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MAGNESIUM SULFATE ANHYDROUS

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ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 12 USDMF, 4 JDMF, 4 NDC API, 5 Listed Suppliers, $ API Reference Price

16 API Suppliers
12 USDMF
4 JDMF
4 NDC API
5 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

107 FDF Dossiers, 66 FDA Orange Book, 14 Europe, 8 Canada, 5 South Africa, 14 Listed Dossiers

107 FDF Dossiers
66 FDA Orange Book
14 Europe
8 Canada
5 South Africa
14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 10GM/20ML (500MG/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 1GM/2ML (500MG/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 25GM/50ML (500MG/ML), SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 5GM/10ML (500MG/ML), EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML), EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML), EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML), EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML), POWDER;ORAL - 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT, TABLET;ORAL - 0.225GM;0.188GM;1.479GM

drugProductComposition
SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 10GM/20ML (500MG/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 1GM/2ML (500MG/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 25GM/50ML (500MG/ML)
SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 5GM/10ML (500MG/ML)
EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)
EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)
EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)
EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)
EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)
EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)
EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)
POWDER;ORAL - 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
TABLET;ORAL - 0.225GM;0.188GM;1.479GM

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 BASF, 1 Bioplus Life Sciences, 1 BioSpectra, 10 Corel Pharma Chem, 2 DFE Pharma, 3 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 11 Roquette, 12 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 32 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 20 Thickeners and Stabilizers, 18 Parenteral, 18 Direct Compression, 14 Co-Processed Excipients, 13 Solubilizers, 11 Lubricants & Glidants, 10 Film Formers & Plasticizers, 9 Empty Capsules, 9 Granulation, 8 Emulsifying Agents, 8 Taste Masking, 6 Disintegrants & Superdisintegrants, 5 Topical, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids, 2 Surfactant & Foaming Agents

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GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 10 Finished Drug Prices

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2 US Medicaid Prescriptions
10 Finished Drug Prices

MARKET PLACE

16 APIs, 6 FDF Dossiers, 1 EXCIPIENTS

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16 APIs
6 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

4 US Patents, 1 US Exclusivities

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4 US Patents
1 US Exclusivities

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

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1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

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EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 34

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API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

107

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

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Data Compilation #PharmaFlow

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166 RELATED EXCIPIENT COMPANIES

269EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 7487-88-9, Magnesium sulphate, Magnesium sulfate anhydrous, Mgso4, Sulfuric acid magnesium salt (1:1), Magnesium sulfate (1:1)

Molecular Formula

MgO₄S

Molecular Weight

120.37 g/mol

InChI Key

CSNNHWWHGAXBCP-UHFFFAOYSA-L

FDA UNII

ML30MJ2U7I

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)

1 2D Structure

Magnesium Sulfate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

magnesium;sulfate

2.1.2 InChI

InChI=1S/Mg.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2

2.1.3 InChI Key

CSNNHWWHGAXBCP-UHFFFAOYSA-L

2.1.4 Canonical SMILES

[O-]S(=O)(=O)[O-].[Mg+2]

2.2 Other Identifiers

2.2.1 UNII

ML30MJ2U7I

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Heptahydrate Magnesium Sulfate

2. Magnesium Sulfate, Heptahydrate

3. Sulfate, Magnesium

2.3.2 Depositor-Supplied Synonyms

1. 7487-88-9

2. Magnesium Sulphate

3. Magnesium Sulfate Anhydrous

4. Mgso4

5. Sulfuric Acid Magnesium Salt (1:1)

6. Magnesium Sulfate (1:1)

7. Magnesiumsulfat

8. Magnesiumsulfate

9. Magnesium Sulfate, Anhydrous

10. Sulfuric Acid Magnesium Salt

11. Magnesium(ii) Sulfate

12. Magnesium;sulfate

13. Magnesium Sulphate Anhydrous

14. Sulfato De Magnesio

15. Chebi:32599

16. Mfcd00011110

17. Magnesium Sulfate,anhydrous

18. Ml30mj2u7i

19. Magnesium Sulphate, Anhydrous

20. Magnesium Sulfate Anhydrous

21. Sulfuric Acid, Mono-c10-16-alkyl Esters, Magnesium Salts

22. Sal Angalis

23. Sal De Sedlitz

24. Tomix Ot

25. 139939-75-6

26. Ot-s (drying Agent)

27. Ot-s

28. 68081-97-0

29. Sulfuric Acid Magnesiumsalt (1:1), Hydrate (8ci,9ci)

30. Caswell No. 534

31. Magnesii Sulfas

32. Magnesii Sulfas; Magnesium Sulfate; Magnesium Sulphate; Mg-ok; Ot-s

33. Anhydrous Magnesium Sulfate

34. Sulfuric Acid Magnesium Salt (van)

35. Arrosalt 2327

36. Hsdb 664

37. Einecs 231-298-2

38. Unii-ml30mj2u7i

39. Epa Pesticide Chemical Code 050503

40. Magnesium Sulfate In Plastic Container

41. Nsc 146179

42. Magnesium Sulfate, Unspecified

43. Sda 15-062-07

44. Ccris 8411

45. Sn 00

46. Einecs 242-691-3

47. Einecs 268-365-0

48. Sulfuric Acid, C10-16 Alkyl Ester, Magnesium Salt

49. Sulphate Of Magnesia

50. (c10-c16) Alkylalcohol Sulfuric Acid, Magnesium Salt

51. Magnesium Sulfate In Dextrose 5% In Plastic Container

52. Ai3-02029

53. Epitope Id:158536

54. Ec 231-298-2

55. C10-c16 Alkyl Alcohol Sulfuric Acid Magnesium Salt

56. Magnesium Sulfate [mi]

57. Chembl2021423

58. Dtxsid6042105

59. Magnesium Sulfate [hsdb]

60. Magnesium Sulfate, Anhydrous Powder

61. Magnesium Sulfate, Anhydrous Granular

62. Akos015902894

63. Db00653

64. Magnesium Sulfate, 1m Aqueous Solution

65. Magnesium Sulfate Anhydrous [ii]

66. 18939-43-0

67. Magnesium Sulfate,anhydrous [vandf]

68. Ft-0628097

69. M1890

70. Magnesium Sulfate Anhydrous [orange Book]

71. Magnesium Sulfate Heptahydrate Solution, 2.25%

72. Magnesium Sulfate, 1m Aqueous Solution, Sterile

73. Magnesium Sulfate Anhydrous [usp Monograph]

74. Q288266

75. Sr-01000944338

76. J-014575

77. J-519590

78. Sr-01000944338-1

79. Magnesium Sulfate, Anhydrous Powder Trace Metals Grade, 99.95%

80. Magnesium Sulfate, Anhydrous Granular Trace Metals Grade, 99.95%

81. Suprep Bowel Prep Kit Component Magnesium Sulfate Anhydrous

82. Magnesium Sulfate Anhydrous Component Of Suprep Bowel Prep Kit

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	MgO₄S
Molecular Weight	120.37 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	0
Exact Mass	119.9367713 g/mol
Monoisotopic Mass	119.9367713 g/mol
Topological Polar Surface Area	88.6 Å²
Heavy Atom Count	6
Formal Charge	0
Complexity	62.2
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Magnesium sulfate
PubMed Health	Magnesium Sulfate
Drug Classes	Anti-Inflammatory, Anticonvulsant, Laxative, Laxative, Hyperosmotic, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent
Drug Label	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...
Active Ingredient	Magnesium sulfate
Dosage Form	Injectable
Route	Injection
Strength	500mg/ml
Market Status	Prescription
Company	Hospira; Fresenius Kabi Usa

2 of 4
Drug Name	Magnesium sulfate in plastic container
Active Ingredient	Magnesium sulfate
Dosage Form	Injectable
Route	Injection
Strength	4gm/100ml (40mg/ml); 4gm/50ml (80mg/ml); 2gm/50ml (40mg/ml); 20gm/500ml (40mg/ml); 40gm/1000ml(40mg/ml)
Market Status	Prescription
Company	Hospira

3 of 4
Drug Name	Magnesium sulfate
PubMed Health	Magnesium Sulfate
Drug Classes	Anti-Inflammatory, Anticonvulsant, Laxative, Laxative, Hyperosmotic, Parenteral Mineral-Trace Mineral, Renal-Urologic Agent
Drug Label	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...
Active Ingredient	Magnesium sulfate
Dosage Form	Injectable
Route	Injection
Strength	500mg/ml
Market Status	Prescription
Company	Hospira; Fresenius Kabi Usa

4 of 4
Drug Name	Magnesium sulfate in plastic container
Active Ingredient	Magnesium sulfate
Dosage Form	Injectable
Route	Injection
Strength	4gm/100ml (40mg/ml); 4gm/50ml (80mg/ml); 2gm/50ml (40mg/ml); 20gm/500ml (40mg/ml); 40gm/1000ml(40mg/ml)
Market Status	Prescription
Company	Hospira

4.2 Therapeutic Uses

Analgesics; Anesthetics; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Cathartics; Tocolytic Agents

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

AN EFFECTIVE & WIDELY EMPLOYED SALINE CATHARTIC. /HEPTAHYDRATE, USP/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 743

FULL DOSES OF SALINE CATHARTICS (15 G MAGNESIUM SULFATE OR ITS EQUIVALENT) PRODUCE A SEMIFLUID OR WATERY EVACUATION IN 3 HR OR LESS. LOW DOSES PRODUCE A LAXATIVE EFFECT WITH GREATER LATENCY.

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1005

A COLD, WET COMPRESS OF MAGNESIUM SULFATE SOLN IN WATER HAS BEEN EMPLOYED IN TREATMENT OF SUCH SKIN DISORDERS AS ERYSIPELAS. HOT CONCN AQ SOLN...(ABOUT 1 LB/PINT OF WATER) ARE SOMETIMES USED IN TREATMENT OF DEEP-SEATED INFECTIONS, CLOTHS BEING SATURATED & APPLIED WHILE HOT. ACTION MUCH LIKE THAT OF POULTICE. /HEPTAHYDRATE/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 743

For more Therapeutic Uses (Complete) data for MAGNESIUM SULFATE (32 total), please visit the HSDB record page.

4.3 Drug Warning

SOME ABSORPTION OF COMPONENT IONS OF SALINE CATHARTICS DOES OCCUR, & IN CERTAIN INSTANCES THEY MAY PRODUCE SYSTEMIC TOXICITY. IN AN INDIVIDUAL WITH IMPAIRED RENAL FUNCTION, ACCUM OF MAGNESIUM IONS IN BODY FLUIDS MAY BE SUFFICIENT TO CAUSE INTOXICATION. MAGNESIUM CATHARTICS SHOULD BE ADMIN ONLY IF RENAL FUNCTION IS ADEQUATE.

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1005

THE DRUG IS GENERALLY SAFE BUT CAN CAUSE TEMPORARY LOSS OF DEEP TENDON REFLEXES IN MOTHER & MAY SUPPRESS SKELETAL MUSCLE ACTIVITY IN NEONATE. IT SHOULD NOT BE USED IN PT WITH HEART DISEASE...

American Medical Association, AMA Department of Drugs. AMA Drug Evaluations. 4th ed. Chicago: American Medical Association, 1980., p. 798

NEONATE MAY BE DROWSY & EXHIBIT RESP DIFFICULTIES & DIMINISHED MUSCLE TONE. HOWEVER...NO RELATIONSHIP BETWEEN PLASMA MAGNESIUM CONCN OF BLOOD COLLECTED FROM UMBILICAL CORD & THE APGAR SCORE /HAS BEEN FOUND/.

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 882

Patients receiving parenteral magnesium sulfate shold be observed carefully, and serum magnesium concn should be monitored to avoid overdosage. ... An IV preparation of a calcium salt (e.g., calcium gluconate) should be readily available for use when magnesium sulfate is given IV. /Magnesium sulfate injection/

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 2163

For more Drug Warnings (Complete) data for MAGNESIUM SULFATE (14 total), please visit the HSDB record page.

4.4 Drug 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.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Magnesium sulfate is 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. Magnesium sulfate is gaining popularity as an initial treatment in the management of various dysrhythmias, particularly torsades de pointes, and dyrhythmias secondary to TCA overdose or digitalis toxicity.

5.2 MeSH Pharmacological Classification

Calcium Channel Blockers

A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)

Anti-Arrhythmia Agents

Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

Analgesics

Compounds capable of relieving pain without the loss of CONSCIOUSNESS. (See all compounds classified as Analgesics.)

Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

Tocolytic Agents

Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete. (See all compounds classified as Tocolytic Agents.)

Anesthetics

Agents capable of inducing a total or partial loss of sensation, especially tactile sensation and pain. They may act to induce general ANESTHESIA, in which an unconscious state is achieved, or may act locally to induce numbness or lack of sensation at a targeted site. (See all compounds classified as Anesthetics.)

5.3 FDA Pharmacological Classification

5.3.1 Pharmacological Classes

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]; Calculi Dissolution Agent [EPC]

5.4 ATC Code

A - Alimentary tract and metabolism

A06 - Drugs for constipation

A06A - Drugs for constipation

A06AD - Osmotically acting laxatives

A06AD04 - Magnesium sulfate

A - Alimentary tract and metabolism

A12 - Mineral supplements

A12C - Other mineral supplements

A12CC - Magnesium

A12CC02 - Magnesium sulfate

B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05X - I.v. solution additives

B05XA - Electrolyte solutions

B05XA05 - Magnesium sulfate

D - Dermatologicals

D11 - Other dermatological preparations

D11A - Other dermatological preparations

D11AX - Other dermatologicals

D11AX05 - Magnesium sulfate

V - Various

V04 - Diagnostic agents

V04C - Other diagnostic agents

V04CC - Tests for bile duct patency

V04CC02 - Magnesium sulfate

5.5 Absorption, Distribution and Excretion

Route of Elimination

Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.

Magnesium sulfate is excreted by the kidneys at a rate that varies from one patient to another but that is directly proportional to the serum concn and glomerular filtration.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 2164

PLASMA CONCN OF MAGNESIUM INCR IN FETUS & APPROACH MATERNAL BLOOD VALUES AFTER MAGNESIUM SULFATE ADMIN IN ECLAMPSIA & PREECLAMPSIA.

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 882

5.6 Metabolism/Metabolites

None

5.7 Biological Half-Life

43.2 hours (for newborns)

5.8 Mechanism of Action

Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Magnesium sulfate reduces striated muscle contractions and blocks peripheral neuromuscular transmission by reducing acetylcholine release at the myoneural junction. Additionally, Magnesium inhibits Ca²⁺ influx through dihydropyridine-sensitive, voltage-dependent channels. This accounts for much of its relaxant action on vascular smooth muscle.

CATHARTIC ACTION RESULTS FROM FACT THAT MGSO4 IS NOT ABSORBED FROM INTESTINAL TRACT, & THUS RETAINS SUFFICIENT WATER WITHIN LUMEN OF BOWEL TO MAKE AN ISOTONIC SOLN. IN EVENT...SALT IS GIVEN IN HYPERTONIC SOLN, SOURCE OF WATER WOULD BE BODY FLUIDS, &...DEHYDRATING ACTION IS EXERTED. /HEPTAHYDRATE, USP/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 743

EXACT MECHANISM OF.../CNS/ DEPRESSANT ACTIVITY IS NOT FULLY KNOWN; HOWEVER, EXCESS MAGNESIUM APPEARS TO DECR AMT OF ACETYLCHOLINE LIBERATED BY MOTOR NERVE IMPULSE. /HEPTAHYDRATE INJECTION USP/

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2002. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2002 (Plus Supplements)., p. 2163

Isolated myometrial strips were obtained from humans undergoing elective cesarean section at term pregnancy and Wistar albino rats on gestational days 19-21. These strips were mounted in organ baths for recording of isometric tensions. The effect of magnesium sulfate, isradipine, and ritodrine on the amplitude and frequency of spontaneous contractions was compared. ... Ritodrine (10-8-10-5 M) concentration-dependently inhibited the frequency and amplitude of spontaneous contractions of myometrial strips. At 10-4 M, tachyphylaxis of ritodrine occurred and contractions started again. Magnesium sulfate (10-7-10-4 M) inhibited the frequency but did not change the amplitude of the spontaneous contractions. Isradipine (10-7-10-4 M) had a concentration-related inhibitor effect on both the frequency and amplitude of the spontaneous contractions. The effects of magnesium sulfate, isradipine, and ritodrine were considerably similar in myometrium strips obtained from pregnant rats and humans. ...

PMID:12225296 Kantas E, et al; Acta Obstet Gynecol Scand 81(9): 825-830 (2002)

API SUPPLIERS

01

Jost Chemical

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

02

Jost Chemical

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

03

Tomita Pharmaceutical

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

04

Macco Organiques, Spol. s.r o

Czech Republic

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

05

Macco Organiques, Spol. s.r o

Czech Republic

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

06

Global Calcium

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharma, Lab & Chemical Expo

Not Confirmed

Not Confirmed

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USDMF

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JDMF

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NDC API

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Listed Suppliers

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API Reference Price

[{"dataSource":"API Import","activeIngredients":"MAGNESIUM SULFATE HEPTAHYDRATE","year":"2021","qtr":"Q2","strtotime":1620930600,"product":"MAGNESIUM SULFATE HEPTAHYDRATE,USP (PARENTERAL DOSAGE FORM)","address":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"TOMITA PHARMACEUTICAL","supplierCountry":"JAPAN","foreign_port":"OSAKA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"33","totalValueFC":"67352.1","currency":"USD","unitRateINR":"2466.8","date":"14-May-2021","totalValueINR":"4933500","totalValueInUsd":"67352.1","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"3950022","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"OSAKA","supplierAddress":"","customerAddress":"6-3-865\/1\/2, FLAT NO.201,GREENLAND APARTMENTS, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645295400,"product":"MAGNESIUM SULFATE","address":"SHANKAR TOWERS PLOT NO. A30,A.I.E BALANAGAR HYDERABAD","city":"HYDERABAD,TELANGANA","supplier":"M\/S. MACCO ORGANIQUES, S.R.O.","supplierCountry":"CZECH REPUBLIC","foreign_port":"NA","customer":"ANTHEA PHARMA PVT LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"15.5","totalValueFC":"397.6","currency":"USD","unitRateINR":"1192","date":"20-Feb-2022","totalValueINR":"29800.91","totalValueInUsd":"397.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"7574319","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SHANKAR TOWERS PLOT NO. A30,A.I.E BALANAGAR HYDERABAD"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645295400,"product":"MAGNESIUM SULFATE, HEPTAHYDRATE PHEUR, USP, INJECTABLE GRADE","address":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta","city":"HYDERABAD","supplier":"MACCO ORGANIQUES INC","supplierCountry":"CZECH REPUBLIC","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"16","totalValueFC":"811.7","currency":"USD","unitRateINR":"1216.8","date":"20-Feb-2022","totalValueINR":"60840","totalValueInUsd":"811.7","indian_port":"MADRAS AIR","hs_no":"29339990","bill_no":"7575043","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Sterile","supplierPort":"NA","supplierAddress":"","customerAddress":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645986600,"product":"MAGNESIUM SULFATE","address":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham","city":"HYDERABAD","supplier":"TOMITA PHARMACEUTICAL","supplierCountry":"JAPAN","foreign_port":"NA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"34","totalValueFC":"68991.6","currency":"USD","unitRateINR":"2585.7","date":"28-Feb-2022","totalValueINR":"5171400","totalValueInUsd":"68991.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"7674941","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719685800,"product":"3014181, 311378- RONACARE MAGNESIUM SULFATE 132219 (CODE. A319A) (RAW MATERIAL FOR MANUFACTURING OF COSMETIC) (NOT FOR F","address":"A-802, Crescenzo, C\/38-39, G-Block","city":"Mumbai","supplier":"INTERCOS EUROPE S.P.A","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"INTERCOS INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"8.5","totalValueFC":"11.3","currency":"EUR","unitRateINR":"941.3","date":"30-Jun-2024","totalValueINR":"941.29","totalValueInUsd":"11.3","indian_port":"Delhi Air","hs_no":"29319090","bill_no":"4261989","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"20123 MILANO, PIAZZA DIAZ, 1 Milano, , ItalySDNF Italy","customerAddress":"A-802, Crescenzo, C\/38-39, G-Block"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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FDF Dossiers

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FDA Orange Book

01

STRIDES PHARMA

India

Pharma, Lab & Chemical Expo

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AA

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

Brand Name : SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

Approval Date : 2023-11-22

Application Number : 215469

RX/OTC/DISCN : RX

RLD : No

TE Code : AA

Portfolio PDF

Product Web Link

Pharma, Lab & Chemical Expo

Not Confirmed

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Europe

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Canada

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS ...DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 10GM/20ML (500MG/ML)

USFDA APPLICATION NUMBER - 19316

DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS ...DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 1GM/2ML (500MG/ML)

USFDA APPLICATION NUMBER - 19316

DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS ...DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 25GM/50ML (500MG/ML)

USFDA APPLICATION NUMBER - 19316

DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS ...DOSAGE - SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 5GM/10ML (500MG/ML)

USFDA APPLICATION NUMBER - 19316

DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)