Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)
Physicians Total Care, 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 (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 as a parenteral anticonvulsant for the prevention and control of seizures (convulsions) in severe toxemia of pregnancy. It effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose. Parenteral administration of the drug is contraindi
Magnesium Sulfate Injection, USP is supplied in single-dose containers as follows: NDC No. Container Total Amount Concentration mEq Mg ++ /mL 54868-5724-0 25 x 10 mL Vials 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 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: November, 2009 Printed in USA EN-2303 Hospira, Inc., Lake Forest, IL 60045 USA Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
MAGNESIUM SULFATE - MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION PHYSICIANS TOTAL CARE, INC. ---------- MAGNESIUM SULFATE INJECTION, USP ANSYR™ PLASTIC SYRINGE Rx only DESCRIPTION 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 I.V. use. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 6.0 (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 lev Preberite celoten dokument