Magnesium Sulfate Heptahydrate (Magnesium Sulfate)

Trade Name : Magnesium Sulfate

Fresenius Kabi Norge AS

INJECTION, SOLUTION

Strength 40 mg/mL

MAGNESIUM SULFATE HEPTAHYDRATE Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Magnesium Sulfate Heptahydrate (Magnesium Sulfate) which is also known as Magnesium Sulfate and Manufactured by Fresenius Kabi Norge AS. It is available in strength of 40 mg/mL per ml. Read more

Magnesium Sulfate Heptahydrate (Magnesium Sulfate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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For Intravenous Use Only
Rx only

Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. u00a0May contain sulfuric acid and/or sodium hydroxide for pH adjustment. u00a0The pH is 4.5 (3.5 to 6.5). u00a0It is available in 4% and 8% concentrations. u00a0See n n n section for the content and characteristics of available dosage forms and sizes. n nn
Magnesium sulfate, USP heptahydrate is chemically designated MgSOn n n u2022 7Hn n n O, colorless crystals or white powder freely soluble in water. n nn
Water for injection, USP is chemically designated Hn n n O. n nn
The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (n n n flexn n n bag). u00a0The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.u00a0 Solutions in contact with the flexible container can leach out certain of the containeru2019s chemical components in very small amounts within the expiration period. u00a0The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.u00a0 Exposure to temperatures above 25u00baC/77u00baF during transport and storage will lead to minor losses in moisture content.u00a0 Higher temperatures lead to greater losses.u00a0 It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.n nn

Magnesium (Mgn n n ) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. n nn
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. u00a0Magnesium 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.u00a0 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. u00a0At this level respiratory paralysis may occur. u00a0Heart block also may occur at this or lower serum levels of magnesium. u00a0
Magnesium acts peripherally to produce vasodilation. u00a0With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. u00a0The 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. u00a0Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours. u00a0Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter.

Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. u00a0When 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. u00a0However, other effective drugs are available for this purpose.

Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

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. u00a0These bone abnormalities include skeletal demineralization and osteopenia. u00a0In addition, cases of neonatal fracture have been reported. u00a0The shortest duration of treatment that can lead to fetal harm is not known. u00a0Magnesium sulfate should be used during pregnancy only if clearly needed. u00a0If 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.

Because magnesium is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. u00a0Urine output should be maintained at a level of 100 mL every four hours. u00a0Monitoring serum magnesium levels and the patientu2019s clinical status is essential to avoid the consequences of overdosage in toxemia. u00a0Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). u00a0Serum magnesium levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). u00a0The strength of the deep tendon reflexes begins to diminish when serum magnesium levels exceed 4 mEq/liter. u00a0Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. u00a0An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium intoxication in eclampsia.
Magnesium sulfate in water for injection should be administered slowly to avoid producing hypermagnesemia.

The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication. u00a0These 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.

Magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. u00a0Disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication. u00a0In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected IV to antagonize the effects of magnesium.
Artificial respiration is often required. u00a0Intravenous 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. u00a0Subcutaneous 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.

Magnesium sulfate in water for injection is intended for intravenous use only. u00a0For 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. u00a0Therefore, in the clinical conditions cited below, both forms of therapy are noted, as appropriate. u00a0
Continuous maternal administration of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities.
In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. u00a0To initiate therapy, 4 g of magnesium sulfate in water for injection may be administered intravenously. u00a0The 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. u00a0Simultaneously, 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. u00a0After 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. u00a0Therapy should continue until paroxysms cease.
A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures. u00a0A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should not be exceeded. u00a0In 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. u00a0Discard unused portion.

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible containers as follows:
*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 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. u00a0Protect from freezing.

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The brand names mentioned in this document are the trademarks of their respective owners.
Manufactured for:
Made in Norway
451339A
Revised: October 2014

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Magnesium Sulfate Heptahydrate (Magnesium Sulfate)

Trade Name : Magnesium Sulfate

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Magnesium Sulfate Heptahydrate (Magnesium Sulfate)

Trade Name : Magnesium Sulfate

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

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General

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