MAGNESIUM SULFATE IN WATER 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:

Athenex Pharmaceutical Division, LLC.

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 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. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MAGNESIUM SULFATE IN WATER- MAGNESIUM SULFATE IN WATER INJECTION,
SOLUTION
ATHENEX PHARMACEUTICAL DIVISION, LLC.
----------
MAGNESIUM SULFATE IN WATER FOR INJECTION
(FOR INTRAVENOUS USE)
ATHENEX
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 SUPPLIEDsection 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 free of polyvinylchloride. 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 magnesium levels
rang