Drug Catalog - Product Detail
MAGNESIUM SULFATE INJ SOL 4% 40MG/ML 500ML X 24
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00409-6729-03 | HOSPIRA | 500 | 20GM/500ML | SOLUTION |
PACKAGE FILES
Generic Name
MAGNESIUM SULFATE IN WATER
Substance Name
MAGNESIUM SULFATE HEPTAHYDRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
NDA020309
Description
DESCRIPTION Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO 4 • 7H 2 O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. 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 plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
How Supplied
HOW SUPPLIED Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows: NDC Number (Unit of Sale) Concentration Total Magnesium Sulfate As the heptahydrate. Total Magnesium Ion Magnesium Sulfate Concentration Magnesium Ion Concentration Osmolarity (calc.) NDC 0409-6729-23 Case of 24 single-dose flexible plastic containers 4 g/100 mL (40 mg/mL) 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-4121-50 Case of 50 single-dose flexible plastic containers 4 g/100 mL (40 mg/mL) 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-6729-03 Case of 24 single-dose flexible plastic containers 20 g/500 mL (40 mg/mL) 20 g 162.3 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-2050-20 Case of 20 single-dose flexible plastic containers 20 g/500 mL (40 mg/mL) 20 g 162.3 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-6729-09 Case of 12 single-dose flexible plastic containers 40 g/1000 mL (40 mg/mL) 40 g 325 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-3164-12 Case of 12 single-dose flexible plastic containers 40 g/1000 mL (40 mg/mL) 40 g 325 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter NDC 0409-6729-24 Case of 24 single-dose flexible plastic containers 2 g/50 mL Partial fill container 50 mL volume in 100 mL container. (40 mg/mL) 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter NDC 0409-5239-60 Case of 60 single-dose flexible plastic containers 2 g/50 mL (40 mg/mL) 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter NDC 0409-6730-13 Case of 24 single-dose flexible plastic containers 4 g/50 mL (80 mg/mL) 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter NDC 0409-6730-60 Case of 60 single-dose flexible plastic containers 4 g/50 mL (80 mg/mL) 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
Indications & Usage
INDICATIONS AND USAGE Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Magnesium Sulfate in Water for Injection is intended for intravenous use only. For the management of pre-eclampsia or eclampsia, intravenous infusions of dilute solutions of magnesium (1% to 8%) are often given in combination with intramuscular injections of 50% Magnesium Sulfate Injection, USP. Therefore, in the clinical conditions cited below, both forms of therapy are noted, as appropriate. Continuous maternal administration of magnesium sulfate in pregnancy beyond 5-7 days can cause fetal abnormalities. In Eclampsia In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. To initiate therapy, 4 g of Magnesium Sulfate in Water for Injection may be administered intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute, or 3.75 mL of a 4% concentration (or its equivalent) per minute, except in severe eclampsia with seizures. Simultaneously, 4 to 5 g (32.5 to 40.6 mEq) of magnesium sulfate may be administered intramuscularly into each buttock using undiluted 50% Magnesium Sulfate Injection, USP. After the initial I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. infusion. Subsequent intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into alternate buttocks every four hours, depending on the continuing presence of the patellar reflex, adequate respiratory function, and absence of signs of magnesium toxicity. Therapy should continue until paroxysms cease. A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should not be exceeded. In the presence of severe renal insufficiency, frequent serum magnesium concentrations must be obtained and the maximum dosage of magnesium sulfate is 20 g per 48 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear. Discard unused portion.