CALCIUM GLUCONATE - calcium gluconate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

A-S Medication Solutions

INN (International Name):

CALCIUM GLUCONATE

Composition:

CALCIUM GLUCONATE 94 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcium Gluconate Injection, USP is used to treat conditions arising from calcium deficiencies such as hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and hypocalcemia due to rapid growth or pregnancy.  It is also used in the treatment of black widow spider bites to relieve muscle cramping and as an adjunct in the treatment of rickets, osteomalacia, lead colic and magnesium sulfate overdosage.  Calcium gluconate has also been employed to decrease capillary permeability in allergic conditions, nonthrombocytopenic purpura and exudative dermatoses such as dermatitis herpetiformis and for pruritus of eruptions caused by certain drugs.  In hyperkalemia, calcium gluconate may aid in antagonizing the cardiac toxicity, provided the patient is not receiving digitalis therapy. Calcium salts are contraindicated in patients with ventricular fibrillation or hypercalcemia.  Intravenous administration of calcium is contraindicated when serum calcium levels are above normal.

Product summary:

Product: 50090-2362 NDC: 50090-2362-0 10 mL in a VIAL, SINGLE-USE

Authorization status:

unapproved drug other

Summary of Product characteristics

CALCIUM GLUCONATE - CALCIUM GLUCONATE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CALCIUM GLUCONATE INJECTION USP
10%
0.465 Elemental Calcium (Ca
) mEq/mL
0.68 mOsmol/mL 680 mOsmol/L
DESCRIPTION:
Calcium Gluconate Injection, USP is a sterile, nonpyrogenic,
supersaturated solution of calcium
gluconate for intravenous use only.
Each mL contains: Calcium gluconate 94 mg; calcium saccharate
(tetrahydrate) 4.5 mg; water for
injection q.s. Hydrochloric acid and/or sodium hydroxide may have been
added for pH adjustment (6.0
to 8.2).
Calcium saccharate provides 6% of the total calcium and stabilizes the
supersaturated solution of
calcium gluconate.
Each 10 mL of the injection provides 93 mg elemental calcium (Ca
) equivalent to 1 g of calcium
gluconate.
The structural formula is:
CLINICAL PHARMACOLOGY:
Calcium is the fifth most abundant element in the body and is
essential for maintenance of the functional
integrity of nervous, muscular and skeletal systems, cell membranes
and capillary permeability. It is
also an important activator in many enzymatic reactions and is
essential to a number of physiologic
processes including transmission of nerve impulses; contraction of
cardiac, smooth and skeletal
muscles; renal function; respiration; and blood coagulation. Calcium
also plays regulatory roles in the
release and storage of neurotransmitters and hormones; in the uptake
and binding of amino acids; in
cyanocobalamin (vitamin B
) absorption; and gastrin secretion.
INDICATIONS AND USAGE:
Calcium Gluconate Injection, USP is used to treat conditions arising
from calcium deficiencies such as
hypocalcemic tetany, hypocalcemia related to hypoparathyroidism and
hypocalcemia due to rapid
++
++
12
growth or pregnancy. It is also used in the treatment of black widow
spider bites to relieve muscle
cramping and as an adjunct in the treatment