Label: CALCIUM CHLORIDE injection, solution

  • NDC Code(s): 0409-1631-10, 0409-1631-40
  • Packager: Hospira, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 26, 2019

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  • SPL UNCLASSIFIED SECTION

    1 Gram (100 mg/mL)

    Represents 27 mg (1.4 mEq) Ca++/mL

    Ansyr™ Plastic Syringe

    A HYPERTONIC SOLUTION IN A 10 ML UNIT OF USE SYRINGE FOR PROMPT INTRAVENOUS INJECTION.

    CAUTION: This solution must not be injected intramuscularly or subcutaneously.

    Administer only by slow injection

    (not to exceed 1 mL/minute)

    Rx only

  • DESCRIPTION

    10% Calcium Chloride Injection, USP 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) in water for injection. It is provided in a 10 mL Unit of Use Syringe 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, USP is 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, USP is oxygen sensitive.

    Calcium Chloride, USP dihydrate is chemically designated CaCl2 • 2H2O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water.

    The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

  • 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%.

  • INDICATIONS AND USAGE

    10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.

  • 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.

  • 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.

  • PRECAUTIONS

    Do not administer unless solution is clear and seal is intact. Discard unused portion.

    Because of its additive effect, calcium should be administered very cautiously to a patient who is digitalized or who is taking effective doses of digitalis or digitalis-like preparations.

    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.

    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.

    Pediatric Use:

    Safety and effectiveness are based on similar clinical conditions in children and adults.

    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.

    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.

  • ADVERSE REACTIONS

    Rapid 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 vasodilatation as well as a local "burning" 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.

  • DRUG ABUSE AND DEPENDENCE

    None known.

  • 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.

  • DOSAGE AND ADMINISTRATION

    10% Calcium Chloride Injection, USP 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 − 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). 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 syringe, 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.

    To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

  • HOW SUPPLIED

    10% Calcium Chloride Injection, USP is supplied in single-dose containers as follows:

    NDC No.

    Container

    Size

    Needle

    0409-1631-10

    Ansyr™ Plastic Syringe

    10 mL

    None



    Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]


  • 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.

  • SPL UNCLASSIFIED SECTION

    Logo

    Hospira, Inc., Lake Forest, IL 60045 USA

    LAB-1022-2.0

    Revised: 01/2018

  • PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label

    10 mL Single-Dose Syringe - Discard Unused Portion NDC 0409-1631-40

    10% Calcium Chloride Injection, USP
    1000 mg/10 mL (100 mg/mL)

    For Intravenous use only.
    2.04 mOsmol/mL (calc.). pH (5.5 to 7.5). Contains no more than 1,000 mcg/L
    of aluminum.

    Hospira

    Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
    Rx only

    RL-7161

    PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

    10 mL

    NDC 0409-1631-40
    Rx only

    10%
    Calcium
    Chloride
    Injection, USP

    1000 mg/10 mL
    (100 mg/mL)

    For Intravenous use only

    Ansyr™

    Single-Dose Syringe
    Discard Unused Portion

    Hospira

    LOT #####AA
    EXP DMMMYYYY

    ◀ PRESS AND PULL TO OPEN ▶

    PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton
  • INGREDIENTS AND APPEARANCE
    CALCIUM CHLORIDE 
    calcium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0409-1631
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0409-1631-1010 in 1 CONTAINER09/14/2005
    1NDC:0409-1631-401 in 1 CARTON
    110 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02111709/14/2005
    Labeler - Hospira, Inc. (141588017)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hospira, Inc.093132819ANALYSIS(0409-1631) , LABEL(0409-1631) , MANUFACTURE(0409-1631) , PACK(0409-1631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Macco Organiques, S.r.o.521632476API MANUFACTURE(0409-1631)