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Palonosetron

Synopsis, Chemistry

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DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - 300MG;EQ 0.5MG BASE, SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML), POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL, SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML), INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - 300MG;EQ 0.5MG BASE
SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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SERVICES

Also known as: 135729-62-3, Palonosetron hcl, Aloxi, Onicit, Palonosetron (hydrochloride), Rs-25259-197

Molecular Formula

C₁₉H₂₅ClN₂O

Molecular Weight

332.9 g/mol

InChI Key

OLDRWYVIKMSFFB-SSPJITILSA-N

FDA UNII

23310D4I19

Isoquinoline and quinuclidine derivative that acts as a 5-HT3 RECEPTOR antagonist. It is used in the prevention of nausea and vomiting induced by cytotoxic chemotherapy, and for the prevention of post-operative nausea and vomiting.

1 2D Structure

Palonosetron

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(3aS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3H-benzo[de]isoquinolin-1-one;hydrochloride

2.1.2 InChI

InChI=1S/C19H24N2O.ClH/c22-19-16-6-2-4-14-3-1-5-15(18(14)16)11-21(19)17-12-20-9-7-13(17)8-10-20;/h2,4,6,13,15,17H,1,3,5,7-12H2;1H/t15-,17-;/m1./s1

2.1.3 InChI Key

OLDRWYVIKMSFFB-SSPJITILSA-N

2.1.4 Canonical SMILES

C1CC2CN(C(=O)C3=CC=CC(=C23)C1)C4CN5CCC4CC5.Cl

2.1.5 Isomeric SMILES

C1C[C@@H]2CN(C(=O)C3=CC=CC(=C23)C1)[C@@H]4CN5CCC4CC5.Cl

2.2 Other Identifiers

2.2.1 UNII

23310D4I19

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-(1-azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1h-benz(de)isoquinolin-1-one

2. 2-qhbiqo

3. Aloxi

4. Palonosetron

5. Palonosetron, (3r)-

6. Palonosetron, (r-(r*,r*))-isomer

7. Palonosetron, (r-(r*,s*))-isomer

8. Palonosetron, (s-(r*,s*))-isomer

9. Rs 25233 197

10. Rs 25233 198

11. Rs 25233-197

12. Rs 25233-198

13. Rs 25233197

14. Rs 25233198

15. Rs 25259

16. Rs 25259 197

17. Rs 25259 198

18. Rs 25259-197

19. Rs 25259-198

20. Rs 25259197

21. Rs 25259198

22. Rs-25233-197

23. Rs-25233-198

24. Rs-25259

25. Rs-25259-197

26. Rs-25259-198

27. Rs25233197

28. Rs25233198

29. Rs25259

30. Rs25259197

31. Rs25259198

2.3.2 Depositor-Supplied Synonyms

1. 135729-62-3

2. Palonosetron Hcl

3. Aloxi

4. Onicit

5. Palonosetron (hydrochloride)

6. Rs-25259-197

7. (s,s)-palonosetron Hydrochloride

8. Palonocetron Hydrochloride

9. Palonosetron (as Hydrochloride)

10. Chebi:85157

11. Rs 25259-197

12. (3as)-2-(3s)-1-azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-1h-benz[de]isoquinolin-1-one Monohydrochloride

13. (3as)-2-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3h-benzo[de]isoquinolin-1-one;hydrochloride

14. 1h-benz[de]isoquinolin-1-one, 2-[(3s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-, Hydrochloride (1:1), (3as)-

15. 23310d4i19

16. Aloxi (tn)

17. Dsstox_cid_26610

18. Dsstox_rid_81765

19. Dsstox_gsid_46610

20. (3as)-2,3,3a,4,5,6-hexahydro-2-((3s)-3-quinuclidinyl)-1h-benz(de)isoquinolin-1-one Monohydrochloride

21. (s)-2-((s)-quinuclidin-3-yl)-2,3,3a,4,5,6-hexahydro-1h-benzo[de]isoquinolin-1-one Hydrochloride

22. (r,s)-palonosetron Hcl

23. (s,r)-palonosetron Hcl

24. Cas-135729-62-3

25. Palonosetron Related Compound C

26. Palonosetron Related Compound D

27. Onicita

28. Paloxi

29. Palonosetron Hydrochloride [usan]

30. Unii-23310d4i19

31. Palonosetron Hydrochloride [usan:jan]

32. Palonosetronhydrochloride

33. Ncgc00166415-01

34. Chembl1720

35. Mls001424202

36. Schembl182478

37. Rs 25259 197

38. Dtxsid8046610

39. (3as)-palonosetron Hydrochloride

40. Palonosetron Hydrochloride- Bio-x

41. Palonosetron Hydrochloride (aloxi)

42. Ex-a4360

43. Hy-a0021

44. Tox21_112421

45. Mfcd00939524

46. Nsc743769

47. S3050

48. Palonosetron Hydrochloride (jan/usp)

49. Akos015895112

50. Akos026751493

51. Tox21_112421_1

52. Ac-1293

53. Ccg-101081

54. Ccg-221268

55. Cs-0621

56. Nc00331

57. Palonosetron Hydrochloride [mi]

58. Palonosetron Hydrochloride [jan]

59. Ncgc00166415-03

60. (3as)-2-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3h-benzo[de]isoquinolin-1-one Hydrochloride

61. As-75066

62. Bp164227

63. Palonosetron Hydrochloride [mart.]

64. Rs 25259

65. Smr000469233

66. Palonosetron Hydrochloride [usp-rs]

67. Palonosetron Hydrochloride [who-dd]

68. Palonosetron Hydrochloride, >=98% (hplc)

69. P-225

70. P2051

71. Palonosetron Hydrochloride [ema Epar]

72. D05343

73. Palonosetron Hydrochloride [orange Book]

74. 729p623

75. Akynzeo Component Palonosetron Hydrochloride

76. Palonosetron Hydrochloride [usp Monograph]

77. 7-amino-3-(hydroxymethyl)-3-cephem-4-carboxylicacid

78. Palonosetron Hydrochloride Component Of Akynzeo

79. Q27158366

80. (s,r)-palonosetron Hydrochloride Contains Up To ~35% (r,r)-isomer

81. 1h-benz[de]isoquinolin-1-one,3,3a,4,5,6-hexahydro-, (3as)- Hydrochloride

82. 1h-benz[de]isoquinolin-1-one,3,3a,4,5,6-hexahydro-, [s-(r*,r*)]-, Hydrochloride

83. Palonosetron Hydrochloride, United States Pharmacopeia (usp) Reference Standard

84. (3as)-2-[(3s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1h-benz[de]isoquinolin-1-one Hydrochloride

85. (3as)-2-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-2,3,3a,4,5,6-hexahydro-1h-benzo[de]isoquinolin-1-one--hydrogen Chloride (1/1)

86. (3as)-2-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3h-benzo[de]isoquinolin-1-one;hydrochloride.

87. (3as)-2-[(s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1h-benz[de]isoquinoline Hydrochloride

88. (3s)-3-[(3as)-1-oxo-3a,4,5,6-tetrahydro-1h-benzo[de]isoquinolin-2(3h)-yl]-1-azabicyclo[2.2.2]octan-1-ium Chloride

89. (5s)-3-[(3s)-1-azabicyclo[2.2.2]octan-3-yl]-3-azatricyclo[7.3.1.0?,(1)(3)]trideca-1(13),9,11-trien-2-one Hydrochloride

90. 1h-benz(de)isoquinolin-1-one, 2-(3s)-1-azabicyclo(2.2.2)oct-3-yl-2,3,3a,4,5,6-hexahydro-, Monohydrochloride, (3as)-

2.4 Create Date

2006-07-28

3 Chemical and Physical Properties

Molecular Formula	C₁₉H₂₅ClN₂O
Molecular Weight	332.9 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	1
Exact Mass	332.1655411 g/mol
Monoisotopic Mass	332.1655411 g/mol
Topological Polar Surface Area	23.6 Å²
Heavy Atom Count	23
Formal Charge	0
Complexity	456
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
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 2
Drug Name	Palonosetron hydrochloride
Drug Label	ALOXI (palonosetron hydrochloride) is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]...
Active Ingredient	Palonosetron hydrochloride
Dosage Form	Injectable
Route	injection
Strength	0.25mg/0.25ml; 0.25mg/5ml; 0.05mg/ml; 0.075mg/1.5ml
Market Status	Tentative Approval
Company	Teva Pharms; Dr Reddys Labs

2 of 2
Drug Name	Palonosetron hydrochloride
Drug Label	ALOXI (palonosetron hydrochloride) is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]...
Active Ingredient	Palonosetron hydrochloride
Dosage Form	Injectable
Route	injection
Strength	0.25mg/0.25ml; 0.25mg/5ml; 0.05mg/ml; 0.075mg/1.5ml
Market Status	Tentative Approval
Company	Teva Pharms; Dr Reddys Labs

4.2 Drug Indication

Aloxi is indicated in adults for:

- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,

- the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Aloxi is indicated in paediatric patients 1 month of age and older for:

- the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antiemetics

Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)

Serotonin 5-HT3 Receptor Antagonists

Drugs that bind to but do not activate SEROTONIN 5-HT3 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT3 RECEPTOR AGONISTS. (See all compounds classified as Serotonin 5-HT3 Receptor Antagonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Serotonin-3 Receptor Antagonist [EPC]; Serotonin 3 Receptor Antagonists [MoA]

5.3 ATC Code

A04AA05