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:

Cardinal Health

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 a 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 Fill Volume Magnesium mg/mL Sulfate mg/mL 96402 63323-064-02 500 mg/mL 2 mL 49.3 194.7 96410P 63323-064-10    500 mg/mL 10 mL 49.3 194.7 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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
CARDINAL HEALTH
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MAGNESIUM SULFATE INJECTION USP
50%
DESCRIPTION
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 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 the bones of
adults, these stores often are not
mobilized sufficiently to maintain plasma levels. Parenteral magnesium
therapy repairs the plasma
deficit and causes deficiency symptoms and signs to cease.
Magnes