Calcium Chloride
American Regent, Inc.
Human Prescription Drug
NDC 0517-6710Calcium Chloride is a human prescription drug labeled by 'American Regent, Inc.'. National Drug Code (NDC) number for Calcium Chloride is 0517-6710. 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: | 0517-6710 |
| 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: | American Regent, 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
|
| 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: | ANDA |
| 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: | 06 Feb, 2018 |
| 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. |
| Application Number: | ANDA209088 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | American Regent, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 828525
|
| 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 |
|---|
| 0517-6710-10 | 10 VIAL, GLASS in 1 BOX (0517-6710-10) / 10 mL in 1 VIAL, GLASS | 06 Feb, 2018 | 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 is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
Warnings:
Warnings 10% calcium chloride injection 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 is administered only by slow intravenous injection (not to exceed 1 ml/min), preferably in a central or deep vein . 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 200 mg to 1 g (2 to 10 ml) at intervals of 1 to 3 days depending on the response of the patient and/or results of serum ionized calcium determinations. repeated injections may be required because of rapid excretion of calcium. the pediatric dosage in hypocalcemic disorders ranges from 2.7 to 5.0 mg/kg hydrated calcium chloride (or 0.136 to 0.252 meq elemental calcium per kg, or 0.027 to 0.05 ml of 10% calcium chloride injection per kg)
Read more.... no data from clinical trials is available about repeated dosages, though textbook references recommend repeat dosages q 4 to 6 hours. caution : 10% calcium chloride injection consists of 1 gram of calcium chloride in a 10 ml vial, or 100 mg/ml. this concentration represents 27 mg or 1.4 meq of elemental calcium per ml. thus, one 10 ml syringe provides 270 mg of elemental calcium. the dosage recommendation in various references is given either as amount of calcium chloride or amount of elemental calcium, and often it is not specified. ionized calcium concentrations should be measured, to assist in dosage adjustment. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .
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. calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation.
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.
Use in Pregnancy:
Pregnancy animal reproduction studies have not been conducted with calcium chloride. it also is not known whether calcium chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. calcium chloride should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use: safety and effectiveness are based on similar clinical conditions in children and adults.
Geriatric Use:
Geriatric use: an evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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 is a sterile, nonpyrogenic, hypertonic solution. each ml contains 100 mg (1.4 meq/ml) of calcium chloride, dihydrate (1.4 meq each of ca ++ and cl â ) in water for injection. it is provided in a 10 ml single-dose vial to facilitate prompt intravenous injection. the solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose injection. the ph of 10% calcium chloride injection is 6.3 (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 is oxygen sensitive. calcium chloride dihydrate is chemically designated cacl 2 ⢠2h 2 o (dihydrate) and is described as 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 â ) 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%.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility: studies with solutions in polypropylene syringes have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Clinical Studies:
Clinical studies medical literature also refers to the administration of calcium chloride in the treatment of magnesium intoxication due to overdosage of magnesium sulfate, and to combat the deleterious effects of hyperkalemia as measured by electrocardiogram (ecg), pending correction of the increased potassium level in the extracellular fluid. however, adequate well-controlled, randomized clinical studies have not been done to support these indications. to report suspected adverse reactions, contact american regent, inc. at 1-800-734-9236 or fda at 1-800-fda-1088 or www.fda.gov/medwatch . american regent shirley, ny 11967 revised: july 2017 in6710 rq1071-00
How Supplied:
How supplied 10% calcium chloride injection, usp is supplied in single-dose containers as follows: ndc no. container size carton 0517-6710-10 glass vial 10 ml 10 vials store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.]
Package Label Principal Display Panel:
Principal display panel container label ndc 0517- 6710 -01 rx only 10% calcium chloride injection, usp 1 gram/10 ml (100 mg/ml) for intravenous use only sterile, nonpyrogenic 10 ml single-dose vial container label
Principal display panel carton labeling ndc 0517-6710-10 10% calcium chloride injection, usp rx only 1 gram/10 ml (100 mg/ml) represents 27 mg (1.4 meq) ca++/ml for intravenous use only 10 x 10 ml single-dose vials american regent, inc. shirley, ny 11967 carton labeling for oh
Serialization label serialization label