Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)
Hospira, Inc.
MAGNESIUM SULFATE HEPTAHYDRATE
MAGNESIUM SULFATE HEPTAHYDRATE 500 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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.]
Abbreviated New Drug Application
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 Preberite celoten dokument