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dantrolene 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 780 | 7261-97-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Skeletal muscle relaxant that acts by interfering with excitation-contraction coupling in the muscle fiber. It is used in spasticity and other neuromuscular abnormalities. Although the mechanism of action is probably not central, dantrolene is usually grouped with the central muscle relaxants.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.10 | g | O |
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) | 5 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 21.22 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 70 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.37 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 0.43 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 10 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.663 | Moderate | 0.69 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 2.203 | Moderate | 0.69 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 77.090 | 10^-6 cm/s | Moderate | 0.69 |
| dh-clint | Dog hepatocyte intrinsic clearance | 5.636 | uL/min/10^6 cells | Moderate | 0.69 |
| dppb | Dog plasma protein binding (% unbound) | 13.520 | % | Moderate | 0.69 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 13.950 | % | Moderate | 0.69 |
| herg | hERG pIC50 | 4.544 | pIC50 | Moderate | 0.69 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.592 | uL/min/10^6 cells | Moderate | 0.69 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.565 | uL/min/mg protein | Moderate | 0.69 |
| hppb | Human plasma protein binding (% unbound) | 9.540 | % | Moderate | 0.69 |
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 5.754 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 8.337 | Moderate | 0.69 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 5.534 | Moderate | 0.69 | |
| mppb | Mouse plasma protein binding (% unbound) | 11.110 | Moderate | 0.69 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 1.109 | Moderate | 0.69 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 0 | High | 1 | |
| pppb | Pig plasma protein binding (% unbound) | 13.220 | % | Moderate | 0.69 |
| rat-kpuu-brain | Rat brain Kpuu | 0.101 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 4.093 | uL/min/10^6 cells | Moderate | 0.69 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 74.870 | % | Moderate | 0.69 |
| rppb | Rat plasma protein binding (% unbound) | 6.260 | % | Moderate | 0.69 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 36.644 | uM | Moderate | 0.69 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 15, 1974 | FDA | PAR STERILE PRODUCTS |
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 |
|---|---|---|---|---|---|---|
| Neuroleptic malignant syndrome | 126.43 | 27.85 | 32 | 1353 | 15064 | 90611998 |
| Rhabdomyolysis | 52.32 | 27.85 | 22 | 1363 | 51234 | 90575828 |
| Respiratory failure | 40.03 | 27.85 | 24 | 1361 | 118394 | 90508668 |
| Choluria | 37.96 | 27.85 | 6 | 1379 | 253 | 90626809 |
| Multiple sclerosis relapse | 32.83 | 27.85 | 16 | 1369 | 52289 | 90574773 |
| Myotonia | 32.14 | 27.85 | 5 | 1380 | 190 | 90626872 |
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 |
|---|---|---|---|---|---|---|
| Neuroleptic malignant syndrome | 220.42 | 25.34 | 69 | 2062 | 21403 | 42597801 |
| Muscle rigidity | 65.15 | 25.34 | 24 | 2107 | 12035 | 42607169 |
| Hyperthermia | 60.54 | 25.34 | 23 | 2108 | 12551 | 42606653 |
| Disseminated intravascular coagulation | 39.76 | 25.34 | 21 | 2110 | 24773 | 42594431 |
| Agitation | 35.96 | 25.34 | 28 | 2103 | 64286 | 42554918 |
| Hypertonia | 34.74 | 25.34 | 12 | 2119 | 4989 | 42614215 |
| Respiratory failure | 34.51 | 25.34 | 37 | 2094 | 128095 | 42491109 |
| Malignant catatonia | 27.43 | 25.34 | 6 | 2125 | 453 | 42618751 |
| Tachycardia | 26.86 | 25.34 | 29 | 2102 | 101058 | 42518146 |
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 |
|---|---|---|---|---|---|---|
| Neuroleptic malignant syndrome | 344.76 | 23.63 | 96 | 3145 | 33963 | 110552095 |
| Hyperthermia | 86.97 | 23.63 | 30 | 3211 | 21242 | 110564816 |
| Respiratory failure | 72.95 | 23.63 | 56 | 3185 | 215276 | 110370782 |
| Muscle rigidity | 68.63 | 23.63 | 26 | 3215 | 24005 | 110562053 |
| Malignant catatonia | 51.84 | 23.63 | 10 | 3231 | 696 | 110585362 |
| Rhabdomyolysis | 48.99 | 23.63 | 35 | 3206 | 120366 | 110465692 |
| Hyperthermia malignant | 43.98 | 23.63 | 12 | 3229 | 3888 | 110582170 |
| Disseminated intravascular coagulation | 43.09 | 23.63 | 22 | 3219 | 41264 | 110544794 |
| Seizure | 41.29 | 23.63 | 41 | 3200 | 221144 | 110364914 |
| Drug ineffective for unapproved indication | 35.30 | 23.63 | 27 | 3214 | 102811 | 110483247 |
| Multiple sclerosis relapse | 33.70 | 23.63 | 20 | 3221 | 50220 | 110535838 |
| Agitation | 30.96 | 23.63 | 26 | 3215 | 113025 | 110473033 |
| Choluria | 30.35 | 23.63 | 6 | 3235 | 474 | 110585584 |
| Labile blood pressure | 29.72 | 23.63 | 8 | 3233 | 2463 | 110583595 |
| Drug ineffective | 27.55 | 23.63 | 102 | 3139 | 1520438 | 109065620 |
| Autonomic nervous system imbalance | 26.94 | 23.63 | 9 | 3232 | 5771 | 110580287 |
| Tachycardia | 25.06 | 23.63 | 32 | 3209 | 226613 | 110359445 |
| Blood creatine phosphokinase increased | 24.66 | 23.63 | 19 | 3222 | 73058 | 110513000 |
| Hypertonia | 23.64 | 23.63 | 9 | 3232 | 8397 | 110577661 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | M03CA01 | MUSCULO-SKELETAL SYSTEM MUSCLE RELAXANTS MUSCLE RELAXANTS, DIRECTLY ACTING AGENTS Dantrolene and derivatives |
| FDA PE | N0000008953 | Decreased Striated Muscle Contraction |
| MeSH PA | D009125 | Muscle Relaxants, Central |
| MeSH PA | D009465 | Neuromuscular Agents |
| CHEBI has role | CHEBI:51371 | muscle relaxant |
| CHEBI has role | CHEBI:63726 | neuroprotective agent |
| CHEBI has role | CHEBI:146223 | ryanodine receptor antagonist |
| FDA PE | N0000175735 | Decreased Striated Muscle Tone |
| FDA EPC | N0000175738 | Skeletal Muscle Relaxant |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Spasticity | indication | 221360009 | |
| Malignant hyperthermia | indication | 405501007 | |
| Muscle spasticity of spinal origin | indication | 416830008 | |
| Malignant Hyperthermia Prevention | indication | ||
| Muscle Spasticity of Cerebral Origin | indication | ||
| Neuroleptic malignant syndrome | off-label use | 15244003 | DOID:14464 |
| Duchenne muscular dystrophy | off-label use | 76670001 | DOID:11723 |
| Glycogen Storage Disease Type V with Muscle Pain | off-label use | ||
| Disorder of lung | contraindication | 19829001 | DOID:850 |
| Acute hepatitis | contraindication | 37871000 | |
| Disorder of muscle | contraindication | 129565002 | DOID:423 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Severe Cardiac Disease | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 7.28 | acidic |
| pKa2 | 0.0 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Ryanodine receptor 1 | Ion channel | ANTAGONIST | Ki | 6.76 | WOMBAT-PK | CHEMBL | |||
| Ryanodine receptor 3 | Ion channel | ANTAGONIST | CHEMBL | CHEMBL | |||||
| CDGSH iron-sulfur domain-containing protein 1 | Membrane other | Ki | 5.68 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4019703 | VUID |
| N0000147795 | NUI |
| D02347 | KEGG_DRUG |
| 24868-20-0 | SECONDARY_CAS_RN |
| 3104 | RXNORM |
| C0010976 | UMLSCUI |
| CHEBI:4317 | CHEBI |
| U1C | PDB_CHEM_ID |
| CHEMBL1201288 | ChEMBL_ID |
| CHEMBL928 | ChEMBL_ID |
| DB01219 | DRUGBANK_ID |
| D003620 | MESH_DESCRIPTOR_UI |
| 6914273 | PUBCHEM_CID |
| 4172 | IUPHAR_LIGAND_ID |
| 2317 | INN_ID |
| F64QU97QCR | UNII |
| 4534 | MMSL |
| 629 | MMSL |
| 66073 | MMSL |
| d00968 | MMSL |
| 001675 | NDDF |
| 004679 | NDDF |
| 372819007 | SNOMEDCT_US |
| 69107004 | SNOMEDCT_US |
| 81946009 | SNOMEDCT_US |
| 4018876 | VANDF |
| 4019703 | VANDF |
| F64QU97QCR | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-4411 | CAPSULE | 25 mg | ORAL | ANDA | 24 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-4422 | CAPSULE | 50 mg | ORAL | ANDA | 24 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-4433 | CAPSULE | 100 mg | ORAL | ANDA | 24 sections |
| Dantrolene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9297 | INJECTION, POWDER, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 17 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7211 | CAPSULE | 25 mg | ORAL | ANDA | 24 sections |
| Dantrium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42023-123 | INJECTION | 20 mg | INTRAVENOUS | NDA | 23 sections |
| Dantrium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42023-124 | CAPSULE | 25 mg | ORAL | NDA | 23 sections |
| Dantrium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42023-125 | CAPSULE | 50 mg | ORAL | NDA | 23 sections |
| Dantrium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42023-126 | CAPSULE | 100 mg | ORAL | NDA | 23 sections |
| RYANODEX dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42367-540 | INJECTION, SUSPENSION | 250 mg | INTRAVENOUS | NDA | 24 sections |
| dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-362 | CAPSULE | 25 mg | ORAL | NDA authorized generic | 23 sections |
| dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-363 | CAPSULE | 50 mg | ORAL | NDA authorized generic | 23 sections |
| dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-364 | CAPSULE | 100 mg | ORAL | NDA authorized generic | 23 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-217 | CAPSULE | 25 mg | ORAL | ANDA | 24 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55154-7140 | CAPSULE | 25 mg | ORAL | ANDA | 23 sections |
| dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-2168 | CAPSULE | 25 mg | ORAL | NDA AUTHORIZED GENERIC | 22 sections |
| dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-2169 | CAPSULE | 50 mg | ORAL | NDA AUTHORIZED GENERIC | 22 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64850-840 | CAPSULE | 25 mg | ORAL | ANDA | 24 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64850-841 | CAPSULE | 50 mg | ORAL | ANDA | 24 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64850-842 | CAPSULE | 100 mg | ORAL | ANDA | 24 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68084-300 | CAPSULE | 25 mg | ORAL | ANDA | 23 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68151-1520 | CAPSULE | 25 mg | ORAL | ANDA | 22 sections |
| dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70518-4622 | CAPSULE | 100 mg | ORAL | NDA authorized generic | 22 sections |
| dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70518-4668 | CAPSULE | 50 mg | ORAL | NDA authorized generic | 22 sections |
| dantrolene sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-1497 | CAPSULE | 25 mg | ORAL | NDA AUTHORIZED GENERIC | 22 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2045 | CAPSULE | 25 mg | ORAL | ANDA | 23 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2046 | CAPSULE | 50 mg | ORAL | ANDA | 23 sections |
| Dantrolene Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72162-2047 | CAPSULE | 100 mg | ORAL | ANDA | 23 sections |
| Revonto | HUMAN PRESCRIPTION DRUG LABEL | 1 | 78670-003 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 22 sections |
| Revonto | HUMAN PRESCRIPTION DRUG LABEL | 1 | 84549-003 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 22 sections |