MAGNESIUM SULFATE IN WATER- magnesium sulfate heptahydrate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

B. Braun Medical Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in pre-eclampsia 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.

Product summary:

Magnesium Sulfate in Water for Injection is supplied in 100 mL fill and 50 mL fill PAB® containers packaged 24 per case as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MAGNESIUM SULFATE IN WATER- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION,
SOLUTION
B. BRAUN MEDICAL INC.
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MAGNESIUM SULFATE IN WATER FOR INJECTION
PAB CONTAINER
FOR INTRAVENOUS USE 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 fill volumes. 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.
Not made with natural rubber latex, DEHP or PVC.
The plastic container is a copolymer of ethylene and propylene
formulated and
developed for parenteral drugs. The copolymer contains no
plasticizers. The safety of
the plastic container has been confirmed by biological evaluation
procedures. The
material passes Class Vl testing as specified in the U.S. Pharmacopeia
for Biological Tests
— Plastic Containers.
The container/solution unit is a closed system and is not dependent
upon entry of
external air during administration. The container has two ports, one
is for the
intravenous administration set covered by a tamperproof barrier and
the other is a
blocked port. Refer to the _DIRECTIONS FOR USE_ of the container to
properly identify
the ports.
No vapor barrier is necessary.
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 ne