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butorphanol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| opioid receptor antagonists/agonists, morphinan derivates | 454 | 42408-82-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Butorphanol is a mixed agonist-antagonist with low intrinsic activity at receptors of the mu-opioid type (morphine-like). It is also an agonist at k-opioid receptors. Its interactions with these receptors in the central nervous system apparently mediate most of its pharmacologic effects, including analgesia.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 12 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 2 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 2 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.82 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 17 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 12 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 41 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.17 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 4.80 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK,TGFBR1 | 19 | |||
| kinase-selectivity-class | AXL,EIF2AK3,GRK2 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 22, 1978 | FDA |
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 279.45 | 30.64 | 104 | 470 | 463505 | 90164368 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 258.33 | 36.29 | 88 | 383 | 454002 | 110134826 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N02AF01 | NERVOUS SYSTEM ANALGESICS OPIOIDS Morphinan derivatives |
| CHEBI has role | CHEBI:35482 | opioid analgesic |
| CHEBI has role | CHEBI:51177 | antitussive |
| CHEBI has role | CHEBI:55322 | μ-opioid receptor agonist |
| CHEBI has role | CHEBI:59282 | κ-opioid receptor agonist |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000701 | Analgesics, Opioid |
| MeSH PA | D000996 | Antitussive Agents |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D009292 | Narcotic Antagonists |
| MeSH PA | D009294 | Narcotics |
| MeSH PA | D018689 | Sensory System Agents |
| MeSH PA | D019141 | Respiratory System Agents |
| FDA MoA | N0000175685 | Partial Opioid Agonists |
| FDA MoA | N0000175686 | Competitive Opioid Antagonists |
| FDA EPC | N0000175692 | Opioid Agonist/Antagonist |
Related Drugs by ATC class:
N02AF Morphinan derivatives 1 drug
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pain | indication | 22253000 | |
| General anesthesia | indication | 50697003 | |
| Labor pain | indication | 247412007 | |
| Sedation as Adjunct to Anesthesia | indication | ||
| Migraine | off-label use | 37796009 | DOID:6364 |
| Chronic disease of respiratory system | contraindication | 17097001 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Chronic heart failure | contraindication | 48447003 | |
| Substance abuse | contraindication | 66214007 | |
| Benign intracranial hypertension | contraindication | 68267002 | DOID:11459 |
| Opioid dependence | contraindication | 75544000 | DOID:2559 |
| Decreased respiratory function | contraindication | 80954004 | |
| Injury of head | contraindication | 82271004 | |
| Impaired renal function disorder | contraindication | 197663003 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Disorder of coronary artery | contraindication | 414024009 |
🐶 Veterinary Drug Use
| Species | Use | Relation |
|---|---|---|
| Cats | Pain caused by major or minor trauma | Indication |
| Cats | Pain associated with surgical procedures | Indication |
| Dogs | Chronic nonproductive cough associated with tracheo-bronchitis, tracheitis tonsillitis | Indication |
| Dogs | Laryngitis and pharyngitis associated with inflammatory conditions of the upper respiratory tract | Indication |
| Horses | Pain associated with colic and postpartum pain | Indication |
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| Torbutrol Injection | Zoetis Inc. | 1 |
| Torbutrol Tablets | Zoetis Inc. | 1 |
| Torbugesic | Zoetis Inc. | 1 |
| Torbugesic-SA | Zoetis Inc. | 1 |
| Dolorex | Intervet Inc. | 1 |
| Butorphanol Tartrate Injection | Dechra Veterinary Products LLC | 1 |
| Butorphic Injection | Akorn Animal Health Inc. | 1 |
| Butorphanol Tartrate Injection | Dechra Veterinary Products LLC | 1 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 9.7 | acidic |
| pKa2 | 8.56 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Mu-type opioid receptor | GPCR | PARTIAL AGONIST | Ki | 9.92 | CHEMBL | CHEMBL | |||
| Kappa-type opioid receptor | GPCR | PARTIAL AGONIST | Ki | 9.92 | CHEMBL | CHEMBL | |||
| Delta-type opioid receptor | GPCR | Ki | 7.92 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019650 | VUID |
| N0000147743 | NUI |
| D00837 | KEGG_DRUG |
| 58786-99-5 | SECONDARY_CAS_RN |
| 1841 | RXNORM |
| C0006491 | UMLSCUI |
| CHEBI:3242 | CHEBI |
| CHEMBL33986 | ChEMBL_ID |
| DB00611 | DRUGBANK_ID |
| CHEMBL299400 | ChEMBL_ID |
| D002077 | MESH_DESCRIPTOR_UI |
| 5361092 | PUBCHEM_CID |
| 7591 | IUPHAR_LIGAND_ID |
| 3620 | INN_ID |
| QV897JC36D | UNII |
| 11596 | MMSL |
| 4315 | MMSL |
| d00838 | MMSL |
| 13936006 | SNOMEDCT_US |
| 373467000 | SNOMEDCT_US |
| 69241001 | SNOMEDCT_US |
| 4018146 | VANDF |
| 4019650 | VANDF |
| 001580 | NDDF |
| 004635 | NDDF |
| QV897JC36D | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-3090 | SPRAY, METERED | 10 mg | NASAL | ANDA | 29 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-3090 | SPRAY, METERED | 10 mg | NASAL | ANDA | 29 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9864 | INJECTION, SOLUTION | 1 mg | INTRAMUSCULAR | ANDA | 28 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9867 | INJECTION, SOLUTION | 2 mg | INTRAMUSCULAR | ANDA | 28 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1623 | INJECTION, SOLUTION | 1 mg | INTRAMUSCULAR | ANDA | 30 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1626 | INJECTION, SOLUTION | 2 mg | INTRAMUSCULAR | ANDA | 30 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 59368-400 | SPRAY, METERED | 10 mg | NASAL | ANDA | 29 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-0813 | SPRAY | 10 mg | NASAL | ANDA | 15 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-0813 | SPRAY | 10 mg | NASAL | ANDA | 15 sections |
| Butorphanol Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2099 | SPRAY | 10 mg | NASAL | ANDA | 14 sections |