Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Magnesium Sulfate Heptahydrate (UNII: SK47B8698T) (Magnesium Cation - UNII:T6V3LHY838)
General Injectables & Vaccines, Inc
Magnesium Sulfate Heptahydrate
Magnesium Sulfate Heptahydrate 500 mg in 1 mL
INTRAMUSCULAR
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 (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 and myocardial damage.
Magnesium Sulfate Injection, USP is supplied in single-dose containers as follows: 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.]
Abbreviated New Drug Application
MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION GENERAL INJECTABLES & VACCINES, INC ---------- 50% MAGNESIUM SULFATE 5 G/ML INJECTION, USP 10 ML PREFILLED SYRINGE ANSYR PLASTIC SYRINGE RX ONLY DESCRIPTION Ansyr™ Plastic Syringe Rx Only 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 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 twitc Přečtěte si celý dokument