MAGNESIUM SULFATE- magnesium sulfate in water for injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Amneal Pharmaceuticals LLC

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

Magnesium Sulfate in Water for Injection is clear and colorless solution filled in intravenous bag and are supplied as 2 g/50 mL (40 mg/mL) and 4 g/100 mL (40 mg/mL). Each 50 mL contains 2 g of magnesium sulfate heptahydrate, USP (equivalent to 16.25 mEq magnesium) in water for injection and each 100 mL contains 4 g of magnesium sulfate heptahydrate, USP (equivalent to 32.5 mEq magnesium) in water for injection. It is available as follows: Strength Each Unit of Sale 2 g/50 mL (40 mg/mL) NDC 70121-1719-1 1 Single-dose Intravenous Bag in an Overwrap NDC 70121-1719-9 Unit of 24 4 g/100 mL (40 mg/mL) NDC 70121-1720-1 1 Single-dose Intravenous Bag in an Overwrap NDC 70121-1720-9 Unit of 24 For more details, please see below table: NDC No. Size Total Magnesium Sulfate Total Magnesium Ion Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity (cal.) 70121-1719-1 50 mL 2 g 16.25 mEq 40 mg/mL 16.25 mEq/50 mL 325 mOsmol/Liter 70121-1720-1 100 mL 4 g 32.5 mEq 40 mg/mL 32.5 mEq/100 mL 325 mOsmol/Liter WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

MAGNESIUM SULFATE- MAGNESIUM SULFATE IN WATER FOR INJECTION
AMNEAL PHARMACEUTICALS LLC
----------
MAGNESIUM SULFATE IN WATER FOR INJECTION
RX ONLY
SINGLE-DOSE INTRAVENOUS BAG
FOR INTRAVENOUS USE ONLY
DESCRIPTION
Magnesium sulfate in water for injection is a sterile, nonpyrogenic,
clear and colorless
solution of magnesium sulfate heptahydrate, USP in water for
injection, USP. 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 is chemically designated as MgSO • 7H
O and its
molecular weight is 246.5 g/mol and having below structural formula:
Magnesium sulfate heptahydrate, USP is white or almost white
crystalline powder or
brilliant colorless crystals which is freely soluble in water, very
soluble in boiling water,
practically insoluble in ethanol (96%).
4
2
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from a specially
formulated non
polyvinylchloride.
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 from 1.3
mEq/liter to 2.1 mEq/liter.
As serum magnesium rises above 4 mEq/liter, the deep tendon reflexes
are first
decreased and then disappear as the serum level approaches 10
mEq/liter. At this level
respiratory paralysis may occur. Heart block also may occur at this or
lower serum
levels of magnesium.
Magnesium acts peripherally t