Drug Facts
Composition & Profile
Identifiers & Packaging
10% Cacliumn Chloride Injection, USP is supplied omn single-dose containers as follows: Unit of Sale Container Total Strength / Total Volume (Concentration) Each Needle NDC 64253-900-91 10 mL Single-dose prefilled syringes, individually pouched, in a carton of 10s Plastic Syringe 1000 mg/10 mL (100 mg/mL) NDC 64253-900-30 10 mL fill in 12 mL Syringe Single-dose prefilled syringes, individually pouched None NDC 64253-900-36 10 mL Single-dose prefilled syringes, individually pouched, in a carton of 60s Plastic Syringe 1000 mg/10 mL (100 mg/mL) NDC 64253-900-30 10 mL fill in 12 mL Syringe Single-dose prefilled syringes, individually pouched None Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]. Do not freeze.; Package Insert Rev 001 - Page 1; Package Insert Rev 001 Page 2; Dispenser Box Label Rev 001; Dispenser Box - 10 Count Rev 002; Dispenser Box - 60 Count Rev 002; Pouch Label Rev 004; Master Carton Label - 10 Count Rev 001; Master Carton Label - 60 count Rev 001; Syringe Label rev. 004
- 10% Cacliumn Chloride Injection, USP is supplied omn single-dose containers as follows: Unit of Sale Container Total Strength / Total Volume (Concentration) Each Needle NDC 64253-900-91 10 mL Single-dose prefilled syringes, individually pouched, in a carton of 10s Plastic Syringe 1000 mg/10 mL (100 mg/mL) NDC 64253-900-30 10 mL fill in 12 mL Syringe Single-dose prefilled syringes, individually pouched None NDC 64253-900-36 10 mL Single-dose prefilled syringes, individually pouched, in a carton of 60s Plastic Syringe 1000 mg/10 mL (100 mg/mL) NDC 64253-900-30 10 mL fill in 12 mL Syringe Single-dose prefilled syringes, individually pouched None Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]. Do not freeze.
- Package Insert Rev 001 - Page 1
- Package Insert Rev 001 Page 2
- Dispenser Box Label Rev 001
- Dispenser Box - 10 Count Rev 002
- Dispenser Box - 60 Count Rev 002
- Pouch Label Rev 004
- Master Carton Label - 10 Count Rev 001
- Master Carton Label - 60 count Rev 001
- Syringe Label rev. 004
Overview
% 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 our certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.
Indications & Usage
% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. 10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
Dosage & Administration
% 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 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). 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.
Warnings & Precautions
% 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. Calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation.
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. To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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