MAGNESIUM SULFATE- magnesium sulfate heptahydrate injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Sun Pharmaceutical Industries, Inc.

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Magnesium Sulfate in Water for Injection is supplied as clear colorless solution in single-dose flexible plastic containers as follows: * 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MAGNESIUM SULFATE - MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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%
concentration. See HOW SUPPLIED section for the content and
characteristics of
available dosage forms and sizes.
Magnesium sulfate heptahydrate, USP 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 a specially
formulated 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-eclamp