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 USA, LLC

INN (International Name):

MAGNESIUM SULFATE HEPTAHYDRATE

Composition:

MAGNESIUM SULFATE HEPTAHYDRATE 500 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia.  In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) or elevated. In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy. Magnesium sulfate injection is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

Product summary:

Product No. NDC No. % Magnesium Sulfate Heptahydrate Volume Fill Magnesium mg/mL Sulfate mg/mL NP6420 63323-064-29 50 20 mL 49.3 194.7 Do not administer unless solution is clear and seal intact. Preservative Free. Discard unused portion. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

unapproved drug other

Summary of Product characteristics

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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MAGNESIUM SULFATE INJECTION USP
50%
DESCRIPTION
Magnesium Sulfate Injection, USP is a sterile, concentrated solution
of magnesium sulfate heptahydrate
for use as an electrolyte replenisher or anticonvulsant by
intramuscular (IM) or intravenous (IV) routes
of administration. Must be diluted before IV use. The product is
available in a 50% concentration.
Each mL contains: Magnesium sulfate heptahydrate 500 mg; Water for
Injection q.s. Sulfuric acid and/or
sodium hydroxide may have been added for pH adjustment (5.5 to 7.0).
Osmolarity: 4,060 mOsmol/L
(calc.); 2.03 mM/mL magnesium sulfate anhydrous; 4.06 mEq/mL magnesium
sulfate anhydrous. THIS
PRODUCT CAN BE USED FOR IM OR IV USE.
The solution contains no bacteriostat, antimicrobial agent or added
buffer (except for pH adjustment) and
is intended only for use as a single dose injection. When smaller
doses are required the unused portion
should be discarded with the entire unit.
Magnesium sulfate heptahydrate is chemically designated MgSO
•7H
O, with a molecular weight of
246.47 and occurs as colorless crystals or white powder freely soluble
in water.
CLINICAL PHARMACOLOGY
Magnesium is an important cofactor for enzymatic reactions and plays
an important role in
neurochemical transmission and muscular excitability.
As a nutritional adjunct in hyperalimentation, the precise mechanism
of action for magnesium is
uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/L) may
develop as early as three to
four days or within weeks.
Predominant deficiency effects are neurological, e.g., muscle
irritability, clonic twitching and tremors.
Hypocalcemia and hypokalemia often follow low serum levels of
magnesium. While there are large
stores of magnesium present intracellularly and in