MAGNESIUM SULFATE IN WATER injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Hospira, Inc.

Designación común internacional (DCI):

MAGNESIUM SULFATE HEPTAHYDRATE

Composición:

MAGNESIUM SULFATE HEPTAHYDRATE 4 g in 50 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows: NDC 0409-6729-23 Case of 24 single-dose flexible plastic containers 4 g/100 mL (40 mg/mL) 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-4121-50 Case of 50 single-dose flexible plastic containers 4 g/100 mL (40 mg/mL) 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-6729-03 Case of 24 single-dose flexible plastic containers 20 g/500 mL (40 mg/mL) 20 g 162.3 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-2050-20 Case of 20 single-dose flexible plastic containers 20 g/500 mL (40 mg/mL) 20 g 162.3 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter 40 g/1000 mL (40 mg/mL) 40 g 325 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-3164-12 Case of 12 single-dose flexible plastic containers 40 g/1000 mL (40 mg/mL) 40 g 325 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-6729-24 Case of 24 single-dose flexible plastic containers 2 g/50 mL† (40 mg/mL) 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter 2 g/50 mL† (40 mg/mL) 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter NDC 0409-6730-13 Case of 24 single-dose flexible plastic containers 4 g/50 mL† (80 mg/mL) 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter 4 g/50 mL† (80 mg/mL) 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter 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.

Estado de Autorización:

New Drug Application

Ficha técnica

MAGNESIUM SULFATE IN WATER- MAGNESIUM SULFATE IN WATER INJECTION,
SOLUTION
HOSPIRA, INC.
----------
MAGNESIUM SULFATE
IN WATER FOR INJECTION
FLEXIBLE PLASTIC CONTAINER
FOR INTRAVENOUS USE ONLY
Rx only
DESCRIPTION
Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic
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% and
8% concentrations. 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.
Water can permeate from inside the flexible plastic 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 magnesium levels
range from 1.3
to 2.1 mEq/liter.
As serum magn