Magnesium sulfate

Overview

A small colorless crystal used as an anticonvulsant, a cathartic, and an electrolyte replenisher in the treatment of pre-eclampsia and eclampsia. It causes direct inhibition of action potentials in myometrial muscle cells. Excitation and contraction are uncoupled, which decreases the frequency and force of contractions. (From AMA Drug Evaluations Annual, 1992, p1083)

Indication

Used for immediate control of life-threatening convulsions in the treatment of severe toxemias (pre-eclampsia and eclampsia) of pregnancy and in the treatment of acute nephritis in children. Also indicated for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those of hypocalcemia. Also used in uterine tetany as a myometriat relaxant.

Associated Conditions

Constipation
Convulsions
Hypomagnesemia
Torsades de Pointes
Barium poisoning
Severe Exacerbation of asthma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure	2025/10/24	NCT07220902	Not Applicable	Not yet recruiting	Nebraska Methodist Health System
Magnesium Sulfate Versus Lidocaine as Additives to Dexmedetomidine for Cough Suppression After Functional Endoscopic Sinus Surgery	2025/10/08	NCT07213037	Not Applicable	Not yet recruiting	Assiut University
Dexmedetomidine Versus Magnesium Sulfate Infusion in Craniotomy	2025/09/30	NCT07199595	Not Applicable	Not yet recruiting	Assiut University
Dexamethasone Versus Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Elective Caesarean Section Under Spinal Anesthesia	2025/08/24	NCT07139522	Not Applicable	Recruiting	Cairo University
Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy	2025/08/19	NCT07131033	Not Applicable	Active, not recruiting	The Second People's Hospital of Huai'an
Magnesium Sulfate in Pediatric Burn Dressing Changes	2025/08/17	NCT07126795	Not Applicable	Not yet recruiting	Hennepin Healthcare Research Institute
Efficacy of Intraoperative Magnesium Sulphate vs Dexmedetomidine on Emergence Agitation in Pediatric Patients	2025/05/18	NCT06977425	Not Applicable	Completed	Ain Shams University
Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia	2025/05/18	NCT06979141	Phase 3	Recruiting	Al-Azhar University
Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke	2025/05/04	NCT06956521	Phase 1	Not yet recruiting	Baylor College of Medicine
Magnesium Sulfate in Bronchial Asthma and Acute Bronchiolitis in Children	2025/05/02	NCT06955559	Phase 3	Not yet recruiting	Assiut University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
TIS-U-SOL	Baxter Healthcare Corporation	0338-0190	IRRIGATION	20 mg in 100 mL	2/21/2014
Magnesium Sulfate	Amneal Pharmaceuticals LLC	70121-1719	INTRAVENOUS	40 mg in 1 mL	1/24/2024
Magnesium Sulfate in Dextrose	Mylan Institutional LLC	67457-567	INTRAVENOUS	1 g in 100 mL	6/28/2019
Magnesium Sulfate	Henry Schein, Inc.	0404-9904	INTRAMUSCULAR, INTRAVENOUS	500 mg in 1 mL	11/9/2023
Magnesium Sulfate	ProPharma Distribution	84549-064	INTRAMUSCULAR, INTRAVENOUS	500 mg in 1 mL	9/17/2025
MAGNESIUM SULFATE IN DEXTROSE	Baxter Healthcare Corporation	0338-1709	INTRAVENOUS	10 mg in 1 mL	8/16/2022
Magnesium Sulfate in Water	WG Critical Care, LLC	44567-420	INTRAVENOUS	2 g in 50 mL	9/20/2023
Magnesium Sulfate	Fresenius Kabi USA, LLC	63323-064	INTRAVENOUS, INTRAMUSCULAR	500 mg in 1 mL	10/29/2018
Magnesium Sulfate	Mylan Institutional LLC	67457-554	INTRAVENOUS	4 g in 100 mL	10/5/2020
Magnesium Sulfate	Hospira, Inc.	0409-1754	INTRAVENOUS, INTRAMUSCULAR	500 mg in 1 mL	7/17/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DBL Magnesium Sulfate Concentrated Injection 49.3%	Siegfried Hameln GmbH	SIN05860P	INJECTION	2.47 g/5 ml	5/21/1991
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION	Fresenius Kabi AB, Site Uppsala	SIN16135P	INJECTION, EMULSION	0.61g/1000ml	3/24/2021
LEMON SWEET PURGATIVE SYRUP	SYARIKAT WEN KEN DRUG SDN BHD	SIN02748P	SYRUP	35.4%	5/9/1989

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
SMOFKABIVEN EMULSION FOR INFUSION	N/A	FRESENIUS KABI HONG KONG LIMITED	N/A	N/A	5/26/2011
PERSTON ENEMA	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	4/26/2001

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BLACKMORES ZINVIT C250	72412	Blackmores Ltd	Medicine	A	12/21/1999
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL	180546	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 2500 mL biofine bag	329619	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020
Phebra MAGNESIUM SULFATE HEPTAHYDRATE 50% 5g/10mL injection vial	160885	Phebra Pty Ltd	Medicine	A	7/13/2009
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 1400 mL biofine bag	329617	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020
MEDICIANZ MAGNESIUM SULFATE HEPTAHYDRATE 50% magnesium sulfate heptahydrate 2.5g/5mL Concentrated injection ampoule	427029	Medsurge Pharma Pty Ltd	Medicine	A	8/5/2024
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 2463 mL	180547	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1477 mL	180543	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion1950 mL biofine bag	329618	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020
MAGNESIUM SULFATE BAXTER READY TO USE magnesium sulfate heptahydrate 4 g/50 mL injection for intravenous infusion bag	410015	Baxter Healthcare Pty Ltd	Medicine	A	3/28/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MAGNESIUM SULFATE IN WATER FOR INJECTION	baxter corporation	02542153	Solution - Intravenous	40 MG / ML	11/18/2024
MAGNESIUM SULFATE INJECTION 50% USP	Sandoz Canada, Inc.	00602264	Liquid - Intravenous , Intramuscular	500 MG / ML	12/31/1984
BYLIUM LIQ	superco enr.	00378607	Liquid - Oral	1.521 G / 10 ML	12/31/1977
MAGNESIUM SULFURICUM-INJEEL LIQ (8D,12D,30D,200D/1.1ML)	Biologische Heilmittel Heel Gmbh	02058715	Liquid - Oral	8 D / 1.1 ML	12/31/1993
AGOBYL GRANULE	desbergers ltée, division of technilab inc.	00303496	Powder - Oral	40 %	12/31/1951
SEL D EPSOM	produits marc-o (1987) inc., division of technilab inc.	00432210	Powder - Oral	null NIL / NIL	12/15/1989
TIS-U-SOL SOLUTION	baxter corporation	00800007	Liquid - Irrigation	20 MG / 100 ML	12/31/1990
MAGNESIA SULFURICA GRAN AND GLOB 5CH-30CH	dolisos laboratoires s.a.	00765740	Tablet - Oral	1 DH / TAB	12/31/1987
MAGNESIUM SULFATE IN WATER FOR INJECTION	baxter corporation	02542161	Solution - Intravenous	80 MG / ML	N/A
MAGNESIUM SULFATE LIQUID (S#208)-LIQ	total health centre	02191768	Liquid - Oral	1 X / ML	6/1/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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