MAGNESIUM SULFATE- 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:

Mylan Institutional LLC

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose. Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

Rezumat produs:

Magnesium Sulfate in Water for Injection is supplied as a clear, colorless solution in single-dose flexible plastic container as follows: NDC No. Size Container Total Magnesium Sulfate** Total Magnesium Ion Magnesium Sulfate** Concentration Magnesium Ion Concentration Osmolarity (calc.) 67457-554-00 100 mL 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/ 100 mL 325 mOsmol/ Liter 67457-553-00 50 mL* 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/ 50 mL 325 mOsmol/ Liter * Partial fill container 50 mL volume in 100 mL container. ** As the heptahydrate. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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MAGNESIUM SULFATE IN WATER FOR INJECTION
FLEXIBLE PLASTIC CONTAINER
Rx only
FOR INTRAVENOUS USE ONLY
DESCRIPTION
Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic,
clear, colorless
solution of magnesium sulfate heptahydrate in water for injection. May
contain sulfuric
acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to
6.5). It is available
in 4% concentration. See _HOW SUPPLIED_ section for the content and
characteristics
of available dosage forms and sizes.
Magnesium Sulfate, USP heptahydrate is chemically designated MgSO •
7H O, colorless
crystals or white powder freely soluble in water.
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from polypropylene. Water
can permeate from
inside the container into the overwrap but not in amounts sufficient
to affect the
solution significantly. Solutions in contact with the plastic
container may leach out certain
chemical components from the plastic in very small amounts; however,
biological testing
was supportive of the safety of the plastic container materials.
Exposure to
temperatures above 25°C/77°F during transport and storage will lead
to minor losses in
moisture content. Higher temperatures lead to greater losses. It is
unlikely that these
minor losses will lead to clinically significant changes within the
expiration period.
CLINICAL PHARMACOLOGY
Magnesium (Mg
) is an important cofactor for enzymatic reactions and plays an
important role in neurochemical transmission and muscular
excitability.
Magnesium prevents or controls convulsions by blocking neuromuscular
transmission
and decreasing the amount of acetylcholine liberated at the end plate
by the motor
nerve impulse. Magnesium is said to have a depressant effect on the
central nervous
system, but it does not adversely affect the mother, fetus or neonate
when used as
directed in eclampsia or pre-eclampsia. Normal serum