MAGNESIUM SULFATE injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)

Dostępny od:

Hospira, Inc.

INN (International Nazwa):

MAGNESIUM SULFATE HEPTAHYDRATE

Skład:

MAGNESIUM SULFATE HEPTAHYDRATE 500 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 or myocardial damage.

Podsumowanie produktu:

Magnesium Sulfate Injection, USP is supplied in single-dose containers as follows: NDC No. Container Total Amount Concentration mEq Mg++ /mL 0409-1754-10 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°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

MAGNESIUM SULFATE- MAGNESIUM SULFATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
MAGNESIUM SULFATE
INJECTION, USP 50%
ANSYR™ PLASTIC SYRINGE
Rx
only
_DESCRIPTION_
Magnesium Sulfate Injection, USP 50% 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 twitching
and tremors. Hypocalcemia and hypokalemia often follow low serum
levels of
magnesiu