MAGNESIUM SULFATE heptahydrate injection solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Fresenius Kabi USA, LLC

INN (nume internaţional):

MAGNESIUM SULFATE HEPTAHYDRATE

Compoziție:

MAGNESIUM SULFATE HEPTAHYDRATE 500 mg in 1 mL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

unapproved drug other

Caracteristicilor produsului

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
_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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MAGNESIUM SULFATE INJECTION, USP
50%
DESCRIPTION
Magnesium Sulfate Injection, USP is a sterile, concentrated solution
of magnesium sulfate heptahydrate
for use as an electrolyte replenisher or anticonvulsant by
intramuscular (IM) or intravenous (IV) routes
of administration. Must be diluted before IV use. The product is
available in a 50% concentration.
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 (5.5-7.0).
Osmolarity: 4060 mOsmol/L
(calc.); 2.03 mM/mL magnesium sulfate anhydrous; 4.06 mEq/mL magnesium
sulfate anhydrous. THIS
PRODUCT CAN BE USED FOR IM OR IV USE.
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