sugammadex Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4233 | 343306-71-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A gamma-cyclodextrin that functions as a reversal agent for the neuromuscular blocker ROCURONIUM BROMIDE.
|
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.18 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.28 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 2.53 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 15, 2015 | FDA | ORGANON USA INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Recurrence of neuromuscular blockade | 171.75 | 51.22 | 21 | 972 | 82 | 46684987 |
| Anaphylactic reaction | 145.71 | 51.22 | 51 | 942 | 53061 | 46632008 |
| Bronchospasm | 83.52 | 51.22 | 25 | 968 | 15682 | 46669387 |
| Bradycardia | 76.16 | 51.22 | 34 | 959 | 66264 | 46618805 |
| Anaphylactic shock | 69.15 | 51.22 | 23 | 970 | 20251 | 46664818 |
| Clonus | 62.49 | 51.22 | 15 | 978 | 4065 | 46681004 |
| Hyperreflexia | 58.72 | 51.22 | 15 | 978 | 5239 | 46679830 |
| Hypoventilation | 52.20 | 51.22 | 13 | 980 | 4097 | 46680972 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Anaphylactic reaction | 140.92 | 64.30 | 46 | 838 | 27936 | 29923658 |
| Negative pressure pulmonary oedema | 132.69 | 64.30 | 19 | 865 | 203 | 29951391 |
| Recurrence of neuromuscular blockade | 126.57 | 64.30 | 17 | 867 | 108 | 29951486 |
| Anaphylactic shock | 117.02 | 64.30 | 34 | 850 | 13959 | 29937635 |
| Cardiac arrest | 84.71 | 64.30 | 45 | 839 | 92805 | 29858789 |
| Neuromuscular block prolonged | 79.21 | 64.30 | 13 | 871 | 356 | 29951238 |
| Bronchospasm | 77.02 | 64.30 | 23 | 861 | 10315 | 29941279 |
| Kounis syndrome | 76.69 | 64.30 | 16 | 868 | 1657 | 29949937 |
| Oxygen saturation decreased | 66.34 | 64.30 | 30 | 854 | 43410 | 29908184 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V03AB35 | VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Antidotes |
| FDA CS | M0081434 | gamma-Cyclodextrins |
| CHEBI has role | CHEBI:51372 | neuromuscular agent |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Reversal of neuromuscular blockade | indication | 241703000 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 7.58 | acidic |
| pKa2 | 7.94 | acidic |
| pKa3 | 8.0 | acidic |
| pKa4 | 8.0 | acidic |
| pKa5 | 8.0 | acidic |
| pKa6 | 8.0 | acidic |
| pKa7 | 8.0 | acidic |
| pKa8 | 8.0 | acidic |
| pKa9 | 13.29 | acidic |
| pKa10 | 13.65 | acidic |
| pKa11 | 13.89 | acidic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | BRIDION | ORGANON SUB MERCK | N022225 | Dec. 15, 2015 | RX | SOLUTION | INTRAVENOUS | June 9, 2023 | REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P146 TO FULFILL THE REQUIREMENTS OF PMR 3003-4 |
| EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | BRIDION | ORGANON SUB MERCK | N022225 | Dec. 15, 2015 | RX | SOLUTION | INTRAVENOUS | June 9, 2023 | REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P146 TO FULFILL THE REQUIREMENTS OF PMR 3003-4 |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D05940 | KEGG_DRUG |
| 343306-79-6 | SECONDARY_CAS_RN |
| 4035288 | VANDF |
| C2699711 | UMLSCUI |
| CHEBI:90952 | CHEBI |
| CHEMBL2107374 | ChEMBL_ID |
| CHEMBL2111107 | ChEMBL_ID |
| D000077122 | MESH_DESCRIPTOR_UI |
| 6918584 | PUBCHEM_CID |
| 8528 | INN_ID |
| DB06206 | DRUGBANK_ID |
| 361LPM2T56 | UNII |
| 1726987 | RXNORM |
| 159483 | MMSL |
| 26064 | MMSL |
| 31376 | MMSL |
| 31381 | MMSL |
| d07361 | MMSL |
| 012914 | NDDF |
| 012915 | NDDF |
| 442340006 | SNOMEDCT_US |
| 442379000 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| BRIDION | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5423 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 28 sections |
| BRIDION | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5425 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 28 sections |
| BRIDION | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71872-7187 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 28 sections |