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1. 10-acetoxy-10,11-dihydro-5h-dibenz(b,f)azepine-5-carboxamide
2. Aptiom
3. Bia 2-093
4. Bia-2-093
5. Zebinix
1. 236395-14-5
2. Bia 2-093
3. Zebinix
4. Exalief
5. Aptiom
6. Stedesa
7. Erelib
8. Pazzul
9. Bia-2-093
10. Eslicarbazepine (acetate)
11. (s)-5-carbamoyl-10,11-dihydro-5h-dibenzo[b,f]azepin-10-yl Acetate
12. Sep-0002093
13. Eslicarbazepine Acetate [usan]
14. Bea68zvb2k
15. Chembl87992
16. Sep - 0002093
17. Chebi:87016
18. [(5s)-11-carbamoyl-5,6-dihydrobenzo[b][1]benzazepin-5-yl] Acetate
19. Bia-2093
20. Exelief
21. (s)-(-)-10-acetoxy-10,11-dihydro-5h-dibenz[b,f]azepine-5-carboxamide
22. S-(-)-10-acetoxy-10,11-dihydro-5h-dibenz[b,f]azepine-5-carboxamide
23. Eslicarbazepine Acetate (usan)
24. (10s)-10-acetoxy-10,11-dihydro-5h-dibenz[b,f]azepine-5-carboxamide
25. (10s)-5-carbamoyl-10,11-dihydro-5h-dibenzo[b,f]azepin-10-yl Acetate
26. (s)-10-acetoxy- 10,11-dihydro- 5h-dibenz[b,f]azepine- 5-carboxamide
27. 5h-dibenz[b,f]azepine-5-carboxamide, 10-(acetyloxy)-10,11-dihydro-, (10s)-
28. Sep 0002093
29. Unii-bea68zvb2k
30. (10s)-5-carbamoyl-10,11-dihydro-5h-dibenzo(b,f)azepin-10-yl Acetate
31. 5h-dibenz(b,f)azepine-5-carboxamide, 10-(acetyloxy)-10,11-dihydro-, (10s)-
32. Bia 2093
33. Zebinix (tn)
34. Aptiom (tn)
35. Eslicarbazepine-acetate
36. Eslicarbazapine Acetate
37. Schembl250594
38. Zinc7295
39. Dtxsid90178308
40. Hms3263m06
41. Hms3885n14
42. Hy-b0703
43. Eslicarbazepine Acetate [mi]
44. Tox21_501102
45. Bdbm50240669
46. Mfcd06798333
47. S4657
48. Akos005145781
49. Ccg-222406
50. Db09119
51. Eslicarbazepine Acetate [mart.]
52. Eslicarbazepine Acetate [vandf]
53. Lp01102
54. Sdccgsbi-0633789.p001
55. Eslicarbazepine Acetate [who-dd]
56. Ncgc00165752-01
57. Ncgc00165752-02
58. Ncgc00165752-04
59. Ncgc00165752-06
60. Ncgc00261787-01
61. Ac-31734
62. As-14058
63. Eslicarbazepine Acetate [ema Epar]
64. E1046
65. Eslicarbazepine Acetate [orange Book]
66. Bia 2-093, >=98% (hplc), Solid
67. D09612
68. H11471
69. Ar-270/43507894
70. Q410273
71. J-015175
72. (s)-10-acetoxy-10,11-dihydro-5hdibenz( B,f)azepine-5-carboxamide
73. 10s)-5-carbamoyl-10,11-dihydro-5h-dibenzo[b,f]azepin-10-yl Acetate
74. 5-(aminocarbonyl)-10,11-dihydro-5h-dibenzo[b,f]azepin-10-yl Acetate
75. 5h-dibenz9b,f)azepine-5-carboxamide, 10-(acetyloxy)-10,11-dihydro-, (10s)-
76. Acetic Acid (s)-5-carbamoyl-10,11-dihydro-5h-dibenzo[b,f]azepin-10-yl Ester
77. Acetic Acid 5-carbamoyl-10,11-dihydro-5h-dibenzo[b,f]azepin-10(s)-yl Ester
| Molecular Weight | 296.32 g/mol |
|---|---|
| Molecular Formula | C17H16N2O3 |
| XLogP3 | 2 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 2 |
| Exact Mass | 296.11609238 g/mol |
| Monoisotopic Mass | 296.11609238 g/mol |
| Topological Polar Surface Area | 72.6 Ų |
| Heavy Atom Count | 22 |
| Formal Charge | 0 |
| Complexity | 440 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Aptiom |
| PubMed Health | Eslicarbazepine (By mouth) |
| Drug Classes | Anticonvulsant, Central Nervous System Agent |
| Drug Label | The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32... |
| Active Ingredient | Eslicarbazepine acetate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 200mg; 600mg; 800mg; 400mg |
| Market Status | Prescription |
| Company | Sunovion Pharms |
| 2 of 2 | |
|---|---|
| Drug Name | Aptiom |
| PubMed Health | Eslicarbazepine (By mouth) |
| Drug Classes | Anticonvulsant, Central Nervous System Agent |
| Drug Label | The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32... |
| Active Ingredient | Eslicarbazepine acetate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 200mg; 600mg; 800mg; 400mg |
| Market Status | Prescription |
| Company | Sunovion Pharms |
Eslicarbazepine acetate is indicated as adjunctive therapy in the treatment of partial-onset seizures that are not adequately controlled with conventional therapy in epileptic patients.
FDA Label
Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.
Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
Treatment of epilepsy with partial-onset seizures
Eslicarbazepine acetate is associated with a dose- and concentration-dependant increase in heart rate and prolongation of PR interval.
Anticonvulsants
Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)
Voltage-Gated Sodium Channel Blockers
A class of drugs that inhibit the activation of VOLTAGE-GATED SODIUM CHANNELS. (See all compounds classified as Voltage-Gated Sodium Channel Blockers.)
N03AF04
N03AF04
Absorption
Eslicarbazepine active metabolite has a high bioavailability and reaches peak serum concentration 1-4 hours after a given dose. Eslicarbazepine acetate absorption is not affected by food.
Route of Elimination
Eslicarbazepine acetate and its metabolites are eliminated primarily via renal excretion. Eslicarbazepine active metabolite is excreted two-thirds in the unchanged form and one-third as a glucuronide conjugate. This accounts for around 90% of total metabolites excreted, with the remaining 10% being minor metabolites. Renal tubular reabsorption is expected to occur with eslicarbazepine.
Volume of Distribution
The apparent volume of distribution of eslicarbazepine is 61.3 L for a body weight of 70 kg based on population PK analysis.
Clearance
Renal clearance of eslicarbazepine was found to be approximately 20 mL/min in healthy subjects with normal renal function.
Eslicarbazepine acetate is rapidly and extensively metabolized to its major active metabolite, eslicarbazepine, via hydrolytic first-pass metabolism. Eslicarbazepine corresponds to about 92% of systemic exposure. Minor active metabolites (R)-licarbazepine and oxcarbazepine consist of <5% of systemic exposure. Active metabolites are then metabolized to inactive glucuronides that correspond to about 3% of systemic exposure. Eslicarbazepine had a moderate inhibitory effect on CYP2C19 and a mild activation of UGT1A1-mediated glucuronidation when studied in human hepatic microsomes. It has been shown to induce CYP3A4 enzymes in vivo.
The apparent plasma half-life of eslicarbazepine is 10-20 hours in healthy subjects and 13-20 hours in epilepsy patients. Steady-state plasma concentrations are attained after 4 to 5 days of once daily dosing.
Eslicarbazepine acetate is converted to the active metabolite eslicarbazepine which carries out its anticonvulsant activity. The exact mechanism of action is unknown, but it is thought to involve the inhibition of voltage-gated sodium channels. In in vitro electrophysiological studies, eslicarbazepine was shown to inhibit repeated neuronal firing by stabilizing the inactivated state of voltage-gated sodium channels and preventing their return to the activated state. In vitro studies also showed eslicarbazepine inhibiting T-type calcium channels, which likely also has a role in anticonvulsant activity.
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DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 22416
DOSAGE - TABLET;ORAL - 400MG
USFDA APPLICATION NUMBER - 22416
DOSAGE - TABLET;ORAL - 600MG
USFDA APPLICATION NUMBER - 22416
DOSAGE - TABLET;ORAL - 800MG
USFDA APPLICATION NUMBER - 22416
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PharmaCompass offers a list of Eslicarbazepine Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Eslicarbazepine Acetate manufacturer or Eslicarbazepine Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eslicarbazepine Acetate manufacturer or Eslicarbazepine Acetate supplier.
PharmaCompass also assists you with knowing the Eslicarbazepine Acetate API Price utilized in the formulation of products. Eslicarbazepine Acetate API Price is not always fixed or binding as the Eslicarbazepine Acetate Price is obtained through a variety of data sources. The Eslicarbazepine Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aptiom manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aptiom, including repackagers and relabelers. The FDA regulates Aptiom manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aptiom API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Aptiom manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aptiom supplier is an individual or a company that provides Aptiom active pharmaceutical ingredient (API) or Aptiom finished formulations upon request. The Aptiom suppliers may include Aptiom API manufacturers, exporters, distributors and traders.
click here to find a list of Aptiom suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aptiom DMF (Drug Master File) is a document detailing the whole manufacturing process of Aptiom active pharmaceutical ingredient (API) in detail. Different forms of Aptiom DMFs exist exist since differing nations have different regulations, such as Aptiom USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aptiom DMF submitted to regulatory agencies in the US is known as a USDMF. Aptiom USDMF includes data on Aptiom's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aptiom USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aptiom suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Aptiom Drug Master File in Korea (Aptiom KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aptiom. The MFDS reviews the Aptiom KDMF as part of the drug registration process and uses the information provided in the Aptiom KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aptiom KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Aptiom API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aptiom suppliers with KDMF on PharmaCompass.
A Aptiom written confirmation (Aptiom WC) is an official document issued by a regulatory agency to a Aptiom manufacturer, verifying that the manufacturing facility of a Aptiom active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aptiom APIs or Aptiom finished pharmaceutical products to another nation, regulatory agencies frequently require a Aptiom WC (written confirmation) as part of the regulatory process.
click here to find a list of Aptiom suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Aptiom as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aptiom API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Aptiom as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Aptiom and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aptiom NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aptiom suppliers with NDC on PharmaCompass.
Aptiom Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Aptiom GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Aptiom GMP manufacturer or Aptiom GMP API supplier for your needs.
A Aptiom CoA (Certificate of Analysis) is a formal document that attests to Aptiom's compliance with Aptiom specifications and serves as a tool for batch-level quality control.
Aptiom CoA mostly includes findings from lab analyses of a specific batch. For each Aptiom CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Aptiom may be tested according to a variety of international standards, such as European Pharmacopoeia (Aptiom EP), Aptiom JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aptiom USP).
