MAGNESIUM SULFATE- magnesium sulfate heptahydrate injection, solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Fresenius Kabi USA, LLC

INN (Међународно име):

MAGNESIUM SULFATE HEPTAHYDRATE

Састав:

MAGNESIUM SULFATE HEPTAHYDRATE 500 mg in 1 mL

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia.  In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) or elevated. In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. Magnesium sulfate injection is also indicated for the prevention and control of seizures in a pre-eclampsia and eclampsia, respectively. Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

Резиме производа:

*Packaged in glass vials. Do not administer unless solution is clear and seal is intact. Contains no preservative.  Discard unused portion. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Статус ауторизације:

New Drug Application

Карактеристике производа

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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MAGNESIUM SULFATE INJECTION, USP
Rx only
50%
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: 4,060 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
causes deficiency
symptoms and si