Magnesium Sulfate

Magnesium Sulfate Heptahydrate


Henry Schein, Inc.
Human Prescription Drug
NDC 0404-9903
Magnesium Sulfate also known as Magnesium Sulfate Heptahydrate is a human prescription drug labeled by 'Henry Schein, Inc.'. National Drug Code (NDC) number for Magnesium Sulfate is 0404-9903. 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: 0404-9903
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: Henry Schein, Inc.
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: ANDA
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: 12 Jan, 2022
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: ANDA075151
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:Henry Schein, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:829762
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.
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
0404-9903-101 SYRINGE, PLASTIC in 1 BAG (0404-9903-10) / 10 mL in 1 SYRINGE, PLASTIC12 Jan, 2022N/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 water

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 (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.

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. intravenous use in the 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 intravenous and intramuscular administration are appropriate. intramuscular administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas intravenous doses will provide a therapeutic level almost immediately. the rate of intravenous 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 intravenous 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
intramuscular injection of the undiluted (50%) solution is appropriate 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 gram, equivalent to 8.12 meq of magnesium (2 ml of the 50% solution) injected intramuscularly every six hours for four doses (equivalent to a total 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 intramuscularly within a period of four hours if necessary. alternatively, 5 grams, (approximately 40 meq) can be added to one liter of 5% dextrose injection, usp or 0.9% sodium chloride injection, usp for slow intravenous 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 total parenteral nutrition, maintenance requirements for magnesium are not precisely known. the maintenance dose used in adults ranges from 8 to 24 meq (1 gram to 3 grams) daily; for infants, the range is 2 to 10 meq (0.25 gram to 1.25 grams) daily. in pre-eclampsia or eclampsia in severe pre-eclampsia or eclampsia, the total initial dose is 10 grams to 14 grams of magnesium sulfate. intravenously, a dose of 4 grams to 5 grams in 250 ml of 5% dextrose injection, usp or 0.9% sodium chloride injection, usp may be infused. simultaneously, intramuscular doses of up to 10 gram (5 grams to 10 ml of the undiluted 50% solution in each buttock) are given. alternatively, the initial intravenous dose of 4 grams 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 intravenously over a period of three to four minutes. subsequently, 4 grams to 5 grams (8 to 10 ml of the 50% solution) are injected intramuscularly 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 intravenous dose, some clinicians administer 1 gram to 2 grams/hour by constant intravenous 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 grams to 40 grams 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 gram to 2 grams given intravenously. for controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 gram administered intramuscularly or intravenously. 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 grams to 4 grams (30 to 40 ml of a 10% solution) administered intravenously over 30 seconds with extreme caution . for reduction of cerebral edema, 2.5 grams (25 ml of a 10% solution) is given intravenously. incompatibilities magnesium sulfate in solution may result in a precipitate formation when mixed with solutions containing: 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. image1.jpg

Contraindications:

Contraindications parenteral administration of the drug is contraindicated in patients with heart block and 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 central nervous system 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 reflect 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 intravenously 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 intravenous calcium.

Description:

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 4 •7h 2 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:

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 levels of magnesium. while there are large stores of magnesium present intracellularly and in the bones of adults, these stores are often 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 en
d 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/liter. as plasma magnesium rises above 4 meq/liter, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 meq/liter. at this level respiratory paralysis may occur. heart block may also 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 intravenous administration of calcium. pharmacokinetics with intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. following intramuscular 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/liter. magnesium is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

How Supplied:

How supplied 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.] product repackaged by: henry schein, inc., bastian, va 24314 from original manufacturer/distributor's ndc and unit of sale to henry schein repackaged product ndc and unit of sale total strength/total volume (concentration) per unit ndc 0409-1754-10 10 ansyr™ plastic syringes in a package ndc 0404-9903-10 1 single-dose ansyr™ plastic syringe in a bag (syringe bears ndc 0409-1754-15) 50% 5 g/10 ml 4 meq/ml image2.jpg

Package Label Principal Display Panel:

Sample package label label1.jpg


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