Cyclobenzaprine
Amrix (cyclobenzaprine) is a small molecule pharmaceutical. Cyclobenzaprine was first approved as Flexeril on 1982-01-01. It is used to treat muscle cramp, muscle rigidity, muscle spasticity, myositis, and pain amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Amrix (generic drugs available since 1989-05-03, discontinued: Flexeril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cyclobenzaprine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMRIX | Teva | N-021777 RX | 2007-02-01 | 2 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amrix | New Drug Application | 2020-06-30 |
| cyclobenzaprine hydrochloride | ANDA | 2023-05-03 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| muscle cramp | HP_0003394 | D009120 | — |
| muscle rigidity | HP_0002063 | D009127 | — |
| muscle spasticity | HP_0001257 | D009128 | — |
| myositis | EFO_0000783 | D009220 | G72.49 |
| pain | EFO_0003843 | D010146 | R52 |
| spasm | — | D013035 | M62.83 |
| tetanus | EFO_0005593 | D013742 | A35 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 1 | 4 | 1 | — | 6 |
| Hiv | D006678 | O98.7 | — | — | — | 1 | — | 1 | |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | 1 | — | 1 |
| Healthy volunteers/patients | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | 2 | 3 |
| Neoplasms | D009369 | C80 | — | — | 1 | — | — | 1 | |
| Hiv enteropathy | D019053 | EFO_0007311 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Gastrointestinal diseases | D005767 | — | 1 | — | — | — | 1 | ||
| Colonic diseases | D003108 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CYCLOBENZAPRINE |
| INN | cyclobenzaprine |
| Description | Cyclobenzaprine is 5-Methylidene-5H-dibenzo[a,d]cycloheptene in which one of the hydrogens of the methylidene group is substituted by a 2-(dimethylamino)ethyl group. A centrally acting skeletal muscle relaxant, it is used as its hydrochloride salt in the symptomatic treatment of painful muscle spasm. It has a role as a muscle relaxant, a tranquilizing drug and an antidepressant. It derives from a hydride of a dibenzo[a,d][7]annulene. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCC=C1c2ccccc2C=Cc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 303-53-7 |
| RxCUI | 21949 |
| ChEMBL ID | CHEMBL669 |
| ChEBI ID | 3996 |
| PubChem CID | 2895 |
| DrugBank | DB00924 |
| UNII ID | 69O5WQQ5TI (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Amrix - Cephalon
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,438 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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17 adverse events reported
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