MAGNESIUM SULFATE- magnesium sulfate heptahydrate injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Gland Pharma Limited

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

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.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

MAGNESIUM SULFATE - MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
GLAND PHARMA LIMITED
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MAGNESIUM SULFATE IN WATER FOR INJECTION
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-eclampsia. Normal
serum magnesium levels range
f