonpyrogenic, hypertonic solution containing 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 unit of use syringe to facilitate prompt intravenous injection. the solution is administered only by intravenous or intraventricular cavity injection as a calcium replenisher. the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. as per usp testing, when diluted with water for injection to make a 5% solution, the ph of calcium chloride injection is 6.3 (5.5 to 7.5). 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) white, odorless fragments or granules freely soluble in water.
Clinical Pharmacology:
Clinical pharmacology calcium is the fifth most abundant element in the body and the major fraction is in the bony structure. calcium plays important physiological roles, many of which are poorly understood. it is essential for the functional integrity of the nervous and muscular systems. it is necessary for normal cardiac function and is one of the factors that operates in the mechanisms involved in the coagulation of blood. calcium chloride in water dissociates to provide calcium (ca ++ ) and chloride (cl¯) ions. they are normal constituents of the body fluids and are dependent on various physiological mechanisms for maintenance of balance between intake and output. approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%.
How Supplied:
How supplied 10% calcium chloride injection, usp is supplied in single-dose containers as follows: ndc no. container size needle 0409-4928-34 lifeshield ® abboject ® unit of use syringe with male luer lock adapter and protected needle 10 ml 20-g store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] abboject® is a trademark of the abbott group of companies lifeshield ® is the trademark of icu medical, inc. and is used under license. distributed by hospira, inc., lake forest, il 60045 usa lab-1241-2.0 revised: 04/2018 logo
Package Label Principal Display Panel:
Principal display panel - 10 ml syringe label calcium chloride 1 gram/10 ml 10 ml single-dose ndc 0409-4928-34 10% calcium chloride inj., usp 1 gram (100 mg/ml) 1.4 meq ca ++ /ml for i.v. use. usual dosage: see insert. sterile, nonpyrogenic. caution: do not inject intramuscularly or subcutaneously. 2.04 mosmol/ml (calc.). ph 6.3 (5.5 to 7.5). contains no more than 1000 mcg/l of aluminum. rx only hospira hospira, inc. lake forest, il 60045 usa rl-0680 (10/04) principal display panel - 10 ml syringe label
Principal display panel - 10 ml syringe carton 10 ml ndc 0409-4928-34 10% calcium chloride injection, usp 1 gram (100 mg/ml) represents 27 mg (1.4 meq) ca ++ /ml lifeshield ® glass abboject ® unit of use syringe with male luer lock adapter and 20-gauge protected needle rx only hospira â press and pull to open principal display panel - 10 ml syringe carton