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butalbital 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| hypnotics, barbituric acid derivatives | 441 | 77-26-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
management of butalbital withdrawal can be simplified by using a phenobarbital-loading protocol; RN given refers to parent cpd
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 3.60 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 22.30 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 35 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PRKDC,STK33,TEK | 20 | |||
| kinase-selectivity-class | GRK2,PDK1 | 2 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 4, 1976 | FDA | ACTAVIS LABS UT 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 |
|---|---|---|---|---|---|---|
| Completed suicide | 302.32 | 16.00 | 158 | 5593 | 144900 | 90477796 |
| Death | 156.18 | 16.00 | 167 | 5584 | 456384 | 90166312 |
| Toxicity to various agents | 110.15 | 16.00 | 112 | 5639 | 287734 | 90334962 |
| Cholecystitis chronic | 57.06 | 16.00 | 22 | 5729 | 9804 | 90612892 |
| Drug abuse | 50.88 | 16.00 | 42 | 5709 | 82305 | 90540391 |
| Cardio-respiratory arrest | 44.95 | 16.00 | 35 | 5716 | 63105 | 90559591 |
| Migraine | 39.09 | 16.00 | 54 | 5697 | 190338 | 90432358 |
| Peritoneal perforation | 33.46 | 16.00 | 6 | 5745 | 126 | 90622570 |
| Poisoning | 29.91 | 16.00 | 16 | 5735 | 15201 | 90607495 |
| Headache | 27.72 | 16.00 | 118 | 5633 | 862628 | 89760068 |
| Injection site necrosis | 23.18 | 16.00 | 7 | 5744 | 1494 | 90621202 |
| Tracheitis | 21.92 | 16.00 | 6 | 5745 | 904 | 90621792 |
| Emotional distress | 21.18 | 16.00 | 18 | 5733 | 36644 | 90586052 |
| Breast cyst | 20.98 | 16.00 | 7 | 5744 | 2060 | 90620636 |
| Respiratory arrest | 20.57 | 16.00 | 17 | 5734 | 33294 | 90589402 |
| Gallbladder disorder | 18.64 | 16.00 | 13 | 5738 | 19790 | 90602906 |
| Product complaint | 17.94 | 16.00 | 11 | 5740 | 13489 | 90609207 |
| Depression | 17.34 | 16.00 | 50 | 5701 | 300551 | 90322145 |
| Hypercoagulation | 16.60 | 16.00 | 6 | 5745 | 2236 | 90620460 |
| Ventricular hyperkinesia | 16.55 | 16.00 | 3 | 5748 | 67 | 90622629 |
| Intentional product misuse | 16.28 | 16.00 | 24 | 5727 | 89580 | 90533116 |
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 |
|---|---|---|---|---|---|---|
| Death | 72.50 | 29.36 | 59 | 616 | 471126 | 42149534 |
| Cardio-respiratory arrest | 42.60 | 29.36 | 20 | 655 | 58616 | 42562044 |
| Drug abuse | 31.70 | 29.36 | 20 | 655 | 104751 | 42515909 |
| Completed suicide | 30.65 | 29.36 | 19 | 656 | 96446 | 42524214 |
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 |
|---|---|---|---|---|---|---|
| Completed suicide | 359.05 | 20.53 | 179 | 4165 | 242202 | 110342753 |
| Death | 267.55 | 20.53 | 219 | 4125 | 698650 | 109886305 |
| Toxicity to various agents | 149.05 | 20.53 | 134 | 4210 | 480421 | 110104534 |
| Cardio-respiratory arrest | 86.92 | 20.53 | 55 | 4289 | 115781 | 110469174 |
| Drug abuse | 72.17 | 20.53 | 58 | 4286 | 177353 | 110407602 |
| Cholecystitis chronic | 52.18 | 20.53 | 18 | 4326 | 9482 | 110575473 |
| Migraine | 36.31 | 20.53 | 39 | 4305 | 171613 | 110413342 |
| Peritoneal perforation | 34.44 | 20.53 | 6 | 4338 | 175 | 110584780 |
| Emotional distress | 30.39 | 20.53 | 20 | 4324 | 44827 | 110540128 |
| Poisoning | 30.06 | 20.53 | 17 | 4327 | 29088 | 110555867 |
| Respiratory arrest | 25.67 | 20.53 | 20 | 4324 | 58279 | 110526676 |
| Injection site necrosis | 25.37 | 20.53 | 7 | 4337 | 1759 | 110583196 |
| Gallbladder disorder | 23.67 | 20.53 | 13 | 4331 | 21016 | 110563939 |
| Headache | 22.67 | 20.53 | 81 | 4263 | 882296 | 109702659 |
| Intentional overdose | 21.08 | 20.53 | 26 | 4318 | 132475 | 110452480 |
| Off label use | 21 | 20.53 | 17 | 4327 | 1500168 | 109084787 |
| Tracheitis | 20.99 | 20.53 | 6 | 4338 | 1715 | 110583240 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA CS | M0002177 | Barbiturates |
| FDA EPC | N0000175693 | Barbiturate |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35717 | sedative |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Tension-type headache | indication | 398057008 | |
| Migraine | off-label use | 37796009 | DOID:6364 |
| Necrotizing enterocolitis in fetus OR newborn | contraindication | 2707005 | |
| Suicidal thoughts | contraindication | 6471006 | |
| Dependent drug abuse | contraindication | 6525002 | |
| Alcoholism | contraindication | 7200002 | |
| Hyperammonemia | contraindication | 9360008 | |
| Peptic ulcer | contraindication | 13200003 | DOID:750 |
| Chronic obstructive lung disease | contraindication | 13645005 | DOID:3083 |
| Hepatic encephalopathy | contraindication | 13920009 | DOID:13413 |
| Chronic disease of respiratory system | contraindication | 17097001 | |
| Mood swings | contraindication | 18963009 | |
| Inflammatory bowel disease | contraindication | 24526004 | DOID:0050589 |
| Depressive disorder | contraindication | 35489007 | |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Gastrointestinal ulcer | contraindication | 40845000 | |
| Hypothyroidism | contraindication | 40930008 | DOID:1459 |
| Hyperactive behavior | contraindication | 44548000 | |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Low blood pressure | contraindication | 45007003 | |
| Bradycardia | contraindication | 48867003 | |
| Vitamin K deficiency | contraindication | 52675005 | DOID:11249 |
| Nasal polyp | contraindication | 52756005 | |
| Acute nephropathy | contraindication | 58574008 | |
| Hepatic failure | contraindication | 59927004 | |
| Drug AND/OR toxin-induced diarrhea | contraindication | 65979008 | |
| Substance abuse | contraindication | 66214007 | |
| Benign intracranial hypertension | contraindication | 68267002 | DOID:11459 |
| Poisoning by acetaminophen | contraindication | 70273001 | |
| Agoraphobia | contraindication | 70691001 | DOID:593 |
| Hepatic coma | contraindication | 72836002 | DOID:12550 |
| Sleep apnea | contraindication | 73430006 | DOID:0050847 |
| Factor II deficiency | contraindication | 73975000 | |
| Reye's syndrome | contraindication | 74351001 | DOID:14525 |
| Gastrointestinal hemorrhage | contraindication | 74474003 | |
| Urethral stricture | contraindication | 76618002 | |
| Thrombotic thrombocytopenic purpura | contraindication | 78129009 | DOID:10772 |
| Decreased respiratory function | contraindication | 80954004 | |
| Injury of head | contraindication | 82271004 | |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Gout | contraindication | 90560007 | DOID:13189 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Hemophilia | contraindication | 90935002 | |
| Anemia due to enzyme deficiency | contraindication | 111577008 | |
| Acute abdominal pain | contraindication | 116290004 | |
| Procedure on urinary system | contraindication | 118677009 | |
| von Willebrand disorder | contraindication | 128105004 | DOID:12531 |
| Seizure disorder | contraindication | 128613002 | |
| Obsessive-compulsive disorder | contraindication | 191736004 | DOID:10933 |
| Insomnia | contraindication | 193462001 | |
| Impaired renal function disorder | contraindication | 197663003 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Sleep automatism | contraindication | 247962006 | |
| Benign prostatic hyperplasia | contraindication | 266569009 | |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Pregnancy, function | contraindication | 289908002 | |
| Lesion of brain | contraindication | 301766008 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Panic disorder | contraindication | 371631005 | DOID:594 |
| Primary adrenocortical insufficiency | contraindication | 373662000 | |
| Operation on gastrointestinal tract | contraindication | 386621005 | |
| Pseudomembranous enterocolitis | contraindication | 397683000 | |
| Respiratory insufficiency | contraindication | 409623005 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Myocardial ischemia | contraindication | 414795007 | DOID:3393 |
| Myocardial infarction in recovery phase | contraindication | 418044006 | |
| Central nervous system depression | contraindication | 418072004 | |
| Porphyria | contraindication | 418470004 | |
| Ultrarapid metabolizer due to cytochrome p450 CYP2D6 variant | contraindication | 422681000 | |
| Dysfunction of sphincter of Oddi | contraindication | 430887001 | |
| Acute erosive gastritis | contraindication | 444926003 | |
| Acute exacerbation of asthma | contraindication | 708038006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 7.65 | acidic |
| pKa2 | 9.34 | acidic |
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 |
|---|---|---|---|---|---|---|---|---|---|
| GABA-A receptor alpha-1/beta-3/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | WOMBAT-PK | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4018107 | VUID |
| N0000179058 | NUI |
| D03182 | KEGG_DRUG |
| 19860 | RXNORM |
| C0054234 | UMLSCUI |
| CHEBI:102524 | CHEBI |
| CHEMBL454 | ChEMBL_ID |
| DB00241 | DRUGBANK_ID |
| 2481 | PUBCHEM_CID |
| C004470 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7138 | IUPHAR_LIGAND_ID |
| 7 | INN_ID |
| KHS0AZ4JVK | UNII |
| 4311 | MMSL |
| 72849 | MMSL |
| d03061 | MMSL |
| 387563005 | SNOMEDCT_US |
| 96196008 | SNOMEDCT_US |
| 4018107 | VANDF |
| 001423 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0054-0650 | CAPSULE | 50 mg | ORAL | ANDA | 33 sections |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0054-3000 | CAPSULE | 50 mg | ORAL | ANDA | 33 sections |
| Butalbital, Acetaminophen, and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0143-0170 | CAPSULE | 50 mg | ORAL | ANDA | 26 sections |
| Butalbital, aspirin, and caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0527-1552 | CAPSULE | 50 mg | ORAL | ANDA | 25 sections |
| Butalbital, Acetaminophen, and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0527-1695 | TABLET | 50 mg | ORAL | ANDA | 28 sections |
| butalbital, acetaminophen and caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0527-4094 | CAPSULE | 50 mg | ORAL | ANDA | 27 sections |
| Butalbital, Acetaminophen, and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0527-4095 | CAPSULE | 50 mg | ORAL | ANDA | 27 sections |
| Butalbital, Acetaminophen, and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0591-2640 | CAPSULE | 50 mg | ORAL | ANDA | 25 sections |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0591-2641 | CAPSULE | 50 mg | ORAL | ANDA | 27 sections |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0591-3220 | CAPSULE | 50 mg | ORAL | NDA authorized generic | 32 sections |
| Butalbital, Acetaminophen, and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0591-3369 | TABLET | 50 mg | ORAL | ANDA | 27 sections |
| butalbital and acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0603-2540 | TABLET | 50 mg | ORAL | ANDA | 25 sections |
| Ascomp with Codeine | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0722-6094 | CAPSULE | 50 mg | ORAL | ANDA | 33 sections |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0722-6670 | CAPSULE | 50 mg | ORAL | ANDA | 32 sections |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | HUMAN PRESCRIPTION DRUG LABEL | 4 | 0722-7028 | CAPSULE | 50 mg | ORAL | ANDA | 32 sections |
| Butalbital, Acetaminophen, and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0722-7029 | CAPSULE | 50 mg | ORAL | ANDA | 27 sections |
| Butalbital and Acetaminophen | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0722-7075 | TABLET | 50 mg | ORAL | ANDA | 25 sections |
| Butalbital, Acetaminophen, and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0722-7320 | TABLET | 50 mg | ORAL | ANDA | 26 sections |
| Butalbital, aspirin, and caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0781-2270 | CAPSULE | 50 mg | ORAL | ANDA | 25 sections |
| Butalbital, Acetaminophen, and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 0904-6938 | TABLET | 50 mg | ORAL | ANDA | 28 sections |
| Butalbital, Acetaminophen and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 10135-628 | CAPSULE | 50 mg | ORAL | ANDA | 25 sections |
| Butalbital, Acetaminophen and Caffeine | HUMAN PRESCRIPTION DRUG LABEL | 3 | 10702-253 | TABLET | 50 mg | ORAL | ANDA | 26 sections |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 11534-187 | CAPSULE | 50 mg | ORAL | ANDA | 27 sections |
| Tencon | HUMAN PRESCRIPTION DRUG LABEL | 2 | 11584-0030 | TABLET | 50 mg | ORAL | ANDA | 28 sections |
| Butalbital, Acetaminophen and Caffeine | Human Prescription Drug Label | 3 | 13107-075 | CAPSULE | 50 mg | ORAL | ANDA | 24 sections |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 13925-535 | CAPSULE | 50 mg | ORAL | ANDA | 14 sections |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 13925-536 | CAPSULE | 50 mg | ORAL | ANDA | 14 sections |
| ACETAMINOPHEN, BUTALBITAL AND CAFFEINE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 16590-022 | TABLET | 50 mg | ORAL | ANDA | 13 sections |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINEPLUS | HUMAN PRESCRIPTION DRUG LABEL | 3 | 16590-581 | TABLET | 50 mg | ORAL | ANDA | 21 sections |
| BUTALBITAL, ASPIRIN, AND CAFFEINE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 16590-911 | CAPSULE | 50 mg | ORAL | NDA authorized generic | 27 sections |