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:

General Injectables & 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 (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) 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, USP is also indicated for the prevention and control of seizures (convulsions) in pre-eclampsia and eclampsia, respectively. Parenteral administration of the drug is contraindicated in patients with heart block and myocardial damage.

Product summary:

Magnesium Sulfate Injection, USP is supplied in single-dose containers as follows: Do not administer unless solution is clear and container is undamaged. Discard unused portion. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
50% MAGNESIUM SULFATE 5 G/ML INJECTION, USP 10 ML PREFILLED SYRINGE
ANSYR PLASTIC SYRINGE
RX ONLY
DESCRIPTION
Ansyr™ Plastic Syringe
Rx Only
Magnesium Sulfate Injection, USP is a sterile solution of magnesium
sulfate heptahydrate
in Water for Injection, USP administered by the intravenous or
intramuscular routes as
an electrolyte replenisher or anticonvulsant. Must be diluted before
intravenous use. May
contain sulfuric acid and/or sodium hydroxide for pH adjustment. The
pH is 5.5 to 7.0.
The 50% concentration has an osmolarity of 4.06 mOsmol/mL (calc.).
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, USP heptahydrate is chemically designated mgSO
•7H O with
molecular weight of 246.48 and occurs as colorless crystals or white
powder freely
soluble in water.
The plastic syringe is molded from a specially formulated
polypropylene. Water
permeates from inside the container at an extremely slow rate which
will have an
insignificant effect on solution concentration over the expected shelf
life. Solutions in
contact with the plastic container may leach out certain chemical
components from the
plastic in very small amounts; however, biological testing was
supportive of the safety of
the syringe material.
CLINICAL PHARMACOLOGY
Magnesium (Mg++) 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/liter)
may develop as early as three to four days or within weeks.
Predominant deficiency effects are neurological, e.g., muscle
irritability, clonic twitc