País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)
Fresenius Kabi USA, LLC
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.
Product No. NDC No. % Magnesium Sulfate Heptahydrate Volume Fill Magnesium mg/mL Sulfate mg/mL NP6420 63323-064-29 50 20 mL 49.3 194.7 Do not administer unless solution is clear and seal intact. Preservative Free. Discard unused portion. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
unapproved drug other
MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION FRESENIUS KABI USA, LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- MAGNESIUM SULFATE INJECTION USP 50% DESCRIPTION Magnesium Sulfate Injection, USP is a sterile, concentrated solution of magnesium sulfate heptahydrate for use as an electrolyte replenisher or anticonvulsant by intramuscular (IM) or intravenous (IV) routes of administration. Must be diluted before IV use. The product is available in a 50% concentration. 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 (5.5 to 7.0). Osmolarity: 4,060 mOsmol/L (calc.); 2.03 mM/mL magnesium sulfate anhydrous; 4.06 mEq/mL magnesium sulfate anhydrous. THIS PRODUCT CAN BE USED FOR IM OR IV USE. 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 Llegiu el document complet