Magnesium Sulfate

Magnesium Sulfate Heptahydrate


Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 63323-064
Magnesium Sulfate also known as Magnesium Sulfate Heptahydrate is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Magnesium Sulfate is 63323-064. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Magnesium Sulfate drug includes Magnesium Sulfate Heptahydrate - 500 mg/mL . The currest status of Magnesium Sulfate drug is Active.

Drug Information:

Drug NDC: 63323-064
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Magnesium Sulfate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Magnesium Sulfate Heptahydrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Fresenius Kabi Usa, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:MAGNESIUM SULFATE HEPTAHYDRATE - 500 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAMUSCULAR
INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 08 Aug, 2000
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 18 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: NDA019316
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Fresenius Kabi USA, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1658221
1658244
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:SK47B8698T
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Calculi Dissolution Agent [EPC]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63323-064-2325 VIAL, GLASS in 1 TRAY (63323-064-23) / 2 mL in 1 VIAL, GLASS (63323-064-21)08 Aug, 2000N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Magnesium sulfate magnesium sulfate heptahydrate magnesium sulfate heptahydrate magnesium cation sulfuric acid sodium hydroxide

Indications and Usage:

Indications and usage 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 a pre-eclampsia and eclampsia, respectively.

Warnings:

Warnings fetal harm: continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. these bone abnormalities include skeletal demineralization and osteopenia. in addition, cases of neonatal fracture have been reported. the shortest duration of treatment that can lead to fetal harm is not known. magnesium sulfate should be used during pregnancy only if clearly needed. if magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5 to 7 days may cause fetal abnormalities. aluminum toxicity: this product contains aluminum that may be toxic. aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calciu
m and phosphate solutions, which contain aluminum. research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. tissue loading may occur at even lower rates of administration. parenteral use in the presence of renal insufficiency may lead to magnesium intoxication. iv use in eclampsia should be reserved for immediate control of life-threatening convulsions.

Dosage and Administration:

Dosage and administration dosage of magnesium sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained. both iv and im administration are appropriate. im administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas iv doses will provide a therapeutic level almost immediately. the rate of iv injection should generally not exceed 150 mg/minute (1.5 ml of a 10% concentration or its equivalent), except in severe eclampsia with seizures (see below). continuous maternal administration of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. solutions for iv infusion must be diluted to a concentration of 20% or less prior to administration. the diluents commonly used are 5% dextrose injection, usp and 0.9% sodium chloride injection, usp. deep im injection of the undiluted (50%) solution is appropriat
e for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children. in magnesium deficiency in the treatment of mild magnesium deficiency, the usual adult dose is 1 g, equivalent to 8.12 meq of magnesium (2 ml of the 50% solution) injected im every six hours for four doses (equivalent to a total of 32.5 meq of magnesium per 24 hours). for severe hypomagnesemia, as much as 250 mg (approximately 2 meq) per kg of body weight (0.5 ml of the 50% solution) may be given im within a period of four hours if necessary. alternatively, 5 g (approximately 40 meq) can be added to one liter of 5% dextrose injection, usp or 0.9% sodium chloride injection, usp for slow iv infusion over a three-hour period. in the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity. in hyperalimentation in tpn, maintenance requirements for magnesium are not precisely known. the maintenance dose used in adults ranges from 8 to 24 meq (1 to 3 g) daily; for infants, the range is 2 to 10 meq (0.25 to 1.25 g) daily. in pre-eclampsia or eclampsia in severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. intravenously, a dose of 4 to 5 g in 250 ml of 5% dextrose injection, usp or 0.9% sodium chloride injection, usp may be infused. simultaneously, im doses of up to 10 g (5 g or 10 ml of the undiluted 50% solution in each buttock) are given. alternatively, the initial iv dose of 4 g may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 ml of a 10% solution or 20 ml of a 20% solution) may then be injected iv over a period of three to four minutes. subsequently, 4 to 5 g (8 to 10 ml of the 50% solution) are injected im into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. alternatively, after the initial iv dose, some clinicians administer 1 to 2 g/hour by constant iv infusion. 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 should not be exceeded. in the presence of severe renal insufficiency, the maximum dosage of magnesium sulfate is 20 grams/48 hours and frequent serum magnesium concentrations must be obtained. continuous use of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. other uses in counteracting the muscle-stimulating effects of barium poisoning, the usual dose of magnesium sulfate is 1 to 2 g given iv. for controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 g administered im or iv. in paroxysmal atrial tachycardia, magnesium should be used only if simpler measures have failed and there is no evidence of myocardial damage. the usual dose is 3 to 4 g (30 to 40 ml of a 10% solution) administered iv over 30 seconds with extreme caution . for reduction of cerebral edema, 2.5 g (25 ml of a 10% solution) is given iv. incompatibilities magnesium sulfate in solution may result in a precipitate formation when mixed with solutions containing: alcohol (in high concentrations) heavy metals alkali carbonates and bicarbonates hydrocortisone sodium succinate alkali hydroxides phosphates arsenates polymyxin b sulfate barium procaine hydrochloride calcium salicylates clindamycin phosphate strontium tartrates the potential incompatibility will often be influenced by the changes in the concentration of reactants and the ph of the solutions. it has been reported that magnesium may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

In magnesium deficiency in the treatment of mild magnesium deficiency, the usual adult dose is 1 g, equivalent to 8.12 meq of magnesium (2 ml of the 50% solution) injected im every six hours for four doses (equivalent to a total of 32.5 meq of magnesium per 24 hours). for severe hypomagnesemia, as much as 250 mg (approximately 2 meq) per kg of body weight (0.5 ml of the 50% solution) may be given im within a period of four hours if necessary. alternatively, 5 g (approximately 40 meq) can be added to one liter of 5% dextrose injection, usp or 0.9% sodium chloride injection, usp for slow iv infusion over a three-hour period. in the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

In hyperalimentation in tpn, maintenance requirements for magnesium are not precisely known. the maintenance dose used in adults ranges from 8 to 24 meq (1 to 3 g) daily; for infants, the range is 2 to 10 meq (0.25 to 1.25 g) daily.

In pre-eclampsia or eclampsia in severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. intravenously, a dose of 4 to 5 g in 250 ml of 5% dextrose injection, usp or 0.9% sodium chloride injection, usp may be infused. simultaneously, im doses of up to 10 g (5 g or 10 ml of the undiluted 50% solution in each buttock) are given. alternatively, the initial iv dose of 4 g may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 ml of a 10% solution or 20 ml of a 20% solution) may then be injected iv over a period of three to four minutes. subsequently, 4 to 5 g (8 to 10 ml of the 50% solution) are injected im into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. alternatively, after the initial iv dose, some clinicians administer 1 to 2 g/hour by constant iv infusion. therapy should continue until paroxysms cease. a serum ma
gnesium level of 6 mg/100 ml is considered optimal for control of seizures. a total daily (24 hr) dose of 30 to 40 g should not be exceeded. in the presence of severe renal insufficiency, the maximum dosage of magnesium sulfate is 20 grams/48 hours and frequent serum magnesium concentrations must be obtained. continuous use of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.

Other uses in counteracting the muscle-stimulating effects of barium poisoning, the usual dose of magnesium sulfate is 1 to 2 g given iv. for controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 g administered im or iv. in paroxysmal atrial tachycardia, magnesium should be used only if simpler measures have failed and there is no evidence of myocardial damage. the usual dose is 3 to 4 g (30 to 40 ml of a 10% solution) administered iv over 30 seconds with extreme caution . for reduction of cerebral edema, 2.5 g (25 ml of a 10% solution) is given iv.

Incompatibilities magnesium sulfate in solution may result in a precipitate formation when mixed with solutions containing: alcohol (in high concentrations) heavy metals alkali carbonates and bicarbonates hydrocortisone sodium succinate alkali hydroxides phosphates arsenates polymyxin b sulfate barium procaine hydrochloride calcium salicylates clindamycin phosphate strontium tartrates the potential incompatibility will often be influenced by the changes in the concentration of reactants and the ph of the solutions. it has been reported that magnesium may reduce the antibiotic activity of streptomycin, tetracycline and tobramycin when given together. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Contraindications:

Contraindications parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

Adverse Reactions:

Adverse reactions the adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication. these include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and cns depression proceeding to respiratory paralysis. hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.

Overdosage:

Overdosage magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication. in the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected iv to antagonize the effects of magnesium. for treatment of overdose artificial respiration is often required. intravenous calcium, 10 to 20 ml of a 5% solution (diluted if desirable with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. subcutaneous physostigmine, 0.5 to 1 mg may be helpful. hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as iv calcium.

For treatment of overdose artificial respiration is often required. intravenous calcium, 10 to 20 ml of a 5% solution (diluted if desirable with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. subcutaneous physostigmine, 0.5 to 1 mg may be helpful. hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as iv calcium.

Description:

Description magnesium sulfate injection, usp 50% is a sterile, nonpyrogenic, concentrated solution of magnesium sulfate heptahydrate in water for injection. it is 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 between 5.5 and 7.0. (osmolarity: 4,060 mosmol/l (calc.); 2.03 mm/ml magnesium sulfate anhydrous; 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 4 •7h 2 o, with a molecular weight of 246.47 and occurs as colorless crystals or white powder freely soluble in water.

Clinical Pharmacology:

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 symptoms and signs to cease. magnesium prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end-plate by
the motor nerve impulse. magnesium is said to have a depressant effect on the central nervous system (cns), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia. normal plasma magnesium levels range from 1.5 to 2.5 meq/l. as plasma magnesium rises above 4 meq/l, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 meq/l. at this level respiratory paralysis may occur. heart block also may occur at this or lower plasma levels of magnesium. serum magnesium concentrations in excess of 12 meq/l may be fatal. magnesium acts peripherally to produce vasodilation. with low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. the central and peripheral effects of magnesium poisoning are antagonized to some extent by iv administration of calcium. pharmacokinetics with iv administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. following im administration, the onset of action occurs in about one hour and persists for three to four hours. effective anticonvulsant serum levels range from 2.5 to 7.5 meq/l. magnesium is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

Pharmacokinetics with iv administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. following im administration, the onset of action occurs in about one hour and persists for three to four hours. effective anticonvulsant serum levels range from 2.5 to 7.5 meq/l. magnesium is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

How Supplied:

How supplied *packaged in glass vials. product code unit of sale each magnesium sulfate heptahydrate fill volume magnesium mg/ml sulfate mg/ml np964003* ndc 63323-064-23 unit of 25 ndc 63323-064-21 500 mg per ml 2 ml 49.3 194.7 do not administer unless solution is clear and seal is intact. contains no preservative. discard unused portion. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature].

Package Label Principal Display Panel:

Package label - principal display - magnesium sulfate 2 ml single dose vial label magnesium sulfate injection, usp 50% 1 gram per 2 ml (500 mg per ml) for im or iv use. must be diluted before iv use. 2 ml single dose vial rx only 4.06 meq/ml 4.06 mosmol/ml package label - principal display - magnesium sulfate 2 ml single dose vial label

Package label - principal display - magnesium sulfate 2 ml single dose vial tray label ndc 63323-064-23 np964003 magnesium sulfate injection, usp for intramuscular or intravenous use. 50% 1 gram per 2 ml (500 mg per ml) must be diluted before intravenous use. 25 x 2 ml single dose vials rx only package label - principal display - magnesium sulfate 2 ml single dose vial tray label


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