Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 10% CALCIUM CHLORIDE INJECTION is supplied in the following dosage forms. NDC 51662-1209-1 10% CALCIUM CHLORIDE INJECTION, USP 1gram (100mg/mL) SYR NDC 51662-1209-2 10% CALCIUM CHLORIDE INJECTION, USP 1gram (100mg/mL) SYR, 1 SYRINGE PER POUCH NDC 51662-1209-3 10% CALCIUM CHLORIDE INJECTION, USP 1gram (100mg/mL) SYR, 1 SYRINGE PER POUCH, 10 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 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.; PRINCIPLE DISPLAY PANEL, SYRINGE 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) SYRINGE LABEL; PRINCIPLE DISPLAY PANEL, 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 ◀ PRESS AND PULL TO OPEN CARTON; PRINCIPLE DISPLAY PANEL, SERIALIZED LABEL SERIALIZED CARTON; PRINCIPAL DISPLAY PANEL - NDC 51662-1209-2 POUCH LABELING NDC 51662-1209-2 POUCH LABELING CARTON LABELING SYRINGE LABEL POUCH LABELING CARTON LABELING SYRINGE LABEL; PRINCIPAL DISPLAY PANEL - NDC 51662-1209-3 CASE LABELING NDC 51662-1209-2 CASE LABELING SERIALIZED CASE RFID LABELING Case Labeling RFID Label
- HOW SUPPLIED 10% CALCIUM CHLORIDE INJECTION is supplied in the following dosage forms. NDC 51662-1209-1 10% CALCIUM CHLORIDE INJECTION, USP 1gram (100mg/mL) SYR NDC 51662-1209-2 10% CALCIUM CHLORIDE INJECTION, USP 1gram (100mg/mL) SYR, 1 SYRINGE PER POUCH NDC 51662-1209-3 10% CALCIUM CHLORIDE INJECTION, USP 1gram (100mg/mL) SYR, 1 SYRINGE PER POUCH, 10 POUCHES PER CASE HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 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.
- PRINCIPLE DISPLAY PANEL, SYRINGE 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) SYRINGE LABEL
- PRINCIPLE DISPLAY PANEL, 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 ◀ PRESS AND PULL TO OPEN CARTON
- PRINCIPLE DISPLAY PANEL, SERIALIZED LABEL SERIALIZED CARTON
- PRINCIPAL DISPLAY PANEL - NDC 51662-1209-2 POUCH LABELING NDC 51662-1209-2 POUCH LABELING CARTON LABELING SYRINGE LABEL POUCH LABELING CARTON LABELING SYRINGE LABEL
- PRINCIPAL DISPLAY PANEL - NDC 51662-1209-3 CASE LABELING NDC 51662-1209-2 CASE LABELING SERIALIZED CASE RFID LABELING Case Labeling RFID Label
Overview
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 CaCl2 · 2H2O (dihydrate) white, odorless fragments or granules freely soluble in water.
Indications & Usage
INDICATIONS & 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.
Dosage & Administration
DOSAGE & 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 of 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.
Warnings & Precautions
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.
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
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.
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