Stem definition | Drug id | CAS RN |
---|---|---|
835 | 113775-47-6 |
Dose | Unit | Route |
---|---|---|
1 | mg | P |
Property | Value | Reference |
---|---|---|
MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.09 ยตM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Vd (Volume of distribution) | 1.60 L/kg | Lombardo F, Berellini G, Obach RS |
CL (Clearance) | 11 mL/min/kg | Lombardo F, Berellini G, Obach RS |
fu (Fraction unbound in plasma) | 0.06 % | Lombardo F, Berellini G, Obach RS |
t_half (Half-life) | 2.20 hours | Lombardo F, Berellini G, Obach RS |
S (Water solubility) | 20 mg/mL | Bocci G, Oprea TI, Benet LZ |
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Date | Agency | Company | Orphan |
---|---|---|---|
Dec. 17, 1999 | FDA | HOSPIRA | |
Jan. 29, 2001 | PMDA | Abbott Japan, Maruishi Pharmaceutical | |
Sept. 15, 2011 | EMA | Orion Corporation |
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 |
---|---|---|---|---|---|---|
Bradycardia | 236.92 | 30.29 | 108 | 3953 | 73119 | 63411842 |
Product administered to patient of inappropriate age | 119.31 | 30.29 | 30 | 4031 | 3238 | 63481723 |
Hypotension | 87.69 | 30.29 | 97 | 3964 | 272507 | 63212454 |
Delirium | 82.28 | 30.29 | 47 | 4014 | 50494 | 63434467 |
Agitation | 80.07 | 30.29 | 49 | 4012 | 59708 | 63425253 |
Upper airway obstruction | 78.07 | 30.29 | 16 | 4045 | 687 | 63484274 |
Floppy iris syndrome | 76.08 | 30.29 | 12 | 4049 | 110 | 63484851 |
Respiratory depression | 73.42 | 30.29 | 29 | 4032 | 13686 | 63471275 |
Glossoptosis | 73.15 | 30.29 | 11 | 4050 | 71 | 63484890 |
Cardiac arrest | 71.59 | 30.29 | 54 | 4007 | 92491 | 63392470 |
Withdrawal syndrome | 69.21 | 30.29 | 31 | 4030 | 19966 | 63464995 |
Respiratory acidosis | 69.05 | 30.29 | 23 | 4038 | 6692 | 63478269 |
Sinus arrest | 61.83 | 30.29 | 16 | 4045 | 1933 | 63483028 |
Respiratory failure | 56.61 | 30.29 | 49 | 4012 | 101809 | 63383152 |
Off label use | 56.36 | 30.29 | 129 | 3932 | 674333 | 62810628 |
Generalised tonic-clonic seizure | 55.44 | 30.29 | 30 | 4031 | 28986 | 63455975 |
Laryngeal stenosis | 55.20 | 30.29 | 13 | 4048 | 1065 | 63483896 |
Tachyphylaxis | 53.42 | 30.29 | 10 | 4051 | 266 | 63484695 |
Hepatic function abnormal | 51.11 | 30.29 | 31 | 4030 | 37111 | 63447850 |
Stress cardiomyopathy | 50.63 | 30.29 | 20 | 4041 | 9430 | 63475531 |
Drug reaction with eosinophilia and systemic symptoms | 48.51 | 30.29 | 29 | 4032 | 33807 | 63451154 |
Local anaesthetic systemic toxicity | 46.86 | 30.29 | 11 | 4050 | 888 | 63484073 |
Acute respiratory distress syndrome | 46.82 | 30.29 | 25 | 4036 | 23509 | 63461452 |
Product closure removal difficult | 44.43 | 30.29 | 6 | 4055 | 15 | 63484946 |
Hyperthermia | 44.28 | 30.29 | 18 | 4043 | 9138 | 63475823 |
Ventricular dysfunction | 42.77 | 30.29 | 13 | 4048 | 2815 | 63482146 |
Phaeochromocytoma crisis | 41.65 | 30.29 | 8 | 4053 | 245 | 63484716 |
Myoclonus | 40.68 | 30.29 | 20 | 4041 | 15848 | 63469113 |
Abdominal compartment syndrome | 40.27 | 30.29 | 9 | 4052 | 584 | 63484377 |
Aplastic anaemia | 40.16 | 30.29 | 17 | 4044 | 9552 | 63475409 |
Drug interaction | 39.48 | 30.29 | 60 | 4001 | 229071 | 63255890 |
Unwanted awareness during anaesthesia | 39.34 | 30.29 | 8 | 4053 | 330 | 63484631 |
Human herpesvirus 6 infection reactivation | 38.53 | 30.29 | 8 | 4053 | 366 | 63484595 |
Laryngospasm | 37.73 | 30.29 | 12 | 4049 | 3016 | 63481945 |
Posterior reversible encephalopathy syndrome | 36.12 | 30.29 | 19 | 4042 | 17326 | 63467635 |
Device pacing issue | 35.26 | 30.29 | 6 | 4055 | 91 | 63484870 |
Tachycardia | 34.34 | 30.29 | 40 | 4021 | 118116 | 63366845 |
Hypernatraemia | 33.54 | 30.29 | 14 | 4047 | 7595 | 63477366 |
Atrioventricular block second degree | 30.88 | 30.29 | 11 | 4050 | 3903 | 63481058 |
Arteriospasm coronary | 30.73 | 30.29 | 11 | 4050 | 3957 | 63481004 |
Postoperative ileus | 30.62 | 30.29 | 7 | 4054 | 503 | 63484458 |
Accident at work | 30.43 | 30.29 | 7 | 4054 | 517 | 63484444 |
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 |
---|---|---|---|---|---|---|
Bradycardia | 371.60 | 24.32 | 207 | 6148 | 75211 | 34875365 |
Diabetes insipidus | 267.56 | 24.32 | 69 | 6286 | 2859 | 34947717 |
Cardiac arrest | 208.88 | 24.32 | 158 | 6197 | 96001 | 34854575 |
Hyperthermia | 148.62 | 24.32 | 60 | 6295 | 10517 | 34940059 |
Intestinal pseudo-obstruction | 144.05 | 24.32 | 38 | 6317 | 1718 | 34948858 |
Product administered to patient of inappropriate age | 133.04 | 24.32 | 41 | 6314 | 3250 | 34947326 |
Arteriospasm coronary | 115.32 | 24.32 | 37 | 6318 | 3345 | 34947231 |
Hyperthermia malignant | 109.04 | 24.32 | 32 | 6323 | 2145 | 34948431 |
Drug withdrawal syndrome | 101.42 | 24.32 | 56 | 6299 | 19778 | 34930798 |
Delirium | 98.99 | 24.32 | 74 | 6281 | 43917 | 34906659 |
Hypotension | 87.09 | 24.32 | 149 | 6206 | 221500 | 34729076 |
Seizure like phenomena | 74.62 | 24.32 | 19 | 6336 | 745 | 34949831 |
Respiratory failure | 71.32 | 24.32 | 93 | 6262 | 108479 | 34842097 |
Postoperative ileus | 71.08 | 24.32 | 18 | 6337 | 690 | 34949886 |
Off label use | 68.35 | 24.32 | 198 | 6157 | 419326 | 34531250 |
Serotonin syndrome | 62.20 | 24.32 | 41 | 6314 | 19892 | 34930684 |
Acute motor axonal neuropathy | 57.43 | 24.32 | 10 | 6345 | 55 | 34950521 |
Tachycardia | 51.59 | 24.32 | 70 | 6285 | 84702 | 34865874 |
Burkholderia test positive | 51.06 | 24.32 | 15 | 6340 | 1008 | 34949568 |
Sedation complication | 50.72 | 24.32 | 17 | 6338 | 1760 | 34948816 |
Withdrawal syndrome | 49.84 | 24.32 | 30 | 6325 | 12425 | 34938151 |
Electrocardiogram QT prolonged | 47.17 | 24.32 | 47 | 6308 | 40905 | 34909671 |
Polyuria | 45.98 | 24.32 | 25 | 6330 | 8549 | 34942027 |
Myoclonus | 45.23 | 24.32 | 30 | 6325 | 14695 | 34935881 |
Epidermolysis bullosa | 44.94 | 24.32 | 9 | 6346 | 115 | 34950461 |
Tachypnoea | 43.75 | 24.32 | 32 | 6323 | 18320 | 34932256 |
Upper airway obstruction | 43.31 | 24.32 | 12 | 6343 | 653 | 34949923 |
Drug ineffective for unapproved indication | 42.68 | 24.32 | 35 | 6320 | 23680 | 34926896 |
Fatigue | 40.54 | 24.32 | 9 | 6346 | 370644 | 34579932 |
Agitation | 40.49 | 24.32 | 51 | 6304 | 57348 | 34893228 |
Malignant catatonia | 38.79 | 24.32 | 9 | 6346 | 237 | 34950339 |
Torsade de pointes | 38.60 | 24.32 | 21 | 6334 | 7188 | 34943388 |
Hyperaesthesia | 37.99 | 24.32 | 18 | 6337 | 4612 | 34945964 |
Product use issue | 36.61 | 24.32 | 51 | 6304 | 63165 | 34887411 |
Laryngomalacia | 36.11 | 24.32 | 9 | 6346 | 323 | 34950253 |
Drug interaction | 34.00 | 24.32 | 104 | 6251 | 225842 | 34724734 |
Product use in unapproved indication | 33.45 | 24.32 | 69 | 6286 | 117430 | 34833146 |
Hypernatraemia | 32.81 | 24.32 | 20 | 6335 | 8470 | 34942106 |
Floppy iris syndrome | 31.53 | 24.32 | 8 | 6347 | 309 | 34950267 |
Multiple organ dysfunction syndrome | 30.57 | 24.32 | 52 | 6303 | 76514 | 34874062 |
Urinary bladder rupture | 29.19 | 24.32 | 6 | 6349 | 88 | 34950488 |
Cardiac arrest neonatal | 28.79 | 24.32 | 5 | 6350 | 27 | 34950549 |
Sinus arrest | 28.36 | 24.32 | 11 | 6344 | 1729 | 34948847 |
Haemodynamic instability | 28.27 | 24.32 | 19 | 6336 | 9504 | 34941072 |
Neuroleptic malignant syndrome | 27.20 | 24.32 | 24 | 6331 | 17910 | 34932666 |
Respiratory depression | 27.19 | 24.32 | 23 | 6332 | 16222 | 34934354 |
Abdominal compartment syndrome | 26.73 | 24.32 | 9 | 6346 | 944 | 34949632 |
Asthenia | 26.67 | 24.32 | 6 | 6349 | 245245 | 34705331 |
Glossoptosis | 26.55 | 24.32 | 6 | 6349 | 140 | 34950436 |
Drug withdrawal syndrome neonatal | 26.46 | 24.32 | 13 | 6342 | 3606 | 34946970 |
Macule | 26.19 | 24.32 | 10 | 6345 | 1507 | 34949069 |
Hypoxia | 25.48 | 24.32 | 40 | 6315 | 55055 | 34895521 |
Transcranial electrical motor evoked potential monitoring abnormal | 24.91 | 24.32 | 4 | 6351 | 12 | 34950564 |
Hypercapnia | 24.47 | 24.32 | 13 | 6342 | 4242 | 34946334 |
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 |
---|---|---|---|---|---|---|
Bradycardia | 472.77 | 25.06 | 260 | 9594 | 135297 | 79599237 |
Diabetes insipidus | 272.89 | 25.06 | 73 | 9781 | 5164 | 79729370 |
Cardiac arrest | 264.39 | 25.06 | 197 | 9657 | 171899 | 79562635 |
Product administered to patient of inappropriate age | 204.65 | 25.06 | 59 | 9795 | 5494 | 79729040 |
Hyperthermia | 187.68 | 25.06 | 74 | 9780 | 17963 | 79716571 |
Intestinal pseudo-obstruction | 143.64 | 25.06 | 38 | 9816 | 2571 | 79731963 |
Delirium | 138.92 | 25.06 | 101 | 9753 | 84526 | 79650008 |
Hypotension | 137.56 | 25.06 | 216 | 9638 | 440101 | 79294433 |
Drug withdrawal syndrome | 121.63 | 25.06 | 67 | 9787 | 34651 | 79699883 |
Arteriospasm coronary | 112.06 | 25.06 | 39 | 9815 | 6677 | 79727857 |
Respiratory failure | 111.32 | 25.06 | 124 | 9730 | 180787 | 79553747 |
Hyperthermia malignant | 107.49 | 25.06 | 31 | 9823 | 2886 | 79731648 |
Respiratory depression | 107.02 | 25.06 | 57 | 9797 | 27573 | 79706961 |
Postoperative ileus | 106.33 | 25.06 | 25 | 9829 | 1040 | 79733494 |
Upper airway obstruction | 104.02 | 25.06 | 26 | 9828 | 1402 | 79733132 |
Agitation | 103.59 | 25.06 | 91 | 9763 | 99624 | 79634910 |
Withdrawal syndrome | 102.89 | 25.06 | 55 | 9799 | 26799 | 79707735 |
Serotonin syndrome | 88.40 | 25.06 | 60 | 9794 | 44967 | 79689567 |
Myoclonus | 85 | 25.06 | 49 | 9805 | 27611 | 79706923 |
Off label use | 84.33 | 25.06 | 274 | 9580 | 906941 | 78827593 |
Glossoptosis | 79.01 | 25.06 | 15 | 9839 | 216 | 79734318 |
Polyuria | 78.67 | 25.06 | 38 | 9816 | 14976 | 79719558 |
Tachypnoea | 73.31 | 25.06 | 47 | 9807 | 32016 | 79702518 |
Tachycardia | 72.32 | 25.06 | 99 | 9755 | 177669 | 79556865 |
Electrocardiogram QT prolonged | 71.67 | 25.06 | 71 | 9783 | 90315 | 79644219 |
Generalised tonic-clonic seizure | 71.06 | 25.06 | 52 | 9802 | 43858 | 79690676 |
Drug interaction | 70.48 | 25.06 | 157 | 9697 | 415026 | 79319508 |
Drug ineffective for unapproved indication | 70.35 | 25.06 | 55 | 9799 | 51183 | 79683351 |
Hypernatraemia | 65.09 | 25.06 | 33 | 9821 | 14418 | 79720116 |
Seizure like phenomena | 65.06 | 25.06 | 19 | 9835 | 1848 | 79732686 |
Sinus arrest | 64.16 | 25.06 | 22 | 9832 | 3600 | 79730934 |
Abdominal compartment syndrome | 63.45 | 25.06 | 18 | 9836 | 1579 | 79732955 |
Stress cardiomyopathy | 57.70 | 25.06 | 28 | 9826 | 11138 | 79723396 |
Respiratory acidosis | 57.62 | 25.06 | 28 | 9826 | 11172 | 79723362 |
Fatigue | 56.96 | 25.06 | 22 | 9832 | 929705 | 78804829 |
Acute motor axonal neuropathy | 55.58 | 25.06 | 10 | 9844 | 105 | 79734429 |
Arthralgia | 55.40 | 25.06 | 4 | 9850 | 571799 | 79162735 |
Multiple organ dysfunction syndrome | 51.96 | 25.06 | 69 | 9785 | 120177 | 79614357 |
Delayed recovery from anaesthesia | 49.48 | 25.06 | 15 | 9839 | 1658 | 79732876 |
Hypoxia | 48.90 | 25.06 | 62 | 9792 | 103181 | 79631353 |
Sedation complication | 48.77 | 25.06 | 28 | 9826 | 15641 | 79718893 |
Torsade de pointes | 48.37 | 25.06 | 30 | 9824 | 19282 | 79715252 |
Drug reaction with eosinophilia and systemic symptoms | 48.21 | 25.06 | 49 | 9805 | 64195 | 79670339 |
Laryngeal stenosis | 46.57 | 25.06 | 13 | 9841 | 1075 | 79733459 |
Atrioventricular block second degree | 45.99 | 25.06 | 21 | 9833 | 7291 | 79727243 |
Product use in unapproved indication | 45.01 | 25.06 | 97 | 9757 | 250262 | 79484272 |
Malaise | 43.22 | 25.06 | 5 | 9849 | 489864 | 79244670 |
Ventricular tachycardia | 42.95 | 25.06 | 38 | 9816 | 41897 | 79692637 |
Epidermolysis bullosa | 42.93 | 25.06 | 9 | 9845 | 219 | 79734315 |
Nausea | 42.26 | 25.06 | 34 | 9820 | 957162 | 78777372 |
Laryngospasm | 40.15 | 25.06 | 16 | 9838 | 3981 | 79730553 |
Paradoxical drug reaction | 40.11 | 25.06 | 19 | 9835 | 7166 | 79727368 |
Product closure removal difficult | 40.00 | 25.06 | 5 | 9849 | 0 | 79734534 |
Headache | 39.09 | 25.06 | 16 | 9838 | 653756 | 79080778 |
Haemodynamic instability | 38.53 | 25.06 | 25 | 9829 | 17357 | 79717177 |
Local anaesthetic systemic toxicity | 37.94 | 25.06 | 11 | 9843 | 1043 | 79733491 |
Ventricular fibrillation | 36.89 | 25.06 | 31 | 9823 | 31895 | 79702639 |
Blood pressure decreased | 36.83 | 25.06 | 53 | 9801 | 99413 | 79635121 |
Diarrhoea | 36.73 | 25.06 | 33 | 9821 | 880456 | 78854078 |
Neuroleptic malignant syndrome | 36.55 | 25.06 | 29 | 9825 | 27530 | 79707004 |
Malignant catatonia | 36.55 | 25.06 | 9 | 9845 | 456 | 79734078 |
Hepatic function abnormal | 36.36 | 25.06 | 45 | 9809 | 73062 | 79661472 |
Acute respiratory distress syndrome | 35.61 | 25.06 | 35 | 9819 | 44032 | 79690502 |
Dizziness | 34.65 | 25.06 | 11 | 9843 | 526430 | 79208104 |
Burkholderia test positive | 34.50 | 25.06 | 9 | 9845 | 576 | 79733958 |
Phaeochromocytoma crisis | 34.11 | 25.06 | 8 | 9846 | 329 | 79734205 |
Shock | 34.10 | 25.06 | 34 | 9820 | 43514 | 79691020 |
Pain in extremity | 34.01 | 25.06 | 3 | 9851 | 364535 | 79369999 |
Hyperpyrexia | 33.67 | 25.06 | 16 | 9838 | 6076 | 79728458 |
Asthenia | 33.13 | 25.06 | 11 | 9843 | 511678 | 79222856 |
Weight decreased | 32.93 | 25.06 | 3 | 9851 | 355195 | 79379339 |
Transcranial electrical motor evoked potential monitoring abnormal | 32.82 | 25.06 | 5 | 9849 | 16 | 79734518 |
Airway complication of anaesthesia | 32.36 | 25.06 | 8 | 9846 | 412 | 79734122 |
Atrioventricular block complete | 32.26 | 25.06 | 22 | 9832 | 16588 | 79717946 |
Drug ineffective | 31.87 | 25.06 | 235 | 9619 | 1080678 | 78653856 |
Oxygen saturation decreased | 31.64 | 25.06 | 57 | 9797 | 128990 | 79605544 |
Aplastic anaemia | 30.76 | 25.06 | 22 | 9832 | 17883 | 79716651 |
Hyperaesthesia | 30.64 | 25.06 | 19 | 9835 | 12203 | 79722331 |
Hypercapnia | 30.60 | 25.06 | 17 | 9837 | 8918 | 79725616 |
Human herpesvirus 6 infection reactivation | 29.86 | 25.06 | 8 | 9846 | 567 | 79733967 |
Anaphylactic shock | 29.85 | 25.06 | 29 | 9825 | 35967 | 79698567 |
Septic shock | 29.80 | 25.06 | 54 | 9800 | 122747 | 79611787 |
Device pacing issue | 29.29 | 25.06 | 6 | 9848 | 130 | 79734404 |
Decreased appetite | 28.95 | 25.06 | 4 | 9850 | 342414 | 79392120 |
Dyspnoea | 28.17 | 25.06 | 39 | 9815 | 856986 | 78877548 |
Sinus bradycardia | 28.11 | 25.06 | 24 | 9830 | 25223 | 79709311 |
Product use issue | 26.55 | 25.06 | 71 | 9783 | 209751 | 79524783 |
Acute respiratory failure | 25.44 | 25.06 | 34 | 9820 | 59507 | 79675027 |
Trigemino-cardiac reflex | 25.21 | 25.06 | 6 | 9848 | 263 | 79734271 |
None
Source | Code | Description |
---|---|---|
ATC | N05CM18 | NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Other hypnotics and sedatives |
FDA MoA | N0000009918 | Adrenergic alpha2-Agonists |
FDA EPC | N0000175554 | Central alpha-2 Adrenergic Agonist |
CHEBI has role | CHEBI:35569 | alpha-adrenergic agonists |
CHEBI has role | CHEBI:35717 | hypnotics |
FDA PE | N0000175975 | General Anesthesia |
MeSH PA | D018663 | Adrenergic Agents |
MeSH PA | D000322 | Adrenergic Agonists |
MeSH PA | D058647 | Adrenergic alpha-2 Receptor Agonists |
MeSH PA | D000316 | Adrenergic alpha-Agonists |
MeSH PA | D000700 | Analgesics |
MeSH PA | D018712 | Analgesics, Non-Narcotic |
MeSH PA | D002491 | Central Nervous System Agents |
MeSH PA | D002492 | Central Nervous System Depressants |
MeSH PA | D006993 | Hypnotics and Sedatives |
MeSH PA | D018377 | Neurotransmitter Agents |
MeSH PA | D018373 | Peripheral Nervous System Agents |
MeSH PA | D018689 | Sensory System Agents |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Conscious sedation | indication | 314271007 | |
Complete atrioventricular block | contraindication | 27885002 | |
Hypovolemia | contraindication | 28560003 | |
Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
Low blood pressure | contraindication | 45007003 | |
Chronic heart failure | contraindication | 48447003 | |
Bradycardia | contraindication | 48867003 | |
Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
Kidney disease | contraindication | 90708001 | DOID:557 |
Disease of liver | contraindication | 235856003 | DOID:409 |
Cardiac Decompensation | contraindication |
Species | Use | Relation |
---|---|---|
Cats | Preanesthesia to general anesthesia | Indication |
Cats | Sedation and analgesia | Indication |
Dogs | Preanesthesia to general anesthesia | Indication |
Dogs | Sedation and analgesia | Indication |
Dogs | Noise aversion | Indication |
Product | Applicant | Ingredients |
---|---|---|
Dexdomitor | Orion Corp. | 1 |
SILEO | Orion Corp. | 1 |
Dexmedesed | Dechra Veterinary Products LLC | 1 |
Dexmedetomidine Hydrochloride Injection | Akorn Animal Health Inc. | 1 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 13.36 | acidic |
pKa2 | 6.76 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | PRECEDEX | HOSPIRA | N021038 | March 13, 2013 | RX | INJECTABLE | INJECTION | 8455527 | Jan. 4, 2032 | USE FOR SEDATION |
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | PRECEDEX | HOSPIRA | N021038 | March 13, 2013 | RX | INJECTABLE | INJECTION | 8455527 | Jan. 4, 2032 | USE FOR SEDATION |
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | PRECEDEX | HOSPIRA | N021038 | Nov. 14, 2014 | RX | INJECTABLE | INJECTION | 8455527 | Jan. 4, 2032 | USE FOR SEDATION |
EQ 0.12MG BASE | IGALMI | BIOXCEL | N215390 | April 5, 2022 | RX | FILM | BUCCAL, SUBLINGUAL | 10792246 | June 26, 2039 | ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION |
EQ 0.12MG BASE | IGALMI | BIOXCEL | N215390 | April 5, 2022 | RX | FILM | BUCCAL, SUBLINGUAL | 11497711 | June 26, 2039 | ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION |
EQ 0.12MG BASE | IGALMI | BIOXCEL | N215390 | April 5, 2022 | RX | FILM | BUCCAL, SUBLINGUAL | 11517524 | June 26, 2039 | ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION |
EQ 0.18MG BASE | IGALMI | BIOXCEL | N215390 | April 5, 2022 | RX | FILM | BUCCAL, SUBLINGUAL | 10792246 | June 26, 2039 | ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY SUBLINGUAL ADMINISTRATION |
EQ 0.18MG BASE | IGALMI | BIOXCEL | N215390 | April 5, 2022 | RX | FILM | BUCCAL, SUBLINGUAL | 11497711 | June 26, 2039 | ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION |
EQ 0.18MG BASE | IGALMI | BIOXCEL | N215390 | April 5, 2022 | RX | FILM | BUCCAL, SUBLINGUAL | 11517524 | June 26, 2039 | ACUTE TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I OR II DISORDER BY BUCCAL ADMINISTRATION |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 0.12MG BASE | IGALMI | BIOXCEL | N215390 | April 5, 2022 | RX | FILM | BUCCAL, SUBLINGUAL | April 5, 2025 | NEW PRODUCT |
EQ 0.18MG BASE | IGALMI | BIOXCEL | N215390 | April 5, 2022 | RX | FILM | BUCCAL, SUBLINGUAL | April 5, 2025 | NEW PRODUCT |
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | PRECEDEX | HOSPIRA | N021038 | Jan. 31, 2020 | RX | INJECTABLE | INJECTION | Dec. 16, 2025 | NEW PATIENT POPULATION |
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | PRECEDEX | HOSPIRA | N021038 | Dec. 17, 1999 | RX | INJECTABLE | INJECTION | Dec. 16, 2025 | NEW PATIENT POPULATION |
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | PRECEDEX | HOSPIRA | N021038 | March 13, 2013 | RX | INJECTABLE | INJECTION | Dec. 16, 2025 | NEW PATIENT POPULATION |
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | PRECEDEX | HOSPIRA | N021038 | March 13, 2013 | RX | INJECTABLE | INJECTION | Dec. 16, 2025 | NEW PATIENT POPULATION |
EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | PRECEDEX | HOSPIRA | N021038 | Nov. 14, 2014 | RX | INJECTABLE | INJECTION | Dec. 16, 2025 | NEW PATIENT POPULATION |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Alpha-2B adrenergic receptor | GPCR | AGONIST | Ki | 9.70 | IUPHAR | CHEMBL | |||
Alpha-2C adrenergic receptor | GPCR | AGONIST | Ki | 9.30 | IUPHAR | CHEMBL | |||
Alpha-2A adrenergic receptor | GPCR | AGONIST | EC50 | 8.82 | CHEMBL | CHEMBL | |||
Alpha-1B adrenergic receptor | GPCR | Ki | 6.50 | PDSP | |||||
Alpha-1A adrenergic receptor | GPCR | Ki | 6.70 | PDSP | |||||
Alpha-1D adrenergic receptor | GPCR | Ki | 10.82 | CHEMBL | |||||
Alpha-2A adrenergic receptor | GPCR | Ki | 10.82 | CHEMBL | |||||
Alpha-1A adrenergic receptor | GPCR | EC50 | 6.42 | CHEMBL | |||||
Adrenergic receptor alpha-2 | GPCR | Ki | 10.82 | CHEMBL | |||||
Adrenergic receptor alpha-1 | GPCR | Ki | 8.30 | CHEMBL | |||||
Alpha-1B adrenergic receptor | GPCR | EC50 | 6.44 | CHEMBL |
ID | Source |
---|---|
4021214 | VUID |
N0000148660 | NUI |
D00514 | KEGG_DRUG |
145108-58-3 | SECONDARY_CAS_RN |
228054 | RXNORM |
4021214 | VANDF |
4021215 | VANDF |
C0113293 | UMLSCUI |
CHEBI:4466 | CHEBI |
CZX | PDB_CHEM_ID |
CHEMBL778 | ChEMBL_ID |
DB00633 | DRUGBANK_ID |
CHEMBL2106195 | ChEMBL_ID |
D020927 | MESH_DESCRIPTOR_UI |
5311068 | PUBCHEM_CID |
6277 | INN_ID |
521 | IUPHAR_LIGAND_ID |
67VB76HONO | UNII |
227894 | MMSL |
29394 | MMSL |
31641 | MMSL |
8598 | MMSL |
d04505 | MMSL |
008084 | NDDF |
008085 | NDDF |
116348007 | SNOMEDCT_US |
437750002 | SNOMEDCT_US |
438079000 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Dexmedetomidine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9525 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 31 sections |
Dexmedetomidine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9525 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 31 sections |
Dexmedetomidine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9526 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 31 sections |
Dexmedetomidine Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9526 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | ANDA | 31 sections |
Dexmedetomidine HCl | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9532 | INJECTION | 100 ug | INTRAVENOUS | ANDA | 30 sections |
Dexmedetomidine HCl | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9532 | INJECTION | 100 ug | INTRAVENOUS | ANDA | 30 sections |
DEXMEDETOMIDINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-9555 | INJECTION | 200 ug | INTRAVENOUS | ANDA | 32 sections |
DEXMEDETOMIDINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-9555 | INJECTION | 200 ug | INTRAVENOUS | ANDA | 32 sections |
DEXMEDETOMIDINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-9555 | INJECTION | 200 ug | INTRAVENOUS | ANDA | 32 sections |
DEXMEDETOMIDINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-9557 | INJECTION | 400 ug | INTRAVENOUS | ANDA | 32 sections |
DEXMEDETOMIDINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-9557 | INJECTION | 400 ug | INTRAVENOUS | ANDA | 32 sections |
DEXMEDETOMIDINE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0338-9557 | INJECTION | 400 ug | INTRAVENOUS | ANDA | 32 sections |
PRECEDEX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9938 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | NDA | 18 sections |
PRECEDEX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9938 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | NDA | 18 sections |
PRECEDEX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0404-9938 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | NDA | 18 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-0155 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 31 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1174 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 37 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1174 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 37 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1174 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 37 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1434 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 36 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1434 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 36 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1434 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 36 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1434 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 36 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1454 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 37 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1454 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 37 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1454 | INJECTION, SOLUTION | 4 ug | INTRAVENOUS | NDA | 37 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1638 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | NDA | 36 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1638 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | NDA | 36 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1638 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | NDA | 36 sections |
Precedex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0409-1638 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | NDA | 36 sections |