CALCIUM GLUCONATE injection solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

REMEDYREPACK INC.

INN:

CALCIUM GLUCONATE

composition:

CALCIUM GLUCONATE 94 mg in 1 mL

prescription_type:

PRESCRIPTION DRUG

authorization_status:

unapproved drug other

SPC

CALCIUM GLUCONATE- CALCIUM GLUCONATE INJECTION, SOLUTION
REMEDYREPACK INC.
_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 of ricke