MAGNESIUM SULFATE 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:

General Injectables and Vaccines, Inc.

INN (International Name):

MAGNESIUM SULFATE HEPTAHYDRATE

Composition:

MAGNESIUM SULFATE HEPTAHYDRATE 500 mg in 1 mL

Administration route:

INTRAMUSCULAR

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 5.2 mEq/L) or elevated. In total parental nutrition (TPN), magnesium sulfate may be added to the nutriend 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:

Above products packaged in plastic vials. Product number with a "P" suffix indicates vial is partially filled. Do not administer unless solution is clear and seal is intact. Contains no preservative. Discard unused portion. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

MAGNESIUM SULFATE- MAGNESIUM SULFATE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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MAGNESIUM SULFATE
DESCRIPTION
45766F/Revised: May 2013
Magnesium Sulfate
Injection, USP
50%
Magnesium Sulfate Injection, USP 50% is a sterile, nonpyrogenic,
concentrated solution
of magnesium sulfate heptahydrate in Water for Injection. It is
administered by the
intravenous (IV) or intramuscular (IM) routes as an electrolyte
replenisher or
anticonvulsant. Must be diluted before IV use.
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. The pH
of a 5% solution is between 5.5 and 7.0. (Osmolarity: 4060 mOsmol/L
(calc.); 2.03
mM/mL magnesium sulfate anhydrous; 4.06 mEq/mL magnesium sulfate
anhydrous).
The solution contains no bacteriostate, antimicrobial agent or added
buffer (except for
pH adjustment) and is intended only for use 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 chemicallly designated MgSO4•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 stlres of magnesium present
intracellularly and in the
bones of adults, these stores often are not mobilized sufficiently to
maintain plasma
levels. Parenteral magnesium therapy repairs the plasma defic