Magnesium Sulfate
Magnesium Sulfate Heptahydrate
Fresenius Kabi Norge As
Human Prescription Drug
NDC 66298-1060Magnesium Sulfate also known as Magnesium Sulfate Heptahydrate is a human prescription drug labeled by 'Fresenius Kabi Norge As'. National Drug Code (NDC) number for Magnesium Sulfate is 66298-1060. 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 - 40 mg/mL . The currest status of Magnesium Sulfate drug is Active.
Drug Information:
| Drug NDC: | 66298-1060 |
| 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 Norge As |
| 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 - 40 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | 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: | 02 Aug, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | ANDA206485 |
| 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 Norge AS
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 829734
1658259
1658262
1658264
1658265
|
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 66298-1060-3 | 50 mL in 1 BAG (66298-1060-3) | 02 Aug, 2017 | N/A | No |
| 66298-1060-4 | 50 mL in 1 BAG (66298-1060-4) | 02 Aug, 2017 | N/A | No |
| 66298-1060-5 | 500 mL in 1 BAG (66298-1060-5) | 02 Aug, 2017 | N/A | No |
| 66298-1060-6 | 1000 mL in 1 BAG (66298-1060-6) | 02 Aug, 2017 | N/A | No |
| 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 sulfuric acid sodium hydroxide magnesium sulfate heptahydrate magnesium cation magnesium sulfate magnesium sulfate heptahydrate sulfuric acid sodium hydroxide magnesium sulfate heptahydrate magnesium cation
Indications and Usage:
Indications and usage magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia 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.
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. parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.
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 to 7 days can cause fetal abnormalities. in pre-eclampsia or 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 iv 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 magnes
Read more...ium sulfate may be administered intramuscularly into each buttock using undiluted 50% magnesium sulfate injection, usp. after the initial iv dose, some clinicians administer 1 to 2 g/hour by constant iv 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.
In pre-eclampsia or 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 iv 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 iv dose, some clinicians administer 1 to 2 g/hour by constant iv 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
Read more...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.
Contraindications:
Contraindications intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.
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 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 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. the flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). the amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the flexible container can leach out certain of the containerâs chemical components in very small amounts within the expiration period. the suitability of the container material has been confirmed by tests in animals according to usp biological tests for plastic containers. exposure to temperatures above 25ºc/77ºf 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.
Clinical Pharmacology:
Clinical pharmacology magnesium (mg ++ ) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. 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, but it does not adversely affect the mother, fetus or neonate when used as directed in eclampsia or pre-eclampsia. normal serum magnesium levels range from 1.3 to 2.1 meq/liter. as serum magnesium rises above 4 meq/liter, the deep tendon reflexes are first decreased and then disappear as the serum level approaches 10 meq/liter. at this level respiratory paralysis may occur. heart block also may occur at this or lower serum levels of magnesium. magnesium acts peripherally to produce vasodilation. with low doses only flushing and sweating occur, but larger doses c
Read more...ause lowering of blood pressure. the central and peripheral effects of magnesium poisoning are antagonized to some extent by intravenous administration of calcium. 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. pharmacokinetics absorption intravenously administered magnesium is immediately absorbed. distribution approximately 1 to 2% of total body magnesium is located in the extracellular fluid space. magnesium is 30% bound to albumin. metabolism magnesium is not metabolized. excretion magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration. special populations renal insufficiency magnesium is excreted solely by the kidney. in patients with severe renal insufficiency, the dose should be lower and frequent serum magnesium levels must be obtained (see dosage and administration ). hepatic insufficiency magnesium is excreted solely by the kidney. no dosing adjustments are necessary in hepatic insufficiency. drug-drug interactions drug induced renal losses of magnesium occur with the following drugs or drug classes: aminoglycosides amphotericin b cyclosporine diuretics digitalis cisplatin alcohol
Pharmacokinetics absorption intravenously administered magnesium is immediately absorbed. distribution approximately 1 to 2% of total body magnesium is located in the extracellular fluid space. magnesium is 30% bound to albumin. metabolism magnesium is not metabolized. excretion magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.
Special populations renal insufficiency magnesium is excreted solely by the kidney. in patients with severe renal insufficiency, the dose should be lower and frequent serum magnesium levels must be obtained (see dosage and administration ). hepatic insufficiency magnesium is excreted solely by the kidney. no dosing adjustments are necessary in hepatic insufficiency. drug-drug interactions drug induced renal losses of magnesium occur with the following drugs or drug classes: aminoglycosides amphotericin b cyclosporine diuretics digitalis cisplatin alcohol
How Supplied:
How supplied magnesium sulfate in water for injection is supplied in single-dose flexible containers as follows: product no. ndc no. size container total magnesium sulfate** total magnesium ion magnesium sulfate** concentration magnesium ion concentration osmolarity (calc.) 610605 66298-1060-3 50 ml* 2 g 16.25 meq 4% (40 mg/ml) 16.25 meq/50 ml 325 mosmol/liter 610601 66298-1060-4 100 ml 4 g 32.5 meq 4% (40 mg/ml) 32.5 meq/100 ml 325 mosmol/liter 610615 66298-1060-5 500 ml 20 g 162.3 meq 4% (40 mg/ml) 32.5 meq/100 ml 325 mosmol/liter 610610 66298-1060-6 1000 ml 40 g 325 meq 4% (40 mg/ml) 32.5 meq/100 ml 325 mosmol/liter 610705 66298-107-05 50 ml* 4 g 32.5 meq 8% (80 mg/ml) 32.5 meq/50 ml 649 mosmol/liter *partial fill container 50 ml volume in 100 ml container. **as the heptahydrate. warning: do not use flexible container in series connections. this container is not made with natural rubber latex or polyvinyl chloride (pvc), non-dehp. store at 20° to 25°c (68° to 77°f) [see
Read more...usp controlled room temperature]. protect from freezing.
Package Label Principal Display Panel:
Package labeling: label1 mgso44g label2 mgso420g mgso440g