MAGNESIUM SULFATE injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Hospira, Inc.

INN (Nama Antarabangsa):

MAGNESIUM SULFATE HEPTAHYDRATE

Komposisi:

MAGNESIUM SULFATE HEPTAHYDRATE 500 mg in 1 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 pre-eclampsia and eclampsia, respectively. Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

Ringkasan produk:

Magnesium Sulfate Injection, USP is supplied as follows: NDC 0409-2168-77 Tray of 25 Single-use Plastic Fliptop Vials 50% 10 g/20 mL (500 mg/mL) Do not administer unless solution is clear and container is undamaged. Contains no preservative. Discard unused portion. Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.]

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

MAGNESIUM SULFATE- MAGNESIUM SULFATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
MAGNESIUM
SULFATE RX
ONLY
INJECTION, USP 50%
FLIPTOP VIAL
DESCRIPTION
Magnesium Sulfate Injection, USP 50% is a sterile, nonpyrogenic,
concentrated solution
of magnesium sulfate heptahydrate in Water for Injection, USP
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 6.0 (5.5 to 7.0). The 50% concentration has an
osmolarity of 4.06
mOsmol/mL (calc.); 2.03 mM/mL magnesium sulfate anhydrous and 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