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Synopsis

Chemistry

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Also known as: 60142-96-3, Neurontin, 1-(aminomethyl)cyclohexaneacetic acid, Gabapentine, Aclonium, 2-[1-(aminomethyl)cyclohexyl]acetic acid
Molecular Formula
C9H17NO2
Molecular Weight
171.24  g/mol
InChI Key
UGJMXCAKCUNAIE-UHFFFAOYSA-N
FDA UNII
6CW7F3G59X

Gabapentin
A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.
Gabapentin is an Anti-epileptic Agent. The physiologic effect of gabapentin is by means of Decreased Central Nervous System Disorganized Electrical Activity.
1 2D Structure

Gabapentin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[1-(aminomethyl)cyclohexyl]acetic acid
2.1.2 InChI
InChI=1S/C9H17NO2/c10-7-9(6-8(11)12)4-2-1-3-5-9/h1-7,10H2,(H,11,12)
2.1.3 InChI Key
UGJMXCAKCUNAIE-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CCC(CC1)(CC(=O)O)CN
2.2 Other Identifiers
2.2.1 UNII
6CW7F3G59X
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-(aminomethyl)cyclohexaneacetic Acid

2. Apo Gabapentin

3. Apo-gabapentin

4. Apogabapentin

5. Convalis

6. Gabapentin Hexal

7. Gabapentin Ratiopharm

8. Gabapentin Stada

9. Gabapentin-ratiopharm

10. Neurontin

11. Novo Gabapentin

12. Novo-gabapentin

13. Novogabapentin

14. Pms-gabapentin

2.3.2 Depositor-Supplied Synonyms

1. 60142-96-3

2. Neurontin

3. 1-(aminomethyl)cyclohexaneacetic Acid

4. Gabapentine

5. Aclonium

6. 2-[1-(aminomethyl)cyclohexyl]acetic Acid

7. Gabapetin

8. Gabapentinum

9. 2-(1-(aminomethyl)cyclohexyl)acetic Acid

10. Cyclohexaneacetic Acid, 1-(aminomethyl)-

11. Fanatrex

12. Gabapentino

13. Gralise

14. Serada

15. [1-(aminomethyl)cyclohexyl]acetic Acid

16. (1-aminomethyl-cyclohexyl)-acetic Acid

17. Goe-3450

18. Gabapentina

19. Go 3450

20. Ci-945

21. C9h17no2

22. Dm-1796

23. Goe 2450

24. Goe 3450

25. Ci 945

26. 1-(aminomethyl)-cyclohexaneacetic Acid

27. Gabarone

28. Dm-5689

29. Chembl940

30. Nsc-742194

31. Gabapentin; Neurontin

32. 6cw7f3g59x

33. Chebi:42797

34. Gabapentino [spanish]

35. Nsc-759254

36. Gabapentine [inn-french]

37. Gabapentinum [inn-latin]

38. Ncgc00015466-08

39. Gabapen

40. Dsstox_cid_74

41. Gabapentino [inn-spanish]

42. Vultin

43. Cas-60142-96-3

44. Gabapentin Gr

45. Dsstox_rid_75350

46. Dsstox_gsid_20074

47. Gbn

48. Gabapentinium

49. Gabapentin (neurontin)

50. Neuontin

51. Sefelsa

52. Therapentin-90

53. Neurontin (tn)

54. Ccris 7210

55. Hsdb 7364

56. Sr-01000000019

57. Einecs 262-076-3

58. Mfcd00865286

59. Brn 2359739

60. Unii-6cw7f3g59x

61. Neurentin

62. Gabapentin-er

63. Novo-gabapentine

64. Gabapentin, Solid

65. Gabapentin [usan:usp:inn:ban]

66. Gabapentin Solution

67. Dds-2003

68. Prestwick_151

69. 1-(aminomethyl)cyclohexaneaceticacid

70. Gralise (tn)

71. Carbatin

72. Gabapetine

73. Tocris-0806

74. Gabapentin [mi]

75. Lopac-g-154

76. Gabapentin [inn]

77. Gabapentin [jan]

78. Prestwick0_000861

79. Prestwick1_000861

80. Prestwick2_000861

81. Prestwick3_000861

82. Gabapentin [hsdb]

83. Gabapentin [usan]

84. G-154

85. Gabapentin [vandf]

86. Gabapentin [mart.]

87. Schembl8343

88. Gabapentin [usp-rs]

89. Gabapentin [who-dd]

90. Lopac0_000582

91. Bspbio_000901

92. Gabapentin (jan/usp/inn)

93. Mls000069358

94. Bidd:gt0656

95. Spbio_002822

96. Bpbio1_000993

97. Gtpl5483

98. Zinc4949

99. Dtxsid0020074

100. Gabapentin [ep Impurity]

101. Gabapentin [orange Book]

102. Gabapentin [ep Monograph]

103. Gabapentin [usp Monograph]

104. Hms1570n03

105. Hms2089j03

106. Hms2097n03

107. Hms2236o03

108. Hms3261f06

109. Hms3650a20

110. Hms3714n03

111. 1-aminomethyl Cyclohexaneacetic Acid

112. 1-aminomethylcyclohexane Acetic Acid

113. Act03340

114. Bcp25698

115. Hy-a0057

116. 1-(aminomethyl)cyclohexanacetic Acid

117. Tox21_110157

118. Tox21_500582

119. Bbl010794

120. Bdbm50080153

121. Nsc742194

122. S2133

123. Stk598009

124. 1-(aminomethyl)cyclohexyl-acetic Acid

125. 1-amino Methyl Cyclohexane-acetic Acid

126. Akos000280865

127. Tox21_110157_1

128. 1-aminomethyl-1cyclohexane-acetic Acid

129. Ab07485

130. Ac-1485

131. Ccg-204671

132. Cs-1545

133. Db00996

134. Ks-1064

135. Lp00582

136. Nsc 742194

137. Nsc 759254

138. Sdccgsbi-0050564.p002

139. 1-aminomethyl-1-cyclohexane-acetic Acid

140. Ncgc00015466-01

141. Ncgc00015466-02

142. Ncgc00015466-03

143. Ncgc00015466-04

144. Ncgc00015466-05

145. Ncgc00015466-06

146. Ncgc00015466-07

147. Ncgc00015466-09

148. Ncgc00015466-11

149. Ncgc00015466-27

150. Ncgc00016891-01

151. Ncgc00021545-02

152. Ncgc00021545-04

153. Ncgc00021545-05

154. Ncgc00261267-01

155. Smr000058311

156. Sbi-0206904.p001

157. Am20070538

158. Eu-0100582

159. Ft-0626586

160. Ft-0668920

161. G0318

162. En300-52516

163. 42g963

164. C07018

165. D00332

166. Gabapentin 100 Microg/ml In Acetonitrile:methanol

167. L000733

168. Q410352

169. Sr-01000000019-2

170. Sr-01000000019-6

171. Sr-01000000019-11

172. Z1258578343

173. Gabapentin, European Pharmacopoeia (ep) Reference Standard

174. Gabapentin, United States Pharmacopeia (usp) Reference Standard

175. Gabapentin, Pharmaceutical Secondary Standard; Certified Reference Material

176. Gabapentin Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

177. Gabapentin Solution, 10 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 171.24 g/mol
Molecular Formula C9H17NO2
XLogP3-1.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass171.125928785 g/mol
Monoisotopic Mass171.125928785 g/mol
Topological Polar Surface Area63.3 Ų
Heavy Atom Count12
Formal Charge0
Complexity162
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameGabapentin
PubMed HealthGabapentin (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelGabapentin tablets USP are an anticonvulsant for oral administration. Gabapentin USP is described as 1-(aminomethyl)cyclohexaneacetic acid. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely s...
Active IngredientGabapentin
Dosage FormTablet; Capsule; Solution
Routeoral; Oral
Strength600mg; 250mg/5ml; 800mg; 400mg; 300mg; 100mg
Market StatusTentative Approval; Prescription
CompanyAmneal Pharms; Mylan Pharms; Ranbaxy; Marksans Pharma; Apotex; Alkem; Aurobindo Pharma; Sun Pharm Inds; Taro; Invagen Pharms; Hikma Pharms; Hikma; Amneal Pharms Ny; Glenmark Generics; Ivax Sub Teva Pharms; Actavis Elizabeth; Teva Pharms; Hi Tech Pharma; A

2 of 6  
Drug NameGralise
PubMed HealthGabapentin (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelGabapentin is 1-(aminomethyl)cyclohexaneacetic acid; -amino-2-cyclohexyl-butyric acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24.The structural formula is:Gabapentin is a white to off-white crystalline solid with a pKa1 o...
Active IngredientGabapentin
Dosage FormTablet
RouteOral
Strength600mg; 300mg
Market StatusPrescription
CompanyDepomed

3 of 6  
Drug NameNeurontin
Drug LabelNeurontin (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, elliptical film-coated tablets containi...
Active IngredientGabapentin
Dosage FormTablet; Capsule; Solution
Routeoral; Oral
Strength600mg; 250mg/5ml; 800mg; 400mg; 300mg; 100mg; 0.0
Market StatusPrescription
CompanyPfizer Pharms; Parke Davis

4 of 6  
Drug NameGabapentin
PubMed HealthGabapentin (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelGabapentin tablets USP are an anticonvulsant for oral administration. Gabapentin USP is described as 1-(aminomethyl)cyclohexaneacetic acid. Gabapentin USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely s...
Active IngredientGabapentin
Dosage FormTablet; Capsule; Solution
Routeoral; Oral
Strength600mg; 250mg/5ml; 800mg; 400mg; 300mg; 100mg
Market StatusTentative Approval; Prescription
CompanyAmneal Pharms; Mylan Pharms; Ranbaxy; Marksans Pharma; Apotex; Alkem; Aurobindo Pharma; Sun Pharm Inds; Taro; Invagen Pharms; Hikma Pharms; Hikma; Amneal Pharms Ny; Glenmark Generics; Ivax Sub Teva Pharms; Actavis Elizabeth; Teva Pharms; Hi Tech Pharma; A

5 of 6  
Drug NameGralise
PubMed HealthGabapentin (By mouth)
Drug ClassesAnticonvulsant, Neuropathic Pain Agent
Drug LabelGabapentin is 1-(aminomethyl)cyclohexaneacetic acid; -amino-2-cyclohexyl-butyric acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24.The structural formula is:Gabapentin is a white to off-white crystalline solid with a pKa1 o...
Active IngredientGabapentin
Dosage FormTablet
RouteOral
Strength600mg; 300mg
Market StatusPrescription
CompanyDepomed

6 of 6  
Drug NameNeurontin
Drug LabelNeurontin (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, elliptical film-coated tablets containi...
Active IngredientGabapentin
Dosage FormTablet; Capsule; Solution
Routeoral; Oral
Strength600mg; 250mg/5ml; 800mg; 400mg; 300mg; 100mg; 0.0
Market StatusPrescription
CompanyPfizer Pharms; Parke Davis

4.2 Therapeutic Uses

Analgesics; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Antiparkinson Agents; Calcium Channel Blockers; Excitatory Amino Acid Antagonists

National Library of Medicine's Medical Subject Headings. Gabapentin. Online file (MeSH, 2016). Available from, as of October 28, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html


Neurontin is indicated for: Management of postherpetic neuralgia in adults. /Included in US product labeling/

NIH; DailyMed. Current Medication Information for Neurontin (Gabapentin) Capsule; Neurontin (Gabapentin) Tablet, Film-coated; Neurontin (Gabapentin) Solution (Updated: August 2016). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388


Neurontin is indicated for: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy. /Included in US product labeling/

NIH; DailyMed. Current Medication Information for Neurontin (Gabapentin) Capsule; Neurontin (Gabapentin) Tablet, Film-coated; Neurontin (Gabapentin) Solution (Updated: August 2016). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388


Horizant (gabapentin enacarbil) Extended-Release Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. /Included in US product label/

NIH; DailyMed. Current Medication Information for Horizant (Gabapentin Enacarbil) Extended-Release Tablets (Updated: July 2015). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4c486fc7-c8c4-4c6c-b30c-366dabaeaadd


For more Therapeutic Uses (Complete) data for GABAPENTIN (12 total), please visit the HSDB record page.


4.3 Drug Warning

VET: In general, avoid the use of the commercially available human oral solution (Neurontin) in dogs as it reportedly contains 300 mg/mL xylitol. As the threshold dose that can cause hypoglycemia in dogs is approximately 100 mg/kg doses of up to 15 mg/kg in dogs using the solution should be safe, but further data is needed to confirm this Additionally, xylitol may be hepatotoxic in dogs. Doses of 500 mg/kg of xylitol are thought to be the threshold for this toxicity, but there have been anecdotal reports of it occuring at much lower doss. In cats, at the dosages used presently, xylitol toxicity dosen not appear to be a problem with gabapentin oral solcuiton, but sue with caution.

Plumb D.C. Veterinary Drug Handbook. 8th ed. (pocket). Ames, IA: Wiley-Blackwell, 2015., p. 649


VET: Sedation and ataxia are probably the most likely adverse effects seen in small animals. Starting the dose at the lower end of the range and increasing with time may alleviate these effects.

Plumb D.C. Veterinary Drug Handbook. 8th ed. (pocket). Ames, IA: Wiley-Blackwell, 2015., p. 650


Gabapentin and gabapentin enacarbil should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2326


FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

NIH; DailyMed. Current Medication Information for Neurontin (Gabapentin) Capsule; Neurontin (Gabapentin) Tablet, Film-coated; Neurontin (Gabapentin) Solution (Updated: August 2016). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388


For more Drug Warnings (Complete) data for GABAPENTIN (37 total), please visit the HSDB record page.


4.4 Drug Indication

In the United States, gabapentin is officially indicated for the treatment of postherpetic neuralgia in adults and for the adjunctive treatment of partial-onset seizures, with or without secondary generalization, in patients 3 years of age and older. In Europe, gabapentin is indicated for adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalization, in patients 6 years of age and older and as monotherapy in patients 12 years of age and older. It is also used in adults for the treatment of various types of peripheral neuropathic pain, such as painful diabetic neuropathy.


Treatment of chronic pain


Treatment of postherpetic neuralgia


5 Pharmacology and Biochemistry
5.1 Pharmacology

Gabapentin is an anti-convulsant medication that inhibits the release of excitatory neurotransmitters, allowing for its use against pathologic neurotransmission such as that seen in neuropathic pain and seizure disorders. It has a wide therapeutic index, with doses in excess of 8000 mg/kg failing to cause a fatal reaction in rats. Gabapentin is ineffective in absence seizures and should be used in caution in patients with mixed seizure disorders involving absence seizures. Gabapentin has been associated with drug reaction with eosinophilia and systemic symptoms (DRESS), otherwise known as multi-organ hypersensitivity. This reaction can prove fatal and early symptoms such as fever, lymphadenopathy, and rash should be promptly investigated.


5.2 MeSH Pharmacological Classification

Anti-Anxiety Agents

Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)


Excitatory Amino Acid Antagonists

Drugs that bind to but do not activate excitatory amino acid receptors, thereby blocking the actions of agonists. (See all compounds classified as Excitatory Amino Acid Antagonists.)


Antimanic Agents

Agents that are used to treat bipolar disorders or mania associated with other affective disorders. (See all compounds classified as Antimanic 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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
GABAPENTIN
5.3.2 FDA UNII
6CW7F3G59X
5.3.3 Pharmacological Classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]; Anti-epileptic Agent [EPC]
5.4 ATC Code

N03AX12

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


N03AX12

S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448


N - Nervous system

N03 - Antiepileptics

N03A - Antiepileptics

N03AX - Other antiepileptics

N03AX12 - Gabapentin


5.5 Absorption, Distribution and Excretion

Absorption

Absorption of gabapentin is thought to occur solely via facilitated transport by the LAT1 transporter within the intestines. As this process is saturable, the oral bioavailability of gabapentin is inversely proportional to the administered dose - the oral bioavailability of a 900mg/day regimen is approximately 60%, whereas a 4800mg/day regimen results in only 27% bioavailability. The Tmax of gabapentin has been estimated to be 2-3 hours. Food has no appreciable effect on gabapentin absorption.


Route of Elimination

Gabapentin is eliminated solely in the urine as unchanged drug. Cimetidine, an inhibitor of renal tubular secretion, reduces clearance by approximately 12%, suggesting that some degree of tubular secretion is involved in the renal elimination of gabapentin.


Volume of Distribution

The apparent volume of distribution of gabapentin after IV administration is 586 L. The drug is found in the CSF in concentrations approximately 9-20% of the corresponding plasma concentrations and is secreted into breast milk in concentrations similar to that seen in plasma.


Clearance

Both the plasma clearance and renal clearance of gabapentin are directly proportional to the patient's creatinine clearance due to its primarily renal elimination.


/MILK/ Gabapentin enters maternal milk. It has been calculated that a nursing human infant could be exposed to a maximum dosage of 1 mg/kg/day. This is 5-10% of the usual pediatric (>3 years old) therapeutic dose. In veterinary patients, this appears unlikely to be of significant clinical concern.

Plumb D.C. Veterinary Drug Handbook. 8th ed. (pocket). Ames, IA: Wiley-Blackwell, 2015., p. 650


The pharmacokinetic properties of gabapentin vary based on the specific formulation of the drug. Following oral administration, gabapentin is absorbed principally in the proximal small intestine via a saturable L-amino acid transport system; as a result, the bioavailability of the drug decreases with increasing doses. Gabapentin gastroretentive tablets are specifically formulated to swell upon contact with gastric fluid to a size that promotes gastric retention for approximately 8-10 hours when taken with a meal; this allows for gradual and slow release of the drug to the proximal small intestine, its principal site of absorption. Following administration of gabapentin gastroretentive tablets in healthy individuals, time to peak plasma concentrations of the drug was increased (about 4-6 hours longer), peak plasma concentrations were increased, and systemic exposure was decreased relative to conventional (immediate-release) gabapentin. Gabapentin enacarbil, a prodrug of gabapentin, is rapidly and efficiently converted to gabapentin by first-pass hydrolysis following oral administration. Unlike gabapentin, gabapentin enacarbil is absorbed via high-capacity transporters throughout the GI tract and is not affected by saturable absorption; this improves bioavailability of the drug and allows for dose-proportional exposure. Food has only a minimal effect on the pharmacokinetics of conventional (immediate-release) formulations of gabapentin, but increases the bioavailability of gabapentin gastroretentive tablets. Administration of gabapentin enacarbil extended-release tablets with food also increases systemic exposure of the drug compared with exposure under fasted conditions.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2326


Less than 3% of gabapentin circulates bound to plasma protein. The apparent volume of distribution of gabapentin after 150 mg intravenous administration is 58 +/- 6 L (mean +/- SD). In patients with epilepsy, steady-state predose (Cmin) concentrations of gabapentin in cerebrospinal fluid were approximately 20% of the corresponding plasma concentrations.

NIH; DailyMed. Current Medication Information for Neurontin (Gabapentin) Capsule; Neurontin (Gabapentin) Tablet, Film-coated; Neurontin (Gabapentin) Solution (Updated: August 2016). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388


Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. Gabapentin is not appreciably metabolized in humans. ... Gabapentin elimination rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance. In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced. Gabapentin can be removed from plasma by hemodialysis.

NIH; DailyMed. Current Medication Information for Neurontin (Gabapentin) Capsule; Neurontin (Gabapentin) Tablet, Film-coated; Neurontin (Gabapentin) Solution (Updated: August 2016). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388


For more Absorption, Distribution and Excretion (Complete) data for GABAPENTIN (9 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Gabapentin is not appreciably metabolized in humans - in humans, metabolites account for less than 1% of an administered dose, with the remainder being excreted as unchanged parent drug in the urine.


Elimination is primarily via renal routes, but gabapentin is partially metabolized bo N-methyl-gabapentin in dogs.

Plumb D.C. Veterinary Drug Handbook. 8th ed. (pocket). Ames, IA: Wiley-Blackwell, 2015., p. 649


All pharmacological actions following gabapentin administration are due to the activity of the parent compound; gabapentin is not appreciably metabolized in humans.

NIH; DailyMed. Current Medication Information for Neurontin (Gabapentin) Capsule; Neurontin (Gabapentin) Tablet, Film-coated; Neurontin (Gabapentin) Solution (Updated: August 2016). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388


5.7 Biological Half-Life

The elimination t1/2 of gabapentin in patients with normal renal function is 5-7 hours. In patients with reduced renal function, the elimination t1/2 may be prolonged - in patients with a creatinine clearance of <30 mL/min, the reported half-life of gabapentin was approximately 52 hours.


In dogs ... elimination half life is approximately 2-4 hours.

Plumb D.C. Veterinary Drug Handbook. 8th ed. (pocket). Ames, IA: Wiley-Blackwell, 2015., p. 649


Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following multiple dosing.

NIH; DailyMed. Current Medication Information for Neurontin (Gabapentin) Capsule; Neurontin (Gabapentin) Tablet, Film-coated; Neurontin (Gabapentin) Solution (Updated: August 2016). Available from, as of October 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388


In cats ... elimination half life of 2.8 hours is similar to dogs.

Plumb D.C. Veterinary Drug Handbook. 8th ed. (pocket). Ames, IA: Wiley-Blackwell, 2015., p. 649


5.8 Mechanism of Action

The precise mechanism through which gabapentin exerts its therapeutic effects is unclear. The primary mode of action appears to be at the auxillary 2-1 subunit of voltage-gated calcium channels (though a low affinity for the 2-2 subunit has also been reported). The major function of these subunits is to facilitate the movement of pore-forming 1 subunits of calcium channels from the endoplasmic reticulum to the cell membrane of pre-synaptic neurons. There is evidence that chronic pain states can cause an increase in the expression of 2 subunits and that these changes correlate with hyperalgesia. Gabapentin appears to inhibit the action of 2-1 subunits, thus decreasing the density of pre-synaptic voltage-gated calcium channels and subsequent release of excitatory neurotransmitters. It is likely that this inhibition is also responsible for the anti-epileptic action of gabapentin. There is some evidence that gabapentin also acts on adenosine receptors and voltage-gated potassium channels, though the clinical relevance of its action at these sites is unclear.


Although the exact mechanism by which gabapentin exerts its analgesic effects is not known, the drug has been shown to prevent allodynia (pain-related behavior in response to normally innocuous stimuli) and hyperalgesia (exaggerated response to painful stimuli) in several models of neuropathic pain. Gabapentin also has been shown to decrease pain-related responses after peripheral inflammation in animals; however, the drug has not altered immediate pain-related behaviors. The clinical relevance of these findings is not known. In vitro studies demonstrate that gabapentin binds to the alpha2delta subunit of voltage-activated calcium channels; however, the clinical importance of this effect is not known.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2326


Gabapentin is an anticonvulsant agent structurally related to the inhibitory CNS neurotransmitter gamma-aminobutyric acid (GABA). Gabapentin enacarbil is a prodrug of gabapentin that is rapidly converted to gabapentin following oral administration; the therapeutic effects of gabapentin enacarbil are attributed to gabapentin. Although gabapentin was developed as a structural analog of GABA that would penetrate the blood-brain barrier (unlike GABA) and mimic the action of GABA at inhibitory neuronal synapses, the drug has no direct GABA-mimetic action and its precise mechanism of action has not been elucidated.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2326


Results of some studies in animals indicate that gabapentin protects against seizure and/or tonic extensions induced by the GABA antagonists picrotoxin and bicuculline or by GABA synthesis inhibitors (e.g., 3-mercaptopropionic acid, isonicotinic acid, semicarbazide). However, gabapentin does not appear to bind to GABA receptors nor affect GABA reuptake or metabolism and does not act as a precursor of GABA or of other substances active at GABA receptors. Gabapentin also has no affinity for binding sites on common neuroreceptors (e.g., benzodiazepine; glutamate; quisqualate; kainate; strychnine-insensitive or -sensitive glycine; alpha1-, alpha2-, or beta-adrenergic; adenosine A1 or A2; cholinergic [muscarinic or nicotinic]; dopamine D1 or D2; histamine H1; type 1 or 2 serotonergic [5-HT1 or 5-HT2]; opiate mc, delta, or k) or ion channels (e.g., voltage-sensitive calcium channel sites labeled with nitrendipine or diltiazem, voltage-sensitive sodium channel sites labeled with batrachotoxinin A 20alpha-benzoate). Conflicting results have been reported in studies of gabapentin affinity for and activity at N-methyl-d-aspartic acid (NMDA) receptors.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 2326


Currently, the clinical management of visceral pain remains unsatisfactory for many patients suffering from this disease. While preliminary animal studies have suggested the effectiveness of gabapentin in successfully treating visceral pain, the mechanism underlying its analgesic effect remains unclear. Evidence from other studies has demonstrated the involvement of protein kinase C (PKC) and extracellular signal-regulated kinase1/2 (ERK1/2) in the pathogenesis of visceral inflammatory pain. In this study, we tested the hypothesis that gabapentin produces analgesia for visceral inflammatory pain through its inhibitory effect on the PKC-ERK1/2 signaling pathway. Intracolonic injections of formalin were performed in rats to produce colitis pain. Our results showed that visceral pain behaviors in these rats decreased after intraperitoneal injection of gabapentin. These behaviors were also reduced by intrathecal injections of the PKC inhibitor, H-7, and the ERK1/2 inhibitor, PD98059. Neuronal firing of wide dynamic range neurons in L6-S1 of the rat spinal cord dorsal horn were significantly increased after intracolonic injection of formalin. This increased firing rate was inhibited by intraperitoneal injection of gabapentin and both the individual and combined intrathecal application of H-7 and PD98059. Western blot analysis also revealed that PKC membrane translocation and ERK1/2 phosphorylation increased significantly following formalin injection, confirming the recruitment of PKC and ERK1/2 during visceral inflammatory pain. These effects were also significantly reduced by intraperitoneal injection of gabapentin. Therefore, we concluded that the analgesic effect of gabapentin on visceral inflammatory pain is mediated through suppression of PKC and ERK1/2 signaling pathways. Furthermore, we found that the PKC inhibitor, H-7, significantly diminished ERK1/2 phosphorylation levels, implicating the involvement of PKC and ERK1/2 in the same signaling pathway. Thus, our results suggest a novel mechanism of gabapentin-mediated analgesia for visceral inflammatory pain through a PKC-ERK1/2 signaling pathway that may be a future therapeutic target for the treatment of visceral inflammatory pain.

PMID:26512901 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4626203 Zhang YB et al; PLoS One. 2015 Oct 29;10(10):e0141142. doi: 10.1371/journal.pone.0141142. eCollection 2015.


The gabapentinoids (pregabalin and gabapentin) are first line treatments for neuropathic pain. They exert their actions by binding to the alpha2delta (a2d) accessory subunits of voltage-gated Ca2+ channels. Because these subunits interact with critical aspects of the neurotransmitter release process, gabapentinoid binding prevents transmission in nociceptive pathways. Gabapentinoids also reduce plasma membrane expression of voltage-gated Ca2+ channels but this may have little direct bearing on their therapeutic actions. In animal models of neuropathic pain, gabapentinoids exert an anti-allodynic action within 30 minutes but most of their in vitro effects are 30-fold slower, taking at least 17 hours to develop. This difference may relate to increased levels of a2d expression in the injured nervous system. Thus, in situations where a2d is experimentally upregulated in vitro, gabapentinoids act within minutes to interrupt trafficking of a2d subunits to the plasma membrane within nerve terminals. When a2d is not up-regulated, gabapentinoids act slowly to interrupt trafficking of a2d protein from cell bodies to nerve terminals. This improved understanding of the mechanism of gabapentinoid action is related to their slowly developing actions in neuropathic pain patients, to the concept that different processes underlie the onset and maintenance of neuropathic pain and to the use of gabapentinoids in management of postsurgical pain.

PMID:27118808 Alles SR, Smith PA; Neuroscientist. 2016 Apr 26. pii: 1073858416628793. (Epub ahead of print)


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CHINAFENGXIN JIANGXI, P.R. 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04-Jan-2021
31-Aug-2024
KGS
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Average Price (USD/KGS)

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
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Average Price
(USD/KGS)
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 100MG

USFDA APPLICATION NUMBER - 20235

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DOSAGE - CAPSULE;ORAL - 300MG

USFDA APPLICATION NUMBER - 20235

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DOSAGE - CAPSULE;ORAL - 400MG

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DOSAGE - TABLET;ORAL - 300MG

USFDA APPLICATION NUMBER - 22544

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DOSAGE - TABLET;ORAL - 450MG

USFDA APPLICATION NUMBER - 22544

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DOSAGE - TABLET;ORAL - 600MG

USFDA APPLICATION NUMBER - 22544

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DOSAGE - TABLET;ORAL - 750MG

USFDA APPLICATION NUMBER - 22544

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DOSAGE - TABLET;ORAL - 900MG

USFDA APPLICATION NUMBER - 22544

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