Country: United States
Language: English
Source: NLM (National Library of Medicine)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)
Medical Purchasing Solutions, LLC
CALCIUM CHLORIDE
CALCIUM CHLORIDE 100 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. 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. None known.
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.]
New Drug Application
CALCIUM CHLORIDE- CALCIUM CHLORIDE INJECTION, SOLUTION MEDICAL PURCHASING SOLUTIONS, LLC ---------- 10% CALCIUM CHLORIDE INJECTION, USP 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 CaCl • 2H O (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 functio Read the complete document