MAGNESIUM SULFATE heptahydrate injection solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)

제공처:

X-GEN Pharmaceuticals, Inc.

INN (International Name):

MAGNESIUM SULFATE HEPTAHYDRATE

구성:

MAGNESIUM SULFATE HEPTAHYDRATE 500 mg in 1 mL

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
X-GEN PHARMACEUTICALS, INC.
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MAGNESIUM SULFATE INJECTION USP
MAGNESIUM SULFATE INJECTION, USP
50%
RX ONLY
DESCRIPTION
Magnesium Sulfate Injection, USP 50% is a sterile, nonpyrogenic,
concentrated solution of magnesium
sulfate heptahydrate in Water for Injection. It is administered by the
intravenous (IV) or intramuscular
(IM) routes as an electrolyte replenisher or anticonvulsant. Must be
diluted before IV use.
Each mL contains: Magnesium sulfate heptahydrate 500 mg; Water for
Injection q.s. Sulfuric acid
and/or sodium hydroxide may have been added for pH adjustment. The pH
of a 5% solution is between
5.5 and 7.0. (Osmolarity: 4060 mOsmol/L (calc.); 2.03 mM/mL magnesium
sulfate anhydrous; 4.06
mEq/mL magnesium sulfate anhydrous).
The solution contains no bacteriostat, antimicrobial agent or added
buffer (except for pH adjustment) and
is intended only for use as a single dose injection. When smaller
doses are required the unused portion
should be discarded with the entire unit.
Magnesium sulfate heptahydrate is chemically designated MgSO •7H O,
with a molecular weight of
246.47 and occurs as colorless crystals or white powder freely soluble
in water.
CLINICAL PHARMACOLOGY
Magnesium is an important cofactor for enzymatic reactions and plays
an important role in
neurochemical transmission and muscular excitability.
As a nutritional adjunct in hyperalimentation, the precise mechanism
of action for magnesium is
uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/L) may
develop as early as three to
four days or within weeks.
Predominant deficiency effects are neurological, e.g., muscle
irritability, clonic twitching and tremors.
Hypocalcemia and hypokalemia often follow low serum levels of
magnesium. While there are large
stores of magnesium present intracellularly and in the bones of
adults, these stores often are not
mobilized sufficiently to maintain plasma levels. Parenteral magnesium
therapy repairs the plasma
deficit and