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:

Physicians Total Care, Inc.

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 (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 as a parenteral anticonvulsant for the prevention and control of seizures (convulsions) in severe toxemia of pregnancy. 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. Parenteral administration of the drug is contraindi

Product summary:

Magnesium Sulfate Injection, USP is supplied in single-dose containers as follows: NDC No. Container Total Amount Concentration mEq Mg ++ /mL 54868-5724-0 25 x 10 mL Vials             Ansyr™    Plastic Syringe       5 g/10 mL    50% 4 mEq/mL 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.] Revised: November, 2009 Printed in USA                           EN-2303 Hospira, Inc., Lake Forest, IL 60045 USA Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, OK     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MAGNESIUM SULFATE - MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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MAGNESIUM SULFATE
INJECTION, USP
ANSYR™ PLASTIC SYRINGE
Rx only
DESCRIPTION
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 I.V. use. May contain sulfuric
acid and/or sodium hydroxide for
pH adjustment. The pH is 6.0 (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 twitching and tremors.
Hypocalcemia and hypokalemia often follow low serum lev