Calcium Chloride
Generic: CALCIUM CHLORIDE INJECTION
Basic Information
Manufacturer
Medefil, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
90b8936e-61f2-5318-e053-2995a90aac44
Indications & Usage
10% 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.
10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
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.
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.
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 .
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 .