MAGNESIUM SULFATE- 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:

Fresenius Kabi Norge AS

INN (International Name):

MAGNESIUM SULFATE HEPTAHYDRATE

Composition:

MAGNESIUM SULFATE HEPTAHYDRATE 80 mg in 1 mL

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 single-dose flexible 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. This container is not made with natural rubber latex or polyvinyl chloride (PVC), Non-DEHP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
FRESENIUS KABI NORGE AS
----------
MAGNESIUM SULFATE
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.
The flexible container is fabricated from a specially formulated
non-plasticized, film containing
polypropylene and thermoplastic elastomers ( FREEflex
bag). The amount of water that can permeate
from the container into the overwrap is insufficient to affect the
solution significantly. Solutions in
contact with the flexible container can leach out certain of the
container’s chemical components in very
small amounts within the expiration period. The suitability of the
container material has been confirmed
by tests in animals according to USP biological tests for plastic
containers. Exposure to temperatures
above 25ºC/77ºF 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 adv